# REGISTRATION 2517-147

## :fti Data Requirements 

### CJ D: Pending; 443257; 2017-RU7;I94;ACTIC>N.iNl 

### :+:**~.m** D:**Clos~;** 442432; 2517-RUT;W02;SMALL 

# -;,;; e D: Pending; 442431; 2517-RU7;"31,';'''"'

## PI.O!; 

# ""' Iii! (OJ



# , •• DP385134;RD/IB; Complete Date: DP385135;RD//B; Complete Datt::: DP385137;RD/IB; Complete Date: DP386764;RD//B; LastPossIble



# -Tracking Create Resubmlssicn fFSLeiters

Action Code Hisfory SecondaryOecisionDP386764;RDIIB; Complete Date: DP385133;RDIIB; Complete Date: DP385134;RDIIB; Complete OBte: DP385135;RDIIB; Complete

## D,I',**"~** DP385137;RDIIB; Complete Date:**7~,** 'iY;.( 

### \(:c**{~r** 

### Q(cfA 

### 3 65\:'::0:; DecIsion status Trscking Create Resubmission FFS Letters

Action Code History SecondaryDecision

# NEW APPLICATIONS DATE: NOV 19 2010 

# FILE NUMBER: ')517- RuT 

# PEP (OPPIN ENTRY) II) /!tn(::lO/Q 

# (Initial & 

# date) FILE ROOl\1:



# ------- (Initial & 

# date) SIG: (InWal 

# & date) 

# F1LE ROOM:



# ------- (Initial & 

# date) .;' ASSIGN TO 

# PM jD 

# (NO DATA)



# __JACKET TO SHELF (DATA)

### DATA PACKAGE BEAN SHEET Date: 04-Apr-2011 Page t of 3 

### * 

### * * Registration Information 

### * * * Decision #: 442431 DP #: (386764) PRIA Parent DP #: Submission

### #: 886190 Registration:**~_~tT~RMT _-:u~_~_RG_~ANT~** 

### __**EIJ~_R9.Ntb**

### __**!_~TQEf;N~R9~** 

### __:!"

__**NYJ~~·A_~**

### __**~.I?_QT=()J** Company: 2517
- SERGEANTS PET CARE PRODUCTS, INC. Risk Manager;**f3~** 

### ___1

0

-**_~Jg_~~~~ ~_E!~_~~_n_** **-J!Q~)_3o.~-":??P1_~_~_O_~_F'X_1** __**~_-7?_3?** _______ Risk Manager Reviewer: Rosanna louie-Juzwiak RlOUIE Sent Date:

Ingredients:**Sf;!~J?_~_fl.e ~** ___

Expedite: 

### 0 Yes • No DP Ingredient See pa.ge 3 Calculated Due Date: 14-Jun-2011



### * * 

### * Data Package Information 

### * * *
Oate Sent: 14-Feb-2011

DP Title: #2S17-RUT CRP Self·Certification Review CSF Included: 

### 0 Yes. No label Included: • Yes 

### 0 No Parent DP#:

Date In Date Out Edited Due Date:

Due Back:

Organization: RD I TRB

# .~.I,d\1 last Possible Science Due Date:**1_~!:A_(3.I~?P1_1** ___ Team Name: Science Due Date: Reviewer Name: louie-Juzwiak, Rosanna

---------------- -------------------- Sub Dala Package Due Date: Contractor Name: 

### '" '" '" Studies Sent for Review'" '" '" Printed on Page 2 

### '" '" '" Additional Data Package for this Decision'" '" '" Can be printed on its own page 

### '" '" '" Data Package Instructions'" '" '" Complete a CRP review for the proposed product. Attached is the self-certification summary provided by the registrant, citing a previously submitted study (MRID 48279601).Page2 DP#: (386764) * * * Studies Sent for Review * * * Decision#: (442431)

i Laboratories, Inc. 28 p.

## PRIA 2 - 21 Day Content Screen Review Worksheet (EPA/OPP Use Only) 

## J/_/ q _ /3 

### 0 123/09 21 Day Screen Start Date: 

### ---'--"-.--.::,,;{-,;,-'''-------c-c Experts In-Processing Signature: 

# 15, (L- DateL 

### 1-26 

### -IfJ FeePaid: Yes /' Division management contacted onissues No,

___ Yes

____ ,Date

______ _ EPA Reg. Number: 

# J,!3/7

# -If U 

# T EPA Receipt Date: / (- 

## 11-.20

1 Itemsfor.Review Application Form (EPA Form 8570-l)(link to form) signed & complete includingpackage type 

### Yes No 

### N/A*

Confidential StatementofFormula all boxes completed, [ann signed, and 

# Y-- 2

3 a) All ioerts (link to hup://www.epa.gov/opprdOOllincrts/), including fragrances, approved for the proposed uses (see FootnoteA) Certification with Respect to Citation ofData (EPA Form 8570-34) (Link to form) completed and signed (N!A 

### if 100% repack) Certificate and data matrix consistent Ifapplicant is relying ondata that are compensable, is the offer to pay statement included. (see Footnote B)
for yes

Formulator's Exemption Statement (EPA Form 8570-27) (Link to form) 

### no

4 completed and signed (N/A ifsource is unregistered or applicant owns the



### 5 DataMatrix (EPA Form 8570-35) (Link to form) both internal and external copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100%

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


### 5 Copies ofLabel (link to http://www.epa.gov/oppfeadl/labelingllrmD 

### 6 (Electroniclabels on CD are encouraged and guidance is available)( link to hUp:!!www.epa.gov/pesticideslregulating/registering/submissionslindex.htm#labels



### 1

### 7 Is the data packageconsistent with PRNotice**86~S** (link to PRN 86-5) 

# A
Notice ofFiling (link to 

### 8 htt[!:lIwww.eQa.gov/Qesticides/reguiatim!ltoierance I!etitions.htm) included with petitions (link to http://www.eva.uov/pesticides/reguIatillgltolerances.htm)

### ~ 9 If

### applicablefor conventional applications, reduced 

### risk rationale (link to http://www.epa.gov/opprdOOl/workpian/reducedrisk.htmI) 

# YRequired Data (link to httl2://www.ena.gov iQesticides/reguIatine1data 

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

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



### 10

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Footnotes A. During the 21 day initial content review, all CSFs will be reviewed to determine whether all inerts listed, including fragrances, are approved for the proposed uses. Ifan unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for example, removing the inert, substituting it with an approved inert, submitting documentation that EPA approved the inert for the proposed pesticidal uses, conecting mistakes on the CSF, etc. or 2) provide the datato support opp approval ofthe inert or 3) withdraw the application. Removing orsubstituting an inert ingredient will require a new CSF and may require submission ofdata. All information. forms, data and documentation resolving the inert issue must have been received by the Agency or the application withdrawn within the 21 day period. otherwise. the Agency will reject the application as described below. To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouraged to verify that all inert ingredients havebeen approved for the application's uses even ifa productis currently registered by consulting the inert Web 3

### site [link to http://www.epa.20v/opprd001/inerts/lists.html] and ifthe inert is not approved, to obtainthe necessary inert approval priorto submitting an application to register a pesticide product containingthatinertingredient. Some inert ingredients are no longer approved for food uses or certaintypes ofuses. The name and/or CAS number on a CSFmust match the name and CAS number on this web site. Simple typographical errors inthe name or CAS numberhave resulted in processing delays. Ifan inert is not listed on the inert ingredient web site and the applicantbelieves that the inelt has been approved, the applicant should contact the Inert IngredientAssessment Branch (lIAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe correspondence with nAB resolving the issue should accompany the application. All new inerts except PIP inerts are reviewed by nAB. The nAB should also be contacted for any questions onwhat supporting data needs to be submitted for and the Agency's inert review process. Questions on PIP inerts should be directed to the Chiefof Microbial Pesticides Branch 

