EPA Registration Jacket 87650‐1
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75-DIiY Leiters 

s: 8752515'2412010; NewR&!,}istration; 

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Tracking 

Create Resubmission 

FFS Letters 

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6
Memorandum 

Date: uS / 2£!: / I V 

To: ____ -'-f~'---i ',---,--,I u"-----___ , Regulatory Manager 

From: Information Services Branch, ITRMD 

Your receipt of this data submission is not an 

indication that MRIDs for the enclosed studies have 

been posted to OPPIN. 

"k " 

We " expect that it will be approximately 5 days 

---from the above date before the study-level data is 

available in OPPIN. 

If you have any questions about this process, 

please contact Teresa Downs (305-5363). 

This is a: ;n fully accepted submission 

D partially accepted submission 

D rejected submission 

7
'" IFee for Servicel (87 2518-

This package includes the following 

@ New Registration 

°Amendment 

for Division 

OAD 

OBPPD 

@RD 

l 

I 

I 

, 0Studies? o Fee Waiver? 

t 0 vol pay % 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: $ I'll I ~LP·UO 

Iilll Inert Clea;ed for Intended Use 

Reviewer: Y&LLuJ.. ~l" Remarks: 

Uncleared Inert in Product 

Date: <512(" /1 0 

8
" Script for RejectioJ!, Phone ""'-

Contact Name: f()Orns()(l I fuGLt\\.tV 

Phone #: Q Q9 - ~,;) ~ - ~Cj 'f 5 

Email: hqjorn3on@tS'GUbO.0)cN 

First CaIlJInitials: Second Call1Initials: 

Date: DiD /01 0(' 105 

Time: /0: 5/ Grf\. q:(J',)Qrn 

Date: O~ /01 -t (('00; ltd 

Time: lo,oOo.m 

os I{)~ 

€JT\1~ Cud __ 

i- , This is f(Y\O \ 'lcd , EPA contractor. NI) 'f,€YI\{ 

t mr~ Ilg'1iSTro.f't I'm calling regarding your submission in support of J 

Bp05Ylil TrohOiCaJ., 

We have found the following deficiencies regarding: 

PR Notice 86.5: Yes or No 

Volume/Study Title: 

Volume/Study Title: 

Volume/Study Title: 

Additional volumes continued on back of page: Yes or No 

Application Package: Yes or No 

d(kta. lIl::i.1Yiy -I? CJk-cwflUcl ruje({nclft ~ eI.J.ideU!'1L fn~ o.lSD!\Ud, 0'u.lomiJl(VJ 10 wfor>? ha.\YU<submltcd. (d)f(lftIJ ro-.r 

GncL /viRID Or Cll0w..t 

These deficiencies have been approved by EPA. 

The corrections can be faxed to 703-305-50601 Attn: _______ . 

Second CaIIJEmaiI: 

I{we do not receive the' corrections by , we will process 

your submission, accordingIy. Please direct all future calls and 

correspondence to the appropriate EPA Risk Manager. 

9
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 the product Fipronil Technical I have also made several attempts to reach you at 

202-828~8945. Please be aware that this is a time sensitive process. 

Please send the corrections at your earliest convenience, 

In the Data Matrix (EPA Form: 8570-35), under cite all data, please specify which 

guidelines are being cited. Alsq under submitter, please add the companies to whom 

an offer to pay has been made. For the section "rvIRID number" you can either cite the 

MRID from the specific companies or write cite-all 

You can send these forms either by fax t0703-305~5060/ ATTN: Jennifer Brandon or email them 

to brandon.jennifer@&J'a.gov. 

If you have any questions or require additional infonnatio.p.please do not hesitate to contact me. 

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 

10
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 of the registration of the 

product Fipronil Technical(EPA Registration Number: 87650-NEW). We have found the 

following deficiencies regarding your submission 

In the Data Matrix (EPA Form: 8570-35), under cite all data, please specify which 

guidelines are being cited. Alsq under submitter, please add the companies to whom 

an offer to pay has been made. For the section "MRlD number" you can either cite the 

MRID from the specific companies or write cite-all 

You can send these fonns either by fax to 703-305-5060/ A TIN: Jennifer Brandon or email them 

to brandon.jennifer@epa.gov. 

If you have any questions or require additional infonnatio:pplease do not hesitate to contact me. 

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 

11
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 

12
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-- 27 -/ CJ Fee Paid: Yes y 

Division management contacted on issues No Yes Date 

EPA Reg. Number: s- 7 c;,S-O - !2 EPA Receipt Date: S--2'i-IO 

1 

2 

3 

Items for Review 

Application Form (EPA Form 8570-1)(link to form) signed & complete 

including package type 

Confidential Statement of Formula all boxes completed, form signed, and 

a) All inerts (link to http://www.epa.gov/opprdOOllinerts/), 

including fragrances, approved for the proposed uses (see 

Footnote A) 

Yes No N/A* 

x 

x 

no 

Certification with Respect to Citation of Data (EPA Form 8570-34) (Link to '\...,-

form) completed and signed (N/A if 100% repack) /\ 

Certificate and data matrix consistent 

If applicant is relying on data that are compensable, is the offer 

to pay statement included. (see Footnote B) 

If is there a letter of Authorization for exclusive use 

yes no 

4 completed and signed (N/A if source is unregistered or 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 of Label (link to http://www.epa.gov/oppfeadlllabeling/lrmD 

6 (Electronic labels on CD are encouraged and guidance is available)(Iink to X 

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

I 

13
7 Is the data package consistent with PR Notice 86-5 (link to PRN 86-5) X 

Notice of Filing (link to 

8 httJ!:llwww . cI!a.g ov/nesticides/regula tinel tolerance Qetitions.htm) included 

with petitions (link to X--

http://www.epa.gov/pesticides/regulating/tolerances.htm) 

9 If applicable for conventional applications, reduced risk rationale (link to 

http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) !x 

Required Data (link to 

htt!!:/ /www.cl!a.gov/(!esticides/regulatiog!dafa reguirements.htm) and/or 

data waivers. See Footnote C. 

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

10 

2 

14
Comments: 

Ci TD::l i e s poss(ci ~70 - 5 laJJ i 0-,,) 

T(Chf\iCO-t 001 imp)JJ.' i\Qh O[1iJ{ * 0.0,'-10... n\~ iY': X r n CXn,yU tu ~c}.f'.~tf tI i-G (J;Ll >.Steti (Jp$ 

((ecll{) lonnlJ.'C rC3iSTP10\:. "(")CO. I rN}) 'W/no fepl,! 

CQUJv \JJi'.1 mCleU. 01.,,/01 ,()Ip/!)S, 0(0/07 ,00rJ (Jfeth:: rJi(uoC\.(W WU'." 

f\t t\JJ\ N.d = 

'€J'f'o.il.:7 U)(IL SCf'·t Dip/OJ _ 0(:'/01 and 0(,10"7 ,nO(lr of thGemo.;b Uf)'J.· 

'f( j"'.J'f nJd e d-rd 0( .. 

(]0 

oro I'}Y; 

* NlA - Not Applicable 

Footnotes 

A. During the 21 day initial content review, all CSFs will be reviewed to determine 

whether all inerts listed, including fragrances, are approved for the proposed useS. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

documentation that EPA approved the inert for the proposed pesticidal uses, correcting 

mistakes on the CSF, etc. or 2) provide the data to support OPP approval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

CSF and may require submission of data. All infonnation, forms, data and 

documentation resolving the inert issue must have been received by the Agency or the 

application withdrawn within the 21 day period, otherwise. the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 21 day initial content screen, applicants are 

strongly encouraged to verify that all inert ingredients have been approved for the 

application's uses even if a prod uct is currently registered by consulting the inert Web 

3 

15
site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to submitting an application 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicant should contact the Inert Ingredient Assessment 

Branch (IIAB) at inertsbranch@epa.govandresolvethe issue. Copies ofthe 

correspondence with lIAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by lIAR. The lIAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm]. 

"When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional infonnation such as an alternate name of the inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOl/inertsftips.pdf] must also be included 

to enable the Agency to detennine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21-day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit information to the individual 

identified by the Agency when the applicant is informed of an unapproved inert. 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSF, the Agency will contact the 

applicant with the following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert If this option is selected and implemented, the Agency may 

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 

16
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant -within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

Ifnone of the above options is selected and implemented during the 2 I-day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

1. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 

17
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

Ifnone of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R30 1 or 

A53 L The Agency recommends that authorizations of offers to pay be submitted with 

other PRlA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to SUbmitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 

18
in the 

7 

19
Material to be added to an e-Jacket/Jacket 

Reg. No. 87650-1 

Description:_N_e_W_Re_9i_s',_a'_ion_, ----------------

1. D Placement within 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 contractors this material: 

[ZJ Newly stamped accepted label 

D 

D 

D 

Notification 

NewCSF 

Other: 

3. Attach thiscoversheet to the top of the material or jacket. It 

must be well organized and clipped together, NOT STAPLED. 

Then give the material with this coversheet to staff in the 

Information Services Center (Room S-4900). 

