# EPA Registration Jacket 2517‐134

### From:

Date: Subject: 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY ANO POLLUTION PREVENTION 

### INTERNAL USE ONLY

- DONOTCITE ORRELEASE
Rosanna Louie-Juzwiak Review, Insecticide Branch November 5, 2010
Note to File, #2517-134, Sergeant's Fipronil 

## +Methoprene Squeeze-on for Dogs
OutstandingIPending Items at Time ofRegistration: 

### 1. Efficacy Review completed October 27,2010 indicated that the "waterproof' claims must be removed from the proposed product labeL Because the me-too product (65331- 5) has the claim, 

### itis not readily clear as to howthis claim was supported, and 

### itis out of the scope ofthis action to investigate the me-too product, the applicant was allowed to retainthe claim provided they chose to do a selective cite-all and offer-to-pay for the efficacy guideline, 810.3300. This optionwas presented because all other efficacy data were cited, and deemed acceptable, from the current dataholder, Merial.

2. Whenthe Storage Stability and Corrosion Characteristics studies (830.6317/830.6320) studies are submitted for review by CHEMlTRB, include in the requestthatthey review the previously submitted and accepted study to supportthe enforcement analytical method (830.1800), whichwas included in an updated datamatrix, provided after the time thatthe product chemistryreviewwas completed. As such, the product registration is contingent onthe acceptability ofthis study to supportthis product.

# 21-Day Screen Completed 

# by Contractor 

# 21-DayExpires on /-)..2

- /0

, 

# Jacket #j{!31

# 7

-t{;U 

# MRID#

---- 

# Content Screen: Recommended to

# ~Fail 86-5 Review: Passed/Failed/§7 

# Transfer This Jacket to:

### Comments: 

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# *N/A

- 

### NotApplicable

Footnotes A. During the 21 day initial content review, all CSFs will bereviewed to determine whether all inerts listed, including fragrances, are approved for theproposed uses. Ifan unapproved inert is identified, the applicantmust either 1) resolvethe inert issueby, for example, removingthe inert, substituting it with an approved inert, submitting documentation that EPA approved**~e** 

### inert forthe proposed pesticidal uses, correcting mistakes onthe CSF, etc. or2)providethe data to support OPP approval oftheinert or 3) withdraw the application. Removing orsubstituting an inertingredient will require a new CSF and mayrequire submission ofdata. All information. forms, data and documentation resolvingthe inert issuemust havebeen receivedbytheAgency orthe applicationwithdrawnwithinthe 21 dayperiod, otherwise. theAgencywill reject the application as described below.
To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouragedto verify that all inertingredients havebeen approved for the application's uses even 

### ifa product is currently registered by consulting the inert Web 3

### site 

### [link to http://www.epa.gov/opprdQOl/inertsl1ists.html] and Ifthe inert is not approved, to obtain the necessaryinert approvalprior to submitting an application to register a pesticide product containing thatinert ingredient. Some inert ingredients are no longer approved for food uses or certain types ofuses. Thename and/or CAS number on a CSF 'must match the name and CAS number onthis web site. Simple typographical errors inthe name orCAS numberhaveresulted inprocessing 

### delays. Ifaninert isnot listed onthe inert ingredientweb site and the applicantbelieves that the inerthasbeen approved, the applicant should contactthe Inert IngredientAssessment Branch 

### (lIAB) at inertsbranch@epa.gov andresolvethe issue. Copies ofthe correspondence with IIAB resolving the issue should accompanythe application. All new inerts exceptPIP inerts arereviewedbyIIAB. The IIAB should also be contacted for anyquestions onwhat supporting data needs to be submitted for and the Agency's inertreviewprocess. Questions onPIP inerts should be directed to the Chiefof Microbial Pesticides Branch [Link to http://www.epa.gov/oppbppdl/biopesticides/contacts bppd.htmJ. When a brand, trade, orproprietaryname ofaninert ingredientis listed on a CSF, additional information such as an alternate name ofthe inert, CAS number orother information [link to http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included to enable theAgency to determine ifithas been approved. Each component ofan inert mixture (including a fragrance) must beidentified. In some cases, the supplierofthe mixture orfragrance mayneed to provide this infonnation to theAgency. Prior to the Agency's receipt ofan application, applicants must arrange with a proprietarymixture or fragrance supplier to provide the component infonnationto the Agency orpromptlyupon EPA's request. Iftheinert ingredients in aproprietaryblend (includingfragrances) cannot orarenotidentified orprovided within the 2 1**~day** 

### content review period, the Agencywill reject the application. Duringthe21 day contentreview, applicants should submit information to the individual identified by the Agency when the applicantis informed ofan unapproved inert. Unapproved Inerts Identified on CSFs All applications except conventional new products andPIPs Once an unapproved inert is identifiedon a CSF, the Agencywill contactthe applicant with the following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS number,providing documentation that theinert hasbeen approved, or removing theunapproved inert from the CSF or replacing it with onethat is approved for the application's uses; or 2. Submit the information_and dataneeded for theAgencyto approvethe unapproved inert. Ifthis option is selected and implemented, theAgencymay request an extension in thePRIA decisionreview timeframe to accommodate the inert review/approval process;
4

### 3. Withdrawme application (theAgencyretains 25% otthe full fee for the fee category estimated); or Ifnoneofthese options is selected and implementedbythe applicant withinthe 21 day content reviewperiod, theAgencywill reject the application and retain 25% ofthefull fee ofthe category identified. Conventional New Product Applications When the RegistrationDivision identifies anunapproved inert on a CSF with an application for a newproduct thatthe applicanthas not identified as requiring an inert approval (R3!1, R312 orR313), it will contact the applicant with the following-options: 1. Correct the applicationby, for instance, correctingthe inert's identityor CAS number, providing documentation that the inerthas been approved, or removingthe unapproved inert from the CSF orreplacing it with one that is approved for the application's uses; or 2. Submitthe infonnation and data needed for theAgencyto approve the unapproved inert, including anyrequired petitionto establish or amend a tolerance or exemption from a tolerance. (This option maychangethePRIA categoryfor the application, which couldrequire a longer decisionreview time and a larger fee. Ifadditional fees aredue, theymustbereceivedbythe Agencywithin the21 daycontentreviewperiod.) 3. Withdraw the application (the Agencyretains 25% ofthe full fee for the fee category estimated); or

Ifnone ofthe above options is selected and implemented during the**21~day** 

### content-reviewperiod, theAgencywillreject the application and retain 25% of the appropriate fee for thenew product-inert approval category. PIP Applications When theBiopesticide and Pollution PreventionDivision identifies an unapproved inert on a PIP CSF and a requestto approve the inert does not accompanythe application, it will contact the applicant with the following options: 1. Correct the applicationby, for instance, correctingthe spellingorname ofthe inert to that in 40 CFR 174, or providing documentation that the inert hasbeen approved; or 2. Submitthe information and dataneeded for theAgency to approvethe unapproved inert. Ifan inert ingredienttolerance exemption petition is required, thepetitionmust bereceivedby the Agency andthe B903 fee paid within the 21 dayperiod. Ifthis option is selected and implemented, the Agency-will discusshannonizing thetimeframe for both actions. 5

### 3. Withdraw the application (theAgencyretains 25% ofthefull fee for the fee category estimated); or Ifnone ofthe aboveoptions is selected and implemented duringthe 21 day contentreview period, theAgencywill reject the application and retain 25% of 

### the fee.

B. A policy on documentation ofoffers to payis still being developed, however, for a me-too orfast track (similar/identical) new product,R300 orA530, an application without the necessary authorizations ofoffers to paywill beplaced into either R301 or A531. The Agencyrecommends that authorizations ofoffers to paybe submitted with otherPRIA applications to avoid delays in the Agency's decision. C. Biopesticide applicants are advisedto contacttheAgencyand discuss studywaivers priorto submitting their applicationto the Agency. Documentation ofsuch discussions should be submitted withthe studywaiver.



### 6

# IFee for Servicel 

# )( 

# (864744<-**~** _____ "

_______________________________________________ __________N ____ 

## This package includes the following 

# @New Registration °Amendment DStudies? o Fee Waiver? ovolpay % Reduction:
__ ,---------------
------------- -------------- 

### -

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

## for Division 

# OAD oBPPD @RD Risk Mgr. 

# [J]J

l__

_____________............ ______ _ _______...._ 

# Receipt No. 

# s-I 864744 EPA File Symbol/Reg. No. 

# I 2517-RGU Pin-Punch Date: 

# I 12/22/2009 This item is NOT subject to FFS action.

,-------------------- ---------- ---- -

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

### --- 

# --------ft;ctionCm1e-:-----· ParenUChild Decisions: Requested: 

# I"f.,:,c= Granted: 

# I'R'3co

'I 

## Amount Due: 

# $ ,\,:' (."s:-. =-:

# ~t--i'.k~I!2jL'..,rJ"~! __

# ,L(;%J~_LI~ILD

# ___ '-

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

. • i

### ~- 

# )6 Inert Cleared for Intended Use 0 

## Uncleared Inert in Product Reviewer:

# ~**b()~~** Date: \2 

## --"3F ' C' '-, 

## Remarks:

# I

, I l 

# ! !

,

# I I iSB'S Front-end PRIA Completeness Screen Draft 3; 10/25107



### L'PA

# RCCCI~~~D_at_:~/)-/-;.-·,p.-/-(l-?----'1E-p-A-R-e-g Number:

# d

# 5/1

# ~~-~=·--l Check List Item Yes Nil N/A

----**-.~-+--** --. 

### lias the PRIA Fcc been Paid; is a copy ofthe check or P<q.gov receipt included in the Submission Package? Is lIll 

### Application Form (EPA Form 8570-1) Included in the ') SubmissIon Package, is it 

### completely filled out and signed / including paci<agc type?

3 

### b <I 

### Confidential Statement ofFormula (EPA Fonn 8570+ 

### 29) IllcJuocd in the Submission Package, is Hcompletely

## ~ Iilied out and 

### signed (boxes 1·21)? 

### I;.; 

### a Formulator's Exemption Statement (EPA Fonn 8570+ / 27) Included in the Submission Package? Is ,1 

### Certification with Respect to Citation of Hahl (EPA 

### h)]Tll**~570<14)** 

### Included in the 

### Submission Package? Is II 

### Ih(a Matrix (EPA FOlm 8570-35) 

### Included in the Submission Package? 

# /

7 Is a 

### Lahcllncludcd in the 

### Submission I'ackage?

# Materialto be added to an e..JacketorJacket Reg. No. 2Sl1- l Y-\

1. rPlacementwithin the e-Jacket/Jacket 

# 'F Default: (chronological, top

# = newest)



## 2. 

# If D File Location: (PDF page number)

Send to Data Extraction contractors this material: Newly stamped accepted label Notification NewCSF

# (I"~) D Other:
__________ _ Attach this coversheettothe top ofthe material orjacket. It must be well-organized and clipped together

- NOT STAPLED. Then give the material with this coversheetto staffin the Information Services Center (Room S-4900). 

# Reviewer's Name: Rosanna Louie Phone: 308.0037 Division: RD 

# Date: 

# 5" 

# Nov 20\0**~\"';EOST..,~** U.S. ENVIRONMENTAL PROTECTION EPA Registmtion No, Date ofIssuance: 

# • • AGENCY


# . ft

. P 7Q Office ofPesticidc Programs 

## NOV 

# -4 1010

# ~~~ Rcgistmtion Division (7504P) 

### 2517-134 \,**~'f(** 1200 Pennsylvania Ave., N.W.

"'1-**~o** Washington, D.C. 20460**~l PRO"';~C**  Term ofIssuance: 

### NOTICE OF PESTICIDE, Conditional Registration Ii:! Registration Time-limited: see conditions below D Reregistration Name ofPesticide Product: (under the Federal Insecticide, Fungicide, Sergeant's Fipronil

## +Methoprene and Rodenticide Act, as amended) Squeeze-on for Dogs Name and Address ofRegistrant (include ZIP Code): Sergeant's Pet CareProducts,Inc. 

### 2625 South ISSth Plaza Omaha,NE 

### 68130 Note: Changes inlabeling differing in substance fromthat accepted in connection with this registration must be submitted to and accepted by the Registration Division priorto use ofthe label in cormnerce. In any correspondence on this product always refer to the above EPA registration number.
On the basis ofinformation furnished bythe registrant, the above named pesticide is hereby registered under the Federal Insecticide, Fungicide and Rodenticide Act. Registration is in no wayto be construed as an endorsement or recommendation ofthis product bythe Agency. In order to protecthealth and the environment, the Administrator, on his motion, may at any time suspend or cancel the registration ofa pesticide in accordance with the Act. The acceptance ofany name in connection with the registration ofaproduct under this Act is not to be construed as giving the registrant a right to exclusive use ofthe name or to its use ifithas been covered by others. This product is conditionallyregistered in accordance with FIFRA §3(c)(7)(a) provided that: I. This registration is**time~limited** and expires two years from the date this product is first released for shipment.
You must providethe Agency with a projectedrelease for shipment date within 

### 30 days ofthe date ofthis Notice ofRegistration. The Agency will calculate the expiration date based on the projected release for shipment date until an actual release for shipment date is provided in writing. 

### 2. Considerlimiting the fonnulations ofeach product to one basic confidential statement offormula. The Agency may require this in the future. It is possible that no additional alternate fonnulation,s orminor formulation amendments will be approved for this product in the future. 

### 3. As a condition ofregistration for this product, within one year from the date ofthis registration, you must submitthe results ofStorage Stability and Corrosion Characteristics studies, corresponding to OCSPP Guidelines 

### 830.6317 and 

### 830.6320, respectively, including interim reports made at 

### 0, 3, 6, 9, and 

### 12 month intervals.
4. The approval ofthis registration is contingent onthe Agency's review to detennine that the study submitted on June 

### 15,2010, to fulfill OPPTS Guideline 

### 830.1800**~** Enforcement Analytical Method, is acceptable to supportthe registration.5. Within one year ofthe date onthis Notice ofRegistration, and priorto formulating this product, you must provide the Agency the foHowing:

a. The registration number and establishment number ofthe manufacturing ortechnical product from which the active ingredient is derived. b. The name and address ofthe entity from which the manufacturing productwas obtained; and c. A copy ofthe bill ofsale for this manufacturing product.
6. You must submit quarterly enhanced incident reports and quarterly sales information in doses sold for this product forthe quarterthatbegins onJanuary 1, 2011. The quarterly reports are due two months after each quarter ends. Please flag any Confidential Business Information as such. Enhanced incident reporting should be submitted to the Product Manager. Quarterly sales information should be submitted to the Registration Division, Immediate Office (attn: KimberlyNesci). The following is a list ofinformation that must be included in the quarterly reports for each incident:
EPARegistration Number Product name (bmndname) Lot# Where purchased: internet, store, veterinarian Active Ingredient(s) Weight range for product
Date onwhich incident occurred. (mm/dd/yyyy) State in which the incident occurred. (standard 2 letter abbreviation) Registrant case # Species: dog, cat, other (specify) Breed: (as reported by petowner) Age: months oryears Sex: M, F, orneutered Weight pounds Primary Route ofExposure: dermal, oral, other animal, inhalation, other Body System: neurological, dermatological, 

### Gr, respiratory, ocular, other Major signs noted with sepamte column for each sign, using standard terminology Timeto Onset (hours, days) Treatedbyveterinarian: yes orno First time productused: yes orno Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) Anyknown precondition EPA Severity Code: death, major, moderate, minor Outcome: died, recovered, still treated, unknown
7. Along with the enhanced incidentreporting, you must submit an analysis ofthe incidents seen, to include the following details:
All incidents should be reported including all minor dermal and ocular irritation reports. Summarytable fordogs showingnumber ofincidents ofeach severity code for eachrouteofexposure. Each incident should only be reported once. Ifone incident has several routes ofexposure, the order should be ocular> oral> dennal. In other words, an incident with both oral and dennal exposure would bereported as oral exposure, and an incident with both ocular and oral exposure would be reported as ocular exposure. A similar summary table for cats (misuse or secondary exposure) showing number of incidents ofeach severity code for each route ofexposure. Summarytable for dogs and table for cats showing number ofincidents that are believed due to secondary exposure (e.g., multi-pet households).
A summarytable for dogs showing number ofincidents for each severity codefor these age ranges: <3 months, 3-6 months, 6-9 months, 9-12 months, 1yr, 2 yr, 3 yr, 4 yr, 5yr, 6 jT, 7yr, 8jT,9yr, IOjT, II yr, 12yr, 13jT, 14jT, 15jT,>15yr.
A summarytable showing the number ofdog incidents for each severity code for each pet weightrange on the product label.
A summarytable for dog weight showing number ofincidents for each product weight range. This table should show number ofincidents in dogs weighing less than that product weight range, number ofincidents in dogs in lower halfofweight range, number ofincidents in dogs inupper halfofweightrange, and dogs weighing more than the product weightrange. Table showing number ofincidents for each dog breed. Table showing number ofincidents in dogs for each clinical sign. Table showing number ofincidents indogs for each organ system. Report aggregate incidents, but do not combine moderate and minor incidents. 8. You must submit and/or cite all data required for registration ofyourproduct under FIFRA Section 3(c)(5) whenthe Agency requires all registrants ofsimilar products to submit such data, and submit acceptable responses required for reregistration ofyour product under FIFRA section 

### 4. All labeling comments below are inreference to the master label: 9. On page 2, delete "VetSpot" and "SentryVet" from the list ofaltematebrand names, because misleading tenns are not pennitted. 10. On page 2 underthe header Multiple Bugs, revise the first claim containing "controls sarcoptic mange" to read "controls mites that may cause sarcoptic mange." 11. On page 4 underthe header All Others, revise the claim "controls sarcoptic mange [infestations]" to "controls mites that may cause sarcoptic mange." 12. On page 4 under the headerAll Others, add the qualifier "8 weeks ofage orolder" at the end of the statement after "puppies." 13. On page 4 underthe list ofclaims, delete the following claims because the Agencyhas not received or approved the proposed text or graphics on these inserts:Delete "clip" and "card" in the "Free with purchase" claim "Monthly application reminder card inside" 14. On page 5 under the list ofclaims, replace the "X" in the last claim to read "3", since this is the only number ofapplications pennitted to be contained in a single package, which has been approved bythe Agency. 15. On page 5 inthe last section ofdog weights, delete the brackets between "puppies" and "8 weeks" because the qualifier "8weeks ofage or older" must accompany any reference to "puppies." 16. On page 5 above the ingredient statement, delete "ingredient statementmaybe on front or back label" because the ingredient statement must be clearly printed onthe front panel ofthe label, and EPA has notreceived any request or rationale from Sergeant's to consider an exception to this**requiremen~** per 40 CFR 156.IO(g)(2)(i). 17. On page 5 under Net Contents, delete the "6 [six]" and "9 (nine]" options because these number ofdoses were not submitted for approval by the Agency and are not pennitted as an option, until new Child Resistant Packaging testing that includes these number ofapplicators per package are submitted to the Agency. 18. On page 6 atthe top ofthe BackPanel section, in order to retain the "sustained release formula" claim, the following revision must be made to the statement: "(The active ingredient in (brand name] features a sustained release fonnula developed for fast acting (and long lasting] control offleas, ticks, mosquitoes and chewing lice for up to 30 days on dogs.]" 19. On page 7 under the Directions for Use section, make the statement "do not allow children to apply product" in all bold and capitalized letters. 20. On page 7 underthe Directions for Use section, delete "Insert Copy" as an option because all language under the Directions for Use must remain together on the labeled package. 21. On page 7 under the Howto Apply section, delete "Repeat application may be made ifnecessary, but" from thelast statement so that the revised statement reads as follows: "Do not apply more than once every 4 weeks." 22. On page 10 underthe Brand Name section, delete "[6][9]"from the second and third claims, and delete all numbers after 

### "yd" inthefifth claim. 23. On page 1 0in thelist ofclaims starting with Brand Name, delete "monthly reminder card" because the Agency has not received or approved the proposed text or graphics. 24. Revise the EPA Registration Number to read: "EPA Registration No. 2517-134" on page 10 of the label. Ifthe Agency detennines that future mitigation measures are necessary for all pet spot-on products, you will be informed, and be expected to comply. Ifmitigation measures are necessary, the Agency may take appropriate regulatory actions. Two copies ofthe finished labeling must be submitted prior to releasing the product for shipment. Ifthese conditions are not complied with, the registration will be subjectto cancellation in accordance with FIFRA sec. 6(e). Your release for shipment ofthe product constitutes acceptance ofthese conditions. A copy ofyour label stamped "Accepted with Comments" is enclosed for your records. Ifyou have any questions concerningthis action, please contact Rosanna**Louie~Juzwiak** at (703)**308~0037.** Enclosure:

- Sergeant's Fipronil 

### + Methoprene Squeeze-on for Dogs Label, StampedAcceptedwith Comments

# «~~vm[#C-- Date: 

## NOV 

## -4 2010
Richard Gebken, Product Manager (10) Registration Division, Insecticide Branch
EPA Form 8570-6

# Sergeant's Master Label 20 October 20I0 Information in ( ] is optional. 

### FRONTPANEL 

### Page 1

### oflO EPA No. 25 17-RGU


## DOG SQUEEZE 

## ON FIPRONIL+METHOPRENE

The followiIlg pages contain the masterlabel, including optional label textlbatmaybe found on final printedproduct labels. The CRP required text will not change.

ACCEPTED 

### with COMMENTS InEPALetterDated: 

## NOV - 4 2010 Underthe Federsllnseeticide, Fungitide, and RodetrticideAet, asamended, for tbe pesticide registered under EPA Reg. No. **2517- 13=t** 

# Sergeant'sMasterLabel 20 October 2010 EPA No. 25I7-RGU Information in [ ] is optional. Page 2 of 10 

### [Optional text appears in brackets

- the final label may include some or all ofthe optional text on front, back or side label panels] 

# Sergeant's Fipronil 

# +Methoprene Squeeze-On for Dogs [ABNs:] [(Sergeant's®) (Sentry®) VetSpotTM Plus (Spot On) for dogs] [(Sergeant's®) (Sentry®) Frontier Gold (Spot On) for dogs] [(Sergeant's®) (Sentry®) Ectoadvance (Spot On) for dogs] [SentryProline (Spot On) for dogs] [SentryVet (Spot On) for dogs] IISENTRY®] FIPROGUARD'" PLUS for dogs] IISergeant's®] PRONYL OTC'M PLUS for dogs] [Apply to puppies over 8 weeks old] [Apply to puppies 8 weeks or older]

# :@--~*~I [Mosquitoes] [. Kills mosquitoes] [within 24 hours] [-Kills [and] [repels] mosquitoes that may transmit heartworm] [Adult Fleas] [·Kills [adult] fleas [for up tothree months.] [·Kills newly emerged adult Fleas before they lay eggs] [·Kills [and repels] Fleas, source of [flea allergy dermatitis] [, flea bit anemia] [and tapeworm infestations]] [. Kills 

### [&] [and] [Repels] Fleas Up to [4 weeks] [1 month] [30 days]!] (. If

### dog is at high risk for flea reinfestation a once a month application may be needed] Multiple Infestations [-Kills [chewing] lice and controls sarcoptic mange] [. Flea 

### [&] [and] Tick Control for Dogs 

### [&] [and] Puppies 8 weeks old 

### [&] [and] older] [·Kills [and] [&] repels] fleas, flea eggs, ticks, [chewing] lice [&] [and] mosquitoes] ['Kills [and] [&] 

### [repels] fleas, ticks, mosquitoes, [chewing] lice, flea eggs, flea larvae [&] 

### [and] [flea pupae] [·Kills 

### [&] [and] [Repels] Fleas, Ticks 

### [&] [and] Mosquitoes] ['Breaks the Flea Life Cycle [forup to three months]] [-Monthly flea, tick, mosquito, lice, and flea egg protection] [-Monthly flea, tick, mosquito and lice protection]

# Sergeant's Master Label 20 October 20I0 EPANo. 25 I7-RGU 

### Information in [ ] is optional. Page 3 of 10 

## FRONT PANEL . DOG SQUEEZE ON FIPRONIL+METHOPRENE

[Ticks] [-Kills fleas, ticks, mosquitoes, flea eggs, and lice] [. [Seven] [7] Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea larvae 

### [&] [and] flea pupae]] 

### [·6 [Six] Way Protection! Kills fleas, ticks, mosquitoes, lice, flea eggs 

### [&] [and] flea 

### larvae] [. [4 Week] 

### [1 month] 

### [30 day] [Flea [and] [&] Tick Treatment] [. [Four (4) Week] 

### [1 month] 

### [30 day] [Flea Tick, Mosquito and Lice Control] [.Use [brand name] monthlyto break the flea life cycle.] 

### [-Use [brand name] monthly to control ticks and chewing lice] [-Monthly flea, tick, mosquito, flea egg, flea larvae and chewing lice protection.] 

### [Once A Month Flea and Tick Treatment] [. [4 week] [I month] 

### [30 day] Flea and Tick Treatment!] [. Kills [&] [and] Repels Fleas, [and] Ticks [and mosquitoes] for up to [4 weeks] [1 

### month] 

### [30 days]!] [. Kills Fleas, Ticks, Flea Eggs 

### & Flea Larvae for up to [4 Weeks] [I month] 

### [30 days]] 

### [-[Images ofthe 

### different kinds ofbugs 

### killed 

### with a line drawn through each bug]]
[-Kills [and] [&] 

### repels] Ticks including those that may transmit Lyme disease] [. Kills [and] [

### &] repels] Ticks for Up to [4 weeks] [I month] 

### [30 days]!] [. [Kills [and Repels] [all stages of] (deer) ticks [before they can] [that] [transmit Lyme disease,] [for up to [4 weekS] [I month] 

### [30 days] [per application]]] [. Kills [and1 [&] repels] Ticks (Including Deer Ticks) for up to [4 weeks] [I month] 

### [30 days]] [. Kills [and] [&] repels] [brown dog ticks,] [American dog ticks,] [and lone star ticks] [and deer ticks] 

### [(Rhipicephalus sanguineus)] [for up to [4 weeks] [I month] 

### [30 days]] [. Kills [&] [and] Repels] American Dog Ticks 

### [(Dermacentor variabilis)] for up to [4 weeks] [I month] 

### [30 days]!] [Flea Eggs and Larvae] [·Controls [flea] reinfestation [for up to [12 weeks] [3 months]]] [.Kills adult fleas, flea eggs, flea larvae and pupae for up to [three months] [12 weeks].] [-Kills all stages 

### ofthe flea (including adult fleas, flea eggs, flea larvae and flea pupae)] [. Ifdog is a high risk for flea reinfestation a once month application may be needed] 

### [.Kills flea eggs [larvae] [pupae] for up to [3 months] [12 weeks]] [. With (S)-methoprene Insect Growth Regulator [IGR] which Breaks the Flea Life Cycle] [. With (S)-methoprene to Break Flea Life Cycle] [. With Insect Growth Regulator [IGR] to Break Flea Life Cycle] [. Dual Action [!]:Fipronil with (S)-methoprene IGR [insect growth regulator] Effectively Breaks the Flea Life Cycle] [.Dual Action [I]: Effectively Breaks the Flea Life Cycle 

### [ill [. Kills Flea Eggs 

### & Flea Larvae for [3 months] [12 weeks]!]

# Sergeant's Master Label 20 October 2010 EPA No. 2517-RGU 

### Infonnation in [ ] is optional. Page 4 of 10 

### FRONT PANEL 

### DOG SQUEEZE ON FIPRONIL+METHOPRENE [. Prevents Flea Eggs From Developing Into Biting Adults] [. Kills all stages ofthe flea life cycle] 

### [-Controls reinfestation [for up to 3 months]] [-Complete protection against all stages ofthe 

### flea life cycle] [All Others] 

### [-For Dogs and Puppies 8 weeks ofage or older] [-Controls sarcoptic mange [infestations]] [·For Dogs [up to 22Ibs.], [23-44Ibs.]' [45-SSlbs.]' [S9-132Ibs.] [·Fast Acting] 

### [-Dogs can be bathed 24 hours after treatment] ['Long Lasting] 

### [·Prevents reinfestation] [·Easy to use [application]] 

### [-Once a month treatment recommended] [·A once 

### monthly application is recommended for chewing lice.] [-Fast Action against [chewing] lice infestations] 

### [. [Three] [3] Applications {for cartons with 3 applicators}] andlor 

### [3 Month Supply] or [12 Week Supply] 

### [. Best ifused 

### year round!] [. (lCON Showing [4 Week] [1 month] [30 day] Protection)] [·4 Week Dose!] [. 1Month Dose!] [. 30 Day Dose!] 

### [. Specially Formulated for Dogs and Puppies] [. [Free] Calendar Stickers Inside!] [. Apply once every [4 weeks] [month] [30 days]!] [. Dogs canbe bathed 24 hours after Spot-on is applied] [·Can be used on breeding, pregnant and lactating [bitches] [female] [dogs]] [. [Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [clip] [card] [inside]] [. Waterproof] 

### [-Can be used on puppies 8weeks ofage and older] [-Monthly application reminder card inside] [. Fipronil (9.S%) +(S)-methoprene (S.S%)] 

### [. Lift [here] for more information] [Contains Fipronil and (S)-methoprene[,] [-]the active ingredients used in Frontline Plus®'] 

### [* 

### [Brand Name] is not manufactured by or distributed by Merial. Frontline Plus® is a registered trademark ofMerial.] [For year-round protection, apply [Brand Name] monthly]

# Sergeant's MasterLabel 20 October 2010 EPA No. 25l7-RGU Informationin [ ] is optional. Page 5 of 10 

### FRONTPANEL. . 

### DOG 

### SQUEEZE ON FIPRONll.+METHoI'RENE [[X) Applications) [For use ONLY on dogs [Up to 22lbs) [23-44 lbs) [45-88lbs) [89-l32lbs) [over 8 weeks ofage)) [For Dogs & 

### Puppies) [8 weeks or older))and))up to 22lbs.) [For Dogs 23-44Ibs.) [For Dogs 45-88lbs.) [ForDogs 89-132Ibs.) 

### [ ] - Denotes Optional Statements and/or Images thatMay be Used on Front, Back or Side Label Panels [Ingredient Statement may be on front orback label]



### ACTIVE INGREDIENTS: Fipronil.

......................................................................9.80% (S)-methoprene

..........................................................8.80% 

### OTHERINGREDIENT**:

................................... 81.40% TOTAL: 100.00% [**diethylene glycol monoethyl ether]

KEEP OUT OF REACH OF CHILDREN CAUTION See [Back)[or)[Side) [Label Panel[s) [or) [insert) for Additional Precautionary Statements



### NET CONTENTS:

[3) [three) [6)[six)[9)[nine) 0.023 fl 

### oz (0.67 mL) applicators [3) [three) [6)[six)[9)[nine) 0.045 fl 

### oz (1.34 mL) applicators [3) [three) [6) [six) [9) [nine) 0.091 fl 

### oz (2.68 mL) applicators [3) [three) [6)[six)[9)[nine) 0.136 fl 

### oz (4.02 mL) applicators


### (END

- FRONT PANEL)

# Sergeant'sMasterLabel 20 October 201 0 EPA No. 25l7-RGU Infonnation in [ ] is optional. Page 6 of 10 

### BACKPANEL DOG SQUEEZE ON FIPRONIL+METHOPRENE [[brand name] contains Fipronil and SwMethoprene (insect growth regulator) (lOR) to effectively kill [and repel] fleas (all stages) and ticks [(including those that maytransmit Lyme Disease)]. [The active ingredients 

### in [brand name] feature a sustained release formula developed to work with the dog's natural skin oils resulting in fast acting [and long lasting] control offleas, ticks 

### mosquitoes and chewing lice [for 30 days] on dogs.] [Brand Name[

# f@'~~:OJ'1 READ ENTIRE LABEL BEFOREEACH USE. USE ONLY ON DOGS AND PUPPIES OVER 8 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS. CAUTION. Hannful ifswallowed. Causes eye irritation. Avoid contact with skin, eyes or clothing. Wash hands thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on puppies under 8 weeks ofage. Individual sensitivities, while rare, may occur after using any pesticide product. [Some dogs may experience temporary startle effects when any product is applied.] Dogs may experience some temporary irritation at the site ofproduct application. Ifsigns persist, orbecome more severe within a few days ofapplication, consult a veterinarian immediately. Ifyour dog has an unusual reaction to the initial application, consult a veterinarian before repeating treatment. Certain medications can interact withpesticides. Consult a veterinarian before using on medicated, debilitated or aged dogs. Call 1-800-781 w 4738 for 24-hour assistance.
FIRST AID Ifswallowed: Call a poison control center or a doctorimmediately for treatment advice. Have person sip a glass ofwater ifable to swallow. Do not induce vomiting unless told to do so by a poison control centeror doctor. Do not give anything by mouth to an unconscious person. lfin eyes: Flush eyes with plenty ofwater. Call a doctor ifirritation persists. Ifon skin: Wash withplenty ofsoap and water. Get medical attention if irritation persists. HOTLINE NUMBER Have the product container or label with you when calling a poison control center ordoctor, or going for treatment. You may also contact lw800-781-4738 for emergency medical treatment infonnation.