### fLink to http://www.epa.gov/oppbppdIlbiopesticides/contacts bppd.htlTI]. When a brand, trade, or proprietary name ofan inert ingredient is listed on aCSF, additional information such as an alternate name ofthe inert, CAS number or other information [link to http://www.cpa.gov/opprdOOllinerls/lips.pdOmustalso be 

### included to enable the Agency to determine ifit ha-; been approved. Each component ofan illelt mixture (including afragrance) must be identified. In some cases, the supplier ofthe mixture orfragrance may need to provide this infonnation to the Agency. Prior to the Agency's receipt ofau application, applicants must an'ange with a proprietary mixture or fragrance supplier to provide the component information to the Agency or promptly upon EPA'srequest. Ifthe inert ingredients in a proprietaryblend (including fragrances) cannot or are not identified or provided within the 21-day content review period, the Agency will reject the application. During the 21 day content review, applicants should submit infonnation to the individual identified by the Agency when the applicant is informed of an unapproved inert. Unapproved InertsIdentified on CSFs All applications except conventional new products and PIPs Once an unapproved inert is identified on a CSF, the Agency will contact the applicant with the following options: 1. 

### Correct the applicationby, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removing the unapproved inert from the CSF orreplacing it with one that is approved for the application's uses; or 2. Submit the infonnation and data needed for the Agency to approve the unapproved inert Ifthis option is selected and implemented, the Agency may request anextension in the PRIA decisionreview timeframe to accommodate the inert review/approval process; 43. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implementedby the applicant within the 21 day content review period, the Agency will reject the application and retain 25% ofthe full fee ofthe category identified. Conventional New ProductApplications When theRegistration Division identifies an unapproved inert on a CSF with an application for a new product that the applicanthas not identified as requiring an inert approval (R311, R312 orR313), it will contact the applicant with the following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removing the unapproved inert from the CSF orreplacing it with one that is approved for the application's uses; or 2. Submitthe infonnation and data needed for the Agency to approve the unapproved inert, including any required petition to establish or amend a tolerance or exemption from a tolerance. (This option maychange the PRIA category for the application, which could require a longer decision review time and a larger fee. If additional fees are due, they must be received by the Agency within the 21 day content review period.) 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or

Ifnone ofthe above options is selected and implemented during the 21-day content-review period, the Agency will reject the application and retain 25% of the appropriate fee for the new product-inert approval category. PIP Applications When the Biopesticide and PollutionPrevention Division identifies an unapproved inert on a PIP CSF and a request to approve the inertdoes not accompany the application, it will contact the applicant with the following options: 1. Correct the application by, for instance, correcting the spelling or name ofthe inert to that in 40 CFR 174, or providing documentation that the inerthas been approved; or 2. Submit the information and data needed for the Agencyto approve the unapproved inert. Ifan inert ingredient tolerance exemption petition is required, the petition must be received by the Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizing the timeframe for both actions. 5

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

B. A policy on documentation ofoffers to payis still being developed, however, for a me-too or fast track (similar/identical) new product, R300 or

### A530, an application without the necessary authorizations ofoffers to pay will be placed into either R30I or 

### A531. The Agencyrecommends that authorizations ofoffers to pay be submitted with other PRIA applications to avoid delays in theAgency's decision. 

## c. Biopesticide applicants are advised to contact the Agency and discuss study waivers prior to 

### submitting their application to the Agency. Documentation ofsuch discussions should be submitted with the study waiver.



### 6

# IFee for Servicel**1~~ThiS** package includes the

# fOIlO~~;;-~-l**~** 

# New Registration 

# °Amendment for Division 

# OAD oBPPD**~RD** 

# y(**(886190/~**

yj

# Studies? :"'l 

# Fee Waiver? ../ Risk Mgr. 

# [JQJ volpay %**Reduct."io~n,~: ==--~**  

# ; L ____________________________

## ~__

## ~______ 

# L _______________**~_____________** 

# _ __ 

# J**~=====::::.:.;** 

# Receipt No. 

# s-I 886190 EPA File Symbol/Reg. No. 

# I 2517-RUT Pin-Punch Date: 

# I 11/19/2010**-~~----------. ~~--~----~-~--~--~---~-~-~~~-~-~~** **--~**

### ------------------------~~-----------j

_I i 

# This item is NOT 

# subject to FFS action.

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

# --, Parent/Child Decisions: 

# i**i~~-~~~~;A;ctton-em:le_:­** 

## Requested: 

# IE-s I 6 

## Granted: 

# I 12') i ()

# LAmount~ue: $ L(

## 1(-0

# 1 (0 1;:"''''0 

# "il,,",r:;r¥ 11/#, 

### /10

# ~ .Inert

# clea~\ef for

# IntEln:d~~ Use ReViewer: oj \ /\ \ ( : \ L_) 

## Uncleared Inert in Product Date: r 

# i

# I Z'f/;L:

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### Remarks:3

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# ,

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## <,**~** -----. 

## ISB'S Front-end PRlA Completeness Screen Draft 3; 10/25/07



### Rcc.:cipl Datc: 

# /1/lf/!2o(O EPA Reg. Number: 

# :)5/7- 

# /?uT

- 

### --- Check List Item Ves No NIA 

### Has lhc PRIA Fce been Paid; is acopy ofthe check

# or(fiiJ

M

___

### ~~ly.gOV receipt included in the Submission Package? 

# tv 

# X
Is Ull 

### Application Form (EPA Fonn 8570-1) Included in the 

# X**SLlhl11is~·dlJlI** 

### Package, is 

### it completely lilled out and signed induding package type?

-**----"-~.---** i:-; 

### a Confidential Statement ofFormula (EPA Fonn 8570- 

# X 29) .Included in thc Submission Package, is it completely 

## n

lied out and signed (boxes 1-21 )?

. 

### ------- Is i.I 

### Formulator's Exemption Statement (EPA 

### FotID 8570- 

# X- 27) Included in the Submission Package?

- -.--._.--- 

### -- b u 

### Ccrtificntioll with Respect to Citation ofData (EPA 

# X hll"l1l**g570~34)** Included in the Submission Package?

-.--**-,,-.---~--** 

# -- ----



### Is a Unta Mnll·ix 

### (EPA Form 8570-35) Included in the 

# :/ Suhmis!>ion Paclwgc'?

"'**~-----** 

### Is u Lnhcllncludcd in the Submission Package? 

# ;<**~.** ---'--- 

### Arc Uata Included in the Submission Package? 

## ;(**-.~** 

### Is the Submission lin Amendment?**-~.**

### -**"",~~OST** ...T. EPA Reg. Number: Dale of Issuance:



## " ENVIRONMENTAL PROTECTION AGENCY 

## f

....**~** U.S.