Richard Gebken Reviewer's Name: ____________ _ 

Phone: 305-6701 Division: ROIIB 

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

Date: January 5, 2011 

20
. ~\1~0 ST..qJ: ., u.s. ENVIRONMENTAL PROTECTION AGENCY EPA Reg. Number: Date of Issuance: ;' ft ''b Office of Pesticide Programs 

~~~ Registration Division (7505C) JAN -.5 2011 '\ ~<{ 87650-1 

'" 0 

1200 Pennsylvania Ave., 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}: 

Fipronext Solutions, Inc. 

3259 Harvey Court 

Pleasanton, CA 94587 

> .. :' •. •• : •. :: •. :.' • ". 

I>'0te: c::J}apges ~:Iabeli,!(ditf?,~"g in ,'sub . 

I 

'starii:'e,uom:,ti),at accePted:iri'ConneCtio~,with this registration must be submftted to ani accepted by the Registration Division prior'to'use of the label in 

'eonllnet:Ce':': Inany'corresp,ondence)n 'thIs prOduct always refcr.to the above EPA registration'number. . . • ••• 

On the basis of information furnished by the registrant, the above named pesticide is hereby registcred/reregistered under the Federal Insecticide, Fungicide 

and Rodenticide Act. 

Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In order to protect health and the 

environment, the Administrator, on his motion, may at any time suspend or cancel the registration of a pesticide in accordance with the Act. The acccptance 

of any name in connection with the registration ofa product under this Act is not to be construed as giving the registrant a right to exclusive use of the name 

or to its use if it has been covered by others. 

This product is conditionally registered in accordance with FIFRA section 3(c)(7)(A) provided 

that you: 

L Submit and/or cite all data required for registration of your product under FIFRA sec 3(c)(5) 

when the Agency requires all registrants of similar products to submit such data; and submit 

acceptable responses required for reregistration of your product under FIFRA section 4. 

(continued on page 2) 

Signaturc of Approving Officinl: Datc: 

~ p,,-S"-' 0 

Richard J. Gebken, Product Manager (10) 

Insecticide Branch, Registration Division (7505P) 

EPA l'onn 3570 . 6 

Page 1 of2 

21
2. Make the following change to the label: 

a. Change the product registration number to "EPA Reg. No. 87650-1" 

3. Product Chemistry: 

a. Within 12 months of the date of this Notice of Registration, you must submit acceptable 

Storage Stability (guideline 830.6317) and Corrosion Characteristic data (guideline 

830.6320) to the Agency for review and approvaL 

4. Submit two copies of the revised final printed label for the record before the product is released 

for shipment. 

If these conditions are not complied with, the registration will be subject to cancellation in 

accordance with FIFRA section 6(e). Your release for shipment of the product constitutes 

acceptance of these conditions. 

A stamped copy of the label is enclosed for your records. 

Richard J. Gebken 

Product Manager (10) 

Insecticide Branch 

Registration Division (7505P) 

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

Page 2 of2 

22
Fipronext 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: 

Fi pronil: [5-am ino-1-(2 ,6-dichloro-4-(trifluoromethyl) 

Page 1 of 4 

phenyl)-4-( (1 ,R, S)-trifluoromethyl)sulfinyl)-1-H-pyrazole-3-ca rbonitrile 

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, (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: 44 Ibs (20 Kg) 

Manufactured for: 

Fipronext Solutions, Inc. 

3259 Harvey Court, 

Pleasanton, CA 94588 

ACCEPTED 

with COMMENTS 

In EPA Letter Dated 

Under ~~ Fe§er~11nsectictde. Fungtc1de. and Rodenticide Act. as amended. for the pe~UcJde 

regist) bSb E!t Reg. No_ 

23
Fipronext Fipronil Technical label version (3) dated January 3, 2011 Page20f4 

FIRST AID 

IF SWALLOWED Immediately call poison control center or doctor for treatment 

advice. 

Do not induce vomITing unless told to do so by a poison control 

center or doctor. 

Have person sip a glass of water if able 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 of water for 15~20 minutes. 

Call a poison control center or doctor for treatment advice. 

IF INHALED Move person to fresh air. 

If person is not breathing, call 911 or an ambulance, then give 

artificial respiration, preferably by mouth~to-mouth if possible. 

Call a poison control center or doctor for 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 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 

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 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 

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 dust/mist 

filtering respirator (MSHNNIOSH approval number prefix TC-21Cj, or a NIOSH approved 

respirator with 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 other waters unless in 

accordance with the requirements of a National Pollutant Discharge Elimination System 

(NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do 

not discharge effluent containing this product to sewer systems without previously notifying the 

24
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 of the EPA. 

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. 

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 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. Improper disposal of excess pesticide is a violation of 

Federal law. If these wastes cannot be disposed of by use according to label instructions, contact 

your State 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 of smoke. 

25
Fipronext Fipronil Technical label version (3) dated January 3, 2011 Page 4 of 4 

IMPORTANT: READ BEFORE USE 

Read the entire Directions for Use, Disclaimer of Warranties and Limitations of Liability before 

using this product. If terms are not acceptable, return the unopened product container at once. 

By using this product, user or buyer accepts the following Disclaimer of Warranties and 

Limitations of Liability. 

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: 

26
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 703-605-0653 

27
DP#: (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 Sent for Review * * * 

A. Unpublished 

Inc. 165 p. 

Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared by Technology 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/Stability to 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 by Technology 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 by Technology Sciences Group, 

Inc. 165 p. 

Brookman, D. (2010) Technical Fipronil; Product Properties Group 830.1670lDiscussion of formation 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 of Technical 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 PTRL West, 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 by Technology 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 by Technology 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 of pH and UV Spectrum. Project Number: 1986W. 

Unpublished study prepared by PTRL West, Inc. 52 p. 

830.70501UVNisible absorption 

28
Page 2 

DP#: (383876) • * • Studies Sent for Review·· * Decision#: (434093) 

29
/ 

! 

I 

Date: December 1,2010 

SUBJECT:FEE. Product Chemistry Review of Fipron1h 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 D VV" 

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 OF FINDINGS: 

1. The registrant has submitted a Confidential Statement of Fonnula for a basic fonnulation (dated 5/2112010) of 

Fipronil Technical. The nominal concentrations of the 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 to guideline 830.1550 (product identity & composition) satisfy 

the requirements of 40CFR§ 158.155 [MRlD No. 481040-0 I]. 

2. The product chemistry data submitted corresponding to guideline 830.1750 (certified limits) satisfy the data 

requirements of 40CFR§ 158.175 [MRlO 481040-01]. 

3. The product chemistry data submitted corresponding to guideline reference 830.1600 (description of materials 

used to produce the product) do not satisfy the data requirements of 40CFR§ 158.160 [MRlO No. 481040-01]. 

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

process) satisfy the data requirements for 40CFR§158.162 [MRIO No. 481040-01]. 

5. The product chemistry data submitted corresponding to guideline reference 830.1670 (discussion on the 

formation of impurities) 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 of 40CFR§158.170 [MRIO No. 481040-01]. 

30
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 of 40CFR§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 of 40CFR§ 158.190. Data gaps were identified for oxidation/reduction:chemical 

incompatibility, storage stability, and corrosion characteristics [MRID Nos. 481040-02 and 481040-02]. 

2 

31
BARCODE: 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). The product chemistry data submitted corresponding to guidelines for 830 Series group A are acceptable, 

with the fonowing exceptions: a) there is a discrepancy between the eSF and product label concerning the 

nomi.nal concentration of active ingredient in the product, b) the product label should use the tenn 2.0% 

"other ingredients" rather than "inert ingredients," and an MSDS was not provided for one of the 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 corrosion characteristics. 

3) TRB does not object to the conditional registration of this product provided that the group B data gaps will 

be fulfilled (comment 2, above) and the label amended per comments in 1, above so that the nominal 

concentration on the label match the nominal concentration on the eSF. 

3 

32
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]~ 

(IUP AC): 5~amino·1-[2,6~dich loro~4~( trifluoromethy I)pheny I H-( I ,R,S H tri fluoromethy Isulfiny 0- 1 Hpyrazole-3-carbonitri Ie 

CAS No.: 120068-37-3 

PC Code No.: 129121 

Molecular Weight: 437.2 

Structural formula: 

4 

33
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 of the impurities add to 

1.5% on the CSF, but the total is given as 2.0%, on 

the product 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 of the five· 

progress 

5 

34

*Manufacturing process information may be entitled to confidential treatment*
BARCODE: 0383876; Reg. No./FILE SYMBOL No.: 87650-R; PRODUCT: Fipronil Technical 

830 S enes S b uogroup B(Ph ystca . ICh . IP - 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 '" Not Applicable; G = Data gap; I = In progress or need upgrade; U = Up-grade 

(additional information required); W '" waivers 

6 

35
BARCODE: 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 for the detennination of levels of fipronil in Technical Fipronil. 

The method is applicable for fipronillevels 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 of fipronil, 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 or equivalent. 

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. Of known 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 if necessary 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 

volumetric flask. Bring lhe flask to volume with dilution solvent, and mix its contents by 

inversion. 

7 

36
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 of Test Substance 

(Technical Fipronif) into a 1 OO-mL volumetric flask. Add about 85 mL methanol to 

dissolve the material, cool the solution if necessary to room temperature, and then 

bring the flask to volume with methanol phase. Mixthe contents of the 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 

Detector wavelength: 

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 % TF A 

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. 

8 

37
BARCODE: D383876; Reg. No./FllE SYMBOL No.: 87650-R; PRODUCT: Fipronil Technical 

8 Chromatography 

Make replicate injections of the Calibrant until the areas of successive injections differ 

by less than 1.2 %. Then make injections in the following sequence: Calibrant, Solution 

C, Solution C, Calibrant. Record the area of the 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. 1 to 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 

38
Pages 39 through 58 contains the description of the product manufacturing process and is not included in this copy.
DATA EVALUATION RECORD 

FIPRONIL 

(Fipronil Technical) 

STUDY TYPES: Product Identity and Composition (OPPTS 830.1550) 

Primary Reviewer: 

Eric B. Lewis, M.S. 

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

Description oftbe Production Process (OPPTS 830.1620) 

Discussion of Formation ofImpurities (OPPTS 830.1670) 

Preliminary Analysis (OPPTS 830.1700) 

Certified Limits (OPPTS 830.1750) 

Enforcement Analytical Method (OPPTS 830.1800) 

Physical and Chemical Characteristics (OPPTS 830.6302-830.7950) 

MRIDs 481040-01 through 481040-04 

Prepared for 

Registration Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Prepared by 

Toxicology and Hazard Assessment Group 

Environmental Sciences Division 

Oak Ridge National Laboratory 

Oak Ridge. TN 37831 

Task Order No. I-58 

Signature: 

Date: 

Secondary Reviewers: 

Sylvia Milanez. 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 subsequent to the contractor's signatures above. 

Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC., for the U.S. Department of Lt.tXgy 

under Contract No. DE-AC05-000R22725. 

59
FIPRONIL TECHNICAL 

For Manufacturing Use Only 

ACTIVE INGREDIENT: 

F ipronil: 5-a mi no-1-(2, 6-d i ch loro-4-(trifl uorome thyl) phenyl) -4-( (1 ,R, S HrifluoromethyJ )sulfi nyl) 