# Sergeant's MasterLabel 20 October 2010 Infonnation in [ ] is optional. 

### BACKPANEL Page 7 of 10

DIRECTIONS FOR USE EPANo. 2517-RGU 

### DOG SQUEEZE ON FIPRONIL+METHOPRENE Itis a violation ofFederal lawto use this product in a manner inconsistent with its labeling. Do not allow childrento apply product. TO PREVENT HARM TO YOU AND YOUR DOG, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS.
Do not use onpuppies under 8 weeks ofage. [Do not split one tube between dogs.] [Do not use multiple tubes on one dog.] Weigh yourdog to be sure you are applying the right dose formulated for the weight ofyour dog. Consult a veterinarian before using this product on debilitated, aged, medicated dogs. Can be used onbreeding, pregnant, or lactating dogs. Consulta veterinarian beforeusing on dogs with knownorgan dysfunction. Dogs may experience some temporary irritation at the site ofproduct application. Certain medications can interact with pesticides. Sensitivities may occur after using ANYpesticide producton dogs. If signs ofsensitivity occur bathe your dog with a mild soap and rinse with large amounts ofwater
. Ifsigns continue, consult a veterinarian immediately. [{Outer Packaging or Insert Copy}

## I How to open: Remove producttubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cut off the narrow end at the notches with scissors.
How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to apply all ofthe solutionto the dog's skin, as directed below. Repeat application may be made if necessary, but do not apply more often than once every 4 weeks. [Optional drawings that mayor may not appearon finished label]

# ~ 

# rl

FREQUENCY OF APPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and mosquito] infestations. [Studies show that] [brand name] kills all stages ofthe flea for up to three months. Apply monthly ifyour dog is at high risk for flea reinfestation[, or in a highly infested environment] Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] remains effective even after bathing, water immersion, or exposure to sunlight. Allowtreated area to dry thoroughly. Do not reapply for 30 days.

# Sergeant's MasterLabel 20 October 20I0 InfOlmation in 

## l ] is optional. 

### BACK PANEL Page 8 oflO EPA No. 25 I7-RGU 

### DOG SQEEZE ON FIPRONIL+METHOPRENE

ForDogs Weighing up to 221bs. [including small dogs and puppies, 8weeks or older): {For cartons containing 0.67 mL (0.023 f1 

### oz) applicator tubes} Apply one tube (0.67ml)(0.023 

### fl oz) [from the back ofthe neck to a point midway betweenthe neck and tail.] [as a spot on the dog's back betweenthe shoulder blades.]
For Dogs Weighing 23

- 44 lbs. 

### {For cartons containing 1.34 mL (0.045 fl 

### oz) applicatortubes} Apply one tube (1.34 ml)(0.045 

### fl. oz.) [from the back ofthe neck to a point midway between the neck and tail.] [as a spot on the dog's back between the shoulder blades.]
For Dogs Weighing 45

- 881bs. 

### Forcartons containing 2.68 mL (0.091 fl 

### oz) applicator tube} Apply one tube (2.68 mL)(0.091 

### fl oz) [from the back ofthe neck to a point midway between the neck and tail.] [as a spot on the dog's back betweenthe shoulder blades.]
For Dogs Weighing 89-132Ibs. 

### {For cartons containing4.02 mL (0.136 fl 

### oz) applicator tube} Apply one tube (4.02 

### mL)(0.136 

### fl oz) [from the back ofthe neck to a point midway between the neck and tail.

## J[as a spot on the dog's back between the shoulderblades.

## J
STORAGE AND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the packuntil readyto use. Store in a cool (below 77°F 

### [2S0C]) dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight. CONTAINER DISPOSAL: If

### empty: Non-refillable container. Do not reuse orrefill this container. Offer for recycling ifavailable. If

### partly filled: Call your local solid waste agency for disposal instructions. Neverplace unused product down any indoor or outdoor drain. 

### [WARRANTY Read the entire Directions for Use and Warranty before using this Product. By using this product, user or buyer accepts the following warranty. The directions for use ofthis product are believed to adequate and must be followed carefully. 

### Itis impossible to eliminate all risks associated with the use ofthis product. Unintended consequences may result because of unknown factors. All suchrisks shall be assumed bythe user or buyer. Sergeant's is committed to providing high quality products. To the extent consistent with applicable law, Sergeant's makes no warranties, express or implied, ofmerchantability or offitness for a particularpurpose or otherwise, that extend beyond statements onthis label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not be liable for indirect, special, incidental or consequential damages. To the extent consistent with applicable law, the exclusive remedy ofthe user or buyer shall not exceed thepurchase price paid.]

# Sergeant's MasterLabel 20 October 2010 EPANo. 2517-RGU Information in 

## I ] is optional. Page 9 of 10 

### BACK PANEL DOG SQEEZE ON FIPRONIL+METHOPRENE [If

### you have questions or comments about this product, please write: [Sergeant's] [SENTRY} Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.J

In Case ofEmergency, call: 1-800-781-4738 Non-Emergency call1-800-224-PETS (7387) [Made in USAJ Distributed by: Sergeant's Pet Care Products, Inc. [BAR CODE AREAJ P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-XX EPA Est. No. XXXXX -XX-XXX {END

- BACK/ SIDE PANEL) [Optional Insert orpackage copy] [Coupon(s) inside or on outside ofbox] 

### [Directions for Use} [Application Instructions[ [How to Apply

- May contain graphics illustrating productuse, e.g., dogwith a drop falling onto its neckfrom a vial on front, side, orback carton label and/or applicator labeling.) [{Outer Packaging or Insert Copy}J 

### How to open 1. Remove product tubes 

### [vial} from the package. 2. Separate one tube from the others. Holding the tube 

### [vial} with notched end pointing up and away from the face and body, cut offthe narrow end at the notches with scissors. How to apply: [Optional drawings that mayor may not appear on finished label]



### 1. Invert tube over dog and use open end to part dog's hair. 2. Squeeze tube firmly to apply all ofthe solution to the dog's skin [as a spot to the dog's back between the shoulder blades.} [or} {from the back ofthe neck to a point midway between the neck and taiL}

# Sergeant'sMasterLabel 20 October 2010 EPA No. 2517-RGU Information in [ ) is optional. Page 10 of 10 

### [Flea life cycle diagram] [Flea Life Cycle] [SampJe coloring and layout may be different on final label]

[Look atthe Label (Look at the Label icon) [Easy] 6 Step [Easy] [Spot On] [Squeeze-On] [Topical] Checklist • Read the label completely and follow directions • Weigh yourpet • Do NOT use dog products on cats • Do NOT treat with more than one pesticide product at a time • Separate animals after treatmentto avoid chance ofingestion • Do NOT split tubes between pets] [Brand Namc[ [Monthly reminder card] [3][6][9] [Month Treatment Tracker] [3][6][9] [Month Application Tracker][[Foryear round protection, apply [Brand Name] monthly.] [Pet's Name (Empty blank for ownerto fill in name)] [First] [1st] [Second] [2nd] [Third] [3rd] [Fourth] [4th] [Fifth][5th] [Sixth][6th] [Seventh [7'h] [Eighth}[S'h] [Ninth] [9"'] [Dose] [Treatment] [Application](Empty blank for owner to fill in date)(Date: MMlDD/YY)] 

### [calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapply [brand name] in 30 days.] [Monthly Application Reminder Magnet (image ofreminder magnet) [Enclosed for your convenience is an application reminder magnet. Pushthe (reset) button, and the reminder light will blink twice. The reminder tag is now set for 30 days. Atthe end of30 days the reminder light will blink, reminding you to reapply [Brand Name]. Press the button once and the blinking light will stop. Pressthe button again andthis will reset the timer for another 30 days.] {END

- OPTIONAL INSERT OR PACKAGE COPY} TUBE 

### I VIAL LABEL FrontLabel {Brand Name}[cat graphic with line throughJ For dogs up to X Ibs Fipronil 9.8% w/w, (S)-methoprene 8.8% w/w 0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 mL {label code} BackLabel KEEP OUT OF REACH OF CHILDREN CAUTION: Read directions and precautions before using. Use scissorsto open. EPA REG. No. 25I7-XX {label code}

# FIPROGUARDTM PLUS

FrontTube Labels BackTube Labels

KEEP OtrfOF REAcH Of[:HIUlR£N lJ'IUTlON' Ra.d d'roC',.ns ,ndprocouno" b,fu",**u~ng,**Us.

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------------------------------>-Decision stedus Trelcking Creede Resubmission FFS Letters

Action Code History Secondary DecisionUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### May4, 2010

OPP DecisionNumber: D-425453 EPA File Symbol orRegistrationNumber: 25l7-RGU OFFICE OF PREVENDON, PESTICIDES AND TOXIC SUBSTA..."JCES



### ProductName: SERGEANT'S FIPRONIL 

### + S-METHOPRENE SQUEEZE-ON FOR DOGS EPA ApplicationReceipt Date: l3-Apr-20l0 EPA WaiverRequest Receipt Date: 13-Apr-20IO EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CARE PRODUCTS, INC.
KELLYR. HOSKlNS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH l58TH PLAZA OMAHA, NE 68l30-l703 SUBJECT: Approval of50% Small Business Waiver Request
Dear Registrant: The Office ofPesticide Programs has approved your request for 50% waiver ofthe pesticide registration fee associated withthe actionreferenced above. The decisionreview periodforthis action will begin onthe date ofthis letter.
TheActionhas been identified as Action Code: R310
NEWPRODUCT;NON-F AST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY);
Ifyou have any questions, please contact the Pesticide Registration ServiceFee Ombudsman, at (703) 305-6249.
Sincerely,

# f2~rJ!kc~ InformationTechnology & 

### Resources Management Division Office ofPesticide Programs

### Revised Data Matrix: James Messina to: Rosarma Louie-Juzwiak 

### 11/04/2010 

### 12:36 PM Show Details

History: This message has been replied to.

James Messina Senior Managing Regulatory Consu!tant Exponent Centerfor Chemical Regu!ation and Food Safety 1150 ConnecticutAvenue, N.W. Suite 1100 Washington, DC 20036 202-772-4932 202-772-4979 fax 301-908-1181 cell 

### Page 1 

### of 1

CONF!DENTIALITY NOTICE: This e!ectronic transmission (including any files attached hereto) may contain information that is privileged, confidential and protected from disclosure. The information is intended on!y forthe use ofthe individual or entity named above and is subject to any confidentiality agreements with such 

### party. Ifthe reader ofthis message is not the intended recipient orany employee oragent responsib!e for delivering the message to the intended reCipient, you are hereby notified that any disclosure, dissemination, copying, distribution, orthe taking ofany action in reliance on the contents ofthis confidential information is strictly prohibited. Ifyou have received this communication in error, please destroy it immediately and notify the sender by telephone. Thank you



### file:IIC:lDocuments and SettingslrlouielLocal SettingsITemplnotesFCBCEEI-web8782.htm 1115/2010

## £, UNITED STATES ENVIRONMENTALPROTECTIONAGENCY 401 M Street, S.W. WASIIINGTON, D.C. 20460



### -.-. "".,-- II review acti\ilies. j ,gthc I 

# I**~~'6O:'** burden 10 Director: UJ 

### DATA MATRIX 1,2010

,. y,
___.>istrant's 1._.._**~** .•**~~.w_** '5 PetCare Produtts, Inc. 2625 Soulh ,**~11;1**.. _10ft On Guideline Reference 1 830.1550,830.1600, l 830.1650,830.1670 ' " 

### IS30.u:m

1:30.1
J,830.6315, 1,830.6317 .iU.Ojj f, lIJU.IHlO

{/**~** Data j Squeeze·On for Dogs '5 Fiproni!'

Product chemistry of Sergeant's Fipronil+Melhoprene Squceze.On for Dogs Storage stability and corrosioncharacteristics

II toxicity

Dennal: Evaluation ofthe DYc>

## -'"1-----_""_.- Orange Label Indicator (3){), sclssors to open -. -ion Package for Scrgeant's Pet CareProducts, Inc.**"~.ion** oflhe Dog Squeeze On 1.34ml White Applicator with Green Label Indicator(3x), scissors to open - f"o>-l as aPoison

. p_ for**~p.r<>p_:lnt'~** Pet CareProducts,Inc. EPA Re No.lFile S mbol 2SI7·RGU Product: Sergeant's Fipronil +"

UDNumber

48059101

48059102

To "'" uEon comEietion 44942004 44942005



# I..--.-**~.d** Title

KellyR."
_ •. .-!'lH f'n.**"'_~**

Inc.

Inc. Sergeant's Pcl t Jnc. 

### I**Inc~** 

# I

MERIALI

Inc.
In,

. !tCare J Inc.

. Ii Affairs**;ef~ ;":~~w**  :'Washington, DC 

### I Page I of6

Sfa"" 

### I Note OWN
OWN OWN
OWN PAY 

### PAY 

### """PAY PAY**~** OWN
OWN
OWN

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## ,eCc,\ l'!

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# IUl!'D

# & UNITED STATESENVIRONMENTALPROTECTIONAGENCY 401 M Street, S.W. WASHINGTON,D.C. 20460 F

....Apl"""f<! OMB N

..l(I7(J.(IOiu

Papenl'Ork Reductioo Act Notite: The**JlIIb]j~** reponing burdenior !.his collection ofllformaiWnlsestimated to average 0.25 hours perlesponsc fOr registrationactIvitieS-and 025 hours perresponse for reregisuation arld special rtvicw activities, includingtime fOflcading the instruction and completing the necessary forms. Send wmmenlsregarding !he burden estimate orMy other aspectofthis collection oflnformalion,including suggestions lOrreducing !he burden to Director: OPPElnformationManagemcntDivision (2t37) U.S. Environmental Protection Agency, 401 M Street, S.W., WlI£hington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Date: November 3, 2010 Applicant's!Registrant'SName & Address Sergeant's PetCareProducts, Inc. 2625 Stmth 158th Plaza, Suite WO, Om;tha, NE 68130·1703 Ingredients: Fipronil, Methoprene GuidelineReferel1:ce Number 

## I Guideline Study Name

870.7200

870.7200

870.7200

870.7200

870.7200

Signature: 

# !/J!.

EPAfOm.**~S7Q:.:1S** (W\i7) EI, 

### " Evaluation ofthe Dog Squer;:zc On 4.02ml White Applicatorwith Blue Label Indicator(3x), scissors to open" F""I as aPoison PreventionPackage for Sergeant's PetCare Produets, Inc. Powell; L.; Paffett;""R: (1995) Domestic AnimafSat"ety Study byTopical Administration to Dogs: Fipronil Spot Treatment (RM 160lE): Lab ProjectNumber: MRX 231950406. Unpublished studyprepared by Huntingdon Research Centre, Ltd. 219 p, Canovas. M.; Villagcliu, J.; Lopez, S.; et al. (1994) Pereutaneous Absorption and Hair, Skin, andFat Distribution of Radioaetivity After Spot-On Application of(Carbon 14)-RM1601 in Beagle Dogs: Lab ProjectNumbcrs: CD·9313405F: Q.42.769. Unpublished study prepared by Centrode Invesligaeion y Desarrollo Aplieado, SAL. 68 p. Nolan-Smith, S. {l999Tf'lproniV(S)-Methoprenei'opical Solution: Target Species Safety Study in the Dog: InterimReport: Lab ProjectNumber: 1686/2: 1686/2-01142: PR&D 0002101. UnpUblished study p)'(:pared bv Covance Laboratories Ltd. 266 p. Nolan-Smith, S. (1999) Fipronill(S).Methoprene Topical Solution: Target Speeies Safety Study in the Dog: ReportAmendment: Amendmentto InlerimReportLab ProjectNumber: 168612: 168612.01142. Unpublished study preparedby Covance Labs., Ltd. 6p. Nolan'Smith, S. (2001) To InvestigateIhe Safety ofaTopical Formulation Containing Jl..fL-2,095,988 509Tin Dogs Weighing Approximately 2kg (+!.1.5kg) at One, Three and Five Times the Maximum Label RecommendedDosage: Final Report: Lab**Projee~** Number: 1686112: 1686112-02160: PR&D 0045801.**U!}~JU)l\ished** sludY',ll"Cpared by CovanceLaboratories. 324 p,_ 

# 1bIL//Ji P'pdV''''iQ

..A;;lil,bl

..**f"b~ly\t.""r_.;oo** EPA**~~gNo.lFi\e** Symbol 2517-RGU Product; Sergeanl's Fipronil + Methoprene Squeeze-Qn for Dogs
MR.lDNumber 48059806

43863802

43577715

44942104

45143901

45612702

Name and TItle Submitter Sergeant'sPet Care Produels, Ine. MERIAL LIMITED

MERIAL LIMITED

MERIAL LIMITED

MERIAL LIMITED

MER1ALLIMITED

Kelly R. Hoskins,. ManaJ,!;erofTe::hnieal Affairs Pa).!e 2 of6

Status .IJ"l"ote 

### OWN

PAY



### OLD

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Dale 11/312010 ",....filil

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## teet**\d~1** WI 01'

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.....td OMll N •. 101U-IlIlH 

### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY**,~.** 

### 401 M Street, S.W.**,~,** 

### WASHINGTON,D.C. 20460 PaperWorkReduction ActNotice: Thepublicreporting burdenfor this collection ofilfonnalion is estimated to average 0.25 hours perresponse for registration activities and 0.25 hours per response for reregistration and special review actimies, includmg timefor reading the tn3eregistrntioncompletingthenecessary fooos. Sendcommentsregarding the burden cstimate or any other aspectofthis collection ofinfonnation.. including suggeSlions for reducing theburden 10 Director.OPPEtnfonnationManagemcnt Division (2137) U.s.EnvironmematProteclionAgency,40t M SlIeet, S.W.,Washington, OC 20460. 00not sendthe fonn to ibis address. 

### DATA MATRIX Date: November 3, 2010 EPARe No.lFileS mbol 2517·RGU P e 3of6 Applicant'slRegistrant'sNlIffie & Address Product: Sergeant's Fipronil +Methoprene Sergeant's PetCareProduets, Inc. 2625 South I58th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs Illgrcdients:**I:i~onil,** Metho ene



### - Guideline Reference Number Guideline Study Name MRlD Number Submitter Status Note 870.7200 Godin, C.; Alva, R. (2000) ML·2,095,988 45620507 MERIALLIMITED PAY 509TIDogiSolution/TopicaVSafelytrolerance/Reproduction, Reactions: Final Report: Lab ProjectNumber: PR&D 0020201: WEL 99885: PR&D 00202. Unpublished study prepared by WhiteEagle Toxicology Laboratory. 123 P. 870.3300 MeCal!:i; McTier, T. (1995)positive Referenced and Untreated 43577712 MERIAL LIMITED OLD Controlled, Confirmatory Laboratory Trial ofRM160lE SPOT· ON FormulationAppliedto Dogs as 3Weight Class Defined Volumes for the Control ofthe CatFlea Ctenocephalides felis, the Brown Dog Tick Rhipicephalus sanguineus, andtheAmerican Dog TIck Dermacentor variabilis: Lab ProjectNumbers: RMlFLSTKSI94/2L: RMlVSR·249LT: PT·249LT. Unpublished study prepared byTRS Labs Inc. 41 p. 870.7200 Astruc, B.; Suberville, S.; Bose, F. et a!. (1998) Evaluationofthe 44487701 MERIAL LIMITED PAY Presence ofM&B46513 on the HairAfter aTopical Application (Spot·on orSpray) ofFipronii to the Dog: Final Report Lab Project Number. MET4I9: ROO2459. Unpublished sltldv oreoared byMeria!. 28 o. Signature: 

# !1.,!J Ii-..J'/d Name and Title 

## D,,, Kelly R. Hoskins, Manaf!erofTechnical Affairs 111312010 EI'A F"""**~57o.1S** ('.91),"<dnlnio

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### UNITED STATES ENVIRONMENTALPROTECTIONAGENCY .l!, 

### 401 M Street,S.W.**-~;** 

### WASHINGTON, D.C. 20460 PaperworkReduction ActNotice: Thepublic reporting buroCll for this collectionofi:1ronnation is estimated to average 0.25 hours perresponsc forreglstrationactivities and0.25 hours perresponse for reregistration and special review activities, including time for reading thc ln4eregistratiOl1completingthe necessary fonns. Sendcomments regarding the burdenestimate orany otheraspectofthis collC{;tion ofinformation, including suggestionsfor reducing the burden to Dircetor: OPPE 1nfonnationManagementDivision (2137) U.S. Environmental Protcction Agency, 401 MStreet, S.W., Wa.'ihington, DC 20460. Donot send thc form to this address. 

### DATAMATRlX Date: November 3. 2010 EPA Re No.lFile S bol 2517-RGU Pa e40f6 Applicanl'slRegistrant'sName & Address Product: Sergeant's Fipronil +Methoprene Sergeant's Pet Care Products,lne. 2625 South 158m Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs In «ilents: Fi ronil, Methoprene Guideline Reference Number Guideline Stud Name MRIDNumber Submitter Stalus Note 133-3 Meo, N.; Gonzalez, C.; Mester, T. (1997) Dennal and Inhalation 44433302 :MERIALLl1\.1ITED PAY ExposureofCommercial PetGroomersDuring Application of Frontline SprayTreatment: Final Report: Lab ProjectNumber: MERIAL-445-SAFXT046: SAFX046: PDA9705. Unpublished study prepared by ABCLabs., California and Aanimal Appcal Grooming Shop & CaseVeterinary Hospital. 1066 p. 133-3 Meo, N.; Gonzalez, c.; Bclcher, T. (1997) Dermal Exposure of 44433303 MERIAL LIMITED PAY Commercial PetGroomers DuringApplication ofFrontline Top Spot: Final Report: Lab ProjectNumber: MERIAL-445- SAFXT047: SAFXT047: EC-97-390. Unpublished study prcpared by ABC Labs., Californiaand Aanimal Appeal Grooming Shop & Case VeterintUY Hospital. 925 p. 132-1 Hughes, D. (1997) Dislodgeable Residues ofFipronil Following 44433305 MERIAL LIMITED PAY Application ofFrontlineTop Spotto Dogs: Final Report: Lab ProjectNumber: COVANCE 6848-101: MERIAL METXT 166: METXT 166. Unpublished study prepared by CovanceLabs. Inc. 161 p. • 

# 7_ Signature: 

# ti, 

# Ltrd...-!.'4! Name and Title Date Kelly R. Hoskins. Manager ofTechnical Affairs 1113/2010 EPAFonn IS1(l.-J5 (9--'17)**E_"i~** an perV"-';"",Availabl", Suri! '_D_ .0

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### 401 M Street, S.W. 

## s- WASHlNGTON, D.C. 20460 PaperworkReduelion ActNotice: Thepublkreporting bmden for this colleclion ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours perresponse for reregistralioo and special review aeli'oities, including time for reading the in5eregistmtioncompletingthe necessary forms. Sendcommentsregarding the burden eslimateor Myotheraspectofthis collection ofinformation, including suggestions forredUCing theburden 10 Direelor: OPPE tnformstionManagementDivision (2131) U.s. Environmental ProlectionAgency, 401 MStreet, S.W., Washington, OC 20460. Do nol selld the fOIm 10 this address. 

### DATAMATRlX Dale: November 3, 2010 EPARe'i'No.lFileS mbol 2517-RGU Pa e50f6 Applicant'sfRegiskanl's Name & Address Product: Sergeant's Fipronil +Methoprene SergeanfsPetCare Products, Ine. 2625 South 1581h Plaza, Strite 100, Omaha, NE**68I30~1703 Squeeze~On**  for Dogs In redients: Fi ronil, Melho rene Guideline Referencc Number Guidelinc Stud Name MRIDNumber Submittcr Status Note**132~1** Hughes, D. (1997) Dislodgeable Residues ofFipronii Fotlowing 44433306 MERIALLlMlTED PAY Application ofFrontline SprayTrealmenl to Dogs: Final Report: Lab ProjectNumber: COVANCE**6848~100: 6848~100:** **MERIA1A45~METXT-165.** Unpublished study prepared by Covance Labs. Inc. 184 p.**132~1** de Fontenay, G.; Campagna, I.; subcrvitle, S. et al. (1997) 44531203 MERIAL LIMITED PAY DislodgClable Residues ofFipronii Following aTopical Application ofFrontline Spot-On Treatment to Dogs: Final Report: tabProjcctNumbcr: 817/024B: MET416: MERJAL-480-MET-416. Unpublished study prepared by Merial Ltd. and Chrysalis Preclinical**Services~Europe.** 68 p. 132-1 de Fonlenay, G.; Campagna, I.; Suberville, S. et al. (1997) 44531204 MERIAL LIMITED PAY Dislodgeable Residues ofFipronli Fottowing aTopical Application ofFrontline Spray Treatmentto Dogs: Final Study: Lab ProjeetNumber: 817/024A: MET414:**MERIAL-480·MET~** 414. Unpublished study prepared byMerialLtd. and Chrysalis Preclinic:ai Services-Europe. 70 tI. N/A Irwin, I. (1997) Use Survey ofComrnerciai and Veterinary Pet 44433301 MERIAL LlMlTED PAY GrOOmers and Pet Owners ofFrontlineTop Spotand Frontline SprayTreatment: Lab ProjectNumber: MERIAL-445-SURVEY. Unpublished study prepared by Wiese Research Associales, Inc. 

### ,40p. Hughes, D. (1997) Validation ofan Analytical Method for the 44433308 MERIAL LIMITED PAY DelermiJ:J.ationofFipronil, M&B45950, and M&B46513 in DyeFree 100%Cotton Gloves: FinalReport: Lab ProjectNumber: COVANCE6848-104: 6848-104: MERIAL METXT 169.**Unpubli~hed** study preparcd by Covancc Labs. Inc. 41 p. Polakoff, B.; Youngren, S. (1997) Non-Dietary RiskAssessment 44433309 MERIAL LIMITED PAY FipronilUse on Pets in aResidential Setting: Lab Projcct**NUmy~~~:~RONIL ~~::** **MERIAL~445-NDRA.** Unpublished stud areq,by.Nov· en Scienccs Inc. 27 p. Signature: 

# 4£ '(/ 0 

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# M' Name and Title Date Kelly R. Hoskins, Manager ofTechnical Affairs 111312010 EPA F<>Im 8571).H (9.97) 8«trQ"ic 

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Guide! Polakoff, B.; Youngren.S. (l997fPet 1 Analysis and Risk Assessment: "'-- Frontline ;'jpray frcatment Lab ProjectNumber: FIPRQNIL 97-11: MERIAIA45·PGRA. Unpublished study prepared by Novigen :, Inc. 17p. ; Walls, C.**('--~'-**

Spot and ExposureAnalysis and Risk Assessment: Lab ProjectNumber: FIPRONIL98·07: MERlAI.-445-LPERA. Unpublished study prepared by Novigen Sciences, Inc. 21 p. e.; Youngren, S. (1998) Frontline on Pets in a .•**_L'~ S.~tting:**  RiskAssessmentofa Low ProbabilityEvent t'osr-f\.ppll<.:(tllvn Acute Exposure: Lab ProjectNumber: FIPRONIL 98-06: MERJAL..445-PGRA. Unpublished study

r ared b Novi en Sciences. Inc. 18 810.3300 

### Em Signature:**OI~""** Submitter 310 MERIALJ



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## {'ec;~ ,tilth.cIDSergeant's PetCare Products, Inc, 2625 South 158th Plaza • Omaha, NE 68130-1770

.. Telephone 402,938.7000 • Fax 402.938.7091

.. www.sergeants.com 

### October 21, 2010 Rosanna Louie-Juzwiak Document Processing Desk Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 Subject: Submission ofProductLabel and Data Matrix Infonnation
Dear Ms. Louie-Juzwiak: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158lh 

### Plaza, Omaha, NE 68130-1770, EPA Company Number 2517) is submitting an updated product label and data matrix in support of the following pending registration application:

• Sergeant's Fipronil 

### +S-Methoprene Squeeze-On for Dogs (EPA File Symbol 25 I7-RGU). Please find enclosed mock labels and a master label for the above-referenced product. The enclosed mock labels (four product sizes) are for the alternate brand name FiproguardTM Plus for Dogs. In addition to the mock labels, Sergeant's is submitting the final master label for Sergeant's Fipronil 

### + S-Methoprene Squeeze-On for Dogs, The master label contains all ofthe alternate brand names and alternate optional label language and claims. Sergeant's requests that the Agency review the mock labels and master label and stamp them as the EPA approved label. Sergeant's confirms that the label language specific to the Child Resistant Packaging (CRP) will be identical to the language found on the enclosed mock label and master label and that it will not change for any ofthe other alternate brand name product labels. Please also find enclosed an updated data matrix (EPA and Public versions). The data matrix was updated to reflect the MRlD numbers identified in EPA's reviews and to remove any ofthe MRlD numbers related to support ofan experimental use permit (Merial Limited). The latter revision was at the request ofEPA. Ifyou have any questions, please contact me at 402-938-7079, Sincerely,

# Jt4~/1- Kelly Hoskins Manager ofTechnical Affairs Sergeant's Pet Care Products, Inc. Enclosures

cc: Richard Gebken, EPAForm App,o

.. d OMB No.**2U70..(lO~U** 

### UNITED STATESENVIRONMENTALPROTECTION AGENCY 

# " ,"!C!"! 

### 401 M Street, S.W.**~""'.** 

### WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofl1formalion is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for ren:gistration and special review activities, including time for reading the instruction and completing the necessary forms. Sendcomments regarding thc burden estimate or any other aspect ofthis collection ofinfonuation, including suggestions for reducing the burden 10 Director. OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 40 IMStreet, S.W., Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Dale: October 20, 2010 EPA RegNo.lFile Symbol 2517-RGU Page Iof9 Applicant'slRegistrant's Name & Address Product: Sergcant's Fipronil +Methoprene SCf£eant'S Pet Carc Products, Inc. 2625 South 158th Plaza, Suile 100, Omaha, NE 68130-1703 Squeeze-On for Dogs Ingredients: Fipronil, Methoprcnc Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note 830.1550,830.1600,830.1620, Product Propcrties Data for Sergcant's FiproniJ + Methoprene 48059101 Sergeant's Pet Care Products, OWN 

# I 830.1650, 830. 1670, 830.I700. Squeeze-On tor Dogs Inc. 830.1750 I 830.1800 Enforcement analytical method 48122601 Sergeant's Pct Care Products, OWN 

# '[---1 Inc. 830.6302,830.6303,830.6304, Product chcmistry of Sergcant's FiproniJ + Melhoprene 48059102 Sergeant's Pet Carc Products, OWN 830.7300, 830.7000, 830.6315, Squeeze-On for Dogs Inc, 

# I

. 830.7100,830.6320,830.6317 

# _ J 830.6317,830.6320 Storage stability alld corrosion characterislics To be submittcd Sergeant's PetCarcProducts, OWN 

### , , UDOn complelion Inc. 870.1100 Acute oral toxicity 44942004 MERIAL LIMITED PAY
870.1200 Acute dcnnal toxicity 44942005 MERIAL LIMITED PAY
870.1400 Primary eyc irritation 44942006 MERIAL LIMITED PAY
870.1500 Primary dennaJ irritation 44942007 Iv1ERIAL LIMITED PAY
870.1600 Dermal scnsitization 44942008 MERIAL LIMITED PAY Evalualion ofthe Dog Squecze On 0.67ml White Applicalor with 48059803 Sergeanl'sPctCareProducts, OWN Orange Label Indicator (3x), scissors to open - F=l as a Poison Inc. Prevenlion Package for Sergeant's Pet Care Producls, Inc. Evaluation oftile Dog Squeeze On 1.34ml White Applicator with 48059804 Sergcallt's Pet Care Products, OWN Green Label Indicator (3x), scissors to open - F=I as a Poison Inc. Prevention Package for Sergeant's Pel Care Products, Inc. Evaluation ofthe Dog Squeeze On 2.68ml White Applicator with 48059805 Scrgcant's Pet Care Products, OWN Red Label Indicator (3x), scissors to open - F=l as a Poison Inc. Prev;;ntion Paekal!C for Sergealit's Pet Care Products, Inc. Signature: 

# ihjl/.' fiLpI;m Name and Title Date Kclly R. Hoskins, Mana.ger ofTeclmicaJ Affairs 1012012010 EPA Form 8571)..35 (9.971 EI«"oo,rA'nd P"OJ VcrsiOll' A

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# Cf"fFn

..App.-.,-.d OMB No. 26'16·0\'160 

### UNITED STATES ENVIRONMENTALPROTECTION AGENCY**~~** .},.,," 

### 401 M Street, S.W• WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofmfOimation is estimated to average 0.25 hours pcrresponse for registration activities aud 0.25 hours perresponse for reregistration and special review activities, including time fur reading the instruction and completi11g the necessary fonns. Sendcomments regarding the burden estimate or any other lISped ofthiscollection ofinformation, including suggestions for reducing the burden to Director: QPPE Information MiIIlagement Division (2137) U.S. Ellvironmcntal Protection Agency, 401 MStreet, S.W., Wasllinglon, DC 20460. Do nOl sendthe form to this address. 

### DATA MATRIX Date: October 20, 2010 EPA Re No.lFileS mbol 2517-RGU Pa e20f9 Applicant'slRegistrant's Name & Addrcss Product: Sergeant's Fipronil + Methoprene Ser,geant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130- 1703 Squeeze-On for Dogs Ingredients: Pi ronil, Metho rene Guideline ReferenceNumber Guideline StudyName MRlD Number Submitter Status I },;{,t

.... Evaluation oftheDog Squeeze On 4.02ml White Applicator with 48059806 Sergeant's Pet Care Products, OWN 

# : BlueLabel Indicator(3x), scissors to open - F=I as a Poison Inc. Prevention Package for Sergeant's Pet Care**Producl~,** Inc. 

### I 870.7200 Powell, 1.; Pafictt, R. (1995) Domestic Animal Safety Study 43863802 MERIAL LIMITED PAY 

# i I by Topical Administration to Dogs: Pipronil SpotTreal.ment (RM 160IE): Lab Project Number: MRX23/950406. Unpublished study prepared by HUlltingdon Research Centre, Ltd. 219 p. 870.7200 Canovas, M.; Villageliu, 1.; Lopez, S.; et ai. (1994) 43577715 MERlALLIMITED OLD 

### I Percutaneous Absorption and Hair, Skin, and Fat Distribution of Radioactivity After Spot-On Application of(Carbon 14)-RMI601 

# I in BeagleDogs: Lab ProjectNumbers: CD-93!3405F: Q-42.769. Unpublished study prepared by Centrode Investigacion y Desarrollo ApJicado, S.A.L. 68 o. 