### .~. 2517-147 08118/2011**,,~** 

### :p'" Office of**Pe~licide** Programs. -'f{ PRQ1\.<;' Term of Issuance; Registration Division (7505C) Conditional 1200 Pennsylvania Avenue NW Name of Pesticide Product: Wa&hingloo, D.C. 20460 Sergeant's Fipronil + Etofenprox + NOTICE OF PESTICIDE, PYliproxyfen Spot On for Cats
X Registration



### --**~-** Reregistration (uoder FIFRA, as amended)

Name and Addr= of Reglslraol (Include ZIP Code), Sergeant's Pet Care Products, Inc. 2625 South 1581h Plaza Omaha,NE 68130-1770

No!e; Changes in labeliog differiog in substance from lhnl ae<;epled in connection with this**regiW<l~on** mUSl be submi"ed 10 aod accepted by the Rt!(lislrnUon
DivisiOn prior 10 US6 ot the taMI in commerce. In aoy correspondence 00 this product always reter to the above EPA regist",Uon number.

On the basis of information tumtshe<:l by the regislrant, the above named peslicide is hereby registere<:l/rereg",tered under the Fe<:leral Inseclicide, Funoicide and**Roden~dde** Act.**R8!1istra~on** is in no way to be construed as an endorsement or recommendation of lhis product by the Agency. In order to protect heallh and the environment,
the Administralor, on his motion, may al any time svspend Or cancel the**re!listra~on** 01 a pesticide in accordance with the Act. The aCCeptance of any name in
conneclion with the registration of a proouCl under this Act is nol to be construed as giving the registrant a right 10 exclusive use of lhe name Or to il3 use if**~** has been coverfHl by others. This product is registered in accordance weth FIFRA sec 3(c)(7)(A), contingent on the following: 

### L Make the following labeling changes before you releasethe product for shipment: a. Revise the EPA RegistrationNumber to read: "EPA Registration No. 2517-147". b. Revise the signal wordto "Caution".

Signature of Approving O1ficial: Oate: See page 4 Richard Gebken, August 18, 2011 Product Manager(RM 10) Insecticide Branch Rel!istration Division(MC 7505P) EPA Form 8570-62

c. Delete the ABN 

### "VetSpof'; implies/ could be confused with FDA approved product. d. Undersubtitle "[Multiple Infestations], revise claim to read [Three {3/ Way Protection]; only three (3) active ingredients on label. 2. This registration is time-limited and expires two years from the date this product is first released fOf shipment. You must provide the Agency with a projected "release for shipment date", in writing within 30days 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. 3. Only one basic confidential statement offorrnula (CSF) will be on file for this product at any time (i.e., no alternate formulations or minorformulation amendments will be submitted and/or approved for this product, except to allow for alternate sources ofany individual inert ingredient). 4. You must submit the following data withinthe timeframes described below: Within sixteen (16) months ofthe date on this Notice ofRegistration, provide to the Agency acceptable data packages for Guideline Studies: OPPTS 830.6320 (Corrosion Characteristics) and OPPTS 830.6317 (Storage Stability). 5. You must submit quarterly enhanced incident reports and quarterly sales information in doses sold for this product for the quarter that begins on October 1, 2011. The quarterly reports are due two months afterthe end ofeachquarter. Please flag any Confidential Business Information CBI) as such. Enhanced incident reporting should be submitted to the Product Manager. Qualterly sales information should be submitted to the Registration Division, Immediate Office (attn: KimberlyNesci). The following is a list ofinformationthatmust be included in the quarterly reports for eachincident: EPA RegistrationNumber Product name (brand name) 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 pet owner) Age: months oryears Sex: M, F, orneutered Weight: pounds Primary Route ofExposure: dennal, oral, other animal, inhalation, other Body System: neurological, dennatological, GI, respiratory, ocular, otherMajor signs noted with separate colun1l1 for each sign, using standard terminologyTime to Onset: (hours,days) Treated 

### by veterinarian: yes or no Firsttime product used: yes or no 

### 3

Misuse: lise on incorrect species, overdose, too frequent dosing, other (describe) Any knownprecondition EPA Severity Code: death, major, moderate, minor Outcome: died, recovered, still treated, unknown 6. Along withthe enhanced incident reporting, you must submit an analysis ofall incidents seen, to include the following details:

a. All minordennal and ocular irritationreports. b. Summary table for cats showing number ofincidents ofeach severity code for eachroute of exposure. Eachincident should only bereported once. Ifone incident has several routes of exposure, the order should be ocular> oral> dermaL In other words, an incident withboth oral and dennal exposure would be reported as oral exposure, and an incidentwith both ocular and oral exposure would be reported as ocularexposure.

c. A similarsummary table for dogs (misuse or secondary exposure) showing number ofincidents ofeach severity code for each route ofexposure. d. Summary table for dogs and table for cats showing number ofincidents that are believed due to secondary exposure (e.g., mUlti-pet households).

e. A summruytable for cats showing number ofincidents for each severitycode for these age ranges: <3 months, 3-6 months, 6-9 months, 9-12 months, 1yr, 2 yr, 3 yr, 4 yr, 5 yr, 6 yr, 7 yr, 8 yr, 9 yr, 10 yr, II yr, 12 )7, 13 yr, 14 yr, 15 yr. >15 yr. f. A summarytable showing the number ofcat incidents for eachseverity code for eachpet weight range on the product label (ifapplicable}.
g. A summary table for cat weight showing number ofincidents for eachproductweight range. This table should show number ofincidents in cats weighing less than that product weight range, number ofincidents in cats in lower halfofweightrange, number ofincidents incats in upper halfofweight range, and cats weighing more than theproduct weight range (if applicable). h. Table showing number ofincidents for each catbreed, where provided.

1. Table showing number ofincidents in cats for each clinical sign. J. Table showing number ofincidents incats for each organ system. 

### k. Report aggregate incidents, but do not combine moderate and minor incidents.

### 4

7. Youmust submit 

### andlor cite all data required for registration ofyourproductunderFIFRA Section 3(c)(5) when the Agency requires all registrants ofsimilarproducts to submit such data, and submit acceptable responses required for re-registration (registration review) ofyour product underFIFRA section 4. IfEPA detennines thatfuture mitigation measures are necessary for allpet spot-on products, the Agency will infolm all registrants concerned. Ifmitigation measures are necessary, EPA maytake regulatory action. Two copies ofthe finished labeling must be submitted priorto releasing the product for shipment. Ifyou fail to comply with the above stated conditions, the registration will be**su~ject** to cancellation in accordance with FIFRA sec. 6(e) and/orautomaticallyexpire. Your release for shipment ofthe product constitutes youracceptance ofthese conditions. A copy ofyourlabel stamped "Accepted with Comments" is enclosed foryour records. Ifyou have any questions conceming this action, please contact Dr. B. A. Akinlosotuvia (703) 605-0653 or akinlosotu.bonaventure@epa.gov. Sincerely, 

# e**J~'/** 

# UI<----.
Richard Gebken, Product Manager(RM 10) Insecticide Branch Registration Division (MC 7505P)
Ellclosures Stamped Label

# Sergeant's@ MasterLabel 29 June 2011 Version 10.3 EPA Reg, No, 2517-RUT Information in [ ] is optional. Page 1of8 EPA Efficacy Review [Optional text appears in brackets-the final label may include some orall ofthe optional text on the front, 

# in s;iD'i'

## q0iiiibi.~"'ljkfio~r side

## lab~,~"'I,**P~,~;I~,I** 

## ',i'?"?"'ii'i;;,,:"!,"?' 

## Sergeant's FiproniI 

# +Etofenprox 

# +Pyriproxyfen Spot On for eats [ABNs:] [(Sergeant's@)(Sentry®)VetSpotTM(SpotOn)forcats] [(Sergeant's®) (Sentry®) FRONTIERGOLD (Spot On) for cats] [(Sergeant's@)(Sentry@)EctoadvanceTM(SpotOn)forcats] [(Sergeant's®) (Sentry®) FrontspotT>1 (Spot On) for cats] [(Sergeant's,) (Sentry,) Firstline (Spot On) for cats] [(Sergeant's,) (Sentry®)Frontedge (Spot On) for cats] [(Sergeant's@)(Sentry') FrontguardTM (Spot On) for cats] ](Sergeant's') (Sentry®) FRONTPRONIL (Spot On) for cats] [(Sergeant's®) (Sentry')FIPROLINE (Spot On) for cats] [(Sergeant's,) (Sentry®) Advanspot (Spot On) for cats] [Apply to kittens over 12 weeks old] [Apply to kittens 12 weeks orolder] ACCEPTED 