-1-H-pyrazole-3-carbonitrile ......................................................................... 98.0% 

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

1'-- "'. ____ 

. ................ 2.0% 

"", ~!/: ftSiriT AL ................................................................................ . 

(/ ~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 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 

"" , , , , > 

" . 

", , ,', , 

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

Page 1 of 4 

, , 

, 

"" , 

60
IF i I call poison control center or doctor treatment 

advice. 

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

center or doctor. 

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

of water 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 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 goggl es, 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 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 of the EPA. 

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

Page 2 of4 

61
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 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 

Store unused product in original container only. out of reach of children 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 accor ding 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 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. 

CONT AINER 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, 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, Disclaimer of Warranties and Limitations of Liability before 

using this product. If terms are not acceptable, return the unopened product container at once. 

By using this product, user or buyer accepts the following Disclaimer of Warranties and 

Limitations of Liability. 

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

Page 3 of4 

62
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 Fipronex! 

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 of4 

63
WASHINGTON 

II SO 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 

I nsecticide 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 argument for 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 of this 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 of the proposed label, 

6) Volumes 1 - 6 (refer to the transmittal document for 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 directly with any questions. 

Sincerely, 

Heather 

Ccb.J~_+iA.t... R. Bjornson /< ?S ~ 

Regulatory Consultant to Fipronext Solutions, Inc. 

Direct dial: (202) 828·8945 

e·mail: hbjornson@tsgusa.com 

64
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 STUDY TITLE 

1 of 6 

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 

65
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 2 012 

66
Technology 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 IPRIA 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: Fipronll Technical [87550-R] 

Dear Mr. Schaible: 

As agenttor, and on behalf of Fipronext Solutions Inc., I am writing to you following 

receipt of an e-mail from Bonaventure Akinlosotu indicating that Team #10 has asked 

you to consult on the request of Fipronext to have the PRIA category of their 

application to register Fipronil Technical [87550-R] changed back from R330 to 

originally submitted R310. 

Given the critical nature of this 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 of the 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 a single 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 PRIA fee had been 

prepaid. That payment was 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 of the application decided to reclassify 

67
( 

Stephen Schaiblo 

Flpronext Solutions Inc" leUer of October 7, 2010 

Page 2. 

the application as R330. The submitter chaUenged this, however the communications 

with Linda Arrington were conducted over the telephone and the reasons for the 

reclassification were not clear. It was not until after my meeting with Richard Gebken 

and SA on September 23 that the reason became clear - there was a clerical error on 

the EPA form 8670-34 where the "selective cite-aU" box was checked instead of the 

"cite-aU" box. While the ''wrong box checked" is an admitted administrative error by the 

submitter, it is Important to note that through the Front End review, which is designed to 

provide an administrative review of the application for completeness and formatting, the 

Agency ignored or missed that (a) the submitter was submitting a R310 application 

[stated in the cover letter and 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 

consistent with a cite-aU application, and accepted the "selective cite-aU" 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 classffication. 

We now come to realize that aU of work that went into the resubmission of a new data 

matrix and label restricting the use-sites in August 2010 and aU of the work to establish 

R310 classification could have been avoided had someone on the classification 

committee or the Front End Screen noticed the discrepancies and made a phone call to 

the submitter for clarification. It is our firm 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 of this matter would 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 so we can only surmise that the clerical error 

on the data certification box is the reason for the 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 of the 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 Fipronext would be 

willing to accept January 14, 2011 as a firm PRIA date for the approval this registration. 

Sincerely, . 

-y..wv..W~V~ 

68
F1PRONEXT TECHNICAL APPLICATlONS 

lain Weatherston 

to: 

Richard Gebken 

1lI0S/20 10 06:42 PM 

Cc: 

ItJibing Lin" 

Show Details 

Richard: 

Page 1 of 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 to what we had to say, asked a lot of quesfrons and said that he would look 'Into our concerns whkh, if 

we have portrayed accurately, he believes that there is probably some relief that he can bring to the situations. 

He advised us not to cancel just yet the scheduled meeting with Lois which is due to take place on November 22. 

Regarding the Fipronext Solutions Technical Firpronil application and understanding the delays caused by both 

parties due to the R330 vs R310 issues, and although he has yet to speak with his chemistry reviewers, he said 

that my proposed PRIA date was reasonable. He also indicated to get the ball rolling I should 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 notwithstanding the potential 

issues which you raised concerning purity of the fipronil and the identity and toxicity of its impurities which we 

addressed with Dan. 

The next step regarding this and the LoradoChem CRP issues is that Dan and I will have another conversation 

next Wednesday by which time he will have spoken to the chemists and also to Roz and we may be in a position 

to chart a definitive course to the two approvals. 

Best regards, 

lain 

file:IIC:lDocurnents and SettingslrgebkenlLoca1 SettingsITemp\notesFCBCEEI-web726l... 11122/2010 

69
.,; ;;;>:':. ~ ""~. 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 Identity and Compos~ion i 48104001 Fipronext Solutions, tnc. OWN 

I 48104001 Fipronext Solulions, Inc. 

OPPTS 830.1600 Description of Starting Materials OWN 

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

OPPTS 830.1670 Discussion of the Formation of Impurities 

48104001 Flpronext Solutions, Inc, OWN 

OPPTS 830.1700 Preliminary AnalYS'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 ; " " o • foj),l:0rjfxj;Sotulions, Inc. OWN . , . - - . OPPTS 830,7000 pH 48104003 Fipronexl Solutions, Inc. OWN 

Signature . . ~ .. "" Name and Title 

~,!Zq~ . . · · Date .o, o, · - Healher R. Bjornson, RegUlatoryConsuliant August 19, 2010 . . · .. · · .-,.,A .-_ ,,,, ... ,,..,,, m " ... , .-. __ , ___ ,_ - _.,., p, -- ". ""r~i""c ""~il,,hIQ "'.,h~;. n"h, O~n~ ••• nr~:n~ ---~--"-- IyPap Agency Internal Use Copy 

70
Form 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 of information 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 UVNisible Absorption 

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 

lyPaper versi 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 Copy 

71
Form Approved OMS 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 of information is estimated to average 0.25 hours per response or registration activities and 0.25 hours per response br 

reregistration and special review activities, 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 of 4 -.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 Oral Toxicity - 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 · . · ~ ~ " ~ · . eo " ~ ~ ~ " "' ~ Hoather R. Bjornson, RegulatoryConsultant August 19, 2010 . ~ ~ " ~ · -- - . . . . 

72
,r~'\, '.\ ""'" f \,,~,?~,.-

Form Approved (XIIIB 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 ror this collection of information 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, RegulatoryConsultant 

73
WASHINGTON 

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 956 t6 

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 

ItCH NO lOGY" 

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 

74
FlpraDell SolDUoDS IDC. 

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. 

If you have any questions concerning this letter, please feel free to contact Mr. 

Abramson directly. Thank you. 

Sincerely yours, " ., 

Dr. Jibing Un 

Chief Executive Officer 

cc; Stanley H. Abramson, Esq. 

75
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 

Organizalion: "R~D~/~T~R~B _______ _ Lasl Possible SCience Due Dale: 20-Jan-2011 / 

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 703-605-0653 

76
D?#: (383877) 

48104005 

48104005 

48104005 

48t04005 

48104005 

4810400S 

Page 2 

* ~ * Studies Sent for 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. 

77
FIPRONIL TECHNICAL 

For Manufacturing Use Only 

ACTIVE INGREDIENT: 

F i pronil: SHami no-1-(2, 6-dichJoro-4-(trifl uoromethy J) phenyl) A-( (1 ,R, S )-trifJ uo romethyJ) 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 > , "" , 

78
FIRST AID 

IF SWALLOWED Immediately call poison control center or doctor for 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 not give 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. 

If person 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 doctor for 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 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 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 goggl es, 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 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 of the EPA. 

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

Page 2 of4 

79
DIRECTIONS FOR USE 

It is a violation of Jaw 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 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 of children and animals. 

PESTICIDE DISPOSAL 

Pesticide wastes are acutely hazardous. Improper disposal of excess pestic'ide is a violation of 

Federal law. If these wastes cannot be disposed of by use accor ding 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 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 of Warranties and Limitations of Liability before 

using this product. If terms are not acceptable, return the unopened product container at once. 

By using this product, user or buyer accepts the following Disclaimer of Warranties and 

Limitations of Liability. 

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

Page 30f4 

80
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 

81
Pages 82 through 85 contains the product confidential statement of formula and is not included in this copy.
ZZillEC/ZOlO 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Subject: Name of Pesticide 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 / ?/~ l' / {} , Technical Review Branch CTRB) t~ 

Registration Division (7505P) T "-=- L-<-~ - r""c,[. ry 

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% 

86
Fipronil (PC Code 129121) 

EPA File Symbol 87650-R, FIPRONIL TECHNICAL 

ACTION REQUESTED: The Risk Manager requests: "For you review: MRlD No. 48104005 

(Rationale for request to bridge data) for an R31O." 

BACKGROUND: Fipronext Solutions Inc. has submitted a Basic Formulation CSF dated 

October 20, 2010, a bridging argument for toxicity data (MRlD 48104005) and a proposed label 

to support the registration ofFIPRONIL TECHNICAL, EPA File Symbol 87650-R. The 

registrant is claiming 87650-R is 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 of data support to satisfy the acute toxicity data requirements. 

The following is from MRID 48104005; "Bridging Argument to support application of toxicity 

data for registered fipronil TGAI (96%) to Fipronil Technical (98.5%)" 

Fipronil Teclmical (98.5% a.i.) produced by Fipronex Solutions, Inc. is expected to be 

sufficiently similar in toxicity profile to currently registered fipronil technical grade active 

ingredients (TGAls) that the toxicity data generated to support these TGAls are 

representative of Fipronil Technical. The fipronil TGAIs registered by BASF (7969-243) 

and Bayer (432-1478) are both 96% a.i., as represented on the labels. The new Fipronex 