### I 870.7200 Nolan-Smith, S. (1999)**Fipronill{S)~Methoprene** Topical Solulion: 44942104 MERIAL LIMITED PAY Target Species Safety Study in the Dog: Intcrim Report: Lab ProjectNumber: 168612: 168612-01142: PR&D0002101. Unpublished study prepared bv Covance Laboratoties Ltd. 266 v. 870.7200**Nolan~Smith,** S. (1999) FiproniU(S)-Methoprene T{lpical Solution: 45143901 MERIAL LIMITED PAY Targct Specics Safety Study in the Dog: Report Amendment: Amendment to Interim Repurt: Lab Project Numbcr: 1686/2:**168612~DI** 142. Unpublished study prepared by Covanre Labs., Ltd. 6 o. 870.7200 Nolan-Smith, S. (2001) To Investigate the Safety ofa Topical 45612702 MERlALLIMITED PAY Formulation Containing ML-2,095,988 509Tin DogsWcighing Approximately 2kg (+!-1.5kg) at One, Three and Five Times the Maximum Label Recommcndcd Dosage: Final Report: Lab Project Number: 1686112: 1686112-D2160: PR&D 0045801. Unpu}llished study prepared by Covance Labomtories. 324 p. Signature: 

# Z-JlJ. r/£'Az·h

EPA f""" S510·J5 (9.9'1) EIO<.1r""r J**""~<t** ",,,,,,,,,Av.il'f'**~i'''"** y Pap.,-ver.ion. Name and Titlc KcIl R. Hoskins, Manae:er ofTechnical Affairs Ag<H<j' lnlorn.l U

..Cupy Date 10/20/2010

# ~)­



# s-;Jf'Fo,m APl,r<wod OMB No. 2070-11060 

### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY 0 

### 401 M Street, S.W

. 

# • WASHINGTON, D.C. 20460 PapelWork Rcdnction Act Notice: The public reporting burden for this COlleelion ofinfonnation is eSlimmed to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, includingtime for reading the in3eregistra!ioncompleting the necessary fonus. Send comments regarding the burden estimate or any other aspeet ofthis collection ofinformation, 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 fom to this address. 

### DATA MATRIX Date: October 20, 20I0 EPA Reg No./File Symbol 2517-RGU Page 3 of9 Applicant'slRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs Ingredients: Fipronil, Methoprene Guideline Refereuee Number Guideline Stud' Name MRlD Number Submitter Status Note 870.7200 Godin, 

### c.; Alva, R. (2000) ML-2,095,988 45620507 MERlAL LIMITED PAY 509T /DoglSolutionff opicallSafetyffolerancelReproduetion, Reactions: Final Report: Lab Project Number: PR&D 0020201: WEL 99885: PR&D 00202. Unpublished study prepared by WhiteEagle Toxicology Laboratory. 123 p. 810.3300 McCall, J. (1999) Dose Titration Study of(S)-Methoprene by 44942105 MERIAL LIMITED PAY Topical Administration to Dogs: Final Report: Lab Project Number: PR&D 0009901. Unpublished study prepared by TRS Labs, Inc. 51 o. 810.3300 Young, D. (1999) Dose Confinnation Study ofTopically 44942106 MERlALLIMITED PAY Administered Fipronil/(S)-Methoprcne Against Adult Ctenocephalides felis(Cat Fleas) iu Dogs: Final Report: Lab Project Number: PR&D 0013501. Unpublished study prepared by Young Veterinary Research Services. 59 D. 810.3300 McCall, J.; Alva, R.; Irwin, J.; ct al. (2002) A Study to 45866902 MERIALLIMITED PAY Evaluate the Efficacy ofFrontline Plus for Control of Mosquitoes, Aedes aegypti, on Dogs: Final Report: Lab Project Number: PR&D0055201. Unpublished study prepared by TRS Labs, Inc. 24 p. Signature: 

# Il/L**/~fh** Name and Title Date 

## , 

# ,o1 Kelly R. Hoskins, Manager ofTechnical Affairs 10/20/2010 EPA F¢nn**~~7o.J5** ( .97) Eloclmnil'"" d Paper eniOll' Avail'lljl ,il\Jb

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### UNITED STATES ENVIRONMENTALPROTECTIONAGENCY o 401 M Street, S.W.
C 

### WASHINGTON, D.C. 20460 For", App,."d OIllB i'le.1070·llQiO

Paperwork ReductiOll Act Notice: The public reporting burtlen fOfthis collection ofinfonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activilies, including time for reading the in4crcgislralioncomplelingthe necessary fonus. Sendcomments regarding the burden estimate orany oIlier aspect oflhis collection ofinfonnation, including suggestions for reducing the burden to Direclor: OPPE InformatiOll Management Division (2137) U.S. Environmental Protection Agency, 40[ M Street, S.W., Washington, DC 20460. Do nO! send tile form to this address. 

### DATA MATRIX Date: October 20, 2010 EPA Re No.lFile Symbol 2517-RGU Pa e 4 of9 Applieant'sJRegistrant's Name & Address Product: Sergeant's Fipronil +Methoprene Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 SQuecze-On for Dogs Ingredients: Fipronil Methoprcne Guidelinc Refercnee Number Guideline Study Name MRID Number Submitter Status Notc 810.3300 Pcngo, G.; Pollmeier, M.; Barrick, R. (2000) An Efficacy Study of 45620501 MERIAL LIMITED PAY Frontline Spray, Frontline Top Spot, and ML-2,095,988 509T, for the Treatment and Control ofTrichodectes canis in the Dog: Final Report: Lab ProjcctNumber: PR&D 0022101, PR&D 00221. Unpublished study prcpared by Centro Vcterinario Oriolo. 24 p. 810.3300 Alva, R.; Barrick, R. (1999) A Study to Detcrminc the Effect of 45620502 MERIAL LIMITED PAY Treatment with Frontline Top Spot on the Prevalence and Scverity ofFlea Allcrgy Dermatitis in Dogs: Final Rcport: Lab Project Number: PR & D 0010201: PR & D 0010202: PR&D 00102. Unpublished study prepared by VCA S1. Petcrsburg Animal Hospital. 45 o. 810.3300 Postal, J.; Lc Nain, S. (1998) Evaluation ofthe Efficacy of 45620503 MERIAL LIMITED PAY RM:J601C/35, in the Treatment ofFlea-Allergy Dermatitis in the Dog, Compared with a Referenec Product: Final Report: Lab Project Number: ASR 19083: CLl276. Unpublished study prepared by MeriaL 92 p. 810.3300 Marchiondo, A. (2001) PR & D 0024101: Frontline 45620504 MERIAL LIMITED FAY SprayfFrontline Spot-OnlML-2, 095, 988 509TlDogs ISolution/Topical: Final Report: Lab Projcet Number: PR&D 0024101: PR&D 00241. Unpublished study prepared by Stillmeadow, Inc. 29 D. 810.3300 Gaxiola, S.; Alva, R.; Irwin, 1. (2001) PR& D 0052301: 45620505 MERIAL LlMrrED PAY Frontline Spray/Frontline Spot-OnIML-2, 095, 988 509TlDogs/Solution/Topieal: Final Report: Lab Project Number: PR&D 0052301, PR&D 00523. Unpublished study prcpared by UniVersity ofSinaloa. 40 p. 810.3300 Pengo, G.; Pollmeicr, M. (2000) Frontline Spray & Top Spot! 45620506 MERIAL LIMITED PAY DogsiSolutionfropical CliniallDose Confirmation/ Ectoparasitcs, Mites, Sarcoptes Scabiei var canis: Final Report: Lab Project Number: PR&D 00I2901: PR&D 00129. Unpublishcd study prcpar,cd by Cenjro Vctcrinario Oriolo. 23 p. Signaturc: // /111 // 1/" L...i Name andTitlc Datc 

## A/ f jl. L.Jmj{

_ IJf Kclly R. Hoskins, Manager ofTcchnieal Affairs 10/20/2010 EPA Form 8'7(I.)S t9 7) Ele<ttooi< P'l"'rV."ioo.**Av,"lf~"'S"bmit** ooly P,pcrvof5lon A&<ncy l"tem.l Use Copy

# ~s '51')!l1'-ctForm Appro,'ed OMP No. 2070·0060 

### UNITED STATESENVIRONMENTAL PROTECTIONAGENCY 

# "**:,:~:::L** 

### 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: TIle public reporting burden for this collection ofinfonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and speeial review activities, including time for reading the instruction!.lI1d completing the necessary fonns. Send comments regarding the burden estimate or any other aspect ofthi; collection ofinfonnation, including suggestions for reducing the burden to Dircctor: OPPE !nfonnationMallagement Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460, Do not semi the fonn to this address. 

### DATA MATRIX Date: October 20, 2010 EPA Reg No.lFile Symbol 2517-RGU Page 5 of9 Applicant'sfRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene Sergeant's Pet CareProducts, Inc. 2625 South I58th Plaza, Suite 100, Omaha, NE 68130- 1703 Squeeze-On for Dogs Ingredients: Fipronil, Methoprene Guideline Reference Number Guideline Study Name MRlD Number Submitter Status Note 870.3300 McCall,J.; McTier, T. (1995) Positive Referenced and Untreated 43577712 MERIAL LIMITED OLD Controlled, Confirmatory Laboratory Trial ofRMI60lE SPOTON Fonnulation Applied to Dogs as 3 Weight Class Defined Volumes for the Control ofthe Cat Flea Ctenocephalides felis, the Brown DogTick Rhipicephalus sanguineus, and the American Dog Tick Dermacentor variabilis: Lab Project Numbers: RMIFLSTKS!94!2L: IU\11 VSR-249LT: PT-249LT. Unpublishcd study prepared by TRS Labs, Inc. 41 P. 870.7200 Astruc, B.; Suberville, S.; Bosc, F. et al. (1998) Evaluation ofthc 44487701 MERIAL LIMITED PAY Presencc ofM&B46513 on the Hair After a Topical Application (Spot-on or Spray) ofFipronil to the Dog: Final Report: Lab ProjectNumber: MET419: R002459. Unpublished study prepared by Meria!' 28 p. 810.3300 Everett, R.; Cunningham,J. (1993) An htvestigation Study to 43121118 MERIAL LIMITED OLD Evaluate the Ellect ofBathing ofLaboratOlY Dogs on the Efficacy ofRM:I601 Spray: Revised: Lab ProjectNumber: RMD 592: P/220LT. Unpublished study prepared by Agresearch Consultants, Inc. 43 p. 810.3300 CrutherS, L. (1993) Efficacy ofRMI60lC at 3 mllkg and 6 mllkg 43121 !22 MERIALLIMITED OLD Against Ixodes scapularis/dammini Nymphs, Dermaccntor variabilis Nymphs, Amblyomma americanum Nymphs, Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair as the Tel>1ing Substrate: Revised: Lab Project Number: 9320: P!225LT. Unpublished study I prepared by Professional Lab and Research Services, Inc. 28 o. Signature: 

# £/LI.I,,[11 Name and Title Date KeJJy R. l'loskins, Manager ofTechnical AlTairs 1012012010 

## <>f EPA Fonn 857()'151?971

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### 'v","""**'"h~"**

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# ,

# J-<~ 

# Y\"o,m App,oved 01'>111 No. 2070·00.0 

### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY 0 

### 401 M Street, S.W. 0 

### WASHINGTON, D.C. 20460 Papcnvork Reduction Aet Notice: The public reportingburden for this collectiou ofinfonnation is estimated to average 0.25 hours perresponse for registration activities and 0.25 hours per response for reregistration and spccial review activities, indudingtimc for reading the in6eregistrationcompletingthenecessary fonns. Send comments regarding the burden estimate or any other aspect ofthis collectiou ofinfonnation, including suggestions for reducillg thc burden to Director: QPPE InfomlationManagement Division (2137) U.S. Environmental Protection Agency, 40IM Street, S.w., Washington, DC 20460. Do not send the Ibnn to this address. 

### DATA MATRIX Date: October 20, 2010 EPA Re No.lFileS mbol 2517-RGU Pa e60f9 ApplicanCslRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene Sergeant's Pet Care Products, Inc. 2625 Soutll I58th Plaza, Suite 100, Omaha, NE 68130·1703 Squeeze-On for Dogs In redients: Fi ronil, Metho rene Guideline Reference Number Guideline Stud Name MRIDNumber Submitter Status Note 810.3300 Pengo, G.; Pollmeier, M. (2002) Study to Confinn the Efficacy of 45628201 MERIAL LIMITED PAY FiproniJ Against Lice in Dogs Under Field Conditions: Final Report: Lab ProjectNumber: PR&D 0037401. Unpublished study prepared b CentroVeterinario Oriolo. 21 o. 133-3 Meo, N.; Gonzalez, C.; Mester, T. (1997) Dermal and Inhalation 44433302 MERIAL LIMITED PAY Exposure ofCommercial Pet Groomers During Application of Frontline Spray Treatment: Final Report: Lab Project Number: MERIAL-445-SAFXT046: SAfX046: PDA9705. Unpublished study prepared by ABC Labs., California and Aanimal Appeal Grooming Shop & Case Veterinary Hospital. 1066 P. 133-3 Meo, N.; GOllZalez, 

### c.; Bclcher, T. (1997) Dennal Exposure of 44433303 MERIAL LIMITED PAY Commercial Pet Groomers During Application ofFrontline Top Spot: Final Report: Lab Project Number: MERIAL-445- SAFXT047: SAFXT047: EC_97_390. Unpublished study prepared by ABC Labs., California and Aanimal Appeal Groomin):!, ShQl) & CaseVeterinary Hospital. 925 p. 132-1 Hughes, D. (1997) Dislodgeable Residues ofFiproniJ Following 44433305 MERlAL LIMITED PAY Application ofFrolltJine Top Spotto Dogs: Final Report: Lab ProjectNumber: COVANCE 6848-101: MERlAL METXT 166: METXT 166. Unpublished study prepared by Covance Labs. Inc. 161 p. /' Signature: 

# L,R/kf/J Name alld Title Date KeJJy R. Hoskins, Manager ofTechnical Affairs 1012012010

" ••**~"._** .,,"" <G 0'**~_** A "_"

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# ....**~**

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# ,.£**~~d&**Form App",

.. d 01\113 No. 2070·0060 

### UNITED STATESENVIRONMENTAL PROTECTIONAGENCY o 401 M Street, S.W. 

# " WASHINGTON, D.C. 20460 Papenvork Reduction Act Nonce: The public reporting burden for this collection ofinformation is estimated 10 averagc 0.25 hours perresponse for registration activities and 0.25 hours pcrresponse for reregistration and special review activities, including time for reading the in7eregistrationcompleting the nccessary forms. Sendcomments regarding thc burden estimate or any othcr aspeclOfthis collection ofinformation, including suggestions for reducing the burden to Director: OPPE InformationManagement Division (2137) U.S. Environmental Protectioll Agency, 40t MStreet, S.W., Washington, DC 20460. Do not selJd the form to this address. 

### DATAMATRlX Date: October 20, 20I0 Applicant'sIRegistrant's Name & Address Sergeant's Pet Care**Product~** htc. 2625 Soutb 158th Plaza, Suite 100, Omaha, NE 68130-1703 Ingredients: FiproniJ, Methoprcne Guideline Reference Number Guideline Stud Name 132-1 H\lghcs, D. (1997) Dislodgeable Residues ofFipronil Following Application ofFronUine Spray Treatment to Dogs: Final Report: Lab ProjectNumber: COVANCE 6848-100: 6848-100: MERlAL-445-METXT-165. Unpublished study prepared by Covance Labs. Inc. 184 p. 132-1 

### ! de Fontenay, G.; Campagna, J.; Suberville, S. et al. (1997) Dislodgeable Residues ofFipronil Following a Topical Application ofFrontline Spot-On Treatment to Dogs: Final Report: Lab Project Number: 817/0248: MET41 6: MERIAL-480-MET-416. Unpublished study prepared by Merial Ltd. and Cbrysa,lis Preclinical**Services-Eu~?pe. ~**  132-1 

### ! de Fontenay, G.; Campagna,J.; Suberville, S. et a!. (1997) Dislodgeable Residues ofFipronil Following a Topical ApplicationofFrontJine Spray Treatment to Dogs: Final Study: Lab Project Number: 817/024A: MET414: MERlAL-480-MET414. Unpublished study prepared by Merial Ltd. and Chrysalis Preclinical Services-Europe. 70...£:.. NlA Irwin, 1. (1997) Use Survey ofCommercial and Vetcrinary Pct Groomers and Pet Owners ofFrontline Top Spot and Frontlinc Spray Treatment: Lab ProjectNumber: MERlAL-445-SURVEY. Unpublished study prepared by Wiese Research Associatcs, Inc. 340 p. Hughes, D. (1997) Validation ofan Analytical Method for the Determination ofFiproniJ, M&B45950, and M&B46513 in DyeFree 100% Cotton Gloves: Final Report Lab Project Numbcr: COVANCE 6848-104: 6848·104: MERlAL METXT 169. Unpublished stuqyprepared by <::;o'lance Labs. Ine. 41 p. Polakoff, B.; Youngren, S. (1997)Non-DictaryRisk Assessment Fipronil Use on Pets in a Residential Setting: Lab Project Number: FIPRONIL 97-09: MERtAL-445-NDRA. Unpublished EPA Reg No'/Fil.e:Symbol 2517·RGU Product: Scrgeant's FiproniJ +Methoprene Squeeze-On**fl?~** Dogs
MRlDNumber 44433306

44531203

44531204

44433301

44433308

44433309 Submitter MERIAL LIMITED

MERlAL LIMITED

MERlAL LIMITED

MERlAL LIMITED

MERIAL LIMITED

MERIAL LIMITED Status PAY

PAY

PAY

PAY

PAY

PAY Page 7 of9

Note

stud re ed b Novi en Sciences, Inc. 27 

# r Signature: Name and Title Date

.**~** KeJJ R. Hoskius, Mana crofTechnical Affairs

## 101201201O~J.;; Agonor rn1«n.1 u..**C~py** 

# '-:Y'\Foem Approv<d OMB N&. 2070-\la60 

### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY
o 

### 401 M Street,S.W. o 

### WASHINGTON, D.C. 20460 Paperwork Redllction Act Notice: The public reportingbmden for this collection ofinfonnation is estimated 10 average 0.25hoursper response for registration lICtivities alld 0.25 hours per response for reregistration and special review activities, incllldingtime for readingthe in8crcgistfationcolllplctingthe necessary fomts. Send comments regarding the bllrden estimate or any other aspect oftJlis collection ofinfonnation, including**sllgge~tions** for rcdocillg the burden 10 Director: OPPE lnfonnaliOilManagement Division (2137) U.S. Environmental ProtectionAgency, 401 M Street, S.W., Washington, OC 20460. Do not sendthe form to this address. 

### DATA MATRIX Date: October 20, 20 I0 Applicant'sfRegislranl'sName & Address Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Ingredients: Fipronil, Methoprene Guidclillc ReferenceNumber 

### I Guideline Study Name Polakoff; 8.; Youngren, S. (1997) Pet Groomer Exposurc Analysis and Risk Assessment: Frontline Top Spot and Frontlinc Spray Treatment: Lab Project Number: FIPRONIL 97-11: MERIAL-445-PGRA. Unpublished studyprepared by Novigen Sciences, hlc. 17 p. Polakoff, B.; Youngren, S.; Walls, C. (1998) Frontline Top-Spot and Frontline Spmy Treatmcnt: Defillitive Short-Term and Intennediate-Tenn Residential Non-Dietary Risk assessment: Lab Project Number: FlPRONIL 98-04: MERIAL445-NDRA. Unpublished study prepared by Novigen Sciences, Inc.**3~** Polakoff, 8.; Youngren, S.; Walls, C. (1998) Frontline Top Spot and Frontlinc Spray Treatment: DefinitivePet Groomer Exposure Analysis and Risk Assessmcnt: Lab ProjectNumber: FIPRONIL 98-07·. MERIAL-445-LPERA. Unpubli&1ed &udy prepared by Novigen Sciences, Inc. 21 p. Polakoff, B.; Youngren, S. (1998) Frontline on Pets ill a Residential Setting: Risk Assessment ofa Low Probability Event Post-Application Acute Exposure: Lab ProjectNumber: EPA Reg No.lFile Symbol 2517-RGU Product: Sergeant's Fipronil + Methoprene Squeeze-On for Dogs
MRIDNumber 44433310

44531206

44531207

44531208 Submitter MERIAL LIMITED

MERlAL LIMITED

MERIAL LIMITED

MERIAL LIMITED Status PAY

PAY

PAY

PAY PaRe 8 of9

Note



# , Signature: FIPRONIL 98-06: MERIAL-445-PGRA. Unpublished study prepared b,· Novigen Sciences, Inc. 18p. 

# JI,,/L,{J,Lb

EPA Fo,m 8S7oJ.J) t9-97) Eleclro""at"il**P.~VeI'ioru** Avail.blr¥m'lt'Only Paper "'''00 Name and Title Kelly R. Hoskins, Manager ofTcchnical Affairs Atoney 1"10"",1**U~Copy** 

## , 

# \

# ~v\Y~**~\** Date 1012012010



### ---

### UNITED STATES ENVIRONMENTALPROTECTIONAGENCY Form A.ppr

... d OMB No.**~O;O·OO60** 

## I

0 

### 401 M Street; S.W. 0 

### WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting hurden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours perresponse for reregistration and special review activities, including time for reading the in9cregislrationcomp!cting the necessary Coons. Scnd comments regarding the burden estimate or any other aspect oftilis collection ofinformation, including suggestions for redociog the burden to Director: QPPE InformatiOll Management Division (2137) U.S. Environmental Protection Agcm:y, 401 M Street, S.W., WashingtOll, DC 20460. Do not sendthe fonn to this address. 

### DATAMATRlX Date; October 20, 2010 EPA Rc NoJFile Symbol 2517-RGU Pa e90f9**Applicant'slRegi~trant's** Name & Address Product: Sergeant's Fiproni! +Methoprene**Se~geant's** Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703**~.queeze-On** for D(}gs In redients: Fi roni!, Metho rene Guideline RefcrcnceNumber Guideline Study Name MRlDNumbcr Submitter Status Note 810.3300 Everett, R.; Cunningham, 1. (1993) A Dose Titration Study to 43121114 MERIAL LIMITED OLD DetennineIhe Optimal Spray Concentration ofRM 1601 for Long Tenn Control ofthe Cat Flea Ctenocephalides fdis and the Brown DogTick Rhipicephalus sanguineus in the Dog: Reviscd: Lab Project Number: RMD 292: P/214LT. Unpublished study prepared by A.t!,research Consultants. 53 p. 810.3300 Cruthers, L. (1993) Product Perfonnance: A Dose Confinnation 43121115 MERlAL LIMITED OLD Study to Verify the Optimal Spray Concentration ofRM 1601 

### rm Long Residual Control ofthe Cat Fica(Ctenocephalides felis) and the BrownDogTick (Rhipicephalus sanguineus) in thc Dog: Revised: Lab ProjectNumber: 9251: P/215LT. Unpublished study prepared by Professional Labs and Research Services, Inc. 51 p. 810.3300 Everett, R.; Cunningham, 1. (1993) A Comparative Evaluation 43121116 MERIALLIMITED OLD of TwoTreatmcntRegimes Using RM 1601 Spray for Control ofthe Cal Flea Ctenocephalides felis on the Dog: Reviscd: Lab ProjectNumber: RMD 692: P/222LT. Unpublished study preparcd by Agresearch Consultants, luc. 4Or· 810.3300 McCall, J.; McTier, T. (1993) Laboratory Evaluation ofRM 43121117 MERIAL LIMITED OLD 1601 Spray for Control Dennaeentor variabilis and Rhipecephalus sanguineus onthe Dog: Lab Project Number: RMffKSl93flL: PS/229LT. Unpublished study prepared by TRS Labs, Inc. 18p. Signature: 

# kA;I 

# /£/0 Name and Title Date Kelly R. Hoskins, Manager ofTcchuical Affairs 1012012010 EPA. Fmm S57()"1> t9.97) EJ<woo'. '"' ,perYo,.,io", A.all7'0/'**~** """Iy Vape' v.,.,;o" A.grn<y IR!<rn.ll1•• Copy 

# jJb "x,!\.LV 

## C'lli'l

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



### Sergeant's Pet Care, Inc. 

### cia Mr. James Messina, Exponent, Inc. 1150 ConnecticutAvenue, NW Suite 1100 Washington, D.C. 20036 

## OCT 1 3 2010 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Follow-up to EPA's Request for Additional Informationto Support Pending Fipronil-containingProductApplications, EPAFile Symbol Nos.: 2517-RGA, 2517-RGL, 2517-RGT, and 25I7-RGU, dated September 10, 2010. 

### Mr. Messina: Thisletteristo follow-up onthe phone conference with Sergeant's and Ms. Deborah Chadbourne, heldon September 30, 2010, where theAgencyprovided additional clarification information concerningEPA'srequest for additional informationto demonstrate the acquisition ofthe Fipronil source usedtoconduct the product studies that accompaniedthe above-referenced applications. TheAgencydetermined

### that at

### thi stime, no additional information

### inresponse

### to EPA's original requestis needed priorto the Agency's completion ofthereview ofthe abovereferenced applications. Furthermore, no additional response to thisrequest isneeded atthis time. However,pleasenote thatiftheAgencydeterminesthatthis information is still needed, that this maybe added as a conditionofregistration. Ifyouhave anyquestionsregarding this action, you'maycontact RosannaLouie-Juzwiak at !ouh':iuz\\**iJk,ro~:Jnnll** 

### ('I**epa,!2()~,** 

### Regards,

# &~_~ 

# c.LLRichard Gebken, ProductManager 10 Insecticides Branch Office ofPesticidePrograms (7504P)

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



### September 10, 2010 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### CERTIFIEDMAIL: ArticleNumber 7006 2150 0002 6305 7545 Sergeant's Pet CareProducts, Inc. 

### clo 

### Mr. KellyHoskins 2625 South 1581h 

### Plaza Omaha, NE 68130-1770
Subject:

Mr. Hoskins: Requestfor Additional Infonnationto Support Pending Fipronil-containing Product Applications EPA File Symbol Nos.: 2517-RGA, Sergeant's Fipronil Squeeze-on [orDogs 2517-RGL, Sergeant'sFipronil 

### + S-methoprene Spot-on for Cats 2517-RGT. Sergeant's Fipronil Spot-on for Cats 2517-RGU. Sergeant'sFipronil 

## +S-methoprene Squeeze-on for Dogs

The Agency is in process ofreviewingthe above-referenced applications for theproposed fipronil-containing spot-onproducts for use onpets. In order to 

### proceed withthese applications, additional infonnationneeded regarding your listed sources ofthe two fipronil technicalproducts identified inthe Fonnulator's Exemption Statement dated December 21, 2009: Within fifteen (15) daysJrom the date ofthis letter((iRbr¢t a copy ofthe bill ofsale showingthepurchase ofthe fipronil technical product(s) used---toconductthe submitted studies (e.g. product chemistry, acute toxicity, and companion animal safety studies to support the above-referencedproposedproducts). Your responsemust identifythe fipronil technicalproduct used for each study submitted to the Agency. Please supplythe following infonnation: 1. The EPA registration number and establishmentnumber ofthe technical product from whichtheproposedproduct is derived, 2. Thename and address ofthe entity from which the manufacturingproduct was obtained,and 3. A copy ofthe Bill ofSale for thepurchase ofthe sourcetechnical productusedin the testing.

### IftheAgency does notreceive the requested documentation by September28, 2010, the Agencymay not be able to grantregistrations fur these products by the current PRIA date of November4,2010. Ifyouhave any questions concerning this matter, you may contact RosannaLouieJuzwiak at (703) 308-0037, or email her at Louie-Juzwiak.Rosanna@epa.Qov.
Sincerely, 

# ;(?J,ccd**C.~L** Richard 

### Gebken ProductManager 10,Insecticides Branch Registration Division

SENDER: COMPLETE THIS SECTION**COMPLET~** THIS SECTION ON O£UVERY

•**~omplete** items 1, 2, and 3. Also complete item 4 if Restricted Delivery Is desired • Print your name and address on the

### ~verse

so that we can return the card to you. • Attach this card to the back of the maiJpiece

or on the front if space permits. ' 1. Article Addressed to:

### ~N'\S 1'f;:f('In'tE,: 9Q.c\)\J..c, 

# ,, C/o \,AR. \(.(;LLI.( !-\05'i-INS 

### 24 L IS 3Cv

..:rH [58\}! PLA 2j"\ pAgent 

### o Addressee

D. Is deliveryaddress_dIfferqni frofrr.iteTn 11 0 Yes

IfYES, enterdelivery addr&sn-beJ;o%'_, 0 No

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- -.!

3. Service Type """',"



### ,..trCertified Mail 0**~** Mail



## o Registered 0 Return ReceIpt for Merchandise 

## o Insured Mall 0 C.O.D.

- 4. Restricted Delivery?fExtm Fee) ,0 'res 2. Article Number (fransferfrom service fabal) 

### 7006 2150 0002 6305 7545 ! PS Form 3811, February 2004 

### ! Demestic RetUrn Receipt

## DATA PACKAGE BEAN SHEET Date: 11-May-2010 Page 1 of 1 

## '* * * Registration Information * * 

### '* Decision 

### #: 425453 DP

### #: (377600) PRIA 

### ParentDP #: Submission 

### #: 873354 Registration: 2517-RGU

- SERGEANT'S FIPRONIL + S,METHOPRENE SQUEEZE-ON I Company: 2517

- SERGEANT'S PET CARE PRODUCTS,**crN~Cc'** ___ _ RiSk Manager: RM 10

- Richard Gebken

- (703) 305-6701 Room# PY1 5-7237 Risk Manager Reviewer: Bonaventure Akinlosotu**BAKrNLO~S~** ____________ _ Sent Date:

--- Calculated Due Date: 04-Nov-2010 Edited Due Date:
____ _ Type of Registration: Product Registration

- Section 3 Adion Desc: (R310) NEW PRODUCT;NDN-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients: 105402, S-Methoprene(B,8%j 129121, Fipronil(9.8%) 

### '* 

### * * Data Package Information 

### * * *
Expedite: 

### 0 Yes • No Dale Sent: 11-May-2010 DP Ingredient: 105402, S-Methoprene 129121, Fipronj_.
____ _ DP Title:**E~ffi~'~oa~'~y** _____ _ CSF Included: • Yes 

## 0 No Label Included: • Yes 

## 0 No Parent DP#:

Assigned To Date In Date Out Due Back:

Organization:**cR~D~/~rB~** _____ _ Last Possible Science Due Date: 05-Dct-2010 Team Name: Efficacy (18) Science Due Date: Reviewer Name:
__________ _ Sub Data Package Due Date:
__ _ Contractor Name:
__________ _ 

## '* '* '* Studies Sentfor Review 

## '* '* '*
No Studies 

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

## '* '* '*
Can be printed on its own page 

## '* '* '* Data Package Instructions

## '* '* '*
For Your Review An R310 action, a new fipronlV3-methoprene EP, presumably me-too of Menal's Frontline 65331-5 Thx, baa

### Efficacy Review
Date: October27, 2010 Efficacy Reviewer: ClaytonMyers, Ph.D., Entomolo mvers.claytonUD,epa.gov 703-347-8874 Risk ManagerRev.: Rosanna Louie Products: 

### EPAReg. #: A.I.'s: Decision #s: 

### DP#s: Submissions: 

### MRIDs: Sergeants Fipronil 

### + S-Methoprene Squeeze-On for Dogs 2517-RGU Fipronil, S-methoprene 425453 377600 R310, NewProducts, RD Science Review Cited: 43121116, 43121117, 43121122, 44942105, 44942106,45620501, 45620502,45620503,45620504,45620505,45620506,45628201, 45866902

Overall Review ofLabel Claims and Directions: Based upon the cited efficacy data for fipronil, claims are supported ondogs for fleas, flea larvae andeggs, breaking ofthe flea life cycle, ticks, sarcoptic mange, mosquitoes, and chewing lice. Waterproofclaims, or statements indicatingthat the productwill work after bathing the animal are not acceptable, as no data was submitted to support the efficacy ofthe product after wetting or bathingthe animal. These claims mustbe removed from the label as listed below: Line byLineReview ofUnacceptable Efficacy Claims: The following claims mustbe deleted from the label: [Dogs can be bathed 24 hours after treatmeR't] [Dogs can be bathed 24 hours after Spot on is applied] [\Vaterprool]

## DATA PACKAGE BEAN SHEET Date:**22~Jun~2010** Page 1 of 1 

## * * * Registration Information 

## * * * Decision 

### #: 425453 DP 

### #: (379384) PRIA Parent DP 

### #: Submission 

### #: 873354 Registration: 2517-RGU - SERGEANT'S FIPRONIL +**S~METHOPRENE SQUf;EZE~ON** 

# pO**~** Company: 2517

- SERGEANTS PET CARE**PRODUCTS~,~IN~C~_~** _______ _ Risk Manager; RM 10

- Richard Gebken

- (703) 305-6701 Room# PY1**S.::723~**_____ _ Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS Sent Date:
___ _ Calculated Due Date: 04-Nov-2010 Edited Due Date:
____ _ Type of Registration: !:.roduct**Reg~1ra1ion** - Sec1ion 3 Action Desc: (R310) NEW PRODUCT;NS'.N-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients: 105402, S-Methoprene(S.S%) 129121. Fipronil(9.S%) 

### * * * Data Package Information 

## * * *
Expedite: 

### 0 Yes" No Date Sent 22-Jun-2010 Due Back: DP Ingredient 105402, S-Me1hoprene



### ---------- .129121,**Fip!~_~~**__ _ 

### -- ----------------------- DP Title: CRP CSF Included: • Yes 

## 0 No label Included: • Yes 

## 0 No Parent DP #:

Assigned To Date In Da1e Ou1

## -~ 

# Lu.lio 

# -1)zi/I_t7- last Possible Science Due Date: 05-0ct-20to Organization: RD I TRB Team Name: Child Resistant Packagi!1L
____ _ Science Due Date: Reviewer Name: Sub Data Package Due Date'. Contractor Name; 

### * * * Studies Sent for Review 

### * * * No Studies 

## ** * Additional Data Package for this Decision 

## *

## * *
Can be printed on its own page 

### * 

## * * Data Package Instructions 

### * * * 

# IFor your review: Application for a fipronill3-methoprene EP, presumably me-too of Merial's 65331-5

# ~.**V'/}t~** Thx, baal'N1TED STATES ENVIRONMEt'iT-\L PROTECTIOi"" A-GE\iCY \VASHlNGTO!\, D.C 2H-!(,U



### NOTE TO RM 10 Bonaventure Akinlosotu 'HFlCIi U]' Cllf\JK.\.L S UTfl ,,,u POll i :Tlo,," I-REVr\TlO, 

### September 28,2010

SUBJECT: Documents To Use With Data for Child-Resistant Packaging EPA FILE NO: 2517-RGT, 2517-RGA, 2517-RGL, 

### & 2517-RGU, DP 377739, 377717, 379385, & 379384 Decision 

### # 425437, 425455, 425454, & 425453 Please note that for EPA FILE NO: 2517-RGT, 2517-RGA, 2517-RGL, & 2517- RGU the following documents were used for the CRP review: • CSF's used for calculation ofthe amount of Fipronil per package were dated April 9, 2010 and MRID 48059501, 48059801,48059401, & 48059101; • CRP Certifications dated May 27, 2010; • Labels to be used for Final stamping should be dated June 29, 2010 as these are the labelswith the acceptable language regarding the opening ofthe CRP. [Ifyou need copies ofthese labels I can email them to you.] Thank you for your cooperation in this matter. Ifyou have any questions please contact me at (703)-308-7368.