### With COMMENTS In EPALetterDated: 

## AUG 18 

## 1011 Under

### the Fedemllnsecticide, Fungicide and Rodenticide Act, As amended, forthe paS1icide Registered under EPAReg. No:

### 7,.~n~/.f1 [Foruse ONLY on cats [[&][and] kittens 12 weeks orolder]OF ALL WEIGHTS] [Foruse ONLY on cats][ofALL weights][over 12 weeks ofage] [Mosquitoes] [-Kills mosquitoes] [Adult Fleas] [. [Full or Partial BrandName] kills adult fleas for up to six weeks] ['Kills Fleas [Up to [4] [6] weeks]!] [-Kills Fleas that may cause flea allergy demmtitis, flea bite anemia, and tapeworm infestation] [-Stops andprevents reinfestation] [-Controls flea reinfestation [forupto six weeks

## 11 [- [Full or Partial BrandName] kills adult fleas forup to six weeks] [-Ifcat is a high risk for flea reinfestation a once month application maybe needed] [-Prevents and controls reinfestations] [FleaEggs and Larvae] [-Stops and prevents infestations] [-Controls flea reinfestation for up to 6 weeks] [. [Full or Partial BrandName] kills adult fleas, flea eggs, [and] flea larvae [andprevents pupae] for up to six weeks] [-[Full orPartial Brand Name] prevents development ofall flea stages for up to 6 weeks] [-Prevents all flea stages (adultfleas, flea eggs, flea pupae 

### and flea larvae)] [-Ifcatis a high risk for flea reinfestation a once month application may be needed]

# Sergeant's® MasterLabel 29 June 2011 Version 10.3 EPA Reg. No. 2517-RUT Infonnation in [ ] is optional. Page 2 of8 EPA Efficacy Review



### [Ticks] [-Kills flea eggs [larvae] for up to [3 months] [12 weeks]] [- [Seven][Six] [Five][7] [6] [5]WayProtection [Kills fleas, ticks, [mosquitoes,] chewing lice, flea eggs, [and] flea larvae [and prevents flea pupae]]] 

### [-With Pyriproxyfen Insect Gwwth Regulator which Breaks the Flea Life Cycle] [-With Pyriproxyfen to Break Flea Life Cycle] 

### [.With Insect Gro-wth Regulator to Break Flea Life Cycle

### J [-TripleAction [!]:Fipronil and Etofenprox with Pyriproxyfen IGR] [Effectively Breaks the Flea Life Cycle

## II [-Triple Action [I]: Effectively Breaks the Flea Life Cycler!]] [-Kills all stages oftheflea life cycle] [-Kills FleaEggs & FleaLarvae [for up to 3 months]!] [-Prevents Flea Eggs From Developing Into Biting Adults] 

### [-Prevents and controls reinfestationsJ
[-Kills Ticks including those that may transmit Lyme disease] [-Kills Ticks [for Up to 4 weeks]!] [-Kills Deer Ticks (which may transmit Lyme disease) forup to [4 weeks] [1 month] [30 days]] [-Kills Ticks (Including Deer Ticks) for up to 4 weeks] [-Kills American Dog Ticks for up to 4weeks] 

### [-Kills [Brown], [American] [and Lone Star] dog ticks for up to 4 weeks] [-Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!] 

### [Multiple Infestations] 

### [(Full or 

### Partial Brand Name) provides convenient and effective flea, tick, [and] chewing lice [and mosquito] control for cats and kittens [12 weeks or older]] [-Controls reinfestation for up to 4 weeks] [- Flea & 

### Tick Control for Cats & 

### Kittens 12 weeks old or older] [-Kills fleas, ticks,[&] chewing lice [& mosquitoes]] 

### [-Kills fleas, ticks, [mosquitoes,] and chewing lice] [-Monthly flea, tick, [mosquito] and chewing lice protection] [-[Four][Three] [4][3] Way Protection] [-[4 Week] [Flea and TickTreatment]] [-[Four (4) Week] [FleaTick, [Mosquito] and Chewing Lice Control]] [-When used monthly [Full orPartial Brand Name] completely breaks the flea life cycle 

### and controls tick and chewing lice infestations.] [-Once A Month Flea and Tick Treatment] [-Kills Fleas and Ticks for up to 4 weeks1] [-Starts to kill fleas and ticks in an hour, continues to kill for amonth] [-Kills [fleas] in 4 hours [and] [ticks in one hour]] 

### [ [Full or Partial Brand Name] kills fleas in 4 hours and Dennacentor ticks in one hour] [-Kills ticks in 1hour] [-Kills fleas and ticks in [24 hours] [1 day]] 

### [-Starts killing fleas and ticks in as little as 1hour]

# Sergeant's@ MasterLabel 29 June 2011 Version 10.3 EPA Reg. No. 2517-RUT Information in [ ] is optional. Page 3 of8 EPA Efficacy Review [All Others] [-Stops and prevents infestations] [-Por Cats and Kittens 12 weeks ofage or older] [oFast Acting] [-Cats can be bathed 24 hours aftertreatment] [oWaterproof] [0Long Lasting] [-PastAction against chewing lice infestations] [0 Three Applications] [3 Month Supply] [12 Week Supply] [- Best ifused yearround!] [0 (ICON Showing 4 Week Protection)] [04 Week Dose!] [0 1Month Dose!] [- Easy to Use Application] [0 Specially Fonnulated for Cats and Kittens [12 weeks or older]] [0 [Free] Calendar Stickers Inside!] [0 [Free] Brochure Inside!] [- [Free] Brochure and Calendar Stickers Inside] [0 Apply once every [4 weeks] [month] [30 days]!] [- Convenientto use] [0 [Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [clip] [insert]] [oPatent Pending] [03 applications]

ACTIVEINGREDIENTS: Fipronil

........................................................9.80% 

### Etofenprox

..................................................15.00% Pyriproxyfen

..............................................................2.20% OTHERINGREDIENT[**]

...._ ......................73.00 % TOTAL: 100.00% [**diethylene glycol monoethyl ether] KEEP OUT OFREACH OF CHILDREN WARNING See [Side] [or] [Back] Panel ForAdditionalPrecautionary Statements NET CONTENTS: [3][Three] 0.017 fl 

### oz [0.50 ml] applicators

# Sergeant's®MasterLabel 29 June 20II Version 10.3 EPA Reg. No. 25I7-RUT Infonnation in [ 

## Jis optional. Page 4 of8 EPA Efficacy Review [BACK/SIDE CARTONLABEL

- MASTERLABEL] 

### [Full orPartialBrand Name) contains FiproniI, Etofenprox and [the insect growth regulator] [IGR) Pyriproxyfento effectively kill fleas, ticks, [mosquitoes) and chewing lice. The active ingredients in [Full orPartial BrandName] features a sustained-release fonnula developed for fast-acting [and long-lasting) control offleas, ticks, [mosquitoes] and chewing lice [for 30 days] on cats [and kittens 12 weeks or older]. READ ENTIRELABEL BEFOREEACH USE. USE ONLY ON CATS AND KITTENS OVER 12 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS. WARNING. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Wash thoroughly with soap and waterafter handling and before eating, drinking, chewing gum, or using tobacco. Remove and wash contaminated clothing before reuse. Hannful ifswallowed. Harmful ifabsorbed through skin. HAZARDS TO DOMESTIC ANIMALS. For external use only. Do notuse on kittens under 12 weeks ofage. Individual sensitivities, while rare, may occur afterusing any pesticide product. [Some cats may experience temporary startle effects when anyproduct is applied.] Ifsigns persist, or becomemore severe within a few days ofapplication, consult a veterinarian immediately. Ifyour pethas an unusual reactionto the initial application, consult a veterinarian before repeating treatment. Certain medications can interactwithpesticides. Consult a veterinarianbefore using onmedicated, debilitatedoraged animals. Call 1·800-224·PETS [7387] for 24-hour assistance.