Fipronil Technical contains 2.6% more ofthe a.i. on a per weight basis than the other two 

TGAIs cited. 

Acute Toxicity 

The 2.6% higher a.i.level in the new Fipronil Technical than is in the currently registered 

fipronil TGAIs is too small to have a significant impact the results of the acute toxicity 

studies, or alter the Toxicity Categories identified for the product by EPA for labeling 

purposes. The reported results from the acute toxicity studies conducted on the currently 

registered fipronil TGAIs are presented in Table 1 along with the corresponding Toxicity 

Categories (data from: FR 62, No 119, 1997). A small increase in Fipronil Teclmical toxicity 

corresponding to the 2.6% increase in a.i., could alter the numerical results of the toxicity 

studies slightly, but would 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. The range of doses that encompass Toxicity Category II is >50 to 500 mglkg. A 

2.6% increase in a.i. dose is unlikely to decrease the LD50 from 97 mglkg to 50 mg/kg or 

less, which would be necessary to decrease the Toxicity Category. Thus, for labeling 

purposes, Fipronil Technical would be Toxicity Category II for acute oral exposure. This 

same pattern holds true for the other acute endpoints offipronil toxicity, such that all routes 

of exposure would still be classified as Category II or higher, even if the slight increase in a.i. 

in Fipronil Technical resulted in a small increase in acute toxicity. Similarly, fipronil TGAI 

was not a sensitizing agent, and a 2.6% increase in a.i. in Fipronil Technical would not 

change that outcome. 

Page 2 of4 

87
Fipronil (PC Code 129121) 

EPA File Symbol 87650-R, FIPRONIL TECHNICAL 

Table 1. Results from acute toxicity studies on currently registered fipronil TGAIs (FR 

62 , No 119 , 1997) 

Study Fipronil TGAI 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 

Rabbit Eye Irritation Moderate; clear in 14 II Clear in 8-21 days 

days 

Dermal Sensitization Not a sensitizer 

COMMENTS AND RECOMMENDATIONS: 

], TRE has compared the 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 searching the OPP electronic databases, TRB was unable to verify all of the acute 

toxicity study results provided in Table 1 by the Registrant. However, TRB was able to locate 

two documents that contained identical acute toxicity profiles for technical Fipronil (M. Copley; 

Fipronil: Third Reevaluation - Report of the Hazard Identification Assessment Review 

Committee; Health Effects Division; 061DEC/2000 and D, Drew; D360652; Fipronil: Human 

Health Risk Assessment Petition to Support and Maintain the 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 toxicity profile for FIPRONIL TECHNICAL, EPA File Symbol 87650-R is as 

follows: 

Acute oral toxicity 

Acute dennal toxicity 

Acute inhalation toxicity 

Primary eye irritation 

Primary skin irritation 

Dennal sensitization 

II 

II 

II 

III 

IV 

Negative 

4. Based on the toxicity profile above, the following are the precautionary and first aid 

statements for this product as obtained from the Label Review System: 

PRODUCT ID #: 087650-00001 

PRODUCT NAME: FIPRONIL TECHNICAL 

PRECAUTIONARY STATEMENTS 

SIGNAL WORD: WARNING 

Page30f4 

88
Fipronil (PC Code 129121) 

EPA File Symbol 87650.R, FIPRONIL TECHNlCAL 

Hazards to Humans and Domestic Animals: 

May be fatal if absorbed through skin. May be fatal if inhaled. May be fatal if swallowed. 

Causes moderate eye irritation. Do not get in eyes, on skin, or on clothing. Wash thoroughly 

with soap and water after handling and before eating, drinking, chewing gum,. using tobacco or 

using the toilet. Wear long-sleeved shirt and long pants, socks, chemical-resistant footwear, and 

gloves. Remove and wash contaminated clothing before reuse. Do not breathe dust. Avoid 

contact with eyes or clothing. [Wear protective eyewear.J* 

* [Protective eyewear may be specified, if appropriate.} 

First Aid: 

If on skin: Take off contaminated clothing. Rinse skin immediately with plenty of water for 15-

20 minutes. Call a poison control center or doctor for treatment advice. 

If inhaled: Move the person to fresh air. If person is not breathing, call 911 or an ambulance, 

then give artificial respiration, preferably mouth-to-mouth ifpossible. Call a 'poison control 

center or doctor for further treatment advice. 

If swallowed: Call a poison control center or doctor immediately for treatment advice. Have 

person sip a glass of water if able to swallow. Do not induce vomiting unless told to by a poison 

control center or doctor. Do not give anything to an unconscious person. 

Ifin 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 doctor for treatment advice. 

Have the product container or label with you when calling a poison control center or doctor or 

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

information. 

5. In addition, TRB noted that the registrant has included additional Precautionary statements. 

TRB finds this additional labeling information acceptable. 

6. The Basic Formulation CSF dated October 20,2010 for the proposed technical product should 

also be reviewed and accepted by the TRE Product Chemistry Team 

7. This memorandum pertains only to the decision concerning whether the subject product is 

similar to the cited product from an acute toxicological view point. For the purposes of this 

action, TRB has made no further determination of the adequacy of the toxicological database or 

the precautionary label of the cited product. 

Page 4 of 4 

89
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(5l UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C, 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours 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 necessary forms. Send comments regarding the burden estimate or any other aspect of this collect1on of 

intormalion, includIng suggestions for reducing the burden to: Direclor. OPPE information Management Dlvision (2137). U.S. Environmenlal Prolection Agency. 401 M Street. S.W., Washing lon, 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 of production process this submission Raymat Materials Inc. PER see LOA 

830.1670 Discussion offormation ofimpurllies Ihis submission Raymat Materials Inc. PER see LOA 

830.1700 Preliminary analysis 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 i 10120/2010 

EPA Form 8570-35 (9-97) I clronic and Paper versions avellable. Submll only Paper version. Agency Internal Use Copy 

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i{' 1 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 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 of this 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, CA 94587 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 ( • 

~:>~ Name and Tirte Date 

i't lain Weatherston Senior Regulatory Consultant 10/20/2010 

EPA Form 8570-35 (9-97) Electro nlijlnd Paper versions available. Submit only Peper version. Agency tntemal Use Copy 

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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 of this 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 I Page 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 BY THE 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 Chemin ova NS t600 Wilson 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. 45 t5 Falls of Neuse Rd., Suite 300, Rateigh NC 27609 

53883 Control Solution Inc., 427 HideAway Circle, Cub Run KY 42729 

54072 / b" Fort Worth TX 76162 

Signature 

~ .. \:::--. ~. V""-- Name and Title Date 

,\ lain Weatherston Senior Regutatory Consultant 10/20/2010 

EPA Form 8570-35 (9-97) Elactronic :l\}d'\Paper versions available. Submit only Paper version. Agency tnternat Use- Copy 

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~"'l UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

~ 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

--- -- Paperwolic Reduction Act Notice: The public reporting burden forthls collection of information Is estimated to average 0.25 hours per rJLpo~e for re!,i(..liJtior. activitieJ Jild 0.25 hours per response for 

reregistration and special review actMties, Including time for reading the inslructlons and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection ot 

information, including suggestions for reducing the burden to: Director, OPPE Information ManagementOivlsion (2137). U.S. Environmental Protection Agency, 401 M Stree~ S.W., Washington, DC 20460. 00 not 

send the form to this address. 

DATA MATRIX 

Date 10/20/20tO EPA Reg No.lFite Symbol 87931-R I Page4 ~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 of Neuse Roard, Suite 300, Raleigh NC 27609 

74888 Residential Exposure Joint Venture 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 

~ - .W~~ Name and Title "''' 

tain Weatherston Senior Regulatory Consultant 10f20f2010 

EPA Fonn 8570-35 (9-97) Electronic ~1 Paper versions available. Submit onty Paper version. Agency tntermll Use Copy 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M street, S.W. 

WASHINGTON, D,C, 20460 

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

reregistration and special review activities, induding time br reading the instruc\"ions 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, 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. NoJFHe Symbol Page 1 of4 ~-~ 

87650"R 

ApPticant's/Registrant Name and Address Product Fipronext Solutions, tnc. 

3259 Harvey Court Frpronil Technical 

Pleasanton, CA 94588 

tngredient Fipronil 

Guideline Reference Number Guideline Study Name C'\ MRtD Number Submitter Status Note 

OPPTS 830.1550 Product Identity and Composition I 48104001 Fipronext Salulions, Inc. OWN 

OPPTS 830.1600 Description of Starting MaterialS 

, 48104001 Fipronext Solutions, Inc. OWN 

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

OPPTS 830. t670 Discussion of the Formation of Impurities 

48104001 Fipronext Solutions, Inc. OWN 

OPPTS 830.1700 Preliminary Analysis 48104004 FiprOnext Solutions, Inc. OWN 

48104001 Fipronext Solutions, tnc. 

:...--.-( 

OPPTS 830.1750 Certified Lim~s OWN , 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. , , o 0 0 

~ '" " " OWN o 0 , o 0 , . OPPTS 830.6313 Stability (High Temperature etc) , , , 0 $8f04,tl0~ : .... .fTJO!1fX~SOlutiOnS, Inc. OWN 0 . OPPTS 830.7000 pH 48104003 Fipronext Solutions, Inc. OWN 

Signature • • .. ~~'" Name and TltIe 

~!Z.f.5~ • 0 • • Date 

'" .0 0 Heather R. Bjornson, RegulatoryConsul\ant August 19, 2010 , - ~ - ~ 00 

· . . , -"--_---..- - """~ C"n~ ""7"."" In A..,.' ""~~'._n;~ __ '"' O_n~. ,, __ ~,~ p' nsavaitable. SubmH only Paper version Agency Internal Use Copy 

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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 of inform arion is estimated to average 025 hours per response 6r registration activifles and 0.25 hoursper response for 

reregistration and speciat review activities, including time br reading the instructions and compteting the neCESsary forms. 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 of 4 ) 

87650·R -~ 

Appllcant's/Registrant Name and Address 

Fipronext Solutions, tnc. 

3259 Harvey Court 

Pleasanton, CA 94588 

tngredient Fipronil 

Guideline Reference Number Gutdeline Study Name 

OPPTS 830.7050 UVNisible Absorption 

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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Ffproni/ Technica/ 

MRtD Number Submitter Status Note 

48104003 Fipronext Sotutions, tnc. OWN 

48104002 Flpronext Solutions, Inc, OWN 

48104002 Fipronext Solutions, Inc. OWN 

48104002 Fipronext Solutions, tnc. OWN 

48104002 Fipronext Solutions, Inc. OWN 

48104002 Fipronext Solutions, Inc, OWN 

48104002 Fipronext Sotutions, Inc. OWN 

48104002 Fipronext Solutions, Inc. OWN 

- i\ 

"CITE·ALl' See attached data submitters list PAY 

"CITE-ALL" See attached data submitters list PAY 

"CITE·All" See attached data submitters list PAY 

"ctTE·ALL" See attached data SUbmitters list PAY 

"CITE·ALL" See attached data submitters list PAY 

Name and Tttle Date 000 0 00 0 

~ " ~ H\l:&tper R. Bjomson, RegulatoryConsuttant August 19, 2010 0 o 0 0 0 o 0 0 

• ~ ~ ~ ~ .. " ~ .. 0 .. ~ ~ ~ ~. , --- - • o Agency tntemat Use Copy 

95
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Form Approved O'v'IB 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 ror this collection of information is estimated to average 0.25 hours per response or registration activities and 0.25 hours per response or 

reregistration and special reviewactivitles, inclu:iing 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 40t M Street, S.W, Washington, DC 20460. Do not 

send the form to this address. 

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,,",.~ 

(2.. i3r--- --_. -

DATA MATRIX 

MRID Number 

'CITE-ALL" 

"CITE-ALL" 

"CITE-ALL" 

"CITE-ALL" 

"CITE-ALL" 

"CITE·ALL" 

"CITE-ALL" 

"CITE-ALL" 

"CITE-ALL' 

"CITE-ALL" 

. .0' • ... • • • . . . • • • .. . • • · n ~ ~ n 

• • "' ~ " '" ~ • · . . - -

EPA Reg, No.JFile Symbol 

87650-R 

Product 

Fipronil Technical 

Submitter 

See attached dala subm'rtters fist 

See attached data submitters list 

See a\tached data submitters list 

See attached data submitters list 

See attached data submitters list 

See attached data submitters list 

Bee attached data submitters list 

See altached data submitters list 