Rosalind 

### L. GrosstiNnED STATES ENVIRONMENTALPROTECTION -\GENCY WASHINGTON, D.C. 2U,.f(,ij



### NOTE TO RM 10 Richard Gebken 'ilT1Cl'**OF\:m:~'lW'\l,,\/\l'Fl\** \,1) 1'01 ,1J-TjU'>: rl{UT\'IIO:;- 

### September 28, 2010

SUBJECT: Resubmission of Data for Child-Resistant Packaging EPA FILE NO: 2517-RGT and 2517-RGL, DP 377739 and 379385 Decision 

### # 425437 and 425454 Please note that for EPA FILE NO: 2517-RGT and 2517-RGL the SeniorAdult Use Effectiveness (SAUE) data are unacceptable. The data exceeded the maximum percentage ofsubjects pertest site per 16 CFR 1700.20(a)(3)(i). Additionally, the data had the maximum number offailures (10 failures) for a pass ofthe SAUE. The registrant will need to submit a revised SAUE study replacing the last nine test subjects from site 902. The report should indicate: which packages were replaced, why, the age, sex, tester, and test site for the replacement subjects. The new report and a newelectronic CD for the study must meet age distribution criteria, sex distribution criteria, maximum percentage of subjects pertest site, and maximum percentage of subjects pertester per 16 CFR 1700.20. Alternatively, a complete new SAUE study may be submitted for review. It will require review ofthe hard copy and electronic version ofthe data. This new/revised study will require the same resource intensive activity ofapproximately 30 days once the reviewer receives the aforementioned submission. Please advise registrant accordingly. Thank you foryour cooperation in this matter. Ifyou have any questions please contact me at (703)-308-7368.

Rosalind 

### L. GrossSergeant's Pet Care Products, Inc, 2625 South 158th Plaza

.. Omaha, NE 681311-1770

.. Telephone 402.938.7000

.. Fax 402,938.7091 • w;vw,sergeants.com



### June 30, 2010 Rosalind Gross 

### clo BonaventureAkinlosotu Registration Division Office ofPesticidePrograms (7504P) U.s. Environmental Protection Agency DocumentProcessing Desk Room S-4900, OnePotomac 

### Yard 2777 South Crystal Drive Arlington, VA

### 22202 Subject: Child Resistant PackagingInfonnation EPAFile Symbols 2517·RGT, 2517-RGA, 2517-RGL & 

### 2517-RGU
DearMs. Gross: Sergeant's Pet CareProducts, Inc, (EPACompany Number

### 2517) is submitting additional infonnation 

### in response to the Agency's questionsregarding Sergeant's Child Resistant Packaging (CRP) 

### studies submitted to EPAonApril 

### 12,2010in support ofthe pending registration applications under EPAFile Symbols: 2517-RGT, 2517-RGA, 25l7-RGL, and 2517-RGU 

### (all of

### which containFipronil at 

### 9,7- 9.8%). Sergeant's generated CRP

### data on a standard white applicatorin sizes 

### 0.5, 0.67,1.34,2.68,and

### 4.02 mL. The following is 

### a summarytable oftheapplicators that were tested and submittedto EPA inthe 

### CRPdata:
Use ApplicatorBase Color FillWeight Color FiU Weight(mL Do.Un 

### to 22 Ib, White Oran2e 0.67 Dog23-44 Ib, White Green 134 00045-88 Ib, White Red 2.68 

### Dog 89-1321b, White 

### Blue 4.02 

## I Cats All Weights White Purple 0.50 

### The CRP data are required because ofthe inclusion ofthe active ingredient fipronil in the pet**squeeze~** 

### onproducts.The CRP testing was conductedon a standard package size and color configuration

### that is 

### identical forthe fipronil onlyproducts and the fipronil 

### +**s~methoprene**

### products; therefore, the submittedCRPdata support all fourpendingproducts regardless ofthe active ingredient content. Based onthis Sergeant's is relying onMRlD's: 48059503, 48059803, 48059804, 48059805, and 48059806 

### to fulfill the CRPdatarequirements for the pending registration applications listed above.

### Once approved and Sergeant's begins to 

### marketthe pesticide products (nowpending under EPA File Symbols: 2517-RGT, 25I7-RGA, 2517-RGL, and 2517-RGU), it will utilize the same applicatorcolor (white) and fill weight colors permL fill weight as was used in the submitted and referenced CRP testing. Based on available information, the density range ofthe pending products on which the CRP data were generated is the same or similar. Therefore, Sergeant's believes the CRP data can be used to 

### supportaU four pending registration applications. Ifyouhave any questions, please contact me at 402-938-7079. Sincerely,



# /14/)£i9z-
Kelly 

### R. Hoskins Manager ofTechnical 

### Affairs

cc: Larry NouvelSergealil's Pet Care Products, Inc. 2625 Soulh 15BlIl Plala Q Onmlm, NE 681311-1770**~** TelcITllone 402.938.7000**~** Fox 402.9.')8.7091 0 wI'lw.sergcanls.com

May 27. 2010
Richard Gebken, PM

### 1 0 Office ofPesticide Programs (7504P) C S. Environillental Protec1lon Agcncy Document Proces5ing Desk Room S-4900, One Potomac Ynrd 2777 South Crystal Dlive Arlington, VA 22202 Sllbject· Child Resistant Packaging Certification Sergeant's Fiprollil + S-methoprcnc Squcc%c-On for Dngs EPA File Symbol 15 I7. R(ll**D~ar** Mr. Gcbkcn:
I certifY'lhat the packaging used for Ihe following product meets the slandards (If40 CFR 157.32. including tbe revised standnrds in 16 CFR 1700.15(b), \vhen testcd by the revised teslll1g procedUl"es in 16 CFR 1700.20, us publisbed in 60 

### fR 37710 (July 21, 1995):

.. Sergeant's Fipronil +**S~l11elhoprclle** Squeezc-Oll for Dogs (EPLI.,. F'lle Symbol 2517- RGU). Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 15S II

, Plna. Omaha. NJ: 68130-1703. EPA CompallY NUTIlber 2517) IS submilling thIS child resist<lllt packaglllg certlrlcatloll to :iUpport Lhe pending product registration for Sergeant's Fipronil 

### + S-\l1cthoprene**Squ~eze-()n** for Dogs 

### O:.PA File Symbol 2517-RGU}. 

### All product labels have language specifying the lise ofscissors to open the product clllHalner and lubellanguage stating tile product is noL to bc ilpplied by children. Ifyou have any queslions, please contact me aI402-938-7079. Sincerely.



## /// :1 II / 

## / tcJ{!.f / /**~'";1~7f-"-nJJ** 

## , Kelly R.&HoskillS ManagerofTcdlllical Affairs

ce' I.arry '\)uuvel

### CHILD-RESISTANT PACKAGING REVIEW Technical Review Branch IN**6/22/~UT** 

### 9/28/2010



# . -**.x:~** 

### RD, TRB, Reviewed by Rosalind 

### L Gross 

### 9128/2010 EPA Reg. No. or File Symbol 2517-RGU DP Barcode DP379384 Decision 

### # 425453 EPA Petition or EUP No.
___ _ Date Division Received 

### 4/12/2010 Type Product(s) Insecticide (flea product) Data Accession No(s). 48059503.48059803,48059804.48059805,48059806 Product MgrJChemical Review Mgr/Contact Person RM 10 Bonaventure Akinlosotu Division ",R",D,-
__ Product Name(s) Sergeant's Fipronil 

### + S-Methoprene Squeeze-On for Dogs
Company Name(s) Sergeant's Pet Care Products, Inc. Submission Purpose 

### Reviewof CRP studies EPA Req. No. 2517-RGA to determine ifthey are adequate to support CRP certification for this product Active Ingredient(s), PC code, & % Fipronil 9_8% 

### S-Methoprene 8.8% Summary of Findings In conclusion all the requirements for CRP have been met for EPA Registration No. 2517-RGA and 2517-RGU. The directions on opening the package given to consumers must be identicalto those given to the seniors during testing. EPA Registration No. 2517-RGT and 2517-RGL do not meet all the requirements for CRP. The SAUE study for EPA Registration No. 2517-RGT exceeds the maximum number ofsubjects per test site (24%) per 16 CFR 1700.20(a)(3)(i). Therefore, the test data is unacceptable. The senior adulttest must be corrected by replacing the last 9 test subjects from site 902 or redoing the entire senior adult test, Ifthe last 9 test subjects from site 902 are replaced, the criteria for the entire 100 test subjects must conform to the criteria in 16 CFR

### 1700.20(a)(3)(i) regarding age and sex distribution, the numberoftest subjects per test site and pertester. The corrected/new study and a new electronic CD for itwill need to be submitted. For details see Analysis of Data and Conclusions section below. 

### Should any human experience/epidemiological evidence indicate a problem once the product is in the marketplace, the Agency reserves the right to reexamine this data comprehensively and to question the child resistance ofthe package involved. Package The package is a white plastic applicator in a rectangle ofplastic. The applicator consists ofthree parts, which are an applicator tip, a cap, and a main chamber body. The applicator looks like a tube in a rectangle ofplastic. Atthe top area of the applicator extending from the cap there is a narrow (needle like) applicator tip. In the rectangle ofplastic surrounding the applicator in the narrow tip area there is a notch on the left and a notch on the right. The package is opened by cutting offthe narrowtip area at the notches with scissors. There are three applicators with a colored stripe on each applicator label connected to each other. The color ofthe stripe is associated with the applicator size. The applicator, which is filled with water as a placebo, comes in 5 different sizes (0.5, 0.67, 1.34, 2.68, 4.02 ml). The instructions given to the seniors for opening the package during eRP testing consisted ofdirections on a label on the back ofthe applicator stating "Use scissors to open." and additional instructions stating "HOW TO OPEN: Remove product tubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cut offthe 

### narrow end at the notches with scissors." Toxicity The toxicity ofthe product is based on the toxicity of Fipronil. The toxic or harmful amount of Fipronil for an 11.4 kg child is 2.5mg/kg times 11.4kg, which equals 28.5mg. Access 

## to a toxic or harmful amt 

### = 28.5mg 

### = 28.5mg divided by [1 030mg/ml x 0.097 Fipronil] 

### = 0.285 ml 

### = 0.29 ml for Fipronil only Cat product EPA REG No. 2517-RGT. Access to a toxic or harmful amt 

### = 28.5mg 

### = 28.5mg divided by [1020mg/ml x 0.097 Fipronil]

# = 0.288 ml 

# = 0.29 ml for Fipronil only Dog product EPA REG No. 2517-RGA Access to a toxic or harmful am! 

### = 28.5mg 

### = 28.5mg divided by [1025 mg/ml x 0.098 Fipronil]

# = 0.284 ml 

# = 0,28 ml for Fipronil & S-Methoprene Cat product EPA REG No. 2517-RGL. Access to a toxic or harmful am!

# =28.5mg 

# = 28.5mg divided by [1020mg/ml x 0.098 Fipronil] 

### = 0.285 ml 

### = 0.29 ml for Fipronil & SMethoprene Dog product EPA REG No. 2517-RGU. Access to one applicator represents a failure for a child for all sizes equal to or greater than 0.28ml for EPA Reg. No. 2517-RGL, or 0.29ml for EPA Reg. No. 2517-RGT, 2517-RGA, and 2517-RGU.

### 3 

### Toxicity, Child Failure, and Package

EPA Reg #I- m! (1m!

... 

### Fr. Oz. (29.6ml Product % FipronH mg FipronH #- unit'" tox 0.033811. oz.) =1 fl. oz.) Density gfml /harm1ul amt

2517-RGT 0.5 0.017 1.030 9.7 49.96 1

2517-RGA 0.67 0.023 1.020 9.7 66.29 1

2517-RGA 1.34 0.045 1.020 9.7 132.58 1

2517-RGA 2.68 0.091 1.020 9.7 265.16 1

2517-RGA 4.02 0.136 1.020 9.7 397.74 1

2517-RGL 0.5 0.017 1.025 9.8 50.23 1

2S17-RGU 0.67 0.023 1.020 9.8 66.97 1

2S17-RGU 1.34 0.045 1.020 9.8 133.95 1

### 4

EPA Reg # ml (1ml= FI. Oz. (29.6ml Product %Flpronll mg Flpronil # unit= tox 0.0338 fl. oz.) =1 fl. oz.) Density g/ml Iharmful amt

2517·RGU 2.68 0.091 1.020 9.8 267.89 1

2517·RGU 4.02 O. t36 1.020 9.8 401.84 1



### Failure Forthe purposes of CRP testing a child failure is access to one applicator for all sizes. Access to one applicator is more than 28.5mg of Fipronil for all sizes. A unitfailure for the child testwas defined as opening the applicator or any partial or complete access to the placebo (water). A SeniorAdult Use Effectiveness failure is failure to access the applicator in the prescribed test time of5 minutes for the first package or 1 minute for the second package, not opening the applicator with scissors along the needle application tip, cutting the applicator between the cap and the body ofthe main chamber, cutting into the body ofthe main chamber ofthe applicator, cutting into the body ofthe main chamber ofthe applicator at other locations, cutting offthe bottom ofthe main chamber ofthe applicator, or not separating a single applicatorfirst and cutting open a second or second and third applicator. Analysis of Data and Conclusion The CRP certifications submitted May 27, 2010 for EPA Registration No. 2517- RGA and 2517-RGU are acceptable. The CRP certifications submitted May 27,2010 for EPA Registration No. 2517-RGT and 2517-RGL are not acceptable, because the CRP Senior Adult Use Effectiveness (SAUE) test is not acceptable. The labels submitted June 29,2010for EPA Registration No. 2517-RGA and 2517-RGU have the same CRP directions as were used in the CRP testing. The labels submitted June 29, 2010 for EPA Registration No. 2517-RGT and 2517-RGL have the same CRP directions as were used in the CRP testing. A screening ofCRP stUdies (MRID numbers 48059503, 48059803, 48059804, 48059805, and 48059806) revealed the CRP study associated with the lowest SAUE was MRID number 48059503 and the lowest child-resistant effectiveness (CRE) was

### MRID number 48059805. A comprehensive review was done for the lowest SAUE including the CRE associated with it (MRID number 48059503) and the lowest CRE including the SAUE associated with it (MRID number 48059805). Child Study 3 white applicators with purple stripe on label size 0.5 ml size (MRID 48059503) involved giving each child 1 set of 3 applicators connected to each other and each applicator containing 0.5 ml ofwater at the start ofthe test. A child failure was defined as access to one applicator. There were no child failures. This study was a pass according to the child sequential test in 16 CFR 1700.20. 5



### SeniorAdult Use Effectiveness Study 3 white applicators with purple stripe on label size 0.5 ml size (MRID 48059503 which is the lowest SAUE) involved having the test subjects open one applicator during a 5 minute test period and a one minute test period. Scissors were made available during testing because the test directions given to the seniors called fortheir use. Data Analysis showed 9 seniors failures with package A and 1 senior failure with package S, which is the maximum number offailures for a passed SAUE. The SAUE is 90%. However, one test site (902) had 33% ofthe test subjects. This exceeds the maximum number of subjects pertest site (24%) per 16 CFR 1700.20(a)(3)(i). Therefore, this CRP test data is unacceptable. The senior adulttest must be corrected by replacing the last 9 test subjects from site 902 or redoing the entire senior adulttest. Ifthe last 9 test subjects from site 902 are replaced, the criteria for the entire 100 test subjects must conform to the criteria in 16 CFR 1700.20(a)(3)(i) regarding age and sex distribution, the number oftest subjects pertest site and pertester. Child Study 3 white applicators with red stripe on label size 2.68 ml size (MRID 48059805 which is the lowest CRE) involved giving each child 1 set of 3 applicators connected to each other and each applicator containing 2.68 ml ofwater at the start ofthe test. A child failure was defined as access to one applicator. The results were two child failures, a 43 month old male accessed 2 applicators before the demonstration and a 51 month old female accessed 1 applicator afterthe demonstration. This studywas a pass according to the child sequential test in 16 CFR 1700.20. SeniorAdult Use Effectiveness Study 3 white applicators with red stripe on label size 2.68 ml size (MRID 48059805) involved having the test subjects open one applicator during a 5 minute test period and a one minute test period. Scissors were made available during testing because the test directions given to the seniors called for their use. The results ofthe study were 98% SAUE. The study is a pass ofthe SeniorAdult test in 16 CFR 1700.20 and the effectiveness specifications in 16 CFR 1700.15(b). Based on the CRE and SAUE values the registrant reported for MRID numbers MRID numbers 48059803, 48059804, and 48059806 along with a computerized analysis ofthe data these studies pass the CRE sequential test chart and SAUE

### requirements in 16 CFR 1700.20 and the effectiveness specifications in 16 CFR 1700.15(b). Forthe details of each study refer to the attached summary chart (summarycht2517-134,135,136,137.doc). 6



### A bridging leiterwas submilted on June 30, 2010 for EPA Registration No. 2517- RGL and 2517- RGU indicating the same size and color package would be used as was tested for EPA Registration No. 2517-RGT (MRID number48059503) and 2517- RGA (MRID numbers 48059803, 48059804, 48059805, and 48059806). On the basis ofthat information:

• EPA Registration No. 2517-RGL does not meet the CRP test requirements because EPA Registration No. 2517-RGT does not meet the CRP test requirements. 

### • EPA Registration No. 2517-RGU meets the CRP test requirements because EPA Registration No. 2517-RGA meets the CRP test requirements. Forthe details ofeach study refer to the attached summary chart (summarycht2517-134,135,136,137,doc), A failure to market these products with the identical size and color packages and fill weight colors as were tested for each size 

### will result in these products needing to submit additional data to 

### establish that they are CRP. In conclusion all the requirements for CRP have been met for EPA Registration No. 2517-RGA and 2517-RGU. The directions on opening the package given to consumers must be identical to those given to the seniors during testing. EPA Registration No. 2517-RGT and 2517-RGL do not meet all the requirements for CRP. The SAUE study for EPA Registration No. 2517-RGT exceeds the maximum numberofsubjects pertest site (24%) per 16 CFR 1700.20(a)(3)(i), Therefore, the test data is unacceptable. The senior adulttest must be corrected by replacing the last 9 test subjects from site 902 or redoing the entire senior adulttest. Ifthe last9 test SUbjects from site 902 are replaced, the criteria for the entire 100 test subjects must conform to the criteria in 16 CFR 1700.20(a)(3)(i) regarding age and sex distribution, the numberoftest subjects pertest site and pertester. The corrected/new study and a new electronic CD for itwill need to be submitted. Should any human experience/epidemiological evidence indicate a problem once the product is in the marketplace, the Agency reserves the right to reexamine this data comprehensively and to question the child resistance ofthe package involved.

### CRPdatasummarycht EPA REG 

### # 2517-RGT Sergeant's Fipronil Spot On For Cats EPA REG 

### # 2517-RGA Sergeant's Fipronil Squeeze On For Dogs Company Name Sergeant's Pet Care Products, Inc. Chemical

- Fipronil 9.7% September 28, 2010

A SeniorAdult Use Effectiveness failure is failure to access the applicator in the prescribed test time of5 min. for the first package or 1 min. for the second package, not opening the applicatorwith scissors along the needle application tip, cutting the applicator between the cap and the body ofthe main chamber, cutting into the body ofthe main chamber ofthe applicator, cutting into the body**~f** 

### the main chamber ofthe applicator at other locations, cutting off the bottom ofthe main chamber ofthe applicator, or not separating a single applicator first and cutting open a second or second and third applicator. A child failure is access to 1 unit Access to 1 unit is more than 28.5mg of Fipronil for all sizes. A unitfailure is opening the applicator or any partial or complete access to the placebo (water). Access to a toxic or harmful amt

# = 28.5mg 

# = 28.5mg divided by 

### [1030mg/ml x 0.097 Fipronil]

# = 0.285 ml 

# = 0.29 ml for Fipronil only Cat EPA REG 

### # 2517-RGT Access to a toxic or harmful amt

# = 28.5mg 

# = 28.5mg divided by [1 

### 020mg/ml x 0.097 Fipronil]

# = 0.288 ml 

# = 0.29 ml for Fipronil only Dog EPA REG 

### # 2517-RGA Access to a toxic or harmful amt

# = 28.5mg 

# = 28.5mg divided by [1025 

### mg/ml x 0.098 Fipronil] 

# = 0.284 ml 

# = 0.28 ml for Fipronil & SMethoprene Cat EPA REG 

### # 2517-RGL Access to a toxic or harmful amt

# = 28.5mg 

# = 28.5mg divided by [1 

### 020mg/ml x 0.098 Fipronil]

# = 0.285 ml 

# = 0.29 ml for Fipronil & SMethoprene Dog EPA REG 

### # 2517-RGU %

### AI

- Fipronil 9.7% Note: The applicator is the child-resistant feature. The applicators are filled in mi. 1



### 1. 

## 2. 3. 10 CRP studies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1.34,2.68, 4.02 ml) for the Fipronil only and the Fipronil and S-Methoprene products. This is based on the registrant's submission of: samples of the applicator as tested and proposed to be marketed for the Fipronil only and the Fipronil and S.Methoprene products, which appeared to be identical; and a June 30, 2010 letter indicating the same applicator color (white) and fill weight colors will be used for both the Fipronil only and the Fipronil and S·Methoprene products as was used in the CRP testing.

### 2

EPA REG # MRID PKG Description Include # Pkges Company Data Data Conclusion ml per Pkg # unitlpkg, child fail ;; # Child Get eRE SAUE Compreh Only include eRE & SAUE via computer analysis units, color, tax/harm =# at Begin ensive Camp units Test Review uter & why Analy sis 2517-RGT 48059503 3 white applicators with t set of 3 

## achild XCRE 

### CRP Certification 5/271

### to is acceptable. Cat Fipronil only 1746-001 purple stripe on label 

### applicators failures = associat Label dated 6/291

## to same CRP directions as connected to each other. 

### connected Pass 50 ed with in study. Each applicator @ O.5ml to each child test lowest 

### Data Analysis showed no child failures. water as placebo. other. SAUE Study is a pass of the child test according to ToX/harm ;;: t applicator, the sequential test chart in t6 CFR 1700.20. child fail:::: t applicator 2517-RGT 48059503 3 white applicators with tsetof3 90% X lowest CRP Certification 5/27/tO is acceptable. Cat Fipronil only 1746-001 purple stripe on label applicators SAUE SAUE Label dated 6/29/tO same CRP directions as connected to each other. connected in study. Each applicator@ 0.5ml to each Data Analysis showed 9 seniors failures with water as placebo. other. package A and 1 senior failure with package Tox/harm:::: t applicator, B, which is the maximum number of failures child fail :::: 1 applicator for a passed SAUE, The SAUE is 90%. However, one test site (902) had 33% ofthe test subjects. This exceeds the maximum number ofsubjects per testsite (24%) per 16 CFR 1700.20(a)(3)(i). Therefore, this CRP test data is unacceptable. The senior adult test must be corrected by replacing the last 9 test subjects from site 902 or redoing the entire senior adult test. Ifthe last 9 test subjects from site 902 are replaced, the criteria for the entire 100 test subjects must conform to the criteria in t6 CFR 1700.20(a)(3)(i) regarding age and sex distribution, the number of test subjects per test site and per tester.

### 3**~PA** REG# MRID PKG Description Include # Pkges Company Data Data Conclusion ml per Pkg # uniUpkg, child fail

# = # Child Gel CRE SAUE Compreh Only include eRE & SAVE via computer analysis units, color, tox/harm 

## = # at Begin ensive Camp units Test Review 

### uler & why Analy 

### sis 2517-RGA 48059803 3white applica10rs with 1Se1of3 

## ochild X CRP CertifiCa1ion 5/27/10 is acceptable. Dog Fipronil 1746-002 orange stripe on label applicators failures = Label dated 6/29/10 same CRP directions as only connec1ed to each O1her. connected Pass 50 in study. Each applica10r @ 

### to each child test Data Analysis showed no child failures. a.67ml wa1er as placebo. other. S1udy is a pass of the child test accord'mg to ToX/harm 

### = 1 applica1or, the sequential1est chart in 16 CFR 1700.20. child fail = 1 appUca10r 2517-RGA 48059803 3 white applicators with 1se1of3 98% X CRP Certification 5/27/10 is acceptable. Dog Fipronil 1746-002 orange stripe on label applicators SAUE Label dated 6/29/10 same CRP direc1ions as only connected 10 each o1her. connected in study. Each applica10r @ to each Data Analysis showed 2 seniors failed to 0.67ml water as placebo. other. open package A SAUE is 98%. The study is ToX/harm

# =1 applica1or, a pass of1he senior adult test in 16 CFR child fail 

## =1 applica10r 1700.20 and the effectiveness specifica1ions in 16 CFR1700.15(b). 2517-RGA 48059804 3 white applicators with 1 setof3 o child X CRP CertifiCa1ion 5/27/10 is acceptable. Dog Fipronil 1746-003 green stripe on label applica10rs failures

# = Label dated 6/29/10 same CRP directions as only connec1ed 10 each other. connected Pass 50 in study. Each applica1or@ to each child tes1 Data Analysis showed no child failures. 1.34ml wa1er as placebo. other. Study is a pass of the child 1es1 according to ToX/harm

# =1 applicator, 1he sequential test chart in 16 CFR 1700.20. chlld fail

# =1 applicator 2517-RGA 48059804 3 white applica10rs wi1h 1 setof3 95% X CRP Certifica1ion 5/27/10 is acceptable. Dog FipronH 1746-003 green s1ripe on label appliCa10rs SAUE Label dated 6/29/10 same CRP directions as only connected 10 each other. connected in study. Each applicator @ to each Data Analysis showed 4seniors failed to open 1.34ml water as placebo. other. packageA and 1 senior failed to open Tox/harm

# =1 applicator, package B. SAUE is 95%. The study is a child fail

# =1 applicator pass of1he senior adult test in 16 CFR 1700.20 and the effec1iveness specifications in 16 CFR1700.15(b).

-------

### 4 I;PA REG # MRID PKG Description Include # Pkges Company Data Data Conclusion ml per Pkg

, # uniVpkg, chlfd fail 

## = # Chifd Get CRE SAUE Compreh Only include eRE & SAUE via computer analysis units, color, tox/harm 

## = # at Begin ensive Camp units Test Review uter &

### why Analy sis 2517-RGA 48059805 3 white applicators with tsetof3 2 child X lowest CRP Certification 5/27/tO is acceptable. Dog Fipronil t746-004 red stripe on label applicators failures 

### = CRE Label dated 6/29/10 same CRP directions as only connected to each other. connected Pass 50 in study. Each applicator@ to each child test Oata Analysis showed 2 child falfures, a 43 2.68mfwater as placebo. otheL month old male accessed 2 applicators before Toxlhann = t applicator, the demonstration and a 51 month old female child fail

# =t applicator accessed one applicator after the demonstration. Study is a pass ofthe child test according to the sequential test chart in t6 CFR t700.20. 25t7-RGA 48059805 3 white applicators with t setof3 98% XSAUE CRP Certification 5/27/tO is acceptable. Dog Fipronil t746-004 red stripe on label applicators SAUE associat Label dated 6/29/10 same CRP directions as ol1ly connected to each other. connected ed with in study. Each applicator @ to each lowest Data Analysis showed 2eniors failed to open 2.68ml water as placebo. other. CRE package A SAUE is 98%. The study is a Tox/harm

# =t applicator, pass of the senior adult test in t6 CFR child fail

# =t applicator 1700.20 and the effectiveness specifications in 16 CFRt700.15(b). '17-RGA 48059806 3white applicators with 1 setof3 t child X CRP Certification 5/271 to is acceptable.**~,og** Fipronif t746-005 blue stripe on label applicators faifure

# = Label dated 6/291 to same CRP directions as only connected to each other. connected Pass 50 in study. Each applicator@ to each chifd test Data Analysis showed one age calculation 4.02ml water as placebo. other. error, a44 month old male was reported as 45 Tox/harm

# =t applicator, months old. The age distribution is not in child fail

# =1 applicator accordancewith 16 CFR 1700.20. The study results are not affected. There was t chifd faHure, a 44 month old male accessed t applicator after demonstration. Study is a pass ofthe chifd test according to the sequential test chart in t6 CFR t700.20.

### 5
EPA REG# MRID PKG Description Include # Pkges Company Data Data Conclusion ml per Pkg # unitlpkg, child fail 

# = # Child Get eRE SAUE Compreh 

### Only include eRE & SAUE via computer analysis units, color, tox/harm ::: # at Begin ensive Camp units Test Review uter & 

### why Analy sis 2517-RGA 48059808 3 white applicators with 1 setof3 97% X eRP Certification 5/27/10 is acceptable. Dog Fipronil 1748-005 blue stripe on label applicators SAUE Label dated 6/29/10 same CRP directions as only connected to each other. connected in study. Each applicator @ to each Data Analysis showed 1 birth date was 4.02ml water as placebo. other. missing, Upon finding it in the hard copy of Tox/harm ::: 1 applicator, data the age calculation was okay. The study child fail ::: 1 applicator results are not affected. There was one age calculation error, but the test subject remained in the same age group. The study results are not affected. The results showed 3 seniors failed to open package A. SAUE is 97%. The study is a pass of the senior adult teSl in 16 CFR 1700.20 and the effectiveness specifications in 16 CFR1700.15(b).6 

### September 28, 2010 CRPdatasummarycht EPA REG 

### # 2517-RGL Sergeant's Fipronil 

### + S-Methoprene Spot On For Cats Company Name Sergeant's Pet Care Products, Inc. Chemical

- Fipronil 9.8% S-Methop,ene 11.8% A SeniorAdult Use Effectiveness failure is failure to access the applicator in the prescribed test time of 5 min. for the· first package or 1 min. for the second package, not opening the applicator with scissors along the needle application tiP. cutting the applicator between the cap and the body ofthe main chamber, cutting into the body ofthe main chamber ofthe applicator, cutting into the body ofthe main :hamber ofthe applicator at other locations, cutting offthe bottom ofthe main chamber ofthe applicator. or not separating a single applicator first and cutting open a second or second and third applicator. A child failure is access to 1 unit. Access to 1 unit is mOre than 28.5mg of Fipronil for all sizes. A unitfailure is opening the applicator or any partial or complete access to the placebo (water). Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by 

### [1030mg/ml x 0.097 Fipronilj = 0.285 ml = 0.29 ml for Fipronil only Cat EPA REG 

### # 2517-RGT Access to a toxic or harmful amt

# =28.5mg 

# =28.5mg divided by 

### [1020mg/ml x 0.097 Fipronilj

# = 0.288 ml 

# = 0.29 ml for Fipronil only Dog EPA REG 

### # 2517-RGA Access to a toxic or harmful amt 

## =28.5mg 

## = 28.5mg divided by [1025 

### mg/ml x 0.098 Fipronilj 

## =0.284 ml 

## =0.28 ml for Fipronil & 5- Methoprene Cat EPA REG 

### # 2517-RGL Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by 

### [1020mg/ml x 0.098 Fipronilj = 0.285 ml 

### = 0.29 ml for Fipronil 

### & 5- Methoprene Dog EPA REG 

### # 2517-RGU 

### Y. AI

- Fipronil 9.8% S-Methoprene 11.8% Note: 

### 1. 

## 2. 3. The applicator is the child-resistant feature. The applicators are filled in mi. 10 CRP studies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1.34, 2.68, 4.02 ml) for the Fipronil only and the Fipronil and S-Methoprene products. This is based on the registrant's submission of: samples of the applicator as tested and proposed to be marketed for the Fipronil only and the Fipronil and S-Methoprene products, which appeared to be identical; and a June 30, 2010 letter indicating the same applicator color (white) and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methoprene products as was used in the CRP testing.

### 7

EPA REG # MRID PKG Description Include # Pkges Company Data Data Conclusion ml per Pkg # unitlpkg, child fail = # Child Get at eRE SAUE Compreh Only include eRE & SAUE via computer
, units, color, tox/harm 

## = # Begin Test ensive Computer analysis I units Review Analysis & why 2517-RGL 3white applicators with 1 setof3 CRP Certification 5/27/10 is Cat Fipronil +**S~** purple stripe on label applicators acceptable. Laber dated 6/29/10 Methoprene connected to each other. connected same CRP directions as in study Each applicator@ O.5ml to each mentioned below. Size not accepted i water as placebo. other. based on: Tox/harm = 1 applicator, MRID 48059503 (1746-001), EPA child fail = 1 applicator Reg No. 2517-RGT. Study is a pass of the child test according to the sequential test chart in 16 eFR 1700.20. The SAUE is 90%. However, one test site (902) had 33% ofthe test subjects. This exceeds the maximum number of subjects pertest site (24%) per 16 CFR 1700.20(0)(3)(1). Therefore, this CRP test data is unacceptable. Bridging Letter6/30/1 0 indicating same size and color package as package tested is okay.