IfIn Eyes

Clothing

IfSwallowed FIRSTAID • Hold eye open and rinse slowly and gently with water for 15·20 minutes. • Remove contact lenses, ifpresent, after the first 5 minutes, then continue rinsing eye. • Call a control center or doctor for further treatment advice. • Take offcontaminated clothing. • Rinse skin immediately with plenty ofwater for 15-20minutes. • Call a control center or doctor for treatment advice. • Call a poison control center or 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 or doctor. 

## • you center or , or treatment. For more information on this pesticide product (including health concerns, medical

. or· caUl-SOO·781-473S.

# Sergeant's@ MasterLabel 29 June 2011 

### Version 10.3 

### EPA Reg. No. 2517-RUT 

### Information 

### in [ ]is optionaL Page 5 of8 EPA Efficacy Review

# Sergeant's®MasterLabel 29June 2011 Version 1003 EPA Reg. No. 25I7-RUT Information in ( ] is optional. Page 6 of8 EPA Efficacy Review DIRECTIONS FORUSE It

### is a violation ofFederal law to use this product in a manner inconsistent with its labeling. READ ENTIRE LABEL BEFORE EACH USE. FOR EXTERNAL USE ON CATS ONLY. Do not use on kittens under 12 weeks ofage. Do not treat your cat with more than one pesticide product at a time. Over dosing your catcan result in serious illness and even death. Bestifused yearround. Consult aveterinarian before using this product on debilitated, aged, medicated cats. Consult aveterinarian before using on cats with known organ dysfunction. Separate the treated cat from all other cats and dogs for 24 hours after treatmenthas been applied. Cats and dogs that actively groom or engage in closephysical contact with treated cat may be atrisk ofserious hannful effects. The most common signs of ingestion are excessive salivation andfoaming at themouth. 

### Ifthese symptoms occur, immediately feed your cat and continue to monitor your pet for the next 24 hours. Sensitivities may occur afterusingANY pesticide product on cats. Ifsigns ofsensitivity occurbatheyour catwith a mild soap and rinsewith large amounts ofwater. If

### signs continue, consult a veterinarian immediately bycalling 1-800-781-4738. [Optional diagram mayormay not appear on the finished label]

# ~)pt**~**
[{OuterPackaging}

## 1 How to open: Removeproduct tubes [vial] from the package. Separate one tube from the others. Holding thetube [vial] with notched end pointing up and away from the face andbody, cut off the narrow end at the notches with scissors. How to apply: While holding the catwith one hand, use the other hand to apply the solution. Invertthe tube[vial] anduse the narrow end to part the cat'shair. Apply contents ofone tube [vial] of{Full orPartialBrand Name} [as a stripe, starting high on the back ofthe cat's neck to infront ofthe shoulderblades] [as a spot betweenthe shoulder blades]. Holdthe catfor a few seconds to give the solutiontime to be absorbed into the cat's coat. When finished, wrap the tube [vial] in paperand put into the trash. Only one applicator per treatment is needed. FREQUENCY OFAPPLICATION Use [Full or Partial BrandName] monthly for complete control offlea, tick [and] chewing lice [and mosquito] infestations. [Full or Partial Brand Name] kills fleas for up to six weeks, and flea eggs, [and] flea larvae [andprevents flea pupae] for up to 12 weeks. Apply monthly, ifyour petis at highrisk for flea reinfestation [, or in a highly infested environment]. Apply monthly to control ticks, [mosquitoes] and chewing lice. [[Full or Partial Brand Name] kills mosquitoes within 24 hours for up to 14 days, and within48 hours for up to 28 days.] [Full or Partial Brand Name] remains effective, even after bathing, water immersion, orexposureto sunlight. Allowtreated areato dry thoroughly. Do not reapply for 30 days.

# Sergeant's® MasterLabel 29 June 2011 Version 10.3 EPA Reg. No. 2517-RUT Information in [ 

### 1 is optional. Page 7 of8 EPAEfficacy Review STORAGEAND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the pack tmtil ready to use. Store in a cool (below 77°F[I][25°C)) dry place inaccessible to children and pets. Do notrefrigerate. Protect from direct sunlight. CONTAINERDISPOSAL: If

### empty: Non-refillable container. Do not reuse or refill 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 Warrantybefore 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. 

### Itis impossible to eliminate all risks associated withthe use ofthisproduct. Unintended consequences may result because of unknown factors. All such risks shall be assumed by the user or buyer.J Sergeant's is committed to providinghigh quality products. To the extent consistent withapplicable law, Sergeant's makes no warranties, express orimplied, ofmerchantability oroffitness 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 orbuyer 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 68154-0399.)
In Case ofEmergency, call: 1-800-781-4738 Non-Emergency call 1-800-224-PETS (7387) [Made in USA) Distributed by: Sergeant's Pet Care Products, Inc. [BAR CODEAREA) P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-RUT EPAEst. No. XXXXX-XX-XXX

# Sergeant's® MasterLabel 29 June 2011 Version 10.3 EPA Reg. No. 25I7-RUT Information in [ ] is optional. Page 8 of8 EPA Efficacy Review 

### {START

- OPTIONAL INSERT ORPACKAGE COPY} [- How to Apply

- May contain graphics illustratingproductuse, e.g., catwith a 

### drop falling ontoits neckfrom a vial on front, side, orbackcarton 

### label and/or applicator labeling.1 

### [Application Instructions][Directions for Use1 [How to Open: 

### 1. Removeproduct tubes 

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

### [vial} withnotched end pointing up and away from the face and body, cut offthenarrow end at the notches with scissors. How to Apply: I. Inverttube over cat and use open end to part eat's hair. 