See attaChed data submitters list 

See altached dae sLbmitters list 

• . 

Status 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

N\lm~ ~d OfiUe 

~ ~ Heat&er R. Bjornson, RegulatoryConsultant n n n " . . 

Page30f4 

Note 

Date 

August t9, 20 to 

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Form Approved 0'IiI8 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 Ihis collection of information is eslimated 10 average 0.25 hours per response flr registration activities and 0.25 hours per response or 

reregislralion and special reviewaclivities, including time or reading the instructions and compleling Ihe necessaryforms. Send comments regarding the burden or anyother aspect of Ihis collection of 

information, including suggestions br reducing the burden to: Director, (FP Information Management Division (2137)U.S. Environmenta Prolection Agency, 401 M Street, S.w., Washington, DC 20460. Do not 

send the form to Ihis address. 

DATA MATRIX 

Date August 19, 2010 Page 4 of4 ". 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 

S;g"'t~ (2.. 0} , " ' , , , , " 

" 

Product 

Frpronri Technical 

MRIO Number Submitter Status Note 

"CITE-ALL" See allached data submillers list PAY 

"CITE-ALL" See attached dala submilters lisl PAY 

"CITE-ALL" See altached dala submillers lisl PAY 

"CITE·ALL" See allached data submillers lisl PAY 

"CITE-ALl" See attached dala submitters list PAY 

"CITE-ALL" See attached data submitters list PAY 

"CITE-ALL" See attached data submitters list PAY 

.' 

" , " ~ 

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"" ~"" '" " : .tle$~~r R Bjornson, RegulatoryConsultant Augusl19,2010 , ." - .. 

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""'''.,., Form Approved OMS No. 2070-0060 

~""l UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

~ 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 1 Of20/20 fO 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 compos Ilion 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 of production process Ihis submission Raymat Materials Inc. PER see LOA 

830.1670 Discussion of formation of impurilies 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 r ExpodabililY this submission Raymat MaterialS inc. PER see LOA 

Signalure ~ .. - • .W~V-~ Name and Tille Dale 

lain Wealherslon Senior Regulatory Consullant I 10/20120 fO 

EPA Fonn 8570-35 (9-97) I clronic and Paper versions evailable. Sub mil only Paper version. Agency Internal Use Copy 

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~ ... ' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

S!I!I:! ' 401 M Street, S.W. :;;' 

WASHINGTON, D.C, 20460 

Paperwork Reduction Act Notice: The pullitc reporting burden for this coliedion of information 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 of this collection of 

information, including suggestions for reducing the burden to: Director, DPPE Information Management Division (2137). U.S. Environmental Prolecijon Agency. 401 M Street, S,W., Washington, DC 20460. Do not 

send the fonn to this address. 

DATA MATRIX 

Dale 10/20/2010 EPA Reg No/FIe Symbol 87931-R I Page 2 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 Densily Irelative 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) Electro n''()lnd Paper versions available. Submit only Paper version. Agency Internal Use Copy 

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.r""" .. Form Approved OMB No. 2070-0060 <t'j UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

~ 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

- 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 of this 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 of Neuse Rd., Suite 300, Raleigh NC 27609 

53883 Con trot Sotution Inc., 427 Hide Away Circte, Cub Run KY 42729 

54022 / boo Fort Worth TX 76f62 

Signature 

~ .. ~~,~-"v cA-- Name and Title Date 

.\ lain Weathers ton Senior Re9ulatory Consultant ; 

10/20/20tO 

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~~l UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

~ 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

--- -- 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 necessary forms. Send comments regarding the burden estimate or any other aspect of this 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, CA 94587 FIPRONIL TECHNICAL 

Ingredient Flpronil (PC Code 129121) 

Guideline Reference Number Guideline Study Name MRID Number Submiller Status Nole 

64240 Combat Insect Control 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 Species Task Force 1350 I Strret, NW., Washington DC 20005 

74054 Irvita Planl Protection NV. 4515 Falls of Neuse 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 Paper version. Agency Internal Use Copy 

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101
Page 102 contains the product confidential statement of formula and is not included in this copy
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 agent for, and on behalf of Fipronext Solutions Inc., I am writing to you following 

receipt of an e-mail from Bonaventure Aklnlosotu indicating that Team #10 has asked 

you to consult on the request of Fipronext to have the PRIA category of their 

application to register Fipronil Technical [87550-R] changed back from R330 to 

originally submitted R310. 

Given the critical nature of this 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 atlached a copy of the 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 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 letter the 

submitter indicated (correctly) that the desired PRIA category was R310 and included 

both the Pay.gov and the Agency tracking lo's indicating that R310 PRIA fee had been 

prepaid. That payment was accepted without question. Data Matrices submitted were 

appropriate to the R310 designation for the use of "ctte all" as the method for satisfying 

the data requirements. The Agency on review of the application decided to reclassify 

103
Slephen Schalbla 

Flpronext Solutions Inc., letter of October 7, 2010 

Page 2. 

the application as R330. The submitter challenged this, however the communications 

with Linda Arrington were conducted over the telephone and the reasons for the 

reclassification were not clear. It was not until alier my meeting with Richard Gebken 

and BA on September 23 that the reason became clear - there was a clerical error on 

the EPA form 8670-34 where the "selective ctte-all" box was checked instead of the 

"cite-all" box. While the "wrong box checked" is an admitted administrative error by the 

submitter, it is important to note that through the Front End review, which is designed to 

provide an administrative review of the application for completeness and formatting, the 

Agency ignored or missed that (a) the submitter was submitting a R310 application 

[stated in the cover letter and 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 

consistent with a ctte-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 of work that went into the resubmission of a new data 

matrix and label restricting the use-sites in August 2010 and all of the work to establish 

R310 classification could have been avoided had someone on the classification 

committee or the Front End Screen noticed the discrepancies and made a phone call to 

the submitter for clarification, It is our firm 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 of this matter would 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 so we can only surmise that the clerical error 

on the data certification box is the reaSOn for the 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 of the 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 Fipronext would be 

willing to accept January 14, 2011 as a firm PRIA date for the approval this registration. 

Sineerely, ' 

104
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 of the proposed label (5 copies). 

Please do not hesitate to contact me directly with any questions. 

Sincerely, 

~Q £')6'---

Heather R. Bjornson 

Regulatory Consultant to Fipronext Solutions, Inc. 

Direct dial: (202) 828-8945 

e~mail: hbjornson@tsgusa.com 

105
WASHtNGTON 

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· t 298 

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-fast track 

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 argument for 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 of this application: 

1) Application for pesticide registration, 

2) Confidential statement of formula, 

3) Certification·with respect to cita1ion of data, 

4) Data matrices (confidential and an non-confidential version), 

5) Five copies of the proposed label, 

6) Volumes 1 - 6 (refer to the 1ransmittal document for 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 hesitate to contact me directly with any questions. 

Sincerely, 

lzfJ004i< (!,~ Heather R. Bjornson 

Regulatory Consultant to Fipronex1 Solutions, Inc. 

Direct dial: (202) 828-8945 

e-mail: hbjornson@tsgusa.com 

106
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 - Part A 

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 

107
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 

108
FIPRONIL TECHNICAL 

For Manufacturing Use Only 

ACTIVE INGREDIENT: 

F i pron i I: 5-ami no-1-(2, 6-d i ch loro-4-(trifl uoromethyl) phe ny I) -4-( (1 ,R, S )-trifl uorom 8th y I) su lfi ny I) 

-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 la etiqueta, busque a alguien para que s e 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 

-'; , 

,', ; 

. . ... 

· . 

· . • 

;" , 

!' -, 

Fipronil Technical label version (1) dated August 19, 20tQ 

Page 1 of4 

,> , , " 

• •• 

• • , > " , 

• • 

, ", 

• ,,' , 

109
FIRST AID 

IF SWALLOWED Immediately cal! poison control center or doctor for treatment 

advice. 

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

center or doctor. 

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

Do not aive an thi ng bv mouth to an unconsciou s person. 

IF ON SKIN OR Take off contaminated clothing. 

CLOTHING Rinse skin immediately with plenty of water 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 doctor for 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 doctor for 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 goggl es, 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 of the EPA. 

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

Page 2 of4 

110
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. If these wastes cannot be disposed of by use accor ding 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, if allowed 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 of Warranties and Limitations of Liability before 

using this product. If terms are not acceptable, return the unopened product container at once. 

By using this product, user or buyer accepts the following D isciaimer of Warranties and 

Limitations of Liability. 

Flpronil Technical label version (1) dated August 19, 2010 

Page 3 of4 

111
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 her ein 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 of 4 

112
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

November 8, 20 I 0 

OPP Decision Nwnber: D-434093 

EPA File Symbol or Registration Nnmber: 87650-R 

Product Name: FIPRONIL TECHNICAL 

EPA Receipt Date: 24-May-2010 

EPA Company Nwnber: 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 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application and certification of 

payment. If you submitted data with this application, the results of the PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide Programs 

has determined that this Action is subject to a Pesticide Registration Service Fee as defined in 

the Pesticide Registration Improvement Act. 

The Action previously identified as R330 has been reclassified as Action Code: R31 0 

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); 

The fee associated with this action is $ 1,145. Payment in the amount of$ 4,284 has been 

received. A refund in the amount of $ 3,139 will be issued when the action is completed. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

113
• ••• ¥ ..... 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 (or the 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: 

Bonaventu re Akinlosotu/DC/U S EP AfUS 

Richard Gebken/DC/USEPAfUS@EPA 

11/08/201006:56:13 AM 

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 cannot send BEANS to TRB for review. 

BA will 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 I gave back to 

the Fipronex agent yesterday. I met with 

From: Stephen SchaiblelDCruSEP AlUS 

114
To: Elizabeth Leovey/DCIUSEPAfUS@EPA 

Cc: Marty Monell/DCIUSEP AfUS@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 met with IB last week and there was 

agreement that we could classify this back to 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 myself to a follow-up letter in 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/DCIUSEP AfUS@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). 

We wi!! 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 contact with lain and that TSG and its client are willing to negotiate 

the PRIA date out further should this be necessary to accommodate completion of the review. 

If you have any further questions about this action, please contact the PM, Richard Gebken, at 