### 8 

### September 28,2010 CRPdatasummarycht EPA REG 

### # 2517-RGU Sergeant's Fipronil 

### + S-Methoprene Squeeze On For Dogs Company Name Sergeant's Pet Care Products, Inc. Chemical

- Fipronil 9.8% S-Methoprene 8.8% A SeniorAdult Use Effectiveness failure is failure to access the applicator in the prescribed test time of 5 min. for the first package or 1 min. for the second package, not opening the applicatorwith scissors along the needle application tip, cutting the applicator between the cap and the body ofthe main chamber, cutting into the body ofthe main chamber 

### ofthe applicator, cutting into the body ofthe main

hamber ofthe applicator at other locations, cutting offthe bottom ofthe main chamber ofthe applicator, or not separating a single applicator first and cutting open a second or second and third applicator. A child failure is access to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. A unitfailure is opening the applicator or any partial or complete access to the placebo (water). Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by 

### [1030mg/ml x 0.097 Fipronilj = 0.285 ml = 0.29 ml for Fipronil only Cat EPA REG 

### # 2517-RGT Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by 

### [1020mg/ml x 0.097 Fipronilj = 0.288 ml = 0.29 ml for Fipronil only Dog EPA REG 

### # 2517-RGA Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1025 

### mg/ml x 0.098 Fipronilj = 0.284 ml = 0.28 ml for Fipronil 

### & SMethoprene Cat EPA REG 

### # 2517-RGL Access to a toxic or harmful am! = 28.5mg = 28.5mg divided by 

### [1020mg/ml x 0.098 Fipronilj = 0.285 ml = 0.29 ml for Fipronil 

### & SMethoprene Dog EPA REG 

## # 2517-RGU 

### 10 AI

- Fipronil 9.8% S-Methoprene 8.8% Note: 

### 1. 

## 2. 3. The applicator isthe child-resistant feature. The applicators are filled in ml, 10 CRP studies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1.34, 2.68, 4.02 ml) for the Fipronil only and the Fipronil and S-Methoprene products. This is based on the registrant's submission of: samples of the applicator as tested and proposed to be marketed for the Fipronil only and the Fipronil and S-Methoprene products, which appeared to be identical; and a June 30, 2010 leiter indicating the same applicator color (white) and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methoprene products as was used in the CRP testing.

### 9
EPA REG # MRID PKG Description Include # Pkges Company Data Data Conclusion ml per Pkg # uniUpkg, child fail = # Child Get CRE SAUE Compreh Only include eRE & SAUE via computer units, color, tax/harm 

## = # at Begin ensive Computer analysis units Test Review Analysis & why 2517-RGU 3 white applicators with 1setof3 CRP Certification 5/27/10 is Dog Fipronil + S- orange stripe on label applicators acceptable. Label dated 6/29/10 Methoprene connected to each other. connected same CRP directions as in study Each applicator@ a.87ml to each mentioned below. Size accepted water as placebo. other. based on: Bridging Letter6/30/10 ToX/harm

## =1 applicator, indicating same size and color child fail 

## =1 applicator package as package tested; and passing eRE & SAUE values per 16 CFR 1700for MRID 48059803 (1746- 002) EPA Reg No. 2517-RGA. 2517-RGU 3 white applicators with 1 set of 3 CRP Certification 5/27/10 is Dog Fipronil + S· green stripe on label applicators acceptable. Label dated 6/29/10 Methoprene connected to each other. connected same CRP directions as in study Each applicator@ 1.34ml to each mentioned below. Size accepted water as placebo. other. based on: Bridging Letter 6/30/10 Toxlhann

## =1 applicator, indicating same size and color child fail 

## =1 applicator package as package tested; and passing CRE & SAUE values per 16 CFR 1700 for MRID 48059804 (1746- 003) EPA Reg No. 2517-RGA. ,J17·RGU 3 white applicators with 1 setof3 CRP Certification 5/27/10 is Dog Fipronil + S· red stripe on label applicators acceptable. Label dated 6129/10 Methoprene connected to each other. connected same CRP directions as in study Each applicator@2.68ml to each mentioned below. Size accepted water as placebo. other. based on: Bridging Letter 6/30/10 Toxlharm

## =1 applicator, indicating same size and color child fail 

## =1 applicator package as package tested; and passing CRE & SAUE values per 16 CFR 1700 for MRID 48059805 (1746- 004) EPA Reg No. 2517-RGA

### 10
EPA REG# MRID PKG Description Include # Pkges Company Data Data Conclusion ml per Pkg # unftlpkg, child fail = # Child Get CRE SAUE Compreh Only include eRE & SAUE via computer units, color, tox/harm = # at Begin ensive Computer analysis uni1s Test Review Analysis & why 2517-RGU 3 white applicators with 1setof3 CRP Certification **5/27/10** is Dog Fipronil + 8- blue stripe on label applicators acceptable. Label dated **6/29/10** Methoprene connected to each other. connected same CRP directions as in study Each applicator@ 4.02ml to each mentioned below. Size accepted water as placebo. other. based on: Bridging Letter **6/30/10** Tax/harm = 1 applicator, indicating same size and color child fail = 1 applicator package as package tested; and passing eRE & SAUE values per 16 CFR 1700 for MRID 48059806 (1746- 005) EPA Reg No. 2517-RGA.

### ProductToxicity based on Flpronil Toxicity Access to a toxic or harmful am! 

## = 28.5mg Fipronil Access to a toxic or harmful amt

# =28.5mg = 

### 28.5mg divided by 

### [1030mg/ml x 0.097 Fipronil] 

# =0.285 ml 

# =0.29 ml for Fipronil only Cat EPA REG 

### # 2517-RGT Access to a toxic or harmful amt 

## = 28.5mg 

## =28.5mg divided by 

### [1020mg/ml x 0.097 Fipronil] 

### = 0.288 ml 

### = 0.29 ml for Fipronil only Dog EPA REG 

### # 2517-RGA Access to a toxic or harmful amt 

### = 28.5mg 

# =28.5mg divided by [1025 

### mg/ml x 0.098 Fipronil] 

# =0.284 ml 

# =0.28 ml for Fipronil & 

### 5- Methoprene Cat EPA REG 

### # 2517-RGL Access to a toxic or harmful amt 

## = 28.5mg = 

### 28.5mg divided by 

### [1020mg/ml x 0.098 Fipronil] = 

### 0.285 ml = 

### 0.29 ml for Fipronil & 5- "ethoprene Dog EPA REG 

### # 2517-RGU 11

EPA Reg # ml (ml 

### = fl. oz. (fl. oz. :: Product % FipronU mg Fipronil # unit = tax Iharmful amt 0.0338 fl. 29.6ml) Density g/ml oz.)

2517-RGT 0.5 0.017 1.030 9.7 49.96 1 2517-RGA 0.67 0.023 1.020 9.7 66.29 1 2517-RGA 1.34 0.045 1.020 9.7 132.58 1 2517-RGA 2.68 0.091 1.020 9.7 265.16 1 2517-RGA 4.02 0.136 1.020 9.7 397.74 1 2517-RGL 0.5 0.017 1.025 9.8 50.23 1 2517-RGU 0.67 0.023 1.020 9.8 66.97 1 2517-RGU 1.34 0.045 1.020 9.8 133.95 1 2517-RGU 2.68 0.091 1.020 9.8 267.89 1 2517-RGU 4.02 0.136 1.020 9.8 401.84 1

## DATA PACKAGE BEAN SHEET Date: 11-May-2010 Page 1 of 1 

### * * * Registration Information 

### * * '" Decision 

### #: 425453 DP 

### #: (377598) PRIA Parent DP 

### #: Submission 

### #: 873354 Registration: 2517-RGU - SERGEANT'S FIPRONIL + S-METHOPRENE SQUEEZE.:ON F Company: 2517

- SERGEANTS PET CARE PRODUCTS, INC. Risk Manager: RM 10

- Richard Gebken

- (703) 305-6701 Room# PY1 S-7237 Risk Manager Reviewer: Bonaventure Akinlosotu BAKJNLOS Sent Date: Calculated Due Date: 04-Nov-2010

--- Type of Registration: Product Registratfon

- Section 3 Edited Due Date:
____ _

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

Ingredients: 105402, S.Methoprene(8.8%) 129121, Fipronil(9,8%) 

### * * * Data Package Information 

### * * * Expedite: 

## 0 Yes. No DP Ingredient: 105402, S-Methoprene 129121, Fipronfi DP Title: TOX: Similarity Date Sent: 11-May-2010 Due Back:
___ _

CSF Included:

.. Yes 

### 0 No Label Included:

.. Yes 

## 0 No Parenl DP #:

____ _
Assigned To Date In O"eO", / 

# -="",,,,,- Last Possible Science Due Date: OS·Oct-2010 Organization:**cR~O~I~T~R~B~** _____ _ Team Name: TDX Science Due Date:
____ _ Reviewer Name:
_____ _ Sub Data Package Due Date:
____ _ Contractor Name:
__________ _ 

### * * * Studies Sentfor Review 

### * * *
No Studies 

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

### * * 

## *
Can be prlnted on**~s** own page 

## * * * Data Package Instructions 

## * * *
For Your Review: An R310 action, a new fipronilJ3-methoprene EP; presumably me-too of Merial's Frontline 65331-5. Thx, baa

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

September 13,2010
MEMORANDUM OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### Subject: Name ofPesticide Product: SERGEANT'S FIPRONIL 

### + S-METHOPRENE SQUEEZE-ON FOR DOGS EPA Reg. No. 

### IFi1e Symbol: 2517-RGU DP Barcodes: DP 377598 Decision No.: 425453 Action Code: R310 PC Codes: 129121 (Fiproni1: 9.8%); 105402 (S-Methoprene: 8.8%)
From: Byron T. Backus, Ph.D., Toxicologist Technical Review Branch Registration Division (7505P) 

### To: Bonaventure Akinlosotu/Richard Gebken RM 10 Insecticide Branch Registration Division (7505P) Registrant: SERGEANT'S PET CARE PRODUCTS, INC.
FORJvruLATION FROM LABEL: Active Ingredient(s): 129121 Fiproni1 105402 (S)-methoprene Other Ingredient(s): TOTAL
ACTION REQUESTED: The llisk Manager requests: Bywt. 

### 9.8% 8.8% 81.4% 100.0% 

### •

"For Your Review: An R310 action, a new fipronillS-methoprene EP; presumablyme-too of Merial's Frontline 65331-5."

Page 1 of3\ 

## ,**c~** \,-lL >'" .; ,',0- v 

### BACKGROUND: To support the registration ofEPA File Symbol 2517-RGU, the registrant is citing 5 acute 

### toxicity studies (MRIDs 44942004 through 44942008), as well as a number ofcompanion animal animal and other studies (MRIDS 43577711, 43863802, 43577715, 44942104, 45143901, 45612702 and 45620507). The material received for review also includes a proposed label, a CSF dated 1212112009, 

### and a copy ofa cover letter dated April 12, 2010. COMMENTS AND RECOMMENDATIONS: 1. After a comparison ofthe CSFs, TRB concludes that**2517~RGU** 

### is toxicologically similar to 

### 65331**~5,** 

### and that the toxicity studies that supported the registration of65331**~5** 

### will also support the registration of2517-RGU. 

### 2. MRIDs 44942004 through 44942008 were reviewed and accepted in a memorandum dated December 12, 1999 from M. Hashim to A. Sibold; the formulation (10% Fipronil and 12% Methoprene) was assigned to EPA Toxicity Category 111 for oral toxicity, and to Category IV for dermal toxicity, primary eye and dennal irritation. The inhalation toxicity study requirement was waived, and, based on the precautionary label recommendations, the productwas assigned to Category IV by that exposure route. The product was negative for dennal sensitization. 3. The companion animal safety study in beagle puppies (MRID 44942104), conducted on a formulation containing 10% Fiproni1 and 9% S-Methoprene, was submitted as an interim report and classified as supplementary/guideline in a TRB review (B. 

### Backus to A. 

### Sibo1d) dated May 5, 2000. Subsequently, additional information (in MR1D 45143901) was submitted to the Agency and reviewed andthe study was reclassified to acceptable in aTRB review (B. Backus to A. Sibold) dated July 11,2000. 4. In a TRB memorandum (M. Hashim & 

### B. Backus to A. Sibo1d) dated October21, 2002, it was stated thatthe study inMR1D 45612702 was acceptable, and that 

### it adequately supported the proposed use ofa 10% Fipronil-9% (S)-Methoprene fonnulation at the label-specified dosage rate of0.67 mLiapplication ondogs weighing lessthan 10 Ibs at 

### no less than 30-day intervals. 5. The memorandmn ofOctober 21,2002 also stated that the study in MRID 45620507 was acceptable, and that the findings ofthis study were adequate to support the use ofEPA Reg. Nos. 65331-3 and**65331~5** 

### at the specified label use rates (varying according to the weight of dog) at 28-day intervals onbreeding, pregnant and lactating bitches. There is no record inIHAD ofa review for MRID 43577711. According to OPPIN Query MRlD 43577711 is a 6-pagedocmnenttitled "Discussionin Support ofBridging Domestic Animal Safety Data on Frontline Spray Treatment to Frontline Spot Treatment" which was submitted in suppott of65331-EUP-E.

Page2of3

### 7. The study in MRID 43863802 titled: "Domestic Animal Safety Study by Topical Administrationto Dogs" was reviewed (sign-offdate 04/03/96) by V. Dobozy in HED. From the review: "The study demonstrated that RM160lE/62 

### (9.7% fipronil) has at least a 5X margin ofsafety in dogs greaterthan 10 weeks ofage. The product label should state that there may be temporary irritation after application." The review of04/03/96 

### also notes the follmving: "The spot-on label states "Fipronil is not absorbed into the body, but rather collects inthe oils ofthe skin and hair follicles. Fipronil continues to be released from hair follicles onto 

### the skinand fur, resulting in long residual activity." A previously submitted study (MRID #43577715) in which radiolabeled fipronil was administered to dogs ata high dose (10 mg/kg) demonstratedthat the chemical is absorbed systemically. Plasmalevels of radioactivity were detected from day 2 to day 30 post-treatment. These statements should be deleted from the label for dogs. A similar study in cats determined that systemic absorption was insignificant." The proposed label for 2517-RGU includes the following claim: "The active ingredientsin [brand name} work by collecting in the hair follicles and skin oils. This product features a sustained-release formula that discharges from the animal's hair follicles using the natural skin oils

... " This should be deleted from 2517-RGU, and the similar claim for 65331-5 ("Fipronil collects inthe oils ofthe skin and hair follicles, and continues to be released from hair follicles onto the skin and coat
...") should be deleted from the label ofthatproduct. 8. TRB concludes that these cited studies will satisfy the toxicity data requirements for the registration of2517-RGU. 9. The proposed precautionary labeling and first aid statements for 2517-RGU are acceptable. 10, For the purposes ofthis action, TRB has not reevaluated previously reviewed data. 11. The CSF (dated 12/2112009) for 2517-RGU shquld also be reviewed and accepted by the TRB Chemistry Team.

Page 3 of3

## DATA PACKAGE BEAN SHEET Date: 11 wMaYw2010 Page t of2 

### * 

### * * Registration Information 

## ** * Decision 

### #: 425453 DP

### #: (377596) PRIA Parent DP#: 

### Submission 

### #: 873354 Registration: 25H,RGU

- SERGEAfliT'S FIPRONIL + S-METHOPR_ENE SQUEEZE-ON F

## ~"-- 

# 0 Company 2512-

# SERG~~T'S PE.:r CA'3E

# ~RSlDU~!S,**~----** -

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

## r1 

# 1J;Y**~** Risk Manager RM 10

- Richard Gebken

- (703) 305_-6I.2.1 Ro£m#

### ~~!§-7237________

### ~~

## l Risk Manager Reviewer**B~mavent~ ~klnlosotu-.!3~~INLOS**  __ __ __ _ __ _ ___ _ ______ 

# 11
v Sent Date: Calculated Due Date: 04-Nov-2010 Edited Due Date: Type of Registration:**~ro~~ct** Registration -_Section.L Actfon Desc:**(~~_1** 0)**N~yv P~.9:~l:'CT;N2N-FAST**  TRACK**(INC,~!:JPES_REVIEWS** OF**~B9P~~T_~!:i~MIS~**

Ingredients:**105402,_S-=Met~.9E.~e:~!:(!~~L**__ 

## ** * Data Package Information * * 

### *
Expedite: 

### 0 Yes" No Due Back:
DP Ingredient:**!_~~~~~_,_~MethJ_~!_e_n~** ________________________________ !?JJ21,**Fi~?.!1!!**__ DP Title: Prod Chem CSF Included:

.. Yes 

### 0 No Label Included:

.. Yes 

## 0 No Parent DP #:

Date In Date Out Organization:**!3:Q_~_TR§** _______,,_________________________ Team Name: CHEM Science Due Date: Reviewer Name: Sub Data Package Due Date:
______________ Contractor Name: 

### * * * Studies Sentfor Review 

## * * *
Printed on Page 2 

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

### * * 

### * No Additional Data Packages 

### * * * Data Package Instructions

### * 

## * *
For Your Review: MRID 480591 -01 & 02 for an R310 action, a fipronilf3-methoprene EP; presumably me-too of Merial's Frontline 65331-5. Thx, baa

### DP BARCODENo.: 377596 FILE SYMBOLNo.:2517-RGU DECISION No.: 425453 PC Coders): 105402,129121 ACTION CODE: R 310 FOOD Use: NO NON-FOOD Use: YES DATE OUT: August 31, 2010

SUBJECT: End Use Product ChemistryReview

FROM:

# r~ 

# .**~.,y\~** 

# I duct**N~e:** 

### SERGEANT'S FIPRONIL+S-METHOPRENE SQUEEZE-ON 

# \r;;,st a i'tairola ("

# ~ " 

# 1

# ~ll0 Product Chemistry Team )(\ 

### ',{vv' -\.'

. Technical ReviewBranch/ Registration Division (7505P)**~** 

### TO: Richard Gebken IBonaventure Akinosotu PM 10 Insecticide Branch 

### I Registration Division (7505P) Company Name SERGEANT'S PET CARE PRODUCTS INC. Formulation Type: LIQUID

INTRODUCTION: The applicant requested a new non food use) end use product. In supportofthe application,the applicant submitted product chemistry data corresponding to guideline 830 series, group A & 

### group B. (MRlD#s 480591-0I and -02). TRB has been asked to determine the acceptability ofthe product chemistry data and the proposed basic and 2 alternate CSF's.

SUMMARY OFFINDINGS: 1. Name ofActive lngredient(s); Fipronil and Methoprene. 2. All ofthe source materials ofthe active ingredient are derived from registered sources. 3. All inert ingredients have been screened by 

### HAB and found to be approved for the proposed labeled uses. 4. Confidential Statement ofFonnula(s); 

### [Xl Basic

- 12121109 

### [X] Alternate # I &# 2 Dated: both

- resubmitted (email)

- Dated: 08/3111

### 0 Dated: 08/31110 

### Alternate CSF(s) complies with 40CFR§152.43: 

### [Xl Yes 

### [l No

5. Product label

### DP BARCODE No.: PC Coders): FOOD Use: Yes 5. Product label FILE SYMBOL No.: 

### Action Code: R310, R 340, 345 NON-FOOD Use: Yes DECISION No.:

a. Ingredient statement: Nominal concentration ofAI listed on CSF(s) concurwith product label (PRNotice 91-2) [X ] Yes, ifnot, explain below: 

### Metallic equivalent: [ Soluble arsenic: [ 

### Isomeric ratios: Acid equivalent: 

### [ [ 

## 1Yes [ 

## 1

Yes [ 

## 1Yes [ 

## 1Yes [ lNA; 

## 1

NA lNA ] NA; 

### {name} acid equivalent = 

### xx % 

### b. Health related sub statements: Product contains? Petroleum distillate at

### > 10%: Methanol at 

### >4%: 

## 1Yes [Xl No [ 

## 1NA 

## 1Yes [Xl No [ 

## 1 NA

c. Physical chemical hazard statement: Product label requires a statement per40 CFR 

### §156.78 for: flammability, explosive potential or electric insulator breakdown? [lYes [lNo [XlNA
Is the sub statement in compliance with PRNotice**97~6?** 

### [ ] Yes, if

### not, explain below: d. Label requires an additional Storage and Disposal statement: [ ] Yes [X] No; ifyes explain below: Applicant needs to submit EnforcementAnalytical Method for Fipronil and methoprene.

2

### DP BARCODE No.: FILE SYMBOLNo.: DECISION No.: PC Coders): FOOD Use: Yes Action Code: R 310, R 340, 345 NON-FOOD Use: Yes
6. Group A: Product Chemistry Data
TRE's determination ofthe acceptability ofthe data for the proposed product is listed in the tables below.


### Data 

### TRB's

Guideline submitted Assessment No. Study Title Yes No ofData MRiDNos. Product Identity & 

### 830.1550 Composition 

### X A 480591-01 Description ofmaterials used 830.1600 

### to produce the product X A 480591-01 Description offonnulation 830.1650 I 

### process X A 480591-01 Discussion onthe formation 830.1670 ofimpurities 

### X A 480591-01 830.1700 Preliminary analysis 

### Standard certified Certified limits limits (158.350) Proposed Limits Justification for 830.1750 wider limits Enforcement analytical 830.1800 method 

### G

A = 

### Acceptance, N = 

### Not Acceptable, G = 

### Data Gap, 

### W = 

### Waiver Request, I = 

### In Progress, NA = 

### NotApplicable

3

### DP BARCODE No.: FILE SYMBOL No.: DECISION No.: PC Code(s): FOOD Use: Yes
7. GroupB: 

### Guideline StudyTitle No.

830.6303 Physical State 830.6315 Flammability 830.6316 Explodability 830.7000 pH 

### 830.7300 Density (units) Action Code: R 310, R 340, 345 NON-FOOD Use: Yes



### Value or Qualitative 

### TRB's Description Assessment ofData Clear yellowliquid A >90°C A Not explosive A Insoluble in water NA 1.00-1.04g/mL A
A = 

### Acceptance, N = 

### Not Acceptable, G = 

### Data Gap, W = 

### Waiver request, NA = 

### Not applicable, 1= 

### Inprogress

CONCLUSIONS: MRIDNos.

480591·02 480591-02 480591-02 480591-02 480591-02

TRB hasreviewed the CSF(s) andproduct chemistry data for the proposed end use product and has concluded: 

### 1. Basic CSF Dated: 

### 08/31110 is Acceptable and attached. 2. Alternate CSF(s) #1  Dated: 

### 08/31110 are Acceptable and attached 3. All required GroupA data were reviewed and determined to be Acceptable except Enforcement Analytical Method for Fipronil and Methoprene. 4. All required Group B data were reviewed and determined to be Acceptable; exceptguidelines 830.6317 (storage stability) and 830.6320 (corrosion characteristics). The registrant is required to generate one year storage stability & 

### corrosion characteristics study. The recommended observations periods are 0,1,3,6,9, & 

### 12 months intervals. 5. The proposed label was screened as it pertains to the product chemistry requirements. The final review ofthe proposed label and uses are thepurview ofthe PM team.

4UNI t c::D STATES ENVIRONMENTAL PROTEC11vN AGENCY WASHINGTON, D.C. 20460



### April19,2010

OPP Decision Number: D-425453 EPA File Symbol or Registration Number: 2517-RGU OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### ProductName: SERGEANT'S FIPRONIL

### + S-METIIOPRENE SQUEEZE-ON FOR DOGS EPA ReceiptDate: 22-Dec-2009 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CARE PRODUCTS, INC.EPA File Symbol or Registration Nwnber:
KELLY R HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTII 158TH PLAZA OMAHA, NE 68130-1703 SUBJECT: Receipt ofApplication and 50% Small Business Waiver Request
Dear Registrant: The Office ofPesticide Programs has received your application, 50% small business waiver request, and cerification ofpayment. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has detennined that this Action is subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Actionhas been identified as Action Code: R31 0 NEW PRODUCT;NON-FASTTRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY);
Your request for waiverhas been forwarded for review. You will be notified inwriting when a detenninationis made regarding yourrequest. Ifyour waiverrequest is approved, the decision reviewtimeperiod will start onthe date ofapproval and we will process a refund ofyour $2,289 overpayment. Ifyour waiverrequest is denied, you will receive an invoice for the outstanding balance.
Ifyouhave any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 305-6249. Sincerely, 

# c:J**/~~** Front End Processing Staff Infonnation Technology & 

### Resources Management Division

### change PRIA code Linda Arrington to: John Jamula 04/16/2010 11:38AM Cc: Bonaventure Akinlosotu, Teresa Downs
Hi 

### JJ and Teresa, Please change the following from R30D to R310. Company has submitted the difference in fee already_**2517~~RGU** 2517-RGL 2517-RGA**2517~RGT** Linda Arrington Registration Division 7033056249 703 305 6920 (fax)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### Apri115,2010

SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703
Report ofAnalysis for Compliance with PR Notice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your 

### submittal of 12-APR-lO. Our 

### staffhas completed a preliminary analysis ofthematerial. 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 copyofyourbibliographyis enclosed, annotated with Master Record ID's (MRIDs) assigned to each document submitted. Pleaseuse these numbers 

### in all future references to these documents. Thank you for your cooperation. Ifyou have any questions concerning this data submission, pleaseraise them with the cognizant Product Manager, to whomthe data have been released.480591·00 Sergeant's Pet Care Products, Inc. 2625 South 1S8th Plaza • Omaha, NE 68130-1nO • Telephone 402.938.7000 • Fax402.938.7091 • www,sergean1s,com


### April 12, 2010 Richard Gebken, PMIO Office ofPesticidePrograms (7504P) 

# u.s. Envirorunental ProtectionAgency 

### DocumentProcessingDesk Room S·4900, One Potomac Yard 2777 South CrystalDrive Arlington, VA 22202 Subject: Sergeant's Fipronil 

### + S-methoprene Squeeze-On for Dogs EPA File Symbol 2517·RGU Responseto theAgency's LetterDated January27,2010 DearMr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158'"Plaza, Suite 100, Omaha, NE 68130-1703, EPA CompanyNumber2517) is submitting additional datato supportthe pendingproductregistration for Sergeant's product Sergeant'sFipronil 

### + S-methoprene Squeeze-On for Dogs (EPAFile Symbol 2517-RGU). The dataarebeing submittedto 

### EPA inresponseto the Agency's letter dated January 27, 2010 (please see enclosed copy). The Agencyrequested Sergeant'sto address deficiencies inthe submission. Please see belowthe Agency's comments (in italics) and Sergeant'sresponse (inbold); 1. The data matrices for the above referenced productsare incomplete. You mustrevise each data matrix bylistingoutspecificMRIDls (where applicable) andstudy title names that are usedto 

### supporteach applicableguideline. Instructions for completingthe EPA form 8570-35 data matrixcOlTectly can be foundwithinPRNotice 98-5. 

### Sergeants is submitting a new data matrix using the selective method ofsupport with this submission package to fulfill the Agency's requirements. 2. The "Cite-all"option forproductchemistry is inadequate. You cannot citeproduct chemistrydata, since Sergeant1sPet CareProducts, Inc. is theformulator of the proposed products. Asa result, you mustsubmitacceptable enduseproductchemistry data in accordance withPRNotice 86-5. 

### In addition,youmustrevise the data matrix as outlinedin 

### #1 above to reflect this change. 

### Sergeantsis submittingnew product chemistry data specific to Sergeants' spot on product Sergeant's Fipronil

## + S-methoprene Squeeze-Onfor Dogs (EPAFile Symbol 2517-RGU). The new studies are beingsubmitted in 

### accordancewith PR Notice 86-5 and Sergeants listed these studies in the new enclosed data matrix.

### Sergeant's Pet Care Products, 

### Inc. 2625 South 158th Plaza • Omaha, NE**68130~1770** • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeants.com 

### 3. In accordance with 40 CFR §152.34, the submittedChildResistantPackaging (eRP) 

### self-certification is unacceptable for eachproduct. The currently approved

### CRP data for the referenced productslistedonyour**8570~1**

### fonn (block #6) 

### are also not citable for purposesof satisfyingthe datarequirements outlinedin40 CFR 

### § 152.34. 

### These 

### eRP tests areproductpackage design specific andunrelatedtoyourproposed package. 

### Sergeants submitted a new Child Resistant Packaging study for review as part of this package (an MRID number has not been assigned). Sergeants listed this new study in the new enclosed data matrix. Accordingto this letter, theAgency re-classified the original application from a R300 new product; me-too fast track ($1,365), to a R310 newproduct; non-fasttrack application ($4,578). Please forward an invoice for the additional fee. Please find enclosed the following documentation in supportofour response: 1. Administrative materials:

• Transmittal document; • EPA Fonn 8570-1: Application for Pesticide Ponn ; • EPA Ponn 8570-34: Certification withRespectto CitationofDataFonn; • EPA Fonn 8570-35: DataMatrix Ponn

- EPA andPublic Versions; and • Additional PRIA Payment ConfIrmation Receipt. 2. Product-specific product chemistry data. If

### youhave any questions regarding this submission, please contactme. Sincerely,

# ~.H!~S**~~** Ie-AT ManagerofTechnical Affairs Sergeant's Pet Care Products, mc. EnclosuresSergeant's Pet Care ProdUcts, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeants.com



### Data TransmittalDocument:



### Submitter: Sergeant's Pet Care Products, Inc, (EPA CompanyNumber2517) 2625 South 158'" Plaza Suite 100 Omaha, NE 68130-1703 Submittal Date: April 12, 2010 

### Volume StudyTitle MRID I 

### Group A Product Chemistry for Sergeant's Fipronil 48059101 

### Dog Spot-On II (2517-RGU) 2 

### Group B Product Chemistry for Sergeant's Fipronil 48059102 

### Dog Spot-OnII (2517-RGU)Please read instructions on reverse before 'p/eting form Form Approv' JMB No 20700060 Approval expires 05-31 98


### - - United States 

### L:LRegistration OPP Identifiel Number 

# EPA Environmental Protection Agency D_Amendment Washington, DC 20460 

# o Other Application for Pesticide

- Section I 1. Company/Product Numbel 2. EPA Product Manager 3. Proposed Classificalion 2517-RGU Richard Gebken 4. Company/Product (Name) PM#10 C8JNone DRestricted Sergeant's Fiproni I+ S-methoprene Squeeze-On For Dogs 5. Name and Address ofApplicant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(I), my Scrgeant's Pet Care Products, Inc. ploduct is similar or identlcal in composition and labeling to: 2625 South 158<11 Plaza Omaha, NE 68130 EPA Reg. No. 65331-5 Product Name FRONTLINE PLUS FOR DOGS D Check ffthls is a new address 

### Section II 

# o Amendment

- Explain below. 

# o Final printed labels in response to Agency letter daled XX-XX-XX

### ~ Resubmission in response to Agency letler dated 01_27_2010 

# o "Me Too" Application 

# o Notification

- Explain below. 

# o Other

- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section 11.)



### Section III 1. Material This Product Will Be Packaqed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container 

### [gJ Yes* 

# fZJ Yes DYes 

# o Metal DNO D No 

### [gJ No

### ~ Plastic If "Yes" No. per If"Yes" No. per DGlass *Certification must Unit Packaging wgt. Container Package wgt. Container DPaper be submitted 0.023 fl oz (0.50 ml) 3,4,6 vials 0.045 fl oz (1.34 ml) 

# I I DOther (Specify) Plastic Bag 0.09t fl oz (2.68 ml) 0.136 t1 oz (4.02 ml) 3. Location of Net Contents Infolmarlon 4. Size(s) Retail Containel 5 Location of Label Direclions [2JLabel D Container 0.023 fl oz (0.50 ml). 0.045 fl oz (1.34 ml), 0.091 fl DOn Can oz(2.68 ml), 0.t36 fl oz(4.02 ml) [SIan Labeling accompanying product 6. Manner in Which Label is Affixed to Product DLithograph**~Other** DPapel glued DStenciled 

### Section IV 1. Contact Point (Complete ilems direct/ be/ow forfdentificatlon ofindividual to be contacted, ifnecessarY, to process this application.) Name Title Telephone No. (Include Area Code) Kelly R. Hoskins Manager ofTechnical Affairs 402-938-7079 Certification 6. Date Application I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I Received acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both (Stamped) under applicable law. 2. Signiyr,e 3, Title BY • 

### OJ

....

# ~**I-bw.~**

# !~T Manager ofTechnical Affairs
4. Typed Name: Kelly R. Hoskins 5. Date: 

# 4//2-/7-0I'DForm Approved OMB Nos, 207(}0060: 2070'{)057; 2070.{)107; 2070-0t22; 2070-0164

","">. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

## (St)

....**-~** 1200 Pennsylvania Avenue, N.W• WASHINGTON, D.C. 20460 Papel\vo!k Redoction ACI NOlice: The public reporting burden for Ihis collcction ofinforrnation is estimated to averagc t 25 hours per response forregistralion and 025 hours per response for reregistration and special review activities, includingtime forreading thc inslructions andcompleting the necessary forms. Send commerts regarding burden estimate or any otheraspeclofthis collection ofinformation, mcluding suggestions for reducing the burden to: Director, Collcction Strategies Division (2822T), U.S. EnvironmemaJ Protection Agcocy, tWO PennsylvaniaAvenue, N,W., Washington, DC 20460, Do not sefid the compleledfmm 10 this address. Certification with Respect to Citation ofData ApplicanfsiRe!listranfs Name, Address, and Telephone Number EPA ReQislration Number/File Symbol Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha, NE 68t30 25t7·RGT Active Inoredien1(s) and/or representative test compound/s) Date Fipronil 0411212010 General Use**Pat~m(s)** (list ai those claimed for this product usm!l 40 CFR Part t58) Prodld Name Indoor non-food Sergeant's Fipronil Only Spot-On (or Cats NOTE: Ifyour product is a too% repackaging ofanother purchased EPA-registered product labeled for all the same uses on your labet, you do not need to submit this form. You must**subm~** the Formulator's ExelTfltion Statement (EPA Form 8570-27). 