### 2. Apply contents ofonetube 

### [vial] of {Full orPartialBrandName} [as a stripe, starting high on the back ofthe cat'sneckto in front ofthe shoulderblades] [as a spot between the shoulder blades]. Squeeze tube firmly to apply all ofthe solution to the cat's skin.] [Optional diagram mayormay not appear onthe finished label]

[Flea life cycle diagram]

[Look atthe Label (Look atthe Label icon) [Easy] 6 Step [Easy][Spot On] [Squeeze-On] [Topical] Checklist • [11 Read the label completely and follow directions • [2] Weighyourpet • [3] Do NOT use Dog products on Cats • [4] Do NOT treat with more than one pesticide product at a time • [5] Separate animals aftertreatment to avoid chance ofingestion • [6] Do NOT split tubes betweenpets] [Full orPartialBrandName] [Monthlyreminder card] [Apply [Full or Partial BrandName] monthly for continuous protection against fleas, ticks, flea eggs, flea larvae [and] chewing lice [andmosquitoes].] [Pet's Name (Emptyblank for owner to fill in name)]

# Sergeant's®MasterLabel 29 June 2011 Version 10.3 EPA Reg. No. 25l7-RUT 

### Information in [ 

### 1 is optional. Page 9 of8 EPA Efficacy Review [First [dose] [Treatment] (Empty blank for ownerto fill in date)] [Second [dose] [Treatment] (Empty blank for owner to fill in date)] [Third [dose] [Treatment] (Empty blank for owner to fill in date)] [calendar stickers with Full or Partial BrandName] [Place stickers on your calendar as a reminder to reapply [Full orPartial BrandName} 

### in 30 days. [Monthly Application Reminder Magnet (image ofreminder magnet) Enclosed for your convenience is an applicationremindermagnet. Push the (reset) buttonto start the clock. After 30days the magnet will flash (and beep) reminding you to reapply [Full or Partial Brand Name}. This application reminder canbe used for future treatments. Just pressthe reset button and in another 30 days the remindermagnet will flash (and beep) reminding you to reapply.] [Optional graphics which mayor may not appear anywhere on the finished label] 

# "Fleas**~** Ticks**~Mosquitoos** " Chewinglice

Front Label 

### {Brand Name} [Foruse only on 

### cats/kittens 12 

### weeks or 

### older] FiproniI9.8%

### w/w, Etofenprox 15%

### w/w, Pyriproxyfen 2.2% 

### w/w 0.017 fl oz [0.50 

### mL] (label code} 

## @ Fleas 

# ® Ticks 

## @ Mosqunoes 

## @ ChewingUce

Back Label KEEP OUT OF REACH OF CHILDREN WARNING: Read directions and precautions before using. Use scissors to open. EPA REG. No. 25l7-RUT (label code}

# I</-'7 RE: NOR for Sergeant's 2517-1A5Cl Bonaventure Akinlosotu to: Richard Gebken Cc: Marion Johnson 08/22/2011 10:48 AM

Richard: As stated in my note to you and Kim (with the draft NORs), I questioned the PPE requirement, per Byron's Tox/PL review. Seemingly unjustifiable, but since you didn't object, I assumed it was part of the 'spot-on' mitigation issue. I spoke with Jim on Friday to inform him that you will clarify with Kim and Byron, and corrections will be make appropriately. Thanks, SA

-----Richard Gebken/DC/USEPAjuS wrote;


### ======================= To: "Jim Messina" <jmessina@exponent.com>, Marion Johnson/DC/USEPA/US@EPA From: Richard Gebken!DC/USEPA/US Date: 08/19/2011 09:27AM Cc: Bonaventure Akinlosotu/DC/USEPA/US@EPA Subject: RE: NOR for Sergeant's 2517-145 Jim, Protective eyewear is not required for products that are homeowner products. BA will need to amend the letter, unless it is part of Kimberly's label review If so, I'll talk to her about this. Whatever the tox category is for the particular product (based on the acute' 6 pack) will determine the signal word. It's not dependent upon eyewear. I never gleaned over the specifics of the label very close before signing as it was late at work, and I needed to get out of the office for a dinner engagement with my daughter and family. When I scanned the labels at the office, a couple of pages may have gone through the scanner stuck together. Sorry about this confusion and delay. I'm including Marion into the discussion, and he can place value on the need for PPE for homeowner products. I'm headed off today for Dr. visits and I'll call you this afternoon from home, since it's my day off. Regards, Richard Gebken BA, Can you check to see how this got on the letter. who determined that protective eyewear was needed? In addition, please get the full label to Jim for 2517-147. -----"James Messina" <jmessina@exponent.com> wrote: To; Richard Gebken/DC/USEPA/US@EPA From; "James Messina" <jmessina@exponent. com> Date: 08/19/2011 08:16AM Cc: Marion Johnson/DC/USEPA/US@EPA, Bonaventure Akinlosotu/DC/USEPA/US@EPA Subject: RE: NOR for Sergeant's 2517-145 Richard,I have reviewed the labels and have a few questions: 1. Is 1b mandatory that we add the wear protective eyewear and change the signal word to Caution or is it optional and the label can stay as Warning with no eyewear? 2. 2517-147 is missing the full label. Can you please send the complete label? Best Regards, James Messina Exponent 202.772.4932 office 301.908.1l81 mobile From: Gebken.Richard@epamail.epa.gov [mailto:Gebken.Richard@epamail.epa.gov] Sent: Thursday, August 18, 2011 11:36 PM To: James Messina Cc: Johnson.Marion@epamail.epa.gov; Akinlosotu.Bonaventure@epamail.epa.gov Subject: NOR for Sergeant's 2517-145 Jim, I tried to bundle all 4 of your labels into a single email but the server will not push information from my home to the Agency's system fast enough, so I'm sending these signally as 4 separate emails. I hope all finds you well Burning the midnight oil right with you consultants! Call me if you have any questions about the ABN and marketing strikes on all the labels. I'll be in Missouri until Tuesday of next week. Regards Richard GebkenRe: Thanks! 

### ['j Kimberly Nesci to; Bonaventure Akinlosotu From: Kimberly Nesd/DC/USEPA/US To: Bonaventure Akinlosotu/DC/USEPAlUS@EPA you're welcome, Bonaventurel anytime, ofcourse. Kimberly Bonaventure Akinlosotu From: To: Date: Subject: 

### Hi Kimberly: Bonaventure Akiniosolu/DC/USEPAIUS Kimberly Nesci/DC/USEPAlUS@EPA 08/18/2011 09:30 AM Re: Thanks! 08/18/2011 09:38 AM

08/18/2011 09:30:51 AM



### Your comments are onpoint and the NORis being revised accordingly. Thanks for your prompt response, and for your usual diligence. B.A Kimberly Nesci No problem; Iwill review right now!!
----- OrigL. Bonaventure Akinlosotu

----- Original Message
----- From: Bonaventure Akinlosotu Sent; 08/18/2011 08:45 AM EDT To: Kimberly Nesci Subject: Re; Thanks! 08/18/2011 09:10:25 AM

The

### PRIA due date is 09/12111, but Marion wants the action completed today. 

### I will be out of the office nextweek. ifyou are can't getto ittoday, I believe Richard can stamp and mail the labels next week. Thanks. Kimberly Nesci From: Kimberly NescllDC/USEPAIUS To: BonaventureAkinlosotu/DC/USEPAlUS@EPA Date: 08/17/2011 03;35 PM Subject Thanks!

### ~=---~=-------------------------------------- Hi Bonaventure! I saw your package for review/concurrence on the Sergeant's products. Thank you! Can you let me know the PRIA date? Friday would be bestfor me, but Ican getyou comments sooner, if needed. Thanks, Kimberly Kimberly Nesci Special AssistantROUTING & TRANSMITTAL SLIP August 

### 17, 2011
TO: (Name, office symbol, room number, building, Agency/Post) Initials 

### Date 1. Kimberly Nesci \\1 

### Registration Division/JO '/' J,' '" /'. / ' ,,' ,, "/ ' 

### 2, Richard J, Gebken, PM 10 

# J**g~'l'Wll** Insecticide Branch/Registration Division

Action 

### File Justify 

### X ApprovaJ!Cuncurrecnce For Clearance Note and Return 

### As Requested For Correction Per Our Conversation Circulate For Your 

### Prepare Reply 

### Information X Comment For Your Siqnature See Me Coordination 

### Investigate REMARKS: 

## NIB

- Urgent review and response requested For your review and concurrence, Conditional NOR for Sergeant's Cat Spot On Products (2517-145, 146, 147 

### & 148). Products contain different combinations of Fipronil, Etofenprox, Methoprene, Pyriproxyfen, Nylar. Thanks for your timely response.