(703)305-6701. 

Regards, Steve 

Stephen A. Schaible, Acting PRIA Ombudsman 

Registration Division 

Office of Pesticide Programs, U.S. EPA 

115
(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 of the Fipronext 

Solutions PRIA category which we would like assigned as R310 and not R330 I am writing to let 

you know that I will be out of the 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 

my colleague Bob Stewart ( rstewart@tsgusa.com ) with a copy to me for continuity. 

Thanks, 

lain 

116
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 of PRIA classification from R330 to R310 for Fipronext Solutions Inc" Fipronil 

Technical 087550~R] 

Stephen: 

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 of the Se ptember 26, e~mail to Richard Gebken. 

I copy of this 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 of these documents and the hard copies 

are identical. 

Regards, 

lain Weatherston 

"Richard: 

With a five hour flight back to Phoenix, I had plenty of time to think about the discussions on 

the R310, R339 issues between the client and the EPA. Much of the 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 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," 

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 of the contacted companies by appending the relevant portion of the 

most recent DSl to the data matrix, 

Also review of the Pesticide Registration Man ual (2010 iteration of the "Blue Book") defines 

the methods of complying with the data compensation requirements of FIFRA 3{c)(1){F) as: 

Cite-All: The applicant cites all the data in the Agency files that are pertinent to EPA's 

consideration ofthe requested registration action. This is further clarified on page 5 of 

Chapter 10 of the manual by saying that applicants may comply with 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 

117
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 of data requirement guideline numbers in the data matrix 

but only a list of the companies sent offer to pay letters. My understanding that this was done. 

The application was submitted as R310 which was invalidated by the ticking oOf the wrong box 

since selective citation (includi9ng selective cite-all) would require the Agency to go outside of 

Registration Division to determine if the 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 

narrow the scope of the uses to which the technical material may be put, e.g. "For use only in 

the formulation of ectoparasitcide products for use on companion animals." 

I believe that this should still be done however EPA Form 8570~34 should also be resubmitted 

signifying the use of the cite-all option (this would negate having to list all of the 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 I will wish to come into the Agency with an 

application to register a 98% or greater technical flpronil. The applicant of this 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 other data requirements. I would 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 

118
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 of data that needs to be 

reference, and address one way or another 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./ Enforcement Analytical 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 

830.7050J-J' UVNisible Absorption 

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 , 

119
(:

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» Chronic Toxicity 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 

Indoor Suliace Residue Dissipation 

(133-3) Dermal Passive DOSimetry Exposure 

(133-4) Inhalation Passive Dosimetry Exposure 

(161-1) Hydrolysis 

860 series Residue Chemistry Data requirements 

120
.... ~ .. " 

.~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 Marty was cc:'d J will need 

to send her an email laying out the situation. Can you please provide me a time-line of the 

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 that this could be 

considered an R31 0 rather than an R330. Can you please layout the issues/deficiencies with 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 of the September 26, e-mail to Richard Gebken. 

I copy of this 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 of these documents and the hard copies are identical. 

Regards, 

lain Weatherston 

"Richard: 

With a five hour flight back to Phoenix, I had plenty of time to think about the discussions.on the R310, 

R339 issues between the client and the EPA. Much of the 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 of data requirements (the data Matrix form 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 

of the contacted companies by appending the relevant portion of the most recent DSL to the data 

matrix. 

121
Also review of the Pesticide Registration Manual (2010 iteration of the "Blue Book") defines the 

methods of complying with the data compensation requirements of FIFRA 3(c){1){F) as: 

Cite-AU: The applicant cites all the data in the Agency files that are pertinent to EPA's consideration of 

the requested registration action. This is further clarified on page 5 of Chapter 10 of the manual by 

saying that applicants may comply with this data compensaffon 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-aU" 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 of data requirement guideline numbers in the data matrix but only a list of the companies 

sent offer to pay letters. My understanding that this was done. The application was submitted as R310 

which was invalidated by the ticking oOf the wrong box since selective citation ('rncludi9ng selective 

cite-all) would require the Agency to go outside of Registration Division to determine if the 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 Jist 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 of the uses to which the technical material may be put, e.g. "For use only in the formulation 

ofectoparasitcide products for use on companion animals." 

I believe that this should still be done however EPA Form 8570-34 should also be resubmitted signifying 

the use of the cite-all option (this would negate having to list all of the 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 I wiU wish to come into the Agency with an 

application to register a 98% or greater technical fipronil. The applicant of this 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 other data requirements. I would like your concurrence 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.tif 

122
Technology 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 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~R] 

Dear Mr. Schaible: 

As agent for, and on behalf of Fipronext Solutions Inc., I am writing to you following 

receipt of an e~mail from Bonaventure Akinlosotu indicating that Team #10 has asked 

you to consult on the request of Fipronext to have the PRIA category of their 

application to register Fipronil Technical [87550·R] changed back from R330 to 

Originally submitted R310. 

Given the critical nature of this 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 of the 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 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 letter the 

submitter indicated (correctly) that the desired PRIA category was R31 0 and included 

both the Pay.gov and the Agency tracking ID's indicating that R310 PRIA fee had been 

prepaid. That payment was accepted without question. Data Matrices submitted were 

appropriate to the R310 designation for the use of "cite all" as the method for satisfying 

the data requirements. The Agency on review of the application decided to reclassify 

123
Stephen Schaibl& 

Flpronext Solutlons Inc., letter of October 7, 2010 

Page 2. 

the application as R330. The submitter challenged this, however the communications 

with Linda Arrington were conducted over the telephone and the reasons for the 

reclassification were not clear. It was not until after my meeting with Richard Gebken 

and BA on September 23 that the reason became clear - there was a clerical error on 

the EPA form 8670-34 where the "selective cite-all" box was checked instead of the 

"cite-all" box. While the "wrong box checked" is an admitted administrative error by the 

submitter, it is important to note that through the Front End review, which is designed to 

provide an administrative review of the application for completeness and formatting, the 

Agency ignored or missed that (a) the submitter was 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 that the 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 of work that went into the resubmission of a new data 

matrix and label restricting the use-sites in August 2010 and all of the work to establish 

R310 classification could have been avoided had someone on the classification 

committee or the Front End Screen noticed the discrepancies and made a phone call to 

the submitter for clarification. It is our firm 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 of this matter would 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 so we can only surmise that the clerical error 

on the data certification box is the reason for the 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 of the 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 Fipronext would be 

willing to accept January 14, 2011 as a firm PRIA date for the approval this registration. 

Sincerely, . 

)'..lO.M W~VUh.-

124
PlIJUIJ ,IJ.ri m.trot:tiD Dn ,."venll bllfD,." 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 

Fipronil Technica! PM' 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 I ond 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 WY" @Y" @ Y., 

,f N, ,f N, N, gM". 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/oW for idantificotion of individus/ to bo contBcttld, if neC(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 ' 

I certify that the statements I hove mad(l on this form and (III attechment!! thareto ate true, eceurat(l end compl(lta. "'ocl-i~'ed ' " ;; , , , I acknowledge 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 

125-Applieant Copy 
WASH1NGTON 

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 

I nsecticide 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 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, 

~~QiS~ Heather R. Bjornson 

Regulatory Consultant to Fipronext Solutions, Inc. 

Direct dial: (202) 828-8945 

e-mail: hbjornson@tsgusa.com 

, . , , 

'" , 

" , , , ,} , 

" > •• s , , 

, 

" , , , " , , , , > > 

126
\, 

F onn~!)prove A dO M B No. 20 70-0 06 0 

fA',. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

{lOlI'Z ,j ' 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 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 necessary forms. Send 

comments regarding burden estimate or any other aspect of this co~ection of information, including suggestions for reducing the burden to". Dkector, OPPE 

Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, 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: If your product is a 100% repackaging of another 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 I am responding to a Data-CalHn Notice, and have included lvith lIlis form a list of companies sent offers of compensalion (the Data Matrix fonn 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 of svpport, and have included with lJ1is form 0 I am using lJ1e selective method of svpport (or cite·all option 

a list of companies sent offers of compensation (the Data Matrix form under the selective method), and have included with this form a 

shOUld be used for this purpose). completed list of data requirements (the Data Matrix form must be 

used). 

SECTION II: GENERAL OFFER TO PAY 

[Required if using 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 of lJ1is application, to the extent required by FIFRA. 

SECTlDN Itt: CERTtFtCAnON 

I certify lIlat this 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, or the 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 of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data 

requirements in effect on the date of approval of lJ1is application if the application sought the initial registration of a product of identical or Similar composijion and 

uses. 

I certify that for each exclusive use study dted in svpport of this registration or reregistration, that I am the original data SUbmitter or that t have obtained 

the wr~ten permission of the original data submitter to cite lJ1at study. 

I certify that for each study c~ed in support of this 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'ltter to use the study in support of this app~cation; (c) all periods of eligibility 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 of compensation, if any, to be paid for the use of the study. 

I certify that in all instances where an offer of compensat"lon is required, copies of all 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 t fail 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. ' , . " " , 

I certify that the statements r have made on this form and att attachments to tt are true, accurate, Clnd comptete. t ackno';rtedge (hat any " 

, " knowingly fatse or misleading statement may be punishabte by fine or imprisonment or both under appticabte 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, ., .. 