# D I am responding to a Data-Call-In Notk;e, and have induded with this form a list of companies sent offers ofcompensation (the Dala Malrix form should be used fur this purpose).

SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

# D I am using the dte-all method ofsupport, and have induded with this form 

## [2] I am using the selective method ofsupport (or dte-all option a lisl ofcompanies sent offers ofcompensation (the Data Matrix furm underthe selecHve method), and have included with this (orm a should be used furthis purpose), completed rlst ofdata requirements (Ihe Data Matrix furm must be used), SECTtONtI: GENERAL OFFER TO PAY [Required if using the cite-all method orwhen using the cite-all option underthe selective method to satisfy one or more data requirements] 

## [2] I hereby offer and agree to pay compensation, to other persons, with regard to the approval ofthis application, to Ihe extent required by FIFRA.

SECTION III: CERTIFICATION I certify that this**app~cation** for registralion, this fonn for reregistration, 0; this Data-Call-In response is supported byall data submitted or dted in the application for registration, the lbrm for reregistration, or the Data-Call-In response. In addition, ifthe cile--all option or cite-all option underthe se!ectjve method is 'Ind'lcated'tTl Section I, th'lS appftcation is supported by ail data in the Agency's files that (1) concern the properties or effects ofthis product or an identical or substantially similar product, or one or more ofthe ingredients in this product; and (2) is a type ofdata that would be required to be submitted under the data requirements in effect on lhe date of approval ofthis application ifthe application sought the inillal registration ofa product of identical or similar composition and uses. I certify that for each exdusive use study cited n support ofthis registration or reregistration, that I am the Original data submitter or that Ihave obtained the**wr~ten** permission ofthe original data submitterto cHe thai study. I certify that for each study cHed in support ofthis registrallon or reregistration that is not an exdusive use study, eHher: (a) Iam the original data submitter; (b) I have obtained the permission ofthe original data submitterto use the study in support ofthis application; (c) all periods ofeligibility for compensation have expired for the sludy; (d) the sludy is in the public literature; or (e) Ihave notified in wilting the company that submttted the study and have Offered (I) to pay compensation to the exlent required by sections 3(c){1){F) and/or 3{c)[2){B) of FIFRA; and**~i)** to commence negotiations to determine the amount and terms ofcompensation, ifany, to be paid fur the use ofthe study. t certify that in all instances where an offer ofcompensation is required, copies ofall offers to pay compensation and evidence oftheir delivery in accordance with sections 3{c){1)(F) ami/or 3(c){2){B) of FIFRA are available andwill be submitted to the Agency upon request. Sholld I fail to produce such evidence \0 the Agency upon request, t undersland that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with FIFRA. I certify thatthe statements I have made onthis form and all attachments to it are vue, accuraB, and complete. I acknolliedge that any knowingly false Of misteadirg statement may be punishable bJ fine or imprisonment or both under applicable law.
Signalure 

# 14&rt f..**Hos/""~**

# / ::C-A-

# 't 

# 4;17.-/1 0 Typed or Prinled Name and Title Kelly R. Hoskins, Manager of Technical Affairs

_ 0 E roni 

## " v ilabl P EPA Form 8570-34 (12 2 03) lect cad Paperversions a a e Submit only aper versIOn.

### Pay.gov

- Online 

### Payment

Online Payment 

### Step 3: Confirm Payment Thank you. Yourtransaction has been successfully completed. Pay.gov Tracking Information Application Nama: PRIA Service Fees Pay,govTracking ID: 250LG67N Agency Tracking 10: 74110736632 Transaction Date and Time: 04/12/2010 14:32 EDT PaymentSummary Account Holder Name: Sergeants Pet Care Products PaymentAmount: $3,213.00 Payment Date: 04113/2010 Decision Number: Registration Number:2517-RGU 

### Page I ofI

11213

AccountType: Business Checking Routing Number: Account Number: *"''''5483 Company Name: Sergeants Pet Care Produc Company Number:2517 Acllon Code: R310



### httos:l/www.nav.lZov/oavR:ov/navments/authorizeACHPavment.htmI 4/1212010

# \ "- 

### AGENCY Form !Il'l'ruv<d 0,\/11 No.**l(r)O.{lQ6~** 

# I 

# I \} 1 

### in**~treet!** S.W. 

# j'**'I~' "~~.,**  

## \\1i,)lll,'-. wAlSHINGTON, D.C. 20460**~~;\** !'t" \' ,

### he**rrpllrt~g**burde!\ for (his c,o!tectlo![ of

### infunHatiol~ is estimated to average 0.25hOtJrs perrespo!lsefor registratio!l a.::iv!tics and (I.2S hours perrespouse for ;

# \~**'~)1)** '1'

# ~\i!l**~ttl~llt'CS,** mdudmg hme for

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# l1eces~ar)' form5. Sendcomments regmdmg the burden eS1lma!eDr Myo!lH!raspeclof1his collee!)on


## ,2t1:t60 ., 10, 

### urltng**~J.ggeiliQ(lsf'lt** reriw:ingtite burden InOi.ro;l(y;: QPPE**!!lfum1.(lJiJ:m1).t:.uw.gt:~ut Dj)<l~im**  (2t17) U.s. Enviv.mme!!l.n..tPro/t'.,ctW(\A?."ew.:y, <ll)tMStreet

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### ., . Do no! sendthe fonn wiliisaddress.

# \\~" 

# -j\1/

I 

### DATAMATRIX**n.\l..t~~** A Ii i2., 2CljIJ EPAR' "(\fuJPikS mooi Z5i7"RGU Pa e, l'Jf7 :**Al1rECJ,Ul..t'sJR..zgl~J.nw.l'£**N-.w,c & Address hQ,;koc.t Sergeant'sfi?r-;mit + M'ViP4?fw.e 

## iSergeant's?cl Care Pwdue'c;, Inc. 2625 South l58thP1aza, Suite 100, Omaha, NE 63DO"l?!)3 Squeeze-On for Dogs

In edients: Fi raniJ, MelllO rene I Guideline ReferenceNumber Guidelilte**Stu~)'**Name MRIDNumbcr Submltter StaIns Note IlBO.1550, l)30.1600, 831}, 1 621}, PWOuo Properties Dam fuz Serge:afJi's PipwIli) +-M{.1)lOpreflC**N~"">** submissiou Sergeant's ?et CarePwduo::ts, O\VN 830.1650, 830.J670, 830. 1700, Squeeze-On for Dogs Jnc. 830.1750 &30.l8OO**£\'.fofc~meru "wii\.iy~K?1**  rnethoo 1'kw S'tIJvmissioo Sl:lgi,"ri','s Pct C':UcPmrl"Utls, 

### OWN hl."-. %30.6302, S3D.6303, 830.6304, Product chemistI)' of Sergeant's Fipronll +Melhoprct1.e New SJlbm)sslon Sergeant'sPet Care Products, 

### mVN 

# I 830.7300, 8.1!l?0(}O, 8.30J1.115,**Sq!lt~eze-Oo.**for Dogs lac. 830,7JOO, 830,6320, 830.63J7 83'i}:63\7,83'i}.1S320 gt07age S'iabi\it)' rmQI::0)703Wnd"ru:rltne'iiSlics To oc whrolwc.J**Serge?,~~'s** Pe£ em\',**P~oo'U"t\S,** OWN UpOIl completion hic. 1S70.J1OD Acme cral toxiclty**44~42004** MBRIAL LlM1TED PAY

.' 31D.l?:ml ACllle dwmttl to:,idty 44942005 MERIAL UMITED PAY 870.1400 Primal)' eye irritation 449420{16 MERlAL LIMITED PAY 

### 1 ' RiG.i5(jfJ Primary demllll irrittttion 449420Q? MERIALUM!TED PA.Y 

### \**.d~** 870.!fiDO Dermal sensitization 44942008 IvIDJUALLlMITED 

## I**E'I1,\..w..~j,o!"\** Qfthe Dog Squeeze On O.67ml Wilile Applicator !villi Nell's!.wmts£!<m Serle?"'

..··**O\¥'J:~** 

# \**O{;l.ng~** l:JbdrnJic;J1or (3x}, scissors toopen" F Ias aPoison '/.." '(:'dCarerroduc\S, Prevenlirm \'m;m"(l 

### 1m Sl!n't('.I"',t's, PdCare Products..Inc. --,v,! \ Stltt W

,**~** + • Evaluation of{he Dog Sqllceze On**I.}~ml** WhittAppiit:alvl Nial )-.'". \ lnc, Green Label lndicator(3x), scissors!() open - F ,las a"Poison ,I Pcl rareProducts, 

### OWN 

# I Pre,'iet\-\iott**p~c** for Serg,canl's PetCareProauets,lnc. . , }kw 5!!Q(Ui:i:iiofl SergcrJl"o' s
.. Enluat"lon ofthe Dog SqacCJt: (hZ.61h>:>.t

### Whlt~**A\1\11(~l!lor** Wltll lac, 

# I Dale 

# J RedLabd In6it<>ltIi {3,,>, 0,ssorstIJ open - F Ias aPOISiln [)41l2f2{\\O PrC"vtlllion Package for Scrgea1l1s

# ret Caet: ?wt\urtJ,**!\~. ~ar.U<"**  and TWe**fT~ea\** Aff;itrs 

## I Signalure: 

# V" **PiLl** 

# e Hosf.u...1 /d':T 'Kcl\;f R, "Ho'ikin$, Managel i) A{c#0'**1"l<r~"(ili,I:"i'J** I --,**~ "'-.-'''~,~,**  ., ".

__**".~,~~.** h"bblo Su'bm1! "")y,!",,'<''''-''''''''Form APlrfov.d OMn**N~.1070·UMO** 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**~** 

# - 401 M Street, S.W. WASHINGTON. D.C. 20460 l'lIpcnvork Reduction ActNotice: The public reporting burden for**~lis** collcclion ofinfonJlalion is estimated to average 0.25 hours per response for registration activilies and 0.25 hours per response tor reregistration :llId special revielV aclivities, including time for rcadi:lg the instmction and completing tbe necessill)' forms. Send cumments regarding the**burd~n** estimate or any otllcr aspect oftbis colleclion ofinformation, including suggestions for reducing the burden to Director: QPpf: inlormationMrumgement Divisioll (2137) U.S. Environmental Protection AgCIICY, 40 IM Street, SW" Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Date: April 12,2010 EPA Reg No.lFile Symbol 2517-RGU Pae20f7 Applicant'siRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene Sergeant's Pet Can: Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs In redients: Fi ronil, lvletho rene Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note Evaluation ofthe Dog Squeeze On 4.02ml White Applicator witll New sublnission Sergemlt's Pet CareProducts, OWN BlueLabel Indicator (3x), scissors to open - F=I as a Poison Inc. Prevention Package for Sergeant's Pet Care Products, Inc. 870.7200 Walker, K. (1995) Discussion il\ Support ofBridging DOlllestie 435777Il MERIAL LIMITED OLD Animal Safety Data on Frontline Spray Treatment to Frontline Spot Treatment Datu Package. Unpublished study prepared by Rhone Merieux, Inc. 6 p. 870.7200 Powell, L.; PaffeU, R. (1995) Domestic Animal Safety Study 43863802 MERIAL LIMITED PAY by Topical Administration to Dogs: Fipronil SpotTreatment (RM 1601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Researeb Centre, Ltd.219p. 870.7200 Canovas, M.; VilJageliu, J.; Lopez, S.; et al. (1994) 43577715 MERIAL LIMITED OLD Percutaneous Absorptioll and I-lair, Skin, and FatDistribution of Radioactivity After Spot-On Application of(Carbol\ 14).RMI601 in BeagleDogs: Lab Project Numbers: CD-93/3405F: Q-42.769. Unpublished study prepared by Centro de Investigacion y DcsarroUo Aplieado, SAL. 68 P. 870.7200 Nolan-Smith, S. (I999) Fiprollil/(S)-Methoprelle Topical Solution: 44942104 MERIAL LIMITED PAY Target Species Safety Study in the Dog: Interim Report: Lab Project Number: 168612: 1686/2-0Il42: PR&D 0002I0L Unpublished study prepared bv Covunee Laboratories Ltd. 266 p. 870.7200 Nolan-Smith, S. (1999) Fiprolli!l(S)-Methoprene Topical Solution: 45143901 MERIAL IJMlTED PAY Targel Species Safety Study in the Dog: Report Amendment: Aillendment to Interim Report: Lab Project Number: 168612: 1686/2·Dl 142. Unpublished study prepared by Covancc Labs., Ltd. 6 p. 870.7200 Nolan-Smith, S. (200I) To Investigate the Safety ofa Topical 45612702 MERIAL LIMITED PAY Formulation Containing ML-2,095,988 509T itl Dogs Weighing Approximately 2kg (+I-I.5kg) at Olle, Three and Five Tillles the Maximulll Labe! Recommended Dosage: Final Report: Lab Project Nllmber: 1686/12: 1686112-D2160: PR&D 004580I. Unpllblished study prepared by Covanee Laboratories. 324 p. Signature: 

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# IHr, Naille and Title Da(e Kelly R. Hoskins, Manager ofTechnical Affairs 04112/2010 EPA Form 8570-35 (9·97)Electrollle""d P.'I'er**Ver~o",** Av,;I,ble submit**~nlv** Paper**ver~,,"** 

## ,ge,«y I""m.1 u,< COpy**~ ~b'm** **'\I~n-"v<d** olr[n No. lO70-0060 

### UNITED STATES ENVIRONMENTALPROTECTION AGENCY 

# " 401 M Street, S.W. 

# " WASHINGTON, D.C. 20460 Papenvork Reduction Act Notice; The public reporting burdcli lor tllis collectioa ofinfonnalion is eSlimated 10 average 0.25 hours Iler response for registration activities and 0.25 ltours per response for reregistration and special review activities, including limll for reading the in3ercgislralioncomplcling the necessary forms. Send (XlmmenlS regarding the burden estimate orany otheraspect oflhis collection ufinformalion, including suggestionsIOf reducing the burden [0 Director: OPPE InformationManagement Divisioll (2\37) U,S. Environmental Protection Agency, 40 IM Street, S W., Washington, DC 20460. Do liD! sentllhe form 10 tllis**~Iddress.** 

### DATA MATRIX Dale: A rilll, 2010 EPARe No.lFileS mbol**2517~RGU** Pae30f7 Applieant'sJRegistrant's Name & Address Pruduet: Sergeant'sFiproni! + Me!hoprene Sergeant's Pet Care Products, Inc. 2625 South I58tll Plaza, Suite 100, Omaha, NE 68130- I703 Squeeze-On for Dogs In redients: Fi ronil, Metho relic Guideline Reference Number Guideline Study Name MRlD Number Submitter Status Note 870.7200 Godin, c.; Alva, R. (2000) ML-2,095,988 45620507 MERIAL LIMITED PAY 509T /Dog/Solutionffopieal/Safetyrroleranee/Reproduetioll, Reactions: Final Report: Lab Project Number: PR&D 0020201: WEL 99885: PR&D 00202. UnpUblished shldy prepared by White Eagle Toxicology Laboratory. 123 o. 810.3300 Evere!!, R.; Cunningham, J. (1993) A Comparative Evaluation of 43121116 MERIAL LlM[TED OLD Twu Treatment Regimes Using RM 1601 Spray for Control or the Cat Flea Ctenocephalides [elis on the Dog: Revised: Lab Project Number: RMD 692: PI222LT. Unpublished study prepared by Agresearch Consultants, Inc. 40 p. 810.3300 McCall, 1.; McTier, T. (1993) Laboratory Evaluation ofRIvI 43121117 MERIAL LIMITED OLD 160tSpray for Control Dermacentor variabilis and Rilipecephalus sanguilleus on tile Dug: Lab Project Number: RMrrKS/93IlL: PS/22!JLT. Unpublished study prepared by TRS Labs, Inc. 18 p. 810.3300 Cruthers, L. (1993) Efficacy ofRlvll60IC at 3 ml/kg and 6 ml/kg 43121122 MERIAL LIMITED OLD Against Ixodes seapularis!danunilli Nymphs, Dermaeeillor variabilis Nymphs, Amblyomma amerieanum Nymphs, Rllipieephalus sanguineus Nymphs, and CtellOcephalides [elides Adults Usillg Trei!!cd Dog Hair as the Testing Substrate: Revised: Lab Project Number: 9320: PI225LT. Unpublished study prepared bv Professional Lab and Research Services, Inc. 28 p. 8\0.3300 McCall, 1. (1999) Dose Titration Study of(S)-Methoprene by 44942105 MER1AL LIMITED PAY Topical Admillistration to Dogs: Final Report: Lab Project Number: i'R&D 000990t. Unpublished study prepared by TRS Labs, Inc. 51 D. 810.3300 Young, D. (!999) Dose Confirmation Study ofTopically 44942106 MERIAL LIMITED PAY Administered Fipronil/(S)-Metiloprene Against Adul! Ctenoeephalides felis(C[u Fleas) in Dogs: Fin\ll Rcport: Lab Project Number: PR&D 0013501. Unpublished study prepared by Young Veterinary Research Services. 59p. Signature: 

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# 12-. Hosu.,.v..!, 

# 12:-A-T Name and Title Date Kelly R. Hoskins, Manager ofTcehlliealAffairs 0411212010**~"A** C·M_**'<7~"** mom,**~,._..** ,_**."~** "••••• " •••,___ •.._.,.",

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..10).111 No. 1070_110('0 

### UNITED STATES ENVIRONMENTALPROTECTION AGENCY 

# " 401 M Street, S.W. e 

### WASHINGTON, D.C. 20460 Papcnvork Reduction Act Notice: Thc public reporting burden for this eollcetion ofinformation is estimated to averagc 0.25 hours per response for registratio!! activities and 0.25 hours per response for reregistration and special revicw aetivilics, including timc tor reading the in4cregistrationcomplcting the ncccssary forms. Send COll1mcnts regarding the borden estimate or any other aspect ofthis collection ofinformati011, including suggestions for reducing the burden to Director: OPPE Infommtlon Managemcnt Division (2137) U.S. Environmcntal Protcction Agency, 401 MStreet, S.W., Washington, DC 20460. Do not send the fonn to dlis address. 

### DATA MATRIX Date:A ri112,2010 EPA Re No'/File S mbol 2517-RGU Pae40f7 Applicant'siRegistrant'sName & Address Product: Sergeant's Fipronil + Methoprene Ser!!eant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs In redients: Fi ronil, Metho rene Guidcliue Reference Number Guideline StudY Name MRID Number Submitter Status Note 810.3300 Pengo, G.; Pollmeier, M.; Barrick, R. (2000) All Efficacy Study of 45620501 MERIAL LIMITED PAY Frontline Spray, Frontline Top Spot, and ML-2,095,988 509T, for the Treatment and Control ofTrichodectes canis in the Dog: Final Report: Lab Project Number: PR&D 0022101, PR&D 00221. Unpublished**stu~yprep',ued** by Centro Veterinario Oriolo. 24p. 810.3300 Alva, R; Barrick, R. (1999) A Study to Determine the Effect of 45620502 MERIAL LIMITED PAY Treatment with Frolltline Top Spot on the Prevalence and Severity ofFlea Allergy Dermatitis in Dogs: Final Report: Lab Project Number: PR & D 0010201: PR & D 0010202: PR&D 00102. Unpublished study prepared by VCA SI. Petersburg Animal HosPital. 45 p. 810.3300 Postal, 1.; Le Nain, S. (1998) Evaluatioll ofthe Efficacy of 45620503 MERIAL LIMITED PAY RM160IC/35, in tite Treatment ofFlea-Allergy Dermatitis in the Dog, Compared with a Referellee Product: Final Report: Lab I'roject NUlllber: ASR 19083: CLl276. Unpublished study

repared by Merial. 92 p. &1(1.3300 Marchiondo, A. (2001) PR & D 002410I: Frontline 45620504 MERIAL I,lMITED PAY Spray/Frontline Spot-OnIML-2, 095, 988 509T/Dugs ISolutionITopical: Final Report: Lab Project Number: PR&D 002410I: PR&D 00241. Unpublished study prepared by Stillmeadow, Inc. 2?p. 810.3300 Gaxiola, S.; Alva, R.; Irwin, 1. (2001) PR& D 0052301: 45620505 MERIAL LIMITED PAY Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509T/Dogs/SolutionfTopieal: Final Report: Lab Project Number: PR&D 0052301, PR&D 00523. Unpublished stody prepared by University ofSinaloa. 40 P. 810.3300 Pengo, G.; Pollmeier, M, (2000) Frolltline Spray & Top Spot! 45620506 MERIAL LIMITED PAY Dogs/Solution(fopieal Clinial/Dose Confirmation! Eetoparasites, Mites, Sarcoptes Scabiei val' canis: FInal Report: Lab Project NUlllber: PR&D 0012901: PR&D 00129. Ulipublishcd study prepared by Centro Veterinario Oriolo. 23 p. Signalllre: 

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# I '9:-/IT Name ami Title Date Kelly It Hoskins, Mallager ofTechnical Affairs 04112/2010 EPA Fo,," 8570-)5 (9.97)**f.1'«T~** and Paper**Ver~M'** Avail,blc S"bmll o"ly**Pa~"v.,..io"** A.,n,v 1",,,,,,, 'I" ,onv ;ency 

# "'Form Approy,d OMB No. !070_00M 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 0 

### 401 M Street, S.W. e 

### WASHINGTON, D.C. 20460 Paperwork Reduetinn Act Notice: The public reporting burden for this collection ofmfornration is estimatcdtn average 0.25 bours per rcsponse for registralion activities and 0.25 bours per response lor rercgistration and special review activities, including timc lorreading tbe in5cregistmtioncompleting the necessary lorms. Send commcnts regarding the burden estimate or any other aspect oftbis collection ofinformation, including suggestions lortedueing the burtlen to Directnr: OPPE InformatiouManagement Division (2137) U.S. Environmental Protection Agency, 40 IMStreet, S.W., Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Date: April 12, 2010 EPA Re No.lFile S mbol 2517-RGU Pa e50f7 Applicant'siRegistrant's Name & Address Product: Sergeant's Fipronil +Methoprene Sergeant's Pet Care Products, Inc. 2625 Sonth 158th Plaza, Suite 100, Omaha, NE 68130-1703 Soueeze-On for Dogs In redients: Fi roni!, Metho rene Guideline Reference Number Guideline SCud Namc MRIDNumber Submitler Slatus Note 810.3300 Pengo, G.; Pollmeier, M. (2002) Study to Confinn the Efficacy of 45628201 MERIAL LIMITED PAY Fipronil Against Lice in Dogs Under Field Conditions: Final Report: Lab Project Number: PR&D 003740L Unpublished study prepared by Centro Veterinario Oriolo. 21 p. 810.3300 McCall, 1.; Alva, R.; Irwin, 1.; etaL (2002) A Study to 45866902 MERIAL LIMITED PAY Evaluate the Efficacy ofFrontlinc Plus for Conlrol of Mosquitoes, Aedes aegypti, on Dogs: Final Report: Lab Project Number: PR&D 0055201. Unpublished sludy prepared by TRS Labs, Ine. 24p. 133-3 Meo, N.; Gonzalez, c.; Mester, T. (1997) Demml and Inhalation 44433302 MERIAL LIMITED 

### PAY Exposure ofCommercial Pet Groomers During Application of Fronlline SprayTrcatmenl: Final Report: Lab ProjectNumber: MERIAL-445-SAFXT046: SAFX046: PDA9705. Unpublished study prepared by ABC Labs., California and Aanimal Appeal Grooming Sh9P& Case Veterinary HospilaL 1066 p. 133-3 Meo, N.; Gonzalez, c.; Belcher, T. (I997) Dermal Exposure of 44433303 MERIAL LIMITED PAY Commercial Pet Groomcrs During Application ofFrontline Top Spot: Final Report: Lab Project Number: MERIAL-445- SAFXT047: SAFXT047: EC-97-390. Unpublished study prepared by ABC Labs., California and Aanimal Appeal Grooming Shop & Case Veterinary Hospital. 925p. 132-1 Hughes, D. (1997) Dislodgeable Residues ofFipronil Following 44433305 MERIAL LIMITED PAY Application ofFrontline Top Spot to Dogs: Final Report: Lab Projeel Number: COVANCE 6848-101: MERIAL METXT 166: METXT 166. Unpublished study prepared by Covance Labs. Inc. 161 p. 132-1 Hughes, D. (1997) Dislodgeable Residues ofFipronii Following 44433306 MERIAL LIMITED PAY Application ofFrontline SprayTreatment to Dogs: Final Report: Lab Project Number: COVANCE 6848-100: 6848-100: MERIAL-445-METXT-165. Unpublished study prepared by Covance Labs. Inc. 184 Signature:

## ~OJ<1 

# 'L**H.,~1.w1....J** 

# ?#tr Name and Title Date Kelly R. Hoskins, Manager ofTechnical Affairs 0411212010 EPA Form gS7()'3S (9-97) Ele<;"@ioand raper V."io", Av"l.ble. Submit only P'PO! versioLL A.,n.V In',,n,' 11,"**r~,w**reregistration and**~** ofinformalion, 20460. Do I
Date: April Ann**Ii('~nt'**siRcgistra s Pct Care I

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### UNITED STATES ENVIRONMENTALPROTECTION AGENCY • 401 M Street, S.W. • WASHINGTON. D.C

.

. The public Icporting burden I ;"t''''·**;n~I",I;n"** to",,. f",**'''~dill~** tlle

__ ions for redllcing the bUrdcll to Dirc"'Ul u,.-t'c J o**~lis** address. the necessary rorms. Division (2137) 

### DATA MATRIX**,,~ ~**  ,>uu.**w~~** :, Inc. 2625 SQuill 158th Plaza, Suite ]00, Omaha, NE 68130-1703

de Foutenay, G.; Campagna,J.; Subcrvlllc, S. ct al. (1997) Dislodgcablc Residues ofFipronil Following a Topical Application ofFrontline Spot-On Treatmenllu Dogs: Final Reporl: Lab Project Number: 817/0248: MET416: :MERIAL-480-MET-416. Unpublished study prepared by Merial Ltd. and Chrvsalis Preclinical Services-Europe. 68 p. de Fontenay, G.; Campagna, J.; Suberville, S. ct al. (1997) Dislodgeable Residues ufFipronil Followiug a Topical Applicalion ofFrontline Spray Treatment to Dogs: Final Study: Lab Project Number: 817/024A: MET414: MERIAL-480-MET414. Unpublished study prepared by Merial Lid. and Chrysulis 70 p. Irwin, 1. (1997) Usc SlIrvey ofCommercialandVeterinary Pet Groomers and Pet Owners ofFrontllne Top Spot and Frontline Spray Treatmenl: Lab Project Number: MERIAL-445·SlJRVEY. Unpublished study prepared by Wiese Research Associates, Inc.**~** ------ Hughes, D. (1997) Validaliun ofan Analytical Method for the lJelermmauon 01 ['Ipronll,**1VI&l:I4.'l~5U,** and M&l:I46.'l lJ m DyeFree 100%Cotton Gloves: Final Report: Lab Project NUfllber: COVANCE 6848·104: 6848-104: MERIAL METXT 169. Ifnn"hli"h"il "Inriv**nr"n~r"ri** hv**r(lV~n"e** Labs. Inc. 41 D. Polakoff, 

### n.; Y01lngren, S. (1997) Non-Dietary Risk. Fipronil Use on Pets in a Residential Setling: Lab Project Nllmber: FIPRONIL 97·09: MERIAL-445·NDRA Unpublished study prepared by Novigen Sciences, Inc. 27 D.

.-.- f, B.;' and R, .• .v""",,, 'VI' '-'1'01 an J r ___ ..... -.__ ";----;- Treatment: Lub Project Number: FIPRONIL 97-11: MERIAL· 445-PGRA. Unpublished study prepared by NOl'igen Sciences, Inc. 17 p. MRIDNUI 44531203

44531204

44433301

44433308 

# I"-p, "**.~".~**......**~n** activities and 0.25 hours perresponse for gthe burden estimate or any other aspectofthis collccuon Agency, 401 M Street, S_W., Washington, DC

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### r ,r Dogs
Submitler MGRIAL LIMITED PAY

I MERIAL LIMITED PAY

MERIAL LIMITED PAY

LIMITED PAY


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### 1/ 

### Il/' "T- Name alld Title**~** (KellyR. Hoskins, Mana er ufTechnieal Affairs**""r~o"** Ag'"")' Inter".1 Usc eop1Form "I'ILrO".d OMI! :.10. 2070·0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 0 

### 401 M Street, S.W. 0 

### WASHINGTON, D.C. 20460 Paperwork Reduction Act NOliec: The public reporting burden for this colteclion ofinformation is estimated to average 0.25 hours per response for regislration aClivilies and 0,25 hours per response fur reregistration and special review activities, including tinle for reading the in7eregistralioncompletingthe necessary fonns. SelldeommenlS regarding the burden estimate or any other aspectofthis collect"lon ofinformalion, including suggestions for redlCing the burden to Direclor·. OPPE In1ormation ManagemelltDivision (2137) U.S, Environmenlal ProtectionAgency, 401 M Slreel, S.W., Washington, DC 20460. Do not sendlhe form to this address, 

### DATA MATRIX Date: April 12,2010 EPA Reg No.lFile Symbol 2517-RGU Page 70f7 Applicant'slRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs Ingredients: Fipronil, Methoprene Guideline Reference NlImber Guideline Study Name MR[DNumber Submitl.cr Status Note Wall, H. (1998) Frontline Products Reports of Suspected 44531205 MERIAL LIMITED PAY Adverse Events Analysis ofBreed, Age and Sex Distribution of Dogs and Cats,**Unp~blished** stlldy prepared by Medal Ltd. 8 p. Polakoff; B.; Youngren, S.; Walls, C. (1998) Frontline 44531206 MERIAL LIMITED PAY Top-Spot and Frontline Spray Treatment: Definitive Short-Term and Intermediate-Term Residential Non-Dietary Risk assessment: Lab Project Number: FIPRONIL 98-04: MERIAL-445-NDRA. Unpublished studv prepared by Novigen Sciences, Inc. 35 P. Polakoff; B.; Youngren, S.; Walls, C. (1998) Frontline Top 44531207 MERIAL LIMITED PAY Spot and Frontline Spray Treatment: Definitive Pet Groomer Exposure Analysis and Risk Assessment: Lab ProjectNumber: FlPRONIL 98-07: MERIAL-445·LPERA. Unpublished stlldy prepared by Novigen Sciences, Inc. 21 p. Polakoff, 8.; Youngren, S. (1998) Frontline on Pets in a 44531208 MERIAL LIMITED PAY Residential Setting: Risk Assessmem oraLow Probability Event Post-Application AcuteExposure: Lab Projeet Number: FIPRONIL 98-06: MERlAL-445-PGRA. Unpublished study I prepared by Novigen Sciences, Inc. 18p. Signature: 

## 1/ 

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# / 2::-A-1 Name and Title Date Kelly R. Hoskins, Manager ofTechnical A1Tairs 04112/2010 EPA Fonn &57().l5 (9_97) EI<'\'1nLC ""d raperv,,,,o,,, Available Sub"Li!" Iy Pap"'"**¥er~o"** Ag.noy In"m.1 U,. Copy**~ ~.**  "**,~0** 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. I\.Tr'Tl\l\J to average the instnletion and cOlllplcling the IIcccssmy forms. burden to Director: OPPE Informa1ion Management Division (2137) U.S. estimate orany other aspect Agency, 401 M Street, S.W, Washington, DC

Sergeant's Pet Care Inc.n**,~-** 

### UNITED STATES ENVIRONMENTALPROTECTIONAGENCY 401 M Street, S.W.

average review activities, suggestions for reducing the instruction and completingthe necessary forms. Send comments regarding the burden estimate or any otheraspect to Director: OPPE Information Management Division (2137) U.s. Environmental Protection Agency, 40I M Street, S.W., Washington, DC

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### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY 

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### UNITED STATES ENVIRONMENTALPROTECTION AGENCY o 

### 401 M Street, S.W. o 

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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY o 

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### D.C. 20460 per response lor registration activities and U.25 hours per response reading the in5cregistrationcompletingthe necessary forms. Send commentS regarding the bmdcneStimate orany other aspect ofthis collection to Director: OPPE InformationManagement Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., Washillgton, DC

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### UNITED STATES ENVIRONMENTALPROTECTIONAGENCY 

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### DATAMATRlX

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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY o 

### 401 M Street, S.W. o reading the in7ercgistratiOllcompleting the necessary forms. SClid comments rcgalliing the burden estimate or any other die burden to Director: OPPE Information Mallagement Division (2137) 

### u.s. EnvirollmclItal Protection Agency, 401 M Street, S.W.,

### FW: Response to EPA Letter James Messina 

### to: Bonaventure Akinlosotu 

### 03/31/201001:15 PM ShowDetails Sorry I misspelled your name in the email address on the first email. Regards, Jim
From: James Messina sent: Wednesday, March 31, 2010 1:11 PM To: akinlostotu.bonaventure@epa.gov 

### Cc: Gebken.Richard@epamail.epa.govi KHoskins@SERGEANTS.com; Rick Tinsworth; Larry Nouvel 

### Subject: Response to EPA Letter
Mr. Akinlosotu, 

### Page 

### 1 of 

### 1

On behalfof ourclient, Sergeant's Pet Care Products, Inc. (Sergeant's), Exponent is responding to EPA's letter datedJanuary 27, 2010 regarding the following registration applications:
1. Sergeant's Fipronil + 5-methoprene Squeeze-On for Dogs (2517-RGUj 2. Sergeant's Fipronil + S-methoprene Squeeze-On for Cats (2517·RGl) 3. Sergeant's Fipronil Squeeze-On for Dogs (2517·RGA) 4. Sergeant's Fipronil Squeeze-On for Cats (2517-RGT) Sergeant's intends to continue the support ofthe above·referenced registrations and will submit supporting CRP data, a revised data matrix and product chemistry data to EPA no later than April 12, 2010.
Ifyou have any questions, please contact me. Best Regards, James Messina Senior Managing Regulatory Consultant Exponent Center for Chemical Regulation and Food Safety 1150 Connecticut Avenue, N.W. Suite 1100 Washington, DC 20036 202-772-4932 202.772·4979 fax 301-908-1181 

### cell

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### 3/31/2010$,

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### Washington, D.C. 20460 

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Wednesday, January 27, 2010 Certified Mail: (ArticleNumber7004-2890·0004-1896-4240) opp 

### Decision Number: D·425453, D425454, D425455, D425437 

### Registrant Name: Sergeant's Pet Care Products OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### RegistrantAddress: James Messina, Senior ManagingRegulatory Consultant Exponent



### Subject: Center for Chemical Regulation and Food Safety 1150 ConnecticutAvenue, N.W. Suite 1100 Washington, DC 20036 DataDeficiency Product Name: Sergeant's Fipronil 

### + Methoprene Squeeze-on for Dogs, Sergeant'sFipronil 

### + Mehoprene Squeeze-On for Cats, Sergeant's Fipronil Squeeze-Onfor Dogs, Sergeant'sFipronil Spot-On for Cats EPA File Symbol: 2517-RGU, 25I7-RGL, 2517-RGA, 2517-RGT respectively. Application Date: December 21, 2009 EPA Receipt Date: December 22, 2009 DearMr. Messina: TheAgencyhas received and begun its in-depth review ofthe subject application and has determinedthat it is incomplete or that further information is needed. This letter is a written notification ofthosedeficiencies and identifies your options under 40 

### CFR 152.105 and Section 33 ofthe Federal Insecticide, Fungicide andRodenticideAct (FIFRA), also known as the Pesticide Registration Improvement Renewal Act (PRIA2). Your options underAO CFR 

### 152.105 and section 33 ofFIFRA are addressed separately because each involves a different timeframe and set 0foptions for responding to this letter. Please ensure that you consider each ofthe sections below in detennininghow andwhen you respond to this letter. 40 CFR 152.105: Pursuantto 40 

### CFR 

### 152.105, you are allowed 75 days from the date ofthis letterending April 12, 2010 to provide a response concerning the deficiencies listed in this letter. Yourresponse

### may include making corrections or additions to complete the application, or notifying the Agency ofthe date on whichyou expectto complete the application, or withdrawing your application. Ifyou do notrespond to this letter within 75 days or ifyou respond 

### with a date on whichyou expect to complete the application but fail to meet that scheduled date, the Agency will treatthe application as ifyou had withdrawnit. Withdrawal concludes the Agency's review ofyour application. Any subsequent submission ofthe same applicationmustthenbe submitted as a new applicationwitha newdeadline for EPA to make a determination on your application and subject to a newregistration service fee. The deficiencies identified in the Agency's review at this time are as follows: 1. The data matrices for the abovereferencedproducts are incomplete, You mustrevise each datamatrixbylisting out specific MRID's (where applicable) and study title names that are usedto support each applicable guideline. Instructions for completing the EPA form 8570-35 data matrix correctly canbe found withip PRNotice 98-5. An electronic copy ofthis PR Notice can be obtained atthe following Agency web site: http://www.epa.gov/opppmsdIIPR Notices!pr98-5.pdf. 2, The "Cite-all" option for productchemistry is inadequate. You cannot citeproduct chemistry data, since Sergeant's Pet CareProducts, Inc. isthe formulator ofthe proposed products, As a result, youmust submitacceptable end use product chemistry datain accordance with PRNotice 86-5. In addition, you mustrevise the data matrix as outlined in#1 above to reflect this change. 3. In accordance with 40 CFR §152.34, the submitted Child Resistant Packaging (CRP) self-certification is unacceptablefor each product. The currently approved CRP data for the referencedproducts listed on your 8570-1 

### form (block #6) are 

### also not citable for purposes of satisfying the datarequirements outlined in 40 CPR 

### § 152.34. These CRP tests are product package design specific and unrelated to your proposedpackage, Furtherreview ofyour application and yourresponse to the deficiencies may identify additional deficiencies andyou will be so infonned.
FIFRA Section 

### 331PRIA: This application is also subject to a deadline for making a determination onthe application underFIFRA Section 33, Pesticide Registration Service Fees, establishedunderPRIA. The time frame for.the Agency to make a determination on this application ends on April 12, 2010 and you have the following three options: 1. 