, , (>1, J{, 

# .. ; : t dJL J//',- J/,/ '---'

FROM: 

### (Name, org. symbol,**~ency/post)** Room No. - Building:

# ~1$117)~ 5-7232
- Potomac Yard South

.A. Akinlosotu, PhD Phone No. Risk Manager 

### (703) 605-0653 Insecticide Branch/Reqistration Division

# /;If{

# 0J4 "'"'f' 

# 'VLIMJ

# ~fV' ::fA)

# ~**~cv,J.uJ** 

# .
, 

## <- EPA Reg. Date

### ~f Issuance: U.S. ENVIRONMENTAL PROTECTION AGENCY ,;."EO toT-of}: 

# . '. Number: 

### i 

### A' Office of Pesticide Programs 08118/2011

# t~·)~) Registration Division (7505C) 2517·145



### ""lJt, PRot,,(j 1200 PennsylvaniaAvenue NW Term of Issuance: Washington, D.C. 20460 Conditional 

### NOTICE OF PESTICIDE: L Registration Name of Pesticide Product: 

### Reregistration Sergeant's Fipronil +Etofenprox + (under FIFRA, as amenoed) Methoprene Spot On for Cats
Name and Address of Registrant (indudeZIP Code): Sergeant's Pet Care Products, Inc. 2625 South 158'" Plaza Omaha, NE 68130·1770



### ,

### Ni}t~::.C·hangeS**'i~)~beii~g** differing,in sllbsia"nce from',that accepted in connegion with thhnegisir'atjon 

### must

### b~'sOQmittedto and


## ,**~~~p~~~**

## 'by**th~'Ii~'gi;;tra'no~'Division'~rlor** to use ot'the tabe! in commerce. In anycorrespondence on this**produ~** always refer'io the

### ;b:;;V~**:'~PA,~~i,~ti~t(;;n ~~ri1b~r.**  " ", '.

### ,~ On the basis of information furnished bythe registrant, the above named pesticide is hereby registered/reregistered underthe Federal Insecticide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation ofthis product bythe Agency. In order to protect health and the environment, the Administrator, on his motion, may at any time suspend orcancel the registration of a pesticide in accordance with theAct. The acceptance ofany name in connection with the registration ofa product underthis Act is not to be construed as giving the registrant a right to exclusive use ofthe name or to its use if it has been covered by others.
This product is registered in accordance with FIFRA sec 3(c)(7)(A), contingent on the following: 

### I. Make the following labeling changes before you release the product for shipment: a. Revisethe EPA RegistrationNumberto reacl: "EPARegistrationNo. 2517-145". b. Revise the precautionary statements to include: 

### "Wearprotective eyewear": and youj may change the signal word to "Caution".
Signature ofApproving Official:
Richard Gebkin, Product Manager (RM 10) Insecticide Branch Registration Division (Me 7505P) EPA Form 8570·6**~'. /~,'-,**  ) /( ; Date: August 18, 2011

v**~:)** r. '" c' .'J : "

{" "- :,</J " 

# , .2

2. This registration is**time~limited** and expires two years from the date this product is first released for shipment. You mustprovide the Agency

### -with a projected "release for shipment date", in writing within 30 days ofthe date ofthisNotice ofRegistration. The Agencywill calculate the expiration date based on the projected "release for shipment date" until an actual release for shipment date is provided in writing. 3. Onlyone basic confidential statement offormula (CSF) will be onfile for this product at any time (i.e., no alternate formulations or minor formulation amendments will be submitted and/or approved for this product). 

### \..-,r-,..V{or



### ... " .'._- 4. Youmust submit the following data withinthetime:frames describecl below: /\ Within sixteen (16) months ofthe date onthis Notice ofRegistration, provide to the Agency acceptable datapackages for Guideline Studies: OPPTS 830.6320 (Corrosion Characteristics) and OPPTS 830.6317 (Storage Stability). 5. You must submit quarterlyenhanced incidentreports and quarterly sales information in doses sold for this product for the quarter that begins on October 1,2011. The quarterly reports are due two months afterthe end ofeach quarter. Please flag any Confidential Business Informati01ICBI) as such. Enhanced incidentreporting should be submitted to the Product Manager. Quarterly srues information should be submittedto the RegistrationDivision, Immediate Office (attn: KimberlyNesci). The following is a list ofinfonnation thatmust be included inthe quarterly reports for each incident EPA Registration Number Product name (brand name) Lot # Where purchased: internet, store, Veterinarian Active Ingredient(s) Weight range for product Date onwhich incident occurred. (mrnldd/yyyy) State in which the incident occurred. (standard 2 letter abbreviation) Registrant case 

### # Species: dog, cat, other (specify) Breed: (as reportedbypet owner) Age: months oryears Sex: M, F, or f!-eutered Weight: pounds PrimaryRoute ofExposure: dennal, oral, other animal, inhalation, other Body System: neurological, dermatological, GI, respiratory, ocular, other Major signs noted with separate column for each sign, using standard terminology Time to Onset: (hours, days) Treated by veterinarian: yes or no Firsttime product used: yes or no3 Misuse: use onincorrect species, overdose, too frequent dosing, other (describe) Anyknownprecondition EPA Severity Code: death, major, moderate, minor Outcome: died,recovered, still treated, unknown 6. Along 

### withthe enhanced incidentreporting, you must submit an analysis ofall incidents seen, to includethe following details:

a. All minor dermal and ocularirritationreports. b. Summary table for cats showing number ofincidents ofeach severity code for each route of exposure. Each incident should only be reported once. Ifone incidenthas several routes of exposure, the order should be ocular> oral> dermal. In other words, an incident with both oral and dermal exposure would be reported as oral exposure, and an incidentwith bothocular and oral exposure would be reported as ocular exposure.

c. A similar sununarytable for dogs (misuse or secondaryexposure) showing number ofincidents ofeach severity code for each route ofexposure. d. Summary table for dogs and table for cats showingnumber ofincidents that are believed due to secondary exposure (e.g., multi-pet households).

e. A summarytable for cats showing number ofincidents for each severity code for these age ranges: <3 months, 3-6 months, 6-9 months, 9-12 months, I yr,2 yr, 3 yr, 4 yr, 5 yr, 6 yr, 7yr, 8 yr, 9 yr, 10 yr, II yr, 12 yr, 13 yr, 14 yr, 15 yr, >15 yr. f. A summary table showing the number ofcat incidents for each severity code for each pet weightrange onthe product label (ifapplicable).
g. A summarytable for cat weight showingnumber ofincidents for each product weight range. This table should shownumberofincidents in cats weighing less than that productweight range, number ofincidents in cats inlower halfofweight range, number ofincidents in cats in upperhalfofweight range, and cats weighing more than the productweightrange (if applicable). h. Table showing number ofincidents for each cat breed, where provided.

L Table showing number ofincidents in cats for each clinical sign. 