127
I (e} 

" ",'> •• '~ 

Form Approved 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 of information is estimated to average 0.25 hoursper response for 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 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 HalVey Court Fipronif Technical 

Pleasanton, CA 94588 

Ingredient Fipronil 

Guideline Reference Number Guideline Study Name . MRtD Number Submitter Status Note 

OPPTS 830.1550 Product Identity and Composition 48104001 Flpronext Solutions, tnc. OWN 

OPPTS 830.1600 Description of Starting Materials 

48104001 Fipronext Solutions, Inc. OWN 

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

OPPTS 830.1670 Discussion of the Formation of Impurities 

48104001 Fipronext Solutions, Inc. OWN 

OPPTS 830.1700 Preliminary Anatysis 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 · · . . .. · ~ ~ .. EP. <:nA "'~. ,~--· m 8570-35 {9-g7] Etectronic and Paper versions available. Submit only Paper version Agency Internal Use Copy 

128
... .. ~ 

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 of information is estimated to average 0.25 hours per response or registration activities and 0.25 hours per 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 UVNisible Absorption 

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: ,... ... .." "', __ ._~_,~ ~_., '"' __ 0, """d"n<> ""~n"hl,,, O;:"h",H ... "h,O~""" "Qr~;~n p lyPap' 

DATA MATRIX 

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 

129
~ 

Form Approved O\i1B 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 of information is estimated to average 0.25 hours per response 6r registratKm activities and 0.25 hours per response or 

reregistration and special review activities, 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 Agency 401 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 870.3 toO 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" 

. ~"w " ". , " , , . > . " > · , " > , , . . , · " > . > · , > . - . 

•• > 

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 

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130
Form 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 of information 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 any other 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--:;-"" ".-" _____ -L_+-___ _ 

Date 

August 19, 2010 

" I Na,ne-ar.,j Title 

: ¥ w " v: v'-le3~h:§r R. Bjornson, RegulatoryConsuttant 

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131
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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 review activities, 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 Harvey Court 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. OWN , 

Fipronext Solutions, Inc. OWN .. --

Fipronext Solutions, Inc. OWN 

Fipronext Solutions, Inc. OWN 

Fipronext Solutions. Inc. . · . . OWN · . . . . • 

· · .. . . . . Pip.-rtln€Xt :?olutions, Inc . OWN · · . . · · .. · . . . · . FirJronext Solutions, Inc . OWN 

Signature 

~(l.(2i\" · · • ,,~~ Name and Title Date 

· · ... ~; ~ Heather R. Bjornson, RegulatoryConsultant August 19. 2010 

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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 of inform ali on is estimated to average 0.25 hours per response or registration activities and 0.25 hours per response or 

reregistratiOll and special review activities, 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 Harvey Court 

Pleasanton, CA 94588 

Ingredient Fipronil 

GUideline Reference Number Guideline Study Name 

Si9"'."' ~ fl-!3r-.- --_. -_ .. -

OATAMATRIX 

MRID NLmber 

EPA Reg. No./File Symbol 

87650-R 

Product 

Fipronil Technrcal 

Submitter 

See attached data submitters list 

See attached dala submilters list 

See attaChed data submitters list 

See attached data submitters list 

See atlached dala submilters list 

See aliached data submitters lisl 

See attached data submitlers list 

See attached data submitters list 

See attached data submitters list 

See attached data submilters list 

Name and Title 

Status 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

Heather R. Bjornson, RegulatoryConsultant 

Page 3 of 4 

Nolo 

Date 

August 19, 2010 

-I 

I 

134
Form 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 of information is estimated to average 0.25 hours per response 6r registration activities and 0.25 hours per response or 

reregistration and speciat review activities, 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 

MRID Number 

-_ .. -

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 tist 

See attached data submitters list 

See attached data submitters list 

Name and Title 

Status 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

Heather R. Bjornson, RegulatoryConsuliant 

Page40f4 

Note 

Date 

August 19, 2010 

l 

---,,-1 

135
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• C""'l"any Addr .. n~ 

;>.GRIC01.TURAL )JI>NDLEM 

~o 1).01( 509 

l'Ii'lCOII.MO 63552 

E"~OSURE TI>SK Fa 

t:!Ti£Xl>ll!:X!.I 

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llenzoic add, 3_~h1oro_2_11 15-ethoxy-1-fllloro 11, 2. ~ I! 

C."."."v # Co"",anY Ad.dr"~$ 

219 FI',c COIIP. AGlHCU1.TUML PRODUcrS Gl'-OU? 

ATTN: MIC)JAEL C. WCKER 

1735 MARK!:T S1', Rf1 1978 

PIlILAOtLfHIIl,P;>' 1910) 

• C0"'P .. ny Ad<hncc 

DW AGRDSCnllCES 1.LC 

9330 ZIDNSVILLE 1<.0 30012E 

INDIMJI\rDLI~, Hi 4626~ 

COIIIpany II C_~ny Addr.,~~ 

666D7 SPRAY DRIFT TASK FORCE 

I1CKElINA, LONG & ALDJUDOt L1.I' 

1900 !( ~TRen, NW 

WIlSIIHIGTOII,OC 20006 

Corol>any 

71754 

company 

71755 

, CcmJ'any Adc!l:eu 

OV'rOOOR RESIDSN'rIAL !:Xi'DSURE TASK FORC 

I3501 STR!:ET, II.W. 

WASIIINGTOII, DC 2DOD5 

* C,,-"ny Ad.d:::o~" 

Jo.r:rnICVLTURA1. REE:NT:t¥ TASK FD1\CS. 

1350 1 STREET, N.W. 

WASHINGTON. DC 20005 

C""",llny llc!d~.,n 

rIFI1A ENDANGEREO s~ECIEE TASK FORCE, L 

C/O HAROLD HIMMELt-lAll IEEVEIU!>GE , DI!\MOIID, 

1350 I STRE!;T, Nt! 

<lASHINGTON, DC 20005 

I"ipronll 

Oat;> <:rypu 

n nl' I FlI!: OT I PC 

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ComP""Y • C_""Y 1.dd:r",u 

'"" S'iNGEIlTA CliOI' I'IiOTSCtIO/1, lite. 

ATTN; IIEGIJ"IITORY ArrAIRS 

PO !lOX 18300 

GREEIlSBORO,NC 21419 

C-P"ny • C"""'''''y 1.ddr",u 

'" Il'AYER CROPSCIENCE e, 2 'r.W. "rzXIINDER DRIVE 

RESEARCH TIUIINGLE PARl(, NC 27709 

~ , C""",anv Md:ru" 

432 !l'1.YER E~lVIRONMENTAL SCIEIlCE 

A BUSINESS GROIJF or BAYER CElOPSCIENCE LF 

PO BOX 12014 

RESEARCH TRI~IlGLE P"RK,NC 27709 

CoI""''''''Y M ~any Md>:",~s 

3~82 IIECKITT BENCKlSER mc. 

Company 

1946 

MOIIIIIS CORPORATE CENT.!:R IV 

399 HlTERl'ACE PARKI1AY 

PARSIFI'ANY,NJ 070S~ 

II C,,,,.,,,ny Add:ro~s 

J. J. MAIJSe'l' CO. 

1273, DIREC'I"OR'S LOOP 

\olOOOBRlIXiE.VII 22192 

, Co"","1IY llddr"u 

BAsr COIU'ORATION 

AGRICULTIJAAL PROOUCTS 

PO BOX 13528 

~ESEI\RCII TRIMGL8 PAAJ(,NC 21709 

C"-,,ny I CoDIpanv lIddrcs. 

%88 CB£l1SICO 

C""PaIlY 

53883 

OIY Of UNITEO INOlIS1"R:;:ES CORP 

PO BOX 142642 

ST LOUIS, I«l 63111 

, C""'P"ny Mdr .. u 

CONTROL 5C"OTIOIIS, IIlC. 

5903 GEOOA-RED BLVFF 

PASJ\.P!,:N1,.TX 71507 

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54022 'fI!'.I'lAC 

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C01OP"ny , COlIIJ'any Md.re"G 

64240 COMBAT INS<:CT CONTROL S~STtl1S 

cto IIE.N!U:L CONSUW:R GOODS me. 

In C STItEE.T, N.W., SUITE. '40 

Wi\SIIINGTON, DC 2000l 

C"""",ny 

65331 

, COOIIPany Adclr .. ,,~ 

M<:RIAL LItH"!;;:D 

3l3~ Si\TELLITE. lILVD, 

DULOTH,GA 30096 

!lLD!:> 500, LOC 10GlI 

C~ ... nv , eollrPanv Address 

66607 SPRA¥ ORIFT TA"oK ro~CE 

MCKtNIII'., LCIIG • ALORI DGE. LL? 

1900 K STREE.T, Nil 

WASIIIHG"T:lII,OC 20006 

C<>lI;>~n'{ It C<>lI;>any Md.re;'~ 

7l75~ OUTOOOR RESIOENTIAL E.XPOSUII£ TASX FORC 

1350 I STREET, II.W. 

WASIUNGTOn, DC 20005 

Co:opanl' It C<>mp ... ny hddreu 

7)755 AGRICULTURAL REEN:!"R~ TASK FORCe 

1350 I STR~£T, II.N. 

IlASIIIIIGTON,OC 20D05 

COJIII)&"V 

73342 

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ilIISRl\IIOS 

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S!\LEl1, V!\ 24153 

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OOCA RATOII,rL 334Se 

C_ra"y ~ C~any lId<;irou 

73989 FIFRlI ENOlltlG"tREO Sf'ECltS TASK FORCE, L 

ctO !lIIROLD HIMMELM!IlI IlI~VERIDGE. • OI!\MOND, 

1350 I STlltET, 11'1 

WASHIIIGTON, PC 20005 

• CoIoJ>&ny Add:ess 

RESIOf:I1TI!\L tllPOSURt 

900 nTII STR£ET, mI, 

N!\SIIINGTON, DC 2DD06 

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By Active Chemical Code -Sep 30, 2009 Edition 

• CollIpany M<h:esa B2E COll.POltATIOll 

1501 EAST 1I00DFIE1O ROllO, StrITE 200 WEST 

SCHAUMaORG, IL 60173 

ec""' .... y·jI 739a9 

C"""' ..... y M<h:"~" 

FIrM -EI1D"'/lGERED SI'ECIE~ TASK FORCE, L 

c/o IlAROLIJ HIMMELMI\II (BEVERIOGE ~ I>lAI1UNI>. 

1350 I STJIIEET, Nfl 

WASHINGTON,DC 20005 

Cc>mpaIW • ColIII> .. "y M<h:us 

HBaB RESIOENTIAL. EXPOSURE ':;OINT VEtlIURE (RE 

900 1 nH STREET, l/W, StrlfE 300 

WASHINGTOn, DC 2000G 

COJopany 

91390 

• CoOlPany Mdr ...... 

hCTINIC 1110. 

7210 CESSNA ORlVE 

GREENSlIORO, NC 27409 

D.ta'lyp .. = 

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SEf!GEANT'S PET CARE PROD~CTS, INC • 2625 SOUTH 15BT!! PLAZA 

OMll1JA,NE 66130 

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THI: HARTZ MOUNTAIN COliI'. 

ATTN: !\oIlERT ROSEllNASSEII 

400 PLlIZll DRIVE 

S~CAOCtrS,N'] 07094 

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WELLMARK HI'l'ERNAT20NAL 

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By Active Chemical Code -Sep 3D, 2009 Edition 

8 C<mtpany Al;!d",,"u 

CHi'!.TTE!'!, !lIC. 

A!TI1' DAVID SCHILLING, 

1715 WEST 38TH ST 

CHJl.l"l'1illO:JGA,!N 31~09 

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ENro1lC!.:tt rRDDUCTS 

MGR REGllLII'l'OR't AFFJ 

Data 'typo" 

/', DlVISION Of RCOITY S~ECIALTY l'ROUUCTS G1' 

H20 S!.WlO/IRD lIlDUSTRIRL BOUL~VARD 

i'!.TLANTl\,GA 30318 

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COIiTROL SOLUTIONS, INC. 

5903 GENOA-RED BLUff 

PASADENA,!X 77501 

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WlNIIGEMENT CO:rrMCT SERVICES, INC. 

!'O 1I0X 5~0;l 

VALOOS!A,GA 3I603 

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M~RIAL LI~IT~D 

3239 S~.TELr.TTE BLVD, 

D!lLUTH,GA 30096 

jI Company Addrl>u 

IILDG SliD, LOC 10611 

SrRA~ DRIn !IISK fORCE 

MCKENN~, LOllG , ALDRTIlGE 

noo K STREE!, Nil 

WASHI1IGTON, DC 20006 

jI C""",any Mdru~ 

"~E CDR~ORATlDI1 

I50I E~ST WOODFIELD ADAD. SUI!E ~OO IIEST 

SCIIMJMBUAG,IL 60113 

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BAllOWi'!. 8IDEINIRDlIM.E11TAL CElITRE L!D 

~O IIOX 5126 

VALOO~!I\,GA 31603 

EGIS PHAIWJ<CEUTlCIH.S PUBLIC LIMI!ED CO 

1150 1StH S!ImET, N.W .. SUITE IOOO 

WASBING!DN,DC 20036 

VALENT !lICISCIENCES CORPORATIDll 

870 TECHNO!.OG't NA~, SUITt 100 

LIl'ltR!YVlt.;,l!:, IL 60048 

En' EX. J:lCU 

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C<mipany lIddre"" D"u:. Types 13H2 /II'lBAANDS 

l1S 112 EAST WIIN STII<:<:T, SUlTE 1 EFF)El(l')EXU 1 FA r n::; )~TOT I p;;lru: 1'l'C 

COfO!'I>ny • 73510 

CCI~ny • 7~O32 

7488. 

C""I'Any • 753}8 

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SALEM, VII 24153 

Company AddJ:"u 

MAru<E:l0lJEST INC. 

IH, 1/2 E MAIN ST, SUl'r<: 1 

SIILEM,VII 24153 

Comp"ny Adclres" 

Al'1l:0 CORPDRATION 

3330 NO~ilC ROAD, BUILDING 0 

SIIG HARBOR,NY lI96J 

RESIDENTIIC ~POSUP..E .:mIJJT 1/E"TUIIE IIIE 

900 17TH S'l'REET, )4., SUITE 300 

W;'SHINGTOIJ,DC 20006 

COIllp"nY lIddr"u 

B2E l<IOTECH Lt.C 

IS01 &7lST WDOOFltLD 1I01lD, SUITE 200 WEST 

SCHIIUMlJIIG, II, 60173 

C""'PAnY IIc1c1r .. u 

ZOCOII INCOIIPORIITEO 

IDOl G STREET, N.W., SUITE 500 ~JEST 

WA5111t<GTON. DC 20001 

.),., '~.~~ .. ,_ ~~~>,JU.o CIUlUCAL wua: 

,105403 

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C_Ilny 

74411 

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INSECT BIOTSCIINOLOt>Y, 

PO SOX 2311 

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! 

UN, .~ STATES ENVIRONMENTAL PROTEC ., AGENCY 

WASHINGTON, D.C. 20460 

June 17,2010 

OPP Decision Number: D-434093 

EPA File Symbol or Registration Number: 87650-R 

Product Name: FIPRONIL TECHNICAL 

EPA Application Receipt Date: 24-May-2010 

EPA Waiver Request Receipt Date: 24-May-2010 

EPA Company Number: 87650 

CornpanyName: FIPRONEX SOLUTIONS, INC 

HEATHER BJORNSON 

TECHNOLOGY SCIENCES GROUP, INC 

FIPRONEX SOLUTIONS, INC 

1150 18TH STREET, NW SUITE 1000 

WASHINGTON, DC 20036-

SUBIECT: Approval of Waiver Request 

Dear Registrant: 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

The Office of Pesticide Programs has approved your request for 75% waiver of the 

pesticide registration fee associated with the action referenced above. The decision review 

period for this action will begin on the date of this letter, 

The Action has been identified as Action Code: R330 

NEW MANUFACTURING USE PRODUCT;OLD Al;SELECTIVE CITATION; 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman, at (703) 305-6249. 

Sincerely, 

c(J.-Jl2- A - _ . " 

.{r- Oscar Morales, tCr 

Infonnation Technology and Resources Management Division ~ 

Office of Pesticide Programs '" 

142
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 of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of24-MAY-IO. Our staff has completed a preliminary 

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

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