### Withdraw the 

### application: You may notifyus not laterthanMarch 31, 2010 

### that you are withdrawing your application. As 

### noted above, withdrawal concludes the Agency's review ofyourapplication; however, you may resubmit your application afterthe deficiencies have been addressed, Shouldyou choose to resubmityour application, it would be subject to a new deadlinefor making a detennination on your application and a newregistration service fee.

- Since a fee was paidwiththis application, the Agency will provide any applicablerefund as soon as practicable.

### 2. Notrespond: Ifyou do notrespond or fail to provide (arevised data matrix, acceptableproduct-specific chemistry data, and acceptable (CRP) data), on or before April 12, 2010, the Agency \vill administratively withdrawyour application. 3. Correct application deficiencies: All acceptable data and data matrix as outlined above mustbe submittedto the Agency on orbefore April 12, 2010. Atthat time, The Agency will re-classify your applications from a R300 newproduct; me-too fast track, to a R31 0 newproduct; non-fast track The Agency will thenrequest additional PRlA 

### fees accordingly, andprocessing will notproceed until all the deficiencies are satisfied and applicable PRlA 

### fees are paid. Please respond to this letter by March 31, 2010 by contacting Mr. BonaventureAkinlosotu at (703) 605-0653, orbye-mail at akinlostotu.bonaventure@epa.govduringthe hours of 7:00 am to 4:00 pm ESTwith a response and for anyquestions concerningthis letter. When submitting infonnation or data in response to this letter, a copy ofthis letter should accompany the submission to facilitate processing. 

# )P,LoI/UL
Richard J. 

### Gebken ProductManager (I

### 0) InsecticideBranch Registration Division (7505P)

### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY Washington, D.C. 20460

Wednesday, January 27, 2010 Certified Mail: (Article Number 7004-2890-0004-1896-4240) 

### opp

### Decision Number: D-425453, D425454, D425455, D425437 

### Registrant Name: Sergeant's Pet Care Products OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### RegistrantAddress: James Messina, Senior Managing 

### Regulatory Consultant Exponent



### Subject: Center for Chemical Regulation andFood Safety 1150 ConnecticutAvenue, N.W. Suite 1100 Washington, DC 20036 DataDeficiency Product Name: Sergeant's Fipronil 

## +Methoprene 

### SqueezeMon for Dogs, Sergeant's Fipronil 

## +Mehoprene 

### SqueezeMOn for Cats, Sergeant's Fipronil Squeeze-Onfor Dogs, Sergeant's Fipronil Spot-Onfor Cats EPA File Symbol: 2517-RGU, 2517-RGL, 2517-RGA, 2517·RGT 

### respectively. ApplicationDate: December 21,2009 EPAReceipt Date: December22, 2009
Dear

### Mr. Messina: The Agencyhas received and begun its in-depthreview ofthe subject application and has determined that it is incomplete orthatfurther information is needed. This letter is a written notification ofthose deficiencies and identifies your options under40 CFR 152.105 and Section 33 ofthe Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), also known as the Pesticide Registration ImprovementRenewal Act (PRIA 2). Your options under 40 CFR 152.105 and section 33 ofFIFRA are addressed separately because each involves a different timeframe and set ofoptions for responding to this letter. Please ensure that you consider each ofthe sections belowin determininghow and when yourespondto this letter. 40 CFR 152.105: Pursuantto 40 CFR 152.105, you are allowed 75 days from the date ofthis letter ending April 

### 12,2010 to provide a response concerning the deficiencies listed in this letter. Your response

### may include making corrections or additions to complete the application, or notifyingthe Agency ofthe date on which you expectto complete the application, or withdrawing your application. Ifyou do not respond to this letter within 75 days orifyou respondwith a date on whichyou expect to complete the applicationbut fail to meet that scheduled date, theAgency will treat the application as ifyouhad withdrawn it. Withdrawal concludes theAgency's review ofyourapplication. Any subsequent submission ofthe same application mustthen be submitted as a new application with a new deadline for EPA to make a determination onyour application and subjectto a new registration service fee. The deficiencies identified in theAgency's review at this time are as follows: 1. The data matrices for the above referenced products are incomplete. You mustrevise each data matrix bylistingout specificMRID's (where applicable) and study title names that are usedto support each applicable guideline. Instructions for completingthe EPA form**8570~35** 

### datamatrix correctly can be found within PRNotice 98-5. An electronic copy ofthis PRNotice can be obtained at the followingAgency web site: http://www.epa.gov/opppmsd1/PR Notices/pr98-5.pdf. 

### 2. The "Cite-all" optionfor product chemistry is inadequate. You carmot cite product chemistry data, since Sergeant's Pet Care Products, Inc. is the formulator ofthe proposed products. As aresult, you must submit acceptable end use product chemistry data in accordance withPRNotice 86-5. In addition, youmust revise the datamatrix as outlined in # 1above to reflectthis change. 3. In accoroance with 40 CFR 

### §152.34, the submitted Child Resistant Packaging (eRP)**self~certification** 

### is unacceptable for eachproduct. The currently approved CRP datafor the referencedproducts listed on your**8570~** 

### 1 form (block #6) are also not citable for purposes of satisfyingthe datarequirements outlined in40 CFR 

### § 152.34. These CRP tests are product package design specific andunrelated to yourproposed package. Furtherreview ofyour application and your response to the deficiencies may identify additional deficiencies andyou will be so infonned. FIFRA Section 331PRIA: This application is also subjectto a deadline for making a determination on the application underFIFRA Section 33, Pesticide Registration ServiceFees, establishedunder PRIA. The time frame for the Agency to make a detennination onthis application ends on April 12,2010 and you have the following three options: 1. Withdraw the application: You may notify us notlater than March 31, 2010 that you are withdrawing your application. As noted above, withdrawal concludesthe Agency's review ofyour application; however, youmay resubmit your application after the deficiencies have been addressed. Should you choosetoresubmit your application, itwould be subjectto a newdeadline for making a detennination onyour application and a newregistration service fee.

- Since a fee was paidwiththis application, the Agency willprovide any applicable refund as soon as practicable.

### 2. Not respond: Ifyou do notrespond or fail to provide (arevised datamatrix, acceptable product-specific chemistry data, and acceptable (CRP) data), on or before April 12, 2010, the Agency will administratively withdraw your application. 3. Correct application deficiencies: All acceptable data and data matrix as outlined above must be submitted to the Agency on orbefore April 12, 2010. Atthattime, The Agency will re-classify your applications from a R300 newproduct; me-too fast track, to a R310 newproduct; non-fasttrack. The Agency will thenrequest additional PRIA fees accordingly, and processing will notproceed until all the deficiencies are satisfied and applicable PRIA fees are paid. Pleaserespondto this letter by March 31, 2010 by contacting Mr. Bonaventure Akinlosotu at (703) 605-0653, orbye-mail at akinJostotu.bonaventure@epa.govduringthehoursof 7:00 am to 4:00 

### pmEST with a response and for any questions concerningthis letter. When submitting infonnation or data in response to this letter, a copy ofthis letter should accompanythe submission to facilitate processing.

# ~UL Richard J. Gebken Product Manager (10) Insecticide Branch Registration Division (7505P)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### December 31, 2009

opp 

### Decision Number:**D~425453** 

### EPA File Symbol or Registration Number: 2517-RGU OH!CEOF PREVEI\'l10N, PESTICIDES AND TOXIC SUBSTANCES



### ProductName: SERGEANT'S FIPRONIL 

## + S-METHOPRENE SQUEEZE-ON FORDOGS EPA Receipt Date: 22-Dec-2009 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CARE PRODUCTS, INC.
KELLYR. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158THPLAZA OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee
DearRegistrant:
The Office ofPesticide Programs has receivedyourapplication and certificationof payment. If

### you submitted data withthis application, the results ofthe PRJ""\f-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has determined that this Action is subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Action has beenidentified as Action Code: R300
NEW PRODUCT;ME-TOO PRODUCT FAST TRACK;
No additional payment is due at this time.
Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 305-6249.

Resources Management DivisionPay.gov**~** Online Payment

.Onlin_e**p~Y.!f1~.'"!.t**... Step 3: Confirm Payment 

### Thank you. Your transaction has been successfully completed. Pay.gov Tracking Information Application Name: PRIA SeNice Fees Pay,gov Tracking 10: 2505HOIN Agency Tracking 10: 74094010968 Transaction Date and Time: 12121/200911:52 EST Payment Summary Account Holder Name: Sergeants Pel Care Producls PaymentAmount $1,365.00 Payment Date: t2122/2009 Decision Number: Registration Number: Page 1of I

Account Type: Business Checking Routing Number: Account Number:

..•
..5483 Company Name: Sergeants Pet Care Produc Company Number: 25t7 ActiOn Code: R300

h1 tps:1Iwww.pay.gov/paygov/paymems/authorizeACHPayment.html 

### 12/21/2009Please read instructions on reverse bmore comp/etinQ form. Fo!m Approved. OMB No. 2070·0060. Approval expires 05·31·98 I Uniled States**~** Registration OPP tdentilier Numbe! 

# EPA Environmental Protection Agency 

# o Amendment Washinglon, DC 20460 

# o Other Application for Pesticide

- Section I t. Company/Product Number 2. EPA Product Manager 3. Proposed Classification 2517-"""

## /?CttL Richard Gebken 4. CompanylProduCl (Name) Sergeam's Fipronil + S·melhoprene Squeeze-On For Dogs PM# to

### ~None DRestricted 5. Name and Address otApplicant (Include ZIP Code) 6. Expedfted Review. In accordance with FIFRA Section 3(C)(3)(b)(I), my Sergeam's Pel Crue Producls, Inc. product is similar or (Jentical in composition and labeling to: 2625 South 158'" Plaza Omaha, NE 68 t30 EPA Reg. No. 6533t-5 Product Name FRON1UNE PLUS FOR DOGS D Check f! Ihis is a flew address Section II 

# D Amendment

- Explain betow. 

# o Flnat printed labels in !esPOnSe to Agency tetter dated XX·XX·XX 

# o Resubmission in response to Agency teller daled XX-XX-XX

### ~ "Me Too" Applical"lon 

# o Notilication' Explain below. 

# o Other

- Explain below. Explanation: Use**add'~'lonal** pagers) if necassary. (For section I and Seclion II.) Submission ofa Hew end-llse registration applicalion.
Section III Aaterial This Product Will Be Packaoed In: l.-nild-Resistant Packaging Unil Packaging Water Soluble Packaging 2. Type ot Container 

### [SJ Yes' 

## !ZJ Yes DYes 

# o Metat ONO 

# o No 

## IZl No 

### [S] Plastic It ''Yes" No. per It 'Yes" No. per OGIaSs 'Certification must unit Packaging wgL Container Package wgt. Container OPaper be submitted 0023 fl 02 (0.50 mil ),4,6 viats 0.045floz(I.34mtJ 

## i I OOther (Specify) Plastic Bag 0091 floz(2.68 mil 0.136 fl oz (4.02 ml)
3. Localion ot Net Conlenls Inlo!mation 4. Size(s) Retail Container 5. Localion ot label Oirections [ZJLabel 

# o Container 0.023 fl oz**(O~O** mt).**0.04~** fl 02 (t 34 mil, 0.091 fl oz (2.68 mt), 0.t36 fl oz (4.02 mt) DOn Can [glOn Labelino accompanying product 6. Manne! in Which label is Altlxed to Product DUthograph IZJOther DPaper glued DSlenCiled Section IV



# --- L Conlact PoinU90mpiele ilems direc/l below loridenli/iclllion 0/ indIVidual 10 be conlacted, ifflecessaf1l, 10 orocess Ihis aaolica/ion Name Tille Telephore I>K>. \1, 'Clude Area Code) Ketty R Hoskins Manager ofTechnical Affairs '<02·':138·707-1**~---** Certification f. Date Appllcalion I cer1ify thai the statemenls I have made on this torm and all attachmenls thereto are true, accurate and complete, 

# , Receivc.d acknowledge Ihat any knOWingly talse or misleading statement may be punishable by fine or Imprisonment or bolh (Stamped) under aoolicable law. 2. Signature 3. Title 

# t, A :&/t ,(1- 

## f Manager ofTechnical Affairs Typed Name/ Kelly tl. Hoskins 5. Date: 12/2 t/2009Sergeant's Pet Care Products, Inc. 2625 South t58th Plaza • Omaha, NE 68t30-1770 • Telephone 402.938.7000 • Fax 402.938.7099 • www.sergeants.com December 21,2009
Richard Gebken,PMIO Office ofPesticide Programs (7504P) (REGFEE) U.S. Environmental Protection Agency Document Processing Desk Room SA900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Sergeant's Fipronil 

### + S-methoprene**Squeeze~On** for Dogs EPA File Symbol 2517-NEW
Dear Mr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeants, EPA Company Number2517) is submitting a "me-too" EPA registration application for the new product Sergeant's Fipronil 

### + S-methoprene Squeeze-On for Dogs (containing the EPA registered active ingredients Fipronil (9.8%) and Smethoprene (8.8%)). Please find enclosed the following documentation in support ofthis registration'. (I) Application for PesticideFonn (8570-1); (2) Certification with Respect to Citation ofData Foml (8570-34); (3) Fomlulator's Exemption Statement Form (8570-27); (4) Data Matrix Foml (8570-35)

- EPA and Public Versions; (5) Confidential Statement ofFormula (two copies); (6) Product Label (five copies); (7) PRIA category R300, Payment Confinnation Receipt; and (8) Letter ofAuthorization. Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs is substantially similar to Medal Limited's EPA registered product FrontLine Plus for Dogs (EPA Registration # 65331-5). Sergeant's has sent offer to pay letters to all data submitters listed on the enclosed data matrix.
We look forward to working with the Agency to register this "me-too" product. Ifyou have any questions, please cOnlaet me at 402-938-7079. Sincerely,

# /~/'L/bL Kelly 

### R. Hoskins Manager ofTechnical Affairs
EnclosuresRll'h:Il'd lH"hkcll jlriH!Ilcl \1:llldgC[**.~.2** DOC:llifleIl! Pnh:cssiIIc!, Ih>sk Ort'i,,'(' 

# ur Pesticide**lir\)J:;rnm~** l .S.**Emirnllm<~nlal** I'rn[..:cli<lll Agl'l1cy I\Olll11 S-,49(lO.**()Il~:** Pntolll;\C )':Jrd ::"77 Soulh CrysI,:1 Drive :\rlinglOll. VA 2211)2--1::;0 I Serg,cant's Pet Care Products, Inc,**:-,('r~l>:ill(S** pI:'[ ('an: ]lruJlIl'h. Illc iSl'rllcnI11·'.1('l:!:'i S\llllh j)R'I' Pleva. Ol1lah:l. l\cbI'IISk:1 6;'; 1':;0- I 771). LPA

### (\)lllP~ll1\' i\I1lllbcr

# 25 I 71,

### ~llllh(ln/CS Fxp()llcllt. Inc. (I ISO C()lllll'cliclH .'\n:nlle, !\\\'. :-lIllie I Ino. \\'iISlllllgh'1l DC 20(J3h) In ,lei on Ull[ bdHlIL as (1111" ;\I1tl]()rii'cd RCprL':!clllilll\''''. Ihr clJ1m;ceSsal"Y interaclloll.\: regardlllg oil 

### oronr prndw:t rc.:gistrati,m ;lpplic;lllllll,s :lIld rcgi:'lmliulls. PIt::lse nule lhis do('s lwt chnng.c tht: currCnl Cikd ;\ulhorizcd**A~L'nl** It)r Scr;;c<lll!'s

.

.I;IlllCS )\"l(,:-;'>ln:1 ,md·()r Rid, TiIIS\l'(lrlll Exponent. hlC, 11511 CUIlIIl:l'liclil i\\ l.'.. ;-.JW Sui(l' I 100 WJsl1illglun. DC 20U:J!) (202) 772-4!Jn (201) T'2-4<j7\)**t~IX** jnJ(:'>",i n(l(a c \ 11' llIC,lJI.,;OIlI n i**il~\Xl(n**h:1I l:;\Il\)1**~clll.,'())** n



# "./5} / 

### " 1>.<:11: R. 11,)skIIlS**\'Llll:I~cr** 01"1 cc]IIlI"',il**Atf~lir:,**Sergeant's Pet Care Products, Inc. 2625 South t581h Plaza • Omaha, NE 68130-1770 • Telephone 402,938.7000 • Fax 402.938.7091 • www.sergeants.com



### December 21. 2009 Richard Gebken, PMIO Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child Resistant Packaging Certification Dear Mr. Gebken: Sergeant's Pet Care Products, Inc. certifies that the packaging used in the manufacture ofthe following products:

• Sergeant's Fipronil Spot-On for Dogs; • Sergeant's Fipronil Spot-On for Cats: • Sergeant's Fipronil 

### + S-methoprene Spot-On for Dogs; and • Sergeant's Fipronil + 

### S-methoprene Spot-On for Cats.
meets the standards of40 CFR 157.32, including the revised standards in 16 CFR 1700.15(b). All product labels have language specifying the use of scissors to open the product container and label language stating the product is not to be applied by children. In addition, Sergeant's is in discussion with approved CRP testing labs to develop a protocol per the revised testing procedures in 16 CFR 1700.20. If

### you have any questions, please contact me at 402-938-7079. Smcerely,

# ;f~/C/~ Kelly R. 

### Hoskins Manager ofTechnical Affairs

cc: Larry NouvelForm approved. OMB No. 2070-0060, 2070·0057. 2070·0 t07. 2070-0122, 2070·0 t64. 

# &EPA**~** 

## ,
United States Environmental Protection Agency Washington, DC 20460 Formulator's Exemption Statement (40 CFR 152,85)
Applicant's Name and Address EPA File Symbol/Registration Number Sergeant's Pet Care Products, Inc. 25 I7-NEW 2625 South 158th Plaza Product Name Omaha, NE 681 30 Fipronil 

### + S-methoprene Squeeze-On for Dogs
Date of Confidential Statement of Formula (EPA Form 8570-4)

12/21/2009 As an authorized representalive of the applicant for registration of the producl idenUfied above. I certity that: (t) This product conlains Ihe tollowing aclive ingredient{s): Fipronil (9.8%) S-methoprene (8.8%)

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result 0/ the use of that active ingredient in the manulacluring, formulalion or repackaging another product which contains that acti"" ingredient which is registered under FIFRA Section 3, is purchased by us from anolher person and meets the lequiremenls ot 40 CFR section t58.50(e}(2) or (3). (3) Indicate by checking (A) or (B) below which paragraph applies:

71 {A} An accurate Conndenlial Statement of Formula (EPA FORM 8570.4) tor the above identified product is attached to this stalemenL That formula statement indicates. by company name, registration number, and product name, the source of the active ingredient{s} listed in paragraph {1}. OR 

# , (6) The Confidential Statemont of Formula (CSF}(EPA Form 8570-4) referenced above and on tile with the EPA is complete, current. an accurate and contains the information required on the current CSF. (4) The following aclive ingredienls in this product qualify for Ihe formulator's exemption.

Source Active Ingredient Product Name Registration Number Fipronil Technical

S-methoprene S-methoprene ,

Signature Name and Title Date

## /~,f'I**/~** , Kelly R. Hoskins, Manager ofTechnrcal Affairs 12/2112009 EPA For" 8570·27 {Rev. 06-2004} Copy 1 EPA**---~** Copy 2

-**App'ic~'11** cOl)y

# II Form AOPfoved OMS Nos, 2070·0060; 2070·0057; 2070·0 to7. 2070·0122: 2070·0t64 UN!TED STATES ENV!RONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.w. WASHINGTON, D,C. 20460
Paperwork Reduclion Act NOlicc: The p.!blic reparting burd:n for Ihis collectian ofinfanmlion is**eSlim~ted** to average t.25 haurs per rcsponse for rcgimatian and 0.25 houl"S perresponse for rcregistration and speciat review IICtivitie&, inc!uJing lime for reading the imtnlctions and completing the necessary**fo'm~.** Send oommer,ts regardmg burden eSlirnatc Or any other aspect ofthis callwion ofinfOll'l1alion, including suggesflons far reducing Ihe burden to: Direclor, Callectian Strategies Divi!ion (2822T), U.S, Environmental PrOlecrion Agency, t200 Pennsytvania Avenue, N.W"**W"shln~ton,** DC 20460, Do nat send Ihe comptered fonn to this address. Certification with Respect to Citation of Data Applicanl's/Registrant's Name, Address, and Telephone Number Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha. NE 68 t30 Active InoredienVsl andlor represenlative test compoundfs) Fipronil, S·methoprene General Use PaUern(s! (f'st al those cla'imed for this product**usin~** 40 CFR Part (58) tndoor non·food EPA**Re~lstration** Number/File Symbol 2517·NEW Data t212112009 Product Name Sergeanl·s**Fipron~ ~** **S-m~IMp,ene** Squeeze-On lorOogs NOTE: Ifyour producl is a !DO% repackaging of anotherpurchased EPA-registered product labeled for alt the same uses onyour label, you do not need to submit this form, You must**subm~** the Formulator's EXCffipi"lon Statemenl (EPA Form 8570·27). 

# o
IZl I am responding to a Data-Call·ln Notice, and have included with this form a list of companies sent offers of compensation (the Oata Matrix form should be used for this purpose)_

SECTtON t: METHOD OF DATASUPPORT (Check one method only) tam US'lng Ihe c·,te-all method ofsupport. and have included with this form a list of compames sent offers of compensalion (the Oala MatriX form should be used for this purpose). 

# o I am using Ihe selective melhod ofsupport (or cite·all option under the seleclive method). and have included wilh this form a completed list of data requirements (the Deta Matrix form must be used). SECTION U: GENERAL OFFERTO PAY IRequired If using the cite-all method or when using Ihe cite-all oplion under the selective method to satisfy one or more data requirementsl 

## [2] I hereby offer and agree to pay compensation. to othar persons. with regard 10 the approval ofthis applcation, to the extent required by FIFRA,

SECTION!fI: CERTIFtCATION I certify thai this applicabon for regislrat,on, this form for reregistration, or this Data-CalHn response is supported by all data submilled or cited in the application for regisuahon, the form for reregislration, or Ihe Data·Call-ln response. In addition, if the cite-all option or cite-aU option underthe selec!"lve method is lndicated in Section I. this application is supported by all data in the Agency·s files that (1) concern the propertles or effects ofthis product or an identical or substantiatly**sim~ar PIO~uct,**  or one or more ofthe ingredienls in this product: and (2) is a Iype of data that would be required to be**subm~ted** under the data requirements in effect on Ihe dale 01 approval of this applicalion if Ihe application sought the initial registration of a producl of identical or**sim~ar** composition and uses. I certify thel for each exclusive use sludy cited in support ofthis registralion or reregis!ralion, that I am the original data submiUer or that I have obtained the wrillen permission 01 the original dala submitter to cite thai study. I certify thai for each study cHad in support ofthis registration or reregistration Ihat is not an exclusive use study, either: (a) I amthe original dl'ta submiller: (b) I hava oblained the permission ofthe onginat data submiUer to use the study in support ofthis application: (c) all periods of eligibility for compensation have exp,red for Ihe study; (d) the sludy is in the public litelature: or (e) I have notified in wriUng tha company that submiUed the study and have offered (I) to pay compensation to the extenl required bysections 3(c)(1)(F) andlor 3(c)(2)(8) of FIFRA; and (ii) 10 commence nego!"iaOons todeterm'lna 'he amount and terms of compensation. if any. to be paid for the use ofthe study. I certify that**I~** all Instances where an offer of compensation is lequired. cop,es of all offers to pay compensalion end**eviden~.e** of Ihe"deliverv in accordance with sectIOns 3(c)( t}(F) andlor 3(c)(2)(8) of FIFRJ'\ are**ava~at:4e** and will be**subm~ted** to the Agency upon request. ShooJd I**fa~** to produce.**s~::h** ev·dence to Ihe Agency "pon requesl, I understand Ihat Ihe Agency may initiate aclion to deny, cancel or suspend Ihe registration of my**~:odu4.** in conlormily wilh FIFRA. I certify that the statements t have made on this form and aU attachments to it are true, accurate, and complete. '.**;":{"~·,..wi!edge** that any knowlngty false or misleading statement may be punishable by fine or impri!ionment or both under applicable law.

### I~----------------------------.------.--------------------- Date TyPed or Printed Name and nle f212 !l2009 Kelly R. Hoskins. Manager ofTechnical A:r"i!.; EPA Form**8~0-34** (t2-2003) Electronic and Paperversions available Submit only Paper version.**~** FonnApprore<i OM5 No. illIfl.OO6/l 

### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY 

## e ;;:<;.y. 

### 401 M Street, S.W. WASHINGTON, D.C. 20460 PaperworkReduction Act Notice: Tnt public rcportillg**burd~n** ror Inis collcClioll ofinfo'mation is eSlinoJICO to average 0.25**nour~** pet tcsponse for ,'cgislrmion JClivilies and 0.25 hours pcr response for rcrcgislr1Ihon and special review ncr;vilic:s. including lime for rending Ille insauction and completinglhe nece.s.<;';lJ"y fo(ms. Send comment, reg.aming the burden estimate or any Oilier ""peel ofIh" collection ofillfonnnlio". 'mcluding ,uggC:SI'lOns forred"cing !lIe burden to Dircc!Dr: OPPE Jnfonnalion Manngcment U.visio" (21 )7) U.S. Env"'.>nmcnt.1.l PrOiection Agency, 401 M Sl=l. $.W" Wasni'l !Qn. DC 20460. Do not send Ihe fonn to lhisaddrcss. 

### DATA MATRIX Dale: 12/21/2009 EPARe No./File 5 mbol: 2517-NEW Pa e1of3 Applicanl's/Regisfranl's Name & Address: Sergeant's Pet Care Producls, Inc 2625 South 1581Jl Plaza, Omaha, NE 68130-1703 Producl: Sergeant's Fipronil + S-melhoprene Squeeze-On for Dogs Ingredient: Fipronil Guideline Reference Guideline Study Name MRID Number Submiller Stalus NOle Number Cile-all Syngenta Crop Protection, Inc (#100) PO Box t8300 Greensboro, NC 27419 Cite-all Bayer CropScience lP (#264) 2 T.W .Alexander Drive Research Triangle Park, NC 27709
Cite-all Bayer Environmental Science (#432) PO Box 12014 Research TrianQls Park, NC 27709 Cite-aU Aeckill Benckiser Inc (#3282) Morris Corporate Center IV 399**:\~~;~~~e** Parkway Parsi an, NJ 07054 Cile-all J,J. Mauget Co. (#7946) 12733**D~~~lor's** Loop Woodbrid e, VA 22192 Cite-all BASF Corporalion (#7969) Agricultural Products PO Box 13528 Research Trianale Park, NO 27709**Sjgnal/~**// /' Name and Tille Dale 

## Jl. 12121/2009 

# A**;~!** Kelly R. Hoskins, Manager01 TeChnical Affairs EPA Fo'm 8.17t**~Sl9** "**(~.** ,,;,**'"~ r>",~**  Vm",o,**A""tl,h~** Submit oo/rP.,,,,,,**>\.~,joo. A~.,,<:y**  lo"mol U" COjlyfonnAppro,'"," OMS No,**IOJ~,lItI(.o** 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**~** 

### w:z 401 M Street, S.W. WASmNGTON, D.C. 20460**l'~pcrwork** Rcdllclion Act NOliee: The public reponing humcn for Ihis eolteelion ofinfnnnation is estimaled 10**n~emge** 0.25 houn; pt:l respunse for regislrntion**neli~itie"** and 0,25 hours jlCJ response for rercgismllion and special**re~iew** aClivilics, including time for reading the instrUelion and eompteting Ihe nceessal)' foolns. Send eommenls rcgnming the hurdc" csri"m\<: or any olher aspect of rhis cotJeelion ofinfornlation. inetudi"B suggeslions for reducing the burde" \0 DirccloL OPPB Informalion Manngemcnr**Di~isio"** (2137) U,S.**En~ironmenml** P>"O\e{:lion Agency> 401 M Strect, S.W

.. Washin IOn. DC 20460, Do nOI sc"d Ihe fonn to this address. 

### DATA MATRIX Dale: 12121/2009 EPA Re No./File S mbol: 2517-NEW Pa 2013 Applican1'slRegis1ranfs Name & Address: Sergeanl's Pet Care produc1s, Inc Product: Sergeanl's Fiptonil + &methoprene Squeeze-On lOt Dogs 2625 Soulh 1581h Plaza, Omaha, NE 68130-1703 In redient Fi ronil Guideline Relerence Guideline Study Name MRID Number Submitter SlaWs Note Number**C~e-all** Chemsico (#9688) Division 01 United Induslries Corp PO Box 142642 SI. Louis, MO 63114**C~e-all** Conlrol Solulions, Inc (#53883) 5903 Genoa-Red Blull Pasadena, TX 77507 Cne-all Virbac (#54022) POBox 16598 Fort Worth, TX 76162 Cite-all Combal Insec1 Con1rol Sys1ems (#64240) CIO Henkel Consumer Goods Inc. 122**ClI;~~et,** NW, Sui1e 740 Washln on, DC 20001 Cite-all Merial Limited (#65331) 3239 Salellile Blvd, Bldg 500, LOC 106B DulU1h, GA 30096 Cite-all Spray Drill Task Force (#66607) McKenna, Long & Aldridge LLP , 1900 K Slreel, NW I

### Washi~;;;~n, DC 20006 Signa 

# h/ Name and nle Dale 

### ; /;/? H / / 

# " 12/21/2009 Kelly R. Hoskins, Managerof Technical Aftairs <D.' r __ <I'm. ""-0.,' "

..**c.~","** '""**"'~"V"'~"' A,~,I.h"**  <,,""'

.. ""'"**"'~'~"'""** A.",,",' r",,,,,,, ",. ,DO" 

# I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY f<mnApprnw:<lOMDN<>.2U10.00c;U In :{i1;(' 

### 401 M Street, S.W. 

### WASHINGTON,D.C. 20460**l'~pc,.wo~k** Rcduclion Act Notice: Thepublie reporting burden for If,;, collection ofinformation is estimated to average 0.25 nours perresponse for registration activities and 0.25 hours per**[e~ponse** for reregistration and specinl ,eview activiti"" including lime for feuding llIe instruclion und eomplcting!he necessary forms_ Send comments regarding llIe burden cstimmt: oranyother lISpeel ofthis cOllttl;on ofin(ormarion, inCluding suggestions ror Icclueing the burden !O Diree'or: OPPE Informalinn**M"nngenl~"l** Division (2137) U.S. Environmemal Protection Agency, 401 M Street, S,W" Washington, DC 20460. 00 not ,end lhe form to Ihis "ddrcs" 

### DATA MATRIX Dale: 12/21/2009 EPA Re No.lFile S mbol: 2517-NEW Pa e 3013 Applicanl's/Registrant's Name & Address: Sergeant's Pet Care Produc1s, Inc Product: Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs 2625 South 1581n Plaza, Omaha, NE 68130-1703 In redient: Fi ronil Guideline Reference Guideline Study Name MAID Number Submitter Status Note Number Cite-all Outdoor Residential Exposure Task Force (#71754) 1350 t Street, NW. Washinoton, DC 20005 Cite-all Agricultural Reenlry Task Force (1171755) 1350 t Street, N.W. Washinoton, DC 20005 Cite-all Ambrands (#73342) t18 Y2 East Main Street, Suite 1 Salem, VA 24153



### -- Cite-ali Innovative Pest Control Products (#73766) PO Box 880216 Boca Raton, FL 33488 Cile-all FtFRA Endangered Species Task Force (#73989) C/O Harold Himmelman (Beveridge & Diamond) 1350 I Streel, NW , Washinoton, DC 20005 Cite-all Residentiat Exposure Joint Vemure (#74888) 900 17!1l Street, NW, Suite 300, Washington, DC 20006 Cite-all Agricultural Handlers Exposure Task Force (#75234)

, PO Box 509

, Macon, MO 63552 L -.- Sig

# '2
Name and Title Date y // / Ketty R. Hoskins, Manager of Technical Alfairs 12/21/2009

f.rA 1'",",**K~10_Jj** I**18w,""~** ,"d i"I'" Vco,,,,", M',iLttk**~"~'""** ""'y r,f'C' "",,,," AI;<'''<Y inltm.1 0,.CopyFonnAI'P""'cd OMI} No.21l'10·00r.o 

### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY**~** SLl 

### 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Redaelion Ad Nolice: The public reponing**b~nlcn** for lhis eo!1ection of information is eSlimated In**a~erage** 0_25 hours per responsc for registration aetivilic.<; and 0.25 hours per lesponse for rcrcgislrmioo and specinl review**aCli~itiCl;.** inell1ding rimc far reading Ihe instruction nnd eonlpleling Ihe ncce.lsary form,. Semi eommenls legarding Ihe burden estimolc or "ny olber aspect of Ihis eolleclion of informnlion. inetuding**svgge.~lion'** for**red~eing** Ibe burden 10 Dircclor: OPPE Infoflnalion Man"gemcnt Divl.ion (2137) U.S. En"lfonmcntnl Proleelion Agcllcy, 401 M 'slrCCI, S.W

..**W~sllln"lon,** DC 2(l460. Do nOI**~end** the form 10 Ihis a.ddre.Is. 

### DATA MATRIX Date: 12121/2009 EPA ReoNo.lFile SYmbol: 2517-NEW Pa e10f3 Appticant'siRegistrant's Name & Address: Sergeant's Pet Care Ploducts, tnc Product: Sergeant's Fipronil + S-methoprene Squeeze·On tor Dogs 2625 South**1581~** Plaza, Omaha, NE 68130-1703 Ingredient: S-methoprene Guideline Reference Guidetine Study Name MRID Number Submitter Status Note Number Cile-att ADM Alliance Nutrition, Inc, (#1157)**tOO~~Orlh** 30'h Street, Box C1 Quine, tL 62305 Cite-all The Hartz Mountain Corp. (-#2596) Attn: Robert Rosenwasser 400 Ptaza Drive Secaucus. NJ 07094 Cite-all Wellmark tnternationat (#2724) 1501 E. Woodfietd Road, Sulte 200 Wesl Schaumbum, IL 60173 Cite-all Chattem, tnc. (#40086) Attn: David Schitting t715 West**38'~** St Chattanoooa, TN 37409 Cite-all Enforcer Products (#40849) A Division of Acuity Specialty Products 1420 Seaboard Industrial Boutevard Atlanta, GA30318 Cite-all Control Solutions, tnc. (#53883) 5903 Genoa-Red Bluft Pasadena. TX 77507 '- Dale

### S,g",,"~..&:' 

## // Name and Tille ,Y" 12/21/2009 

# /J 4" "'.;-' Kelly R. Hoskins, Manager ot Technical Alfairs
"I'A ,

### no", ""n." IQ '!h,","" ,,>oJ I'M''''' V,"m'" "YoIil.lbl" Suti<"" ,,"Iv r,,,,,**,~,,,no.** Agon<y**I~"m'>ll!**..Copyrom, I\pproYl!(l OMIl riQ.. '(I7o·rn'w 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**~ ~iZ**  

### 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwurk Rcduclion Ad Notice: The public rcporting burden fOI ,his colleclion ofinformation is cslil1'alCd to avcragc 0_25 hours per response fOllcgisllalion aClivilies and 0.25 hOUIS per lesponse fOI reregi<lralion amI special revicw aClivili",., including lime rOI re.'\ding 'he inslruction and COn'p1cling lhe nccessnry forn"'_ Scnd commen'S regarding 'he**bUI~cn cslin~'le**  or any olher**,,-~pec,** or ,hi, COlicclion of infonflntion, including suggc,lions for reducing lhe bUlden to Dileclo!: OPl'E In[Olmntion Management Division (2137) U.S. Environmental PIOlcclion Agcncy, 401 M Streel. S.W., Washin lon, OC 20460. Do nOl seud lhe form '0 this address. 

### DATA MATRIX Date: 12/21/2009 EPARe No.lRle S mbol: 25f7-NEW Pa e 20f3 Applicant's/Registranl's Name & Address: Product: Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs Sergeant's Pet Care Products, Inc 2625 South 158'M Plaza, Omaha, NE 68130-1703 In redient S-metho rene Guideline Reference Guideline Study Name MRID Number Submiller Status Note Number Cite-all Management Contracl Services, Inc. (#63823) PO Box 5209 Valdosta, GA 31603 Cite-all Merial Limited (#65331) 3239 Satellite Blvd, Bldg 500, LOC 106B Duluth, GA 30096 Cite-all Spray Drift Task Force (#66607) McKenna, Long & Aldridge, LLP 1900 K Street, NW**Washi~~ton,** DC 20006 Cite-all B2E Corporalion (#69554) 1501 East Woodfield Road Suite 200 West**Schaumbu'r~:** IL60173 Cite-all Babolna Bioenvkonmental Centre Ltd (n-?0062) PO Box 5126 Valdosta, GA 31603 Cite-all EGIS Pharmaceuticals Public Limited Co. 

### ,**{#72947~** , , 1150 t8 Street, NW, Suite fOOD 

# : Washinoton, DC 20036 Signature Name and Title Date

# ~L,t/,h,e_ 12121/2009 Keillt R. Hoskins, Manager 01 Technical Affairs r.M "onll**~** -:.'i 9-97 ::k:<: 0""**'"~** P' "Vc"'>",l\v.lliAl>]o .'"bm"'''''1 P'1",,,,,,,,OO "&,ncy 'n"m>l ,-",Comfor", "l'pmYC<) OMD No.107!',<>Mn 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

# '" 

# "'" 401 M Street, S.W. WASHINGTON, D.c' 20460**P~perwork** Reduclion Act Notice: The public reponillg burden for lhis collection of infomlaJinn is CSlimateil to**~vcrage** 0.25 hours per**re~po[)se** for registration activities and 0.25 hours pcr rcsponse f[)r reregislmt'on nnd**spcci~t** review activities, including thDC fur fe<,ding the inslruction**~nd** cornplet'mg Ihe**necess~ry** forms. Send colnmems regarding the burden estimlltc or any otlEcraspec1 oFlhis collection of informntion. including suggestions for reducing the burden 10 Director: OPPE**lnform~tion** Manngement Division (2137) U.S, Environmenmt Prmeclion Agency. 401 M Strrel, S.W., Wasl'inglon, DC 20460. O[) not semt Ihc form to this address. 

### DATA MATRIX Dale: 1212112009 EPA R!39 No/File §yrnbol: 2517-NEW Pa e 30t3 Applicant'sfRegislrant's Name & Address: Sergeant's Pet Care Products, Inc 2625 South 1581" Plaza, Omaha, NE 68130-1703 Product: Sergeant's Fipronil + S-melhoprene Squeeze-On for Dogs Ingredient: S-melho eoe Guideline Reterence Guideline Study Name MRID Number Submitter Status Note Number Cite-aU Valent Bio5Ciences Corporation (#73049) 870 Technology Way, Suite 1000 libertyville, Jl60048 Cite-all AMBRANDS (#73342) t t8 \'2 East Main Street, Suile 1 Salem, VA 24153 Cite-all Marketquest, Inc., (#73510) t 18 Y2 East Main Street. Suite 1 Salem, VA 24153 Cite"all AMZO Corporation (#74032) i 3330 Noyac Roed, Building D SaQ Harbor, NY 11963 Cite-all Residential Exposure Joint Venture (#74888) gOO 1ylM Street, NW, Suite 300
, Wash'lnoton, DC 20006 Cite-all B2E Bio1ech, LLC (#75318) 1501 East Woodfield Road,**Su~e** 200 West , Schaumburg, IL 60173 Cite-alt ZaCOR Incorporated (#82122) I 1001 G Street NW, Suite 500 West WashinQton, DC 2000t ; Signalure Name and Tille Dale 

# I



# /UA' /L

# /,i;'.;~,~ Kelly R. Hoskins, Manager at Technical AUairs 12/2112009

EPA Fern' $\**~,-** 

### '''Y91) 1)10<''''"''"00 r,!,," v,·,S;;;;;,**A'~",I»:. S"~m"** ""iy I'"!",, ",',,,". Agency In

..,",1 Uso ("oryft 

# - UNITED STATES ENVIRONMENTALPROTECTION AGENCY 401 M Street, S.W. D.C. average 0.25 hours per response for registration activities alld 0.25 hours perresponse completing the necessary fOrms. Send commems regardingthe burden estimate or any othera.>pect OflhlS lnfonnaliOfl Mallagement Division (2\37) U.S. Environmental Protection Agency, 401 M Street, S,W

.. ""

# .......... '

# ...... "-

### ........**~,.** Date: 12/21/2009 EPA Re No.lFfle S mbo!: 2517-NEW Pa e 1 of 3 Applicant's/Regislrant's Name & Address: Sergeant's Pet Care Products, Inc Product: Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs

,. NE 68130-1703**~** 

# - UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY 401 M Street, S.W.**~d** 

### 20460 per response for registration activities and 025 hours per [eSpOllse instruction and completing the necessary foms. Send comments regarding the burden estimateor any other aspect ofthis to Director: OPPE Infonnation Management Division (2137) U.S. EnvirOnmental Protection Agency, 401 M Street, S.W.,

UrI..I..M. 112009 EPA Re No.lF IRegistrant's Name &Address: Pet Care Products, Inc Product: Sergeant's FipronH + S-methoprene Squeeze-On for Dogs



### ___'h_. "

___ 0

__

Corp

500, LOC 1068**~** 

# -

reregistratioJl and spec"ial review activities, i 

### UNITED STATES ENVIRONMENTALPROTECTION AGENCY 401 M Street,S.W.

average 0.25 hours per response for registration activities and 0.25 hours pef response for
of infonnatioJl, including suggestions for reducing the instruction and completing the necessary fonns. Send comments regarding the burden estimate or anyother aspeci ofthis collectIOn to Director: OPPE Information Management Division (2137) U.s. ErlVHonmental Protection Agency, 401 M Street, S.W" Washington, DC

Product Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs

300,

Kelly R Hoskins, Manager of Technical Affairs 12/21/2009**~** 

# -

loe 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W.

0,25 hours per response for registration activities and 0.25 hours per response for reading the instruction illld completingthe necessary fomts. Send comments regarding the burden estimateor any other aspect ofthis the burden to Director: OPPE Information Management Division (2137) U,S. ElivironmcntaI Protection Agency, 401 M Street, S,W" 

### DATA

Product Sergeant's Fipronil + S·methoprene Squeeze-Onfor Dogs

Attn: Robert Rosenwasser 400 Plaza Drive Secaucus, NJ 07094
1501 E. Suite 200 West

Pasadena, TX

of Technical Affairsn 

# - UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. 

### SHINGTON, D.C. : information is estimated 10 a 'cragc U

..D hours per respollse lOr reglsrratlon ijCllvltles ana U,L) hours per respouse IhSlruCllun ana completing the necessary forms_ Send comments regarding the burden estimate or any other aspect oflhis to Director: OPPE Information Managcmcnl Divisioll (2137) U.s. EnvironmclUal Protection Agency, 401 M Strcet, S.W.,

500, LOC t068

LLP

12121/2009 .,..,,,,""n 

# -

reregistration and special review activities, i: 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON. D.C. 20460 to average 0.25 hours per response for reading the instruction and completing the necessary forms. Send comments regarding Ihe burden estimate or any other aspect ofinformation, including suggestions for reducing Do not burdell to Director: QPPE Inronnation Management Division (2137) U.S. Environmental Proteclion Agency, 40) M Street, S.W., Washington, DC



# '"e Product: Sergeant's Fipronil + S-melhoprene Squeeze-On for Dogs



### NE

Suite 200 West

Kelly R. Hoskins, Manager of Technical Affairs 12/2112009

# Sergeant's Master Label 21 December 2009 EPA Submission Information in 

## I ]is optional. Page I of9 EPA No. 25 I7-XX 21 December 2009 FRONT PANEL 

## DOG SQUEEZE ON FIPRONI.l<+METHOPRENE [Optional text appears in brackets
- the final label may include some or all ofthe optional text on front, back or side label panels] 

## Sergeant's Fipronil 

# + Methoprene Squeeze-On for Dogs [ABNs:[ [(Sergeant's) (Sentry) Frontspot Plus (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) Firstline Plus (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) FrontedgePlus (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) VetSpot Plus (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) Frontguard Plus (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) Frontier Gold (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) Frontpronil Plus (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) Fiproline Plus (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) Ectoadvance (Spot On) for dogs (and puppies)[ [(Sergeant's) (Sentry) Gold FrontSpot (Spot On) for dogs (and puppies)[ [SentryProline (Spot On) for dogs (and puppies)[ [SentryVet (Spot On) for dogs (and puppies)[ [Mosquitoes] [- Kills mosquitoes] [within 24 hours] [-Kills [and] [repels] mosquitoes that may transmit heartworm] 

### [Adult Fleas[ [-Kills adult fleas [for up to three months.] [-Kills newly emerged adult Fleas before they Jay eggs] [-Kills [and repels] Fleas, source of[flea allergy dermatitis] [, flea bit anemia] [and tapework infestations]] 

### [- Kills [&] 

### [and[ [Repels] Fleas Up to [4 weeks] [1 month[ [30 days]'] [. If

### dog is at high risk for flea reinfestation a once amonth application may be need-::J} Multiple Infestations [-Kills [chewing] lice and controls sarcoptic mange] [- Flea 

### [&[ [and[ Tick Control for Dogs 

### [&] [and[ Puppies 8 weeks old 

### [&[ [and[ older[ [-Kills [and[ 

### [&[ repels] fleas, flea eggs, ticks, [chewing] lice 

### [&[ [and] mosquitoes[ [-Kills [and] 

### [&] [repels] fleas, ticks, mosquitoes, [chewing] lice, flea eggs, 

### larvae 

### [&J [and[pupae] [-Kills 

### [&[ [and[ [Repels[ Fleas, Ticks 

### [&[ [and[ Mosquitoes[ [-Breaks the Flea Life Cycle [for up to three monthsJl [-Monthly flea, tick, mosquito, lice, and flea egg protection] [-Monthly flea, tick, mosquito and lice protection]

# Sergeant's Master Label 21 December 2009 EPA Submission EPA No. 2517,XX 21 December 2009 

### Information in [ ] is optional. Page 2 of9 

### FRONT PANEL DOG SQUEEZE ON I'IPRONIL+METHOPRENll

[Ticks] [oKills fleas, ticks, mosquitoes, flea eggs, and lice] [• [Seven] [7J Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea larvae [&] [and] flea pupae]] 

### [06 [Six] Way Protection! Kills fleas, ticks, mosquitoes, lice, flea eggs [&] [and] flea larvae] [. [4 Week] [I month] [30 day] [Flea [and] [&] Tick Treatment] [. [Four (4) Week] [I month] [30 day] [FleaTick, Mosquito and Lice Control] [·Use [brand name] monthly to break the flea life cycle.] [·Use [brand name

## Jmonthly to control ticks and chewing lice] [oMonthly flea, tick, mosquito, flea egg, flea larvae and chewing lice protection.] [Once A Month Flea and Tick Treatment] [. [4 week] [I month] [30 day] Flea and Tick Treatment!] [. Kills [&] [and] Repels Fleas, [and] Ticks [and mosquitoes] for up to [4 weeks] [I month] [30 days]'.] [. Kills Fleas, Ticks, Flea Eggs & 

### Flea Larvae for up to [4 Weeks] 

### [I month] [30 days]] [·[Images ofthe different kinds ofbugs killed with a line drawn through each bug]]
[oKills [and] [&] repels] Ticks including those that maytransmit Lyme disease] [. Kills [and] 

### [&]repels] Ticks for Up to [4 weeks] [I month] [30 days]!] [. [Kills [and Repels] [all stages of] (Deer) Ticks [before they can] [that] [transmit Lyme Disease,] for up to [4 weeks] [I month] [30 days] [per application]] [. Kills [and] [&] repels]Ticks (Including DeerTicks) for up to [4 weeks] [I monthj [30 days]] [. Kills [and] [&] repels] [Brown Dog ticks,] [American Dog ticks,] [and 

### ',ope Star ticks

## J [and deer ticks] ( [(Rhipicephalus sanguineus)] for up to [4 weeks] [I month]**~30 d,~'s]]**  

### [0 Kills [&] [and] Repels] American Dog Ticks [(Dermacentor variabilis)] f(n up to [4 weeks] [I month] [30 days]'] [Flea Eggs and Larvae] ['Controls [flea] reinfestation [for up to [12 weeks] [3 months]]] [oKills adult fleas, flea eggs, flea larvae and pupae for up to [three months] [12 weekslJ [oKills all stages ofthe flea (including adult fleas, flea eggs, flea pupae and flea larvae)] [. Ifdog is a high risk for flea reinfestation a once month application may be needed] [·Kills flea eggs [larvae] [pupae] for up to [3 months] [12 weeks]] 

### [0 With (S)-methoprene Insect Gro\Vth Regulator [IGR] which Breaks the Flea Life Cycle] 

### [0 With (S)-methoprene to Break Flea Life Cycle] [. With Insect Growth Regulator [IGR] to Break Flea Life Cycle] 

### [0 Dual Action [!]:Fipronil with (S)-methoprene IGR [insect gro\Vth regulator] Effectively Breaks the Flea Life Cycle] [·Dual Action [']; Effectively Breaks the Flea Life Cycle [']] 

### [0 Kills Flea Eggs & 

### Flea Larvae for [3 months] [12 weeks]!]

# Sergeant's Master Label 21 December 2009 EPA Submission Information in [ ] is optional. Page 3 of9 EPA No. 2517-XX 21 December 2009 

# l

FRONT PANEL DOG SQUE&ZE ON FIPRONIL+METlfQPRENE [. Prevents Flea Eggs From Developing Into Biting Adults] [. Kills all stages ofthe flea life cycle] [-Controls reinfestation [for up to 3 months]] [-Complete protection against all stages ofthe flea life cycle] [All Others] [oPor Dogs and Puppies 8 weeks ofage or older] [·Controls Sarcoptic Mange [infestations]] [·For Dogs [up to 22lbs], [23-44Ibs], [45-88Ibs], [89-132Ibs.] [·Past Acting] [-Dogs can be bathed 24 hours after treatmentl [·Long Lasting] [·Prevents reinfestation] 

### [oEasy to 

### use [application]] [-Once a month treatment recommended} roA once monthly application is recommended for chewing lice.] [oFast Action against [chewing] lice infestations] [. Three Applications {for cartons with 3 applicators}] andlor [3 Month Supply] or [12 Week Supply] [. Four Applications {for cartons with 4 applicators}

## Jand/or [4 Month Supply] or [16 Week Supply] 

### [0 Six Applications {for cartons with 6 applicators}] and/or [6 Month Supply] or [24 Week Supply] 

### [0 Best 

### ifused yearround!] [. (ICON Showing [4 Week] [I month] [30 day] Protection)] [. 4 Week Dose!] [. I Month Dose!] [. 30 Day Dose!] 

### [0 Specially Formulated for Dogs and Puppies] 

### [0 [Free] Calendar Stickers Inside!] 

### [0 [Free] Brochure Inside!] [. [Free] Brochure and Calendar Stickers Inside

## J [. Apply once every [4 weeks] [month] [30 days]'] [. Dogs can be bathed 24 hams after**Spot~on** 

### is applied] [-Can be used on breeding, pregnant and lactating [bitches] [female dogs]] 

### [0 [Free with purchase] [Free inside] Monthly Application Reminder [Magnet} [clip] [card] [inside]] 

### [0 Waterproof] [-Can be used on puppies 8 weeks ofage and older] ["Monthly application reminder card inside] [For Dogs & 

### Puppies] [8 weeks or older] [and] [up to 22Ibs.] [For Dogs 23-44 Ibs.]

# Sergeant's Master Label 21 December 2009 EPA Submission Information in 

## I Jis optional. 

### Page 4 of9 EPA No. 25 I7-XX 21 December 2009 FRONTPANEL pOG SQUEEZE ON FIPRONIL+METHOPRENE ]ForDogs 45-88Ibs.] ]ForDogs 89-132 Ibs.] 

## IJ - Denotes Optional Statements and/or Images that May be Used on Front, Back or Side Label Panels [Ingredient Statement may be on front or back label]



### ACTIVE INGREDIENTS: Fipronil
H ••••••••••••••••••••••• ,. •••••••••••••••••••••••••••••••••••••••••••••••

### 9.8% (S)-methoprene

..............................................................8.80/0 

### OTHERINGREDIENTS:

........................................81.4% TOTAL: 100.0%

KEEP OUT OFREACH OF CHILDREN CAUTION See [Back][or][Side] [Label Panel[sJ [or) [insert] for Additional Precautionary Statements



### NET CONTENTS: Contains (3) 

### (4) (6)-0.023 fl 

### oz (0.67 ml) applicators Contains (3) 

### (4) (6)-0.045 fl 

### oz (1.34 ml) applicators Contains (3) 

### (4) (6)-0.091 fl 

### oz (2.68 ml) applicators Contains (3) (4) (6)-0.136 fl 02 

### (4.02 ml) applicators
{END

- FRONT PANEL}

# Sergeant's Master Label 2 I December 2009 EPA Submission 

### EPA No. 2517-XX Information in [ ] is optional. Page 5 of9 21 December 2009 

## BACK PANEL O'{)G SQUEEZE ON 

## FI!'IlPNIL+MllT@!,RENE [brand name] 

### cOll.tains Fipronil and S-Methoprene (insect growth regulator) (lOR) to effectively kill [and repel] fleas (all stages) and ticks [(including those that may transmit Lyme Disease)]. The active ingredients in [brand name] work 

### by collecting in the hair follicles and skin oils. This product features a sustained-release formula that discharges from the animal's hair follicles using the natural skin oils, resulting in fast-acting [and long-lasting] control offleas, ticks, mosquitoes and chewing lice [for 30 days]. 

### [Diagram with visual ofFipronil collecting and being released from hair follicle]
READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES OVER 8 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS. CAUTION. Harmful if

### swallowed. Causes eye irritation. Avoid contact with 

### skin, eyes or clothing. Wash thoroughly with soap and water after handling. HAZARDS 

### TO DOMESTIC ANIMALS. For external use only. Do not use on puppies under 8 weeks ofage. Individual sensitivities, while rare, may occur after using any pesticide product. 

### Pets may experience some temporary irritation at the site ofproduct application. Ifsigns persist, or become more severe within a few days ofapplication, consult a veterinarian immediately. If your pet has an unusual reactionto the initial application, consult a veterinarian before repeating 

### treatment. Certain medications can interact with pesticides. Consult a veterinarian before using on medicated, debilitated or aged animals. Call 1-800-224-PETS [7387] for 24-hour assistance. PHYSICAL OR CHEMICAL HAZARDS COMBUSTABLE: Do not use or store near heator open flame.
FIRST AID Ifswallowed Call a poison control center for a doctor immediately for treatment advice. Have person sip a glass ofwater ifable to swallow. Do not induce vomiting unless told to do so by a poison control center ordoctor. Do not give anY1hing by mouth to anunconscious person. Ifin eyes Flush eyes with plenty ofwater. Call a doctor ifirritation persists.

Ifon skin Wash with plenty ofsoap and water. Get medical attentioii if irritation persists.

- 

### HOTLINE NUMBER 

## -

Have the product container or label with you when calling a poison control**cer.t~r** 

### cr doctor, or going for treatment. You may also contact 1-800-224-PETS [7387J for emergency medic'li treatment infonnation.

# Sergeant's MasterLabel 21 December 

### 2009 EPA Submission EPANo. 2517-XX Information in [ ] is optional. Page 6 0[9 

### BACK PANEL
DIRECTIONS FOR USE 21 December 

### 2009 

### DOG SQUE.EZE ON**FIPRO~IL+METHQPRENE** 

### It is a violation ofFederal law to use this product in a manner inconsistent with its labeling. Do not allow childrento apply product. TO PREVENT HARM TO YOU AND YOUR PET, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOTUSE ON OTHER ANIMALS.
Do not use on puppies under 8 weeks ofage. Weigh your dog to be sure you are applying the right dose formulated for the weight ofyour pet. Best ifused year round. Consult a veterinarian before using this product on debilitated, aged, medicated dogs. Can be used on breeding, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known organ dysfunction. Pets may experience some temporary irritation at the site ofproduct application. Certain medications can interact with pesticides. Sensitivitiesmay occur after using ANY pesticide product on pets. Ifsigns ofsensitivity occur bathe your dog with a mild soap and rinse with large amounts ofwater. Ifsigns continue, consult a veterinarian immediately.
HOW TO APPLY AND OPEN CHILD RESISTANT PACKAGING: Remove product tube from package. Holding tube with top end pointing up and away from face and body, cut offtop end with scissors. Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to apply all ofthe solution to the dog's skin, as directed below. Repeat application may be made ifnecessary, but do not apply more often than once every 4 weeks. FREQUENCY OF APPLICAnON Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and mosquito] infestations. (Studies show that] (brand name] kills all stages ofthe flea for up to three months. Ifyour pet is at high risk for flea reinfestation[, or in a highly infested environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing lice. (Brand name] remains effective even after bathing, water immersion, or exposure to sunlight. Allowtreated area to dry thoroughly. Do not reapply for 30 days.
For Dogs Weighing up to 221bs. (including small dogs and puppies, 8 weeks or older}: {For cartons containing .67 ml (0.023 fl. 

### oz.) applicator tubes} Apply one tube (.67ml)(0.023 fl. 02.) 

### from the back ofthe neck to a point midway betweer: t!1e neck and tail.
For Dogs Weighing 23

- 441bs. {For cartons containing 1.34 ml (0.045 fl. 

### oz.) applicator tubes} Apply one tube (1.34 ml)(0.04S fl. oz.) from the back ofthe neck to a point mi(h'v3Y uetween the neck and tail.
For Dogs Weighing 45

- 88 lbs. For cartons containing 2.68 ml (0.091 fl. 

### oz.) applicator tube} Apply one tube (2.68 ml )(0.091 

### fl. oz.) from the back ofthe neck to a point midway between the neck and tail.

# Sergeant's Master Label 21 December 2009 EPA Submission EPA No. 25 1 7-XX Information in [ 

## 1 is optional. Page 7 of9 

### BACKPANEL
For Dogs Weighing 89-132 Ibs. 

### {For cartons containing4.02ml (0.136 fl. oz.) applicator tube} 21 December 2009 

### DOG SQEEZE ON FIPRONIL+METHOIlRENE
Apply one tube (4.02 ml)(O.136 

### fl. oz.) from the back ofthe neck to a point midway between the neck and taiL STORAGE AND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool (below 77°F 

### [25°C)) dry place inaccessible to children and pets. Do notrefrigerate. Protect from direct sunlight. CONTAINER DISPOSAL: 

### Ifempty: Non-refillable container. Do not reuse or refill this container. Offer for recycling 

### ifavailable. 

### Ifpartly filled: Call yOUf 

### local solid waste agency for disposal instructions. Never place unused product down any indoor oroutdoor drain. [WARRANTY Read the entire Directions for Use and Warranty before usingthis Product. By using this product, user or buyer accepts the following warranty. The directions for use ofthis product are believed to adequate and must be followed carefully. It 

### is impossible to eliminate all risks associated with the use ofthis product. Unintended consequences may result because of unknown factors. All such risks shall be assumed by the user or buyer. Sergeant's is committed to providing high quality products. To the extent consistent with applicable law, Sergeant's makes no warranties, express or implied, ofmerchantability or offitness for a particular purpose or otherwise,that extend beyond statements on this label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not be liable for indirect, special, incidental or consequential damages. To the extent consistent with applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.) [Ifyou have questions or comments aboutthis product, please write: Sergeant's Consumer Response. P.O. Box 540399. Omaha, NE 681 54-0399.J

In Case ofEmergency, call: 1-800-781-4738 [For more infonnation) [Visit us at:] [www.sergeants.comJ Non-Emergency call1-800-224-PETS (7387) [Made in USAJ

Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-XX EPA Est. No. XXXXX -XX -XXX [BAR CODE t.:<EAJ

# Sergeant's Master Label 21 December 2009 EPA Submission 1nformation in [ ] is optional. Page 

### 80f9 EPA No. 2517-XX 21 December 2009 

### BACK PANEL DOG SQEEZE ON FIPRONIL.+METHQp.RENE {END

- BACK I 

### SIDE PANEL) {START

- OPTIONAL INSERT OR PACKAGE COPY) 

### (. How to Apply 

### and Open Child Resistant Packaging

- May contain graphics illustrating product usc, e.g., dog with a drop falling onto its neck from a vial on front, side, orbackcarton label and/or applicator labeling.] [How to Apply 1. Remove product tube from package. Holding tube withtop end pointing up and away from face and body, cut offtop end with scissors. [image oftube and end being cut off] 2. Invert tube over dog and use open end to part dog's hair. 3. Squeeze tube firmly to apply all ofthe solution to the dog's skin from the back ofthe lleck to a point midway between the neck and tail.] [Flea life cyc1e diagram] [Look at the Label (Look at the Label icon) 6 Step [Spot On] [Squeeze-On] [Topical] Checklist • Read the label completely and follow directions • Weigh your pet • Do NOT use Dog products on Cats • Do NOT treat with more than one pesticide product at a time • Separate animals after treatment to avoid chance ofingestion • Do NOT split tubes between pets] 

### [Brand Name] [Monthly reminder card] [For year round protection apply [Brand Name] monthly.] [Pet's Name (Empty blank for owner to fill in name)] [First [dose] [Treatment] (Empty blank for owner to fill in date)] [Second (dose] [Treatment] (Empty blank for owner to fill in date)] [Third [dose] [Treatment] (Emptyblank for owner to fill in date)] [Fourth [dose] [Treatment] (Empty blank for owner to fill in date)] [Fiffb [dose] [Treatment] (Empty blank for owner to fill in date)] [Sixth [dose] [Treatment] (Empty blank for owner to fill in date)] [calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapl,iy [brand name] in 30 days.] [Monthly Application Reminder Magnet (image ofreminder magnet) Enclosed for your convenience is an application reminder magnet. Push the (reset) button, allti the reminder light will blink twice. The reminder tag is now set for 30 days. At the end of30 days the reminder light will blink, reminding you to reapply [Brand Name]. Press the button once and the blinking light will stop. Press the button again and this will reset the timer for another 30 days.] {END

- OPTlONAL INSERT OR PACKAGE COPY)

# Sergeant's MasterLabel 21 December 2009 EPA Submission EPA No. 25 I7-XX Informationin [ 

## 1is optional. Page 9 of9 21 December 2009 

### rUBE I 

### VIAL LABEL Front Label {Brand Name} Fipronil 9.8% W/W, (S)-methoprene 8.8% W/W 0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 mL {label code} Back Label KEEP OUT OF REACH OF CHILDREN CAUTION: Read directions and precautions before using. Open with scissors. EPA REG. No. 2517-XX {label code}