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

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

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

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

Manager, to whom the data have been released. 

143
UNI1 cO STATES ENVIRONMENTAL PROTECT'''N AGENCY 

WASHINGTON, D.C. 20460 

May 26, 2010 

PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT 

OR PAY ON-LINE AT www.Pay.Gov (See Below for Details) 

OPP Decision Number: D-434093 

EPA File Symbol or Registration Number: 87650-R 

Product Name: FIPRONIL TECHNICAL 

EPA Receipt Date: 24-May-2010 

EPA Company Number: 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 

TOXIC SUBSTAl'lCES 

SUBJECT: Receipt of Application and 75% Small Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has received your application and 75% small business 

waiver request. If you submitted data with this application, the results of the PRN-86-5 screen 

wiIl be communicated separately. During the administrative screen, the Office of Pesticide 

Programs has determined that this Action is subject to a Pesticide Registration Service Fee as 

defined in the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R330 

NEW MANUFACTURING USE PRODUCT;OLD AI;SELECTIVE CITATION; 

Your request for waiver has been forwarded for review. You will be notified in writing when a 

determination is made regarding your'request. If your waiver request is approved, the decision 

review time period will start on either the date of approval or the receipt of payment, whichever 

is later. If you would like to avoid delaying the start date, you may pay the amount listed below 

at this time. If your waiver request is denied, you will receive an invoice for the outstanding 

balance. 

The fee associated with this action is $ 4,284 (25% or $ 17,136). Payment in the amount of$ 

1,144.50 has been received. Please remit additional payment in the amount of $ 3,139.50 to: 

144
By USPS: 

USEPA Washington Finance Center 

Pesticide Registration Service Fee 

PO Box 979074 

St. Louis, MO 63197-9000 

By Courier: 

U.S. Bank 

Government Lockbox 979074 

1005 Convention Plaza 

SL-MO-C2-GL 

St. Louis, MO 63197 

Telephone: (412) 236-2294 

All payments must be in United States currency by check, bank draft, or money order 

drawn to the order of the Environmental Protection Agency. To ensure proper credit, please 

write the OPP DECISION NUMBER on your check, and enclose a copy of this letter with your 

payment. 

Effective November 1,2006, fees may be paid on-line via credit card or electronic fund 

transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select 

"search by fann name." From the next page, select "P," then click on "Pesticide Registration 

Improvement Act. Fee Payment" and complete the form, making certain to use the decision 

number and registration number on the invoice you receive from the Pesticide Program in the 

space provided. 

A PRlA decision time review period will not start until a fee waiver is granted and/or the 

Agency recei~es certification that the outstanding fee has been paid. If the Agency does not 

receive certification of payment for this action or a fee waiver request within the next 45 days, 

the Agency will presume that you no longer want to pursue this action. The Agency will then 

initiate a process that may result in administrative withdrawal of this action. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 305-6249. 

145
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 argument for 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 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 (refer to 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 directly with 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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146
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'()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 

147
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 of2 

148
Pfe.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 if this is 8 noW edd,,,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.) 

PRIA Category 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 of indivfduBl to btl contac/od, if necflssary, to procoss 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. , , " , , , , , " 

2~ 3. TItlll , 1 , t • " « 0, , RegUlatory Consultanllo Fipronext Solutions, Inc. " , " > , , -' 

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" , 4. Typod Name 5. Dato , 

. " , " , Heather R. Bjornson May 21,2010 , " " , ,0 > 0 

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

149-Applicant Copy 
Pay.gov - Online Payment 

Online Payment 

Step 3: Confirm Payment 

Thank you. 

Your transaction has been successfully completed. 

Pay.gov Tracking Information 

Application Name: PRIA Service Fees 

Pay.gov Tracking 10: 250S70L8 

Agency Tracking 10: 74117800617 

Transaction Date and Time: 0512412010 10:50 EDT 

Payment Summary 

Address Information Account Information Payment Information 

Page 1 of! 

1 1213 

Account Holder Heather R. Card Type: American Express Payment Amount: $1,144.50 

Name: Bjornson 

1150 18th Street 

Billing Address: NW 

Billing Addres2~ Ste. 1000 

City: Washington 

State 1 Province: DC 

Zip 1 Postal 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 5/24/2010 

150
Form 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 for reading the instructions and completing the necessary fonns. Send 

comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE 

Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street. S.w., Washington. DC 20460. 

Do not send the completed form to this address. 

Certtfication with Respect to Citation of Data 

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 of another 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 a f,st of companies sent offers of compensation (the Data Matrix form shOUld 

be used lor this purpose). 

SEcnON I: METHOO OF DATA SUPPORT (Check one methOd only) 

I am using the cite-all method of support, and have included with this form 

a fist of compan·les sent offers of compensat"lon (the Data Matrix form 

should be used for this purpose). 

I am using Ille setective melllod of support (or cite-all option 

under Ille selective method), aru:i have induded w~h this form a 

completed list of data requirements (the Data Matrix form must be 

used). 

SECTION II: GENERAL OFFER TO PAY 

[Required if using Ille c~e-all method or when 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: CERTtFtCA nON 

I certify that this application for registration, this form for reregistration, or this Data-Gall-In response is supported by all data submitted or cited in Ille 

appl"lcafion for reg·,stration, Ille form for reregistration, or the Data-Call-In response. In addition, if the cite-all option or cite-alt option under the selective method is 

indicated in Section I, this application is supported by all data in the Agency's files that (t) concem the properties or effects of this product or an identical or 

substantially similar product. or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data 

requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and 

uses. 

I certily that far each exclUSive use stUdy cited in support of this registration or reregistration, that I am the original data submitter or that I have Obtained 

the written permission of the orig·lnat data subm·rtter to c·rte that study. 

I certify that for each study c~ed in support of this registration or reregistration that is not an exdusive use study. either: (a) I am the originat data 

submitter: (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility 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, if any, to be paid for the use of the study. 

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery 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 I fail 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 that the statements t have made on this form and all attachments to it are true, accurate, and COm91,t.e, J xknow:cdJe that any 

knowingly false or misteading statement may be punishable by fine or tmprisonment or both under appllcabte taw. ~: ,j , 

Date 

5121/2010 

EPA Form 8570-34 (9-97) Electronic and Paper versions available. &lbmit only Paper version. 

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Typed or Printed N~";;J ~ ~nd'Titie , 

Heather R. Btarns01!, F.egulatory A3ent ' , ",~j" 

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151
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 

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152
FIRST AID 

IF SWALLOWED Immediately call poison control center or doctor for treatment 

advice. 

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

center or doctor. 

Have person sip a glass of water 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 of water for 15-20 minutes. 

Call a poison control center or doctor for treatment advice. 

IF INHALED Move person to fresh air. 

If person is not breathing, call 911 or an ambulance, then give 

artificial respiration, preferably by mouth-to-mouth if possible. 

Call a poison control center or doctor for 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 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 symptons of 

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 latal il 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 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 other waters 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, 

153

2010 
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 or rodenticide 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.) 

• Domestic Outdoor (fawns, perimeters, & ornamentals), 

• Commercial/lndustriallfnstitutional (indoor & outdoor), 

• Food Handling Establishments (edible product areas), 

• Terrestrial Non-Food (sod farms, golf courses, non-agricultural sites), 

• Modes of transportation. 

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 of children and animals. 

PESTICIDE DISPOSAL 

Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide is a violation of 

Federal law. If these wastes cannot be disposed of by use according to label instructions, contact 

your State Pesticide or 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 bag into 

manufacturing equipment. Then dispose of empty 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. If terms are not acceptablE:l"r;E:itun;l,the ~r,;opened product container at once. 

By using this product, user or buyer aC,cepts.the foflow,ing Disclaimer of Warranties and 

Limitations of LiabWty. . 

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

154
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: 

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

155
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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 fur this cOllection of information is estimated to average 0.25 hours per 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 Harvey Court Fipronil Technical 

Pleasanton, CA 94588 

Ingredient Fipronil 

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

OPPTS 830.1550 Product Identity and Composition This submission Fipronext Solutions, Inc. OWN 

OPPTS 830.1600 Description of Starting 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 of tmpucities 

This submission Fipronext Solutions, tnc, OWN 

OPPTS 830.1750 Certified limits 

This submission Fipronext Solutions, Inc. OWN - OPPTS 830.1800 Enforcement AnaMical 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 

156
';;" 

,;,,~ 

\ 

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 br this coliection of informal ion 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 comments regarding the burden or any other 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 HaNey Court 

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 'sion 

DATA 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 

Name and 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 

157
, 

.,'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 of information is estimated to average 0.25 hoursper response for registration act~/::j3:; aMc :l.25 hJ-"fS per response or 

reregistration and special review activities, 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 

158
/.-' 

. 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 of information 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 Harvey Court 

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 onlyPaper version 

DATA 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 

May 21,2010 

-

159
',~,-

',-

PR FORII8-11 

--

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

"qLa~~t:. 

~NO. 

CONFIDENTIAL STATEMENT OF FORMULA ENCLOSED 

DATE 

SUBMITTED 

~tfl/1) 

. 

. 

. 

. 

. 

.... , ••• m,., ____ , 

SUBMITTED BY (.-) 

APPLICANT BASte SuPPuER 

. 

. 

. 

Do Not Write Comments, 

Formula, or Parts of 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 United States Department Oof AgrIcultUre or other Federal agencies., 

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 authority of Section 4, of the -FederallnsectJdde. 

FUngicide, and Rodetrtldde Act."-

160
Page 161 contains the product confidential statement of formula and is not included in this copy.