### J. Table showing number ofincidents in cats for each organ system. 

### k. Report aggregate incidents, butdo not combine moderate and minor incidents. 7. You must submit and/or cite all datarequired for registration ofyour productunderFIFRA Section 3(c)(5) when the Agency requires all registrants ofsimilarproducts to submit such data, and submit acceptable responses required for re-registration (registrationreview) ofyourproduct under FIFRA section 4.4 IfEPA determines that future mitigation measures are necessary for all pet spot-onproducts, the Agency will inform all registrants concerned. Ifmitigation measures are necessary, EPA may take regulatory action. Please note that the label for this product was approved with the understanding that it is consistent -with the labeling for similar pet spot on products. Two copies ofthe finished labelingmust be submitted priorto releasing the product for shipment. Ifyou fail to complywiththe above stated conditions, the registration will be subject to cancellation in accordance with FIFRA sec. 6(e) andlor automatically expire. Your release for shipment ofthe product constitutes your acceptance ofthese conditions. A copy ofyour label stamped "Accepted with Comments" is enclosed for your records. Ifyou have anyquestions concerning this action, please contact Dr. B. A. Akinlosotu via (703) 605-0653 or akinlosotu,bonaventure@epa.gov.

Enclosure 

# "

### July 26, 2011 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLL\JTIO;\, PREVENTIO:"i OFFlCE OFPESTICIDE PROGRAMS

REGISTRATIO;\' DIVISION (7505P)



### MEMORANDUM Subject: Name 

### ofPesticide Product: 

### EPA Reg. No. IFile Symbol: DP Barcode: Decision No.: Action Code: 

### PC Codes: SERGEANT'S FIPRONIL 

### + ETOFENPROX 

### + METHOPRENE SPOT-ON FOR CATS 2517-RUL DP 391870 442446 R310 129121 (Fipronil: 9.8%) 128965 (Etofenprox: 15%) 105402 (S-Methoprene: 11.8%) From: Byron T. Backus, Ph.D., Toxicologist Technical ReviewBranch Registration Division (7505P) 

# n t. ().,....lI.--. 

# t"", 1-t..
- 

## -z.,., "



## J..-']- 

# rr**'1~~** To: Bonaventure AkinlosotuiRichard Gebken, 

### RM 10 Insecticide Branch Registration Division (7505P) Registrant: 

### SERGEANT'S PET CARE PRODUCTS, INC. FORMULATION FROMLABEL: Active Ingredient(s): 

### 129121 Fipronil 128965 Etofenprox 105402 S-Methoprene OtherIngredient(s): TOTAL ACTION REQUESTED: 

### The RiskManager requests: bywt. 9.80% 15.00% 11.80% 63.40% 100.00"/0

"For your review: Response to EPA'sDERdated May 16, 2011 for CAS study (MRJD 48302108) to upgrade initial reviewfrom supplemental to acceptable data, in support 

### ofthe registration for 4 

### products (2517-RUL, RUA, RUT and RUI).

IBACKGROUND: The material received includes a document (MRID 48513201) titled: Support Data to Upgrade the Study "CompanionAnimal Safety Evaluation ofa Spot-On Containing Two Toxicants and Two Insect Growth Regulators on Kittens and Cats" From Supplemental to Acceptable EPA Reg. No. 25 17-RUT, 25 17-RUA, 25 1 7-RUL, 25l7-RUIMRID 48302108. COMMENTS AND RECOMMENDATrONS: 1. With the additional information in MRID 48513201, 

### IRB has revised the DER for the companion animal safety study (MRID 48302108) and its accompanying data analysis report (MRID 48302109). 2. There were dermal effects. Two adult cats in group Bl (IX) scratched the application site and lost hair after application, and the report states that these lesions were considered to be a result of exposure to the test material. One ofthese cats (963 FES) had preexisting alopecia (measuring 3 mm x 3 mm onthe dorsal neck, between the ears) on days**~**7 and -1, and thenhad a scratch mark (20 mm x 10 nun) on days + 1and + 7 at the application site, "moving anterior." The second (966 2C7) had no preexisting condition, but then had a scratch mark at the application site on study days +1, +7, and +14. In the discussion on p. 38 ofMRID48513201 it is stated that: "The 

### de 

### novo hair loss and local sensory irritation (scratch marks) recorded for cat 966 2C7 must 

### be assumed to be a consequence ofthe application ofSergeant's test substance. However, its immediate onset (within 24 hours) suggests that this was not an irritant butrather an allergic reaction to a component, or components, ofthe test substanceto which this cat may have been previously exposed. Although the history ofthis catin this test facility is not available, it is known that

...this facility was active in the testing offipronil-containing me-too products, including spot-ons (that may have also contained the same or similar inerts)

....there is a substantial possibility that cat 966 2C7had beenpreviously used in such testing andrecycled into Sergeant'sprotocol." None ofthe adult cats in the 5X group had any dermal effects. Because the dermal effects inthe two IX adult cats were relatively minor, didnotrequire treatment, and because similar effects were not observed in the 5X group, TRB concludes that these effects should not impact oneither the registration or labeling ofthe supported products. Onekitten 

### (CCO F92)inthe IX (AI) group had scabs on the back ofthe head from day 7 to 14 and scabs between the shoulder blades on days 7 and 8; this kitten was an albino. One kitten (female CC2 AB1) in the 5X group (also an albino) had acute wet eczema onthe neck and shoulders from day3 to 14, and this required treatment with Dennavet Cream. It is stated (p. 36) that this lesion: "

...was considered to be related to the application ofthe test substance." From page 37 ofMRID 48513201 both ofthe albino kittens were littennates, and there were no other kittens (albino or otherwise) from this litter in this study. As noted on p. 37 ofMRID 48513201: "It is unfortunate that albino kittens, a comparative rarity in the catpopulation, were included in a companion animal safety study. The literature on defects or susceptibilities associated with albinism in cats describes a propensity for deafuess, but nO references to dermatologic effects. However, one must suspect that the unique skin reactions inthe area oftest substance application to these two albino kittens maynot properly be extrapolated to what will occur inthe US catpopulationwhen this product may be released onto the market." 2

### 3. TRB has concludedthat the mostprobable explanation for the observed effects in the albino kittens is that the toxicity was due to a fipronil photodegradate (MB46513, also known as fipronildesulfinyl) which is more toxic than the parent compolUld. It

### has been established that fipronil accumulates in sebaceous glands. The dose-relatedresponse observed in the albino kittens (which lack melanin, which would normally block light from reaching fipronil) is consistent with fonnation ofthis photodegradate (particularly as effects appeared on day3 in the 5X kitten and on day 7 in the IXkitten). The possibility also exists thatthe presence ofone or more ofthe other ingredients in this formulation may have enhanced the formation ofthis photodegradate in the albino kittens. 4. The registrant should provide the Agency with any additional information available from this studyrelevant to the formation ofthe fipronil degradate, including (ifpossible) the fur coloration ofthe animals at the application site and the level and type oflighting that the cats and kittens were exposed. This information should be received within 6 months ofthe issuance ofa registration. 5. This companion animal safety study in adult cats and kittens is upgraded to Acceptable and does satisfy the guideline requirementfor a companion animal safety study (OPPTS 870.7200) in cats 

# 1 5and/orkittens with the stipulationthat labeling indicates that this product is not to be used on 6 

### Lalbino cats or kittens. 6. Refer to the attached DER for additional comments.



### 3**,~** I( 

### ! 'EPA Primary Reviewer: Byron T. Backus, Ph.D. Technical Review Branch, Registration Division (7505P) EPA Tertiary Reviewer: KitFanvell, D.V.M. RiskAssessmentBranch VII, HED (7509P) 

### Signature: 

# (3**~'\'.** (3.......J--... Date:

### :r~t.1**l,..~ ~l'**  

## //-'A-f Signature:

### _~/I.A~~,--c;tc:---;-r-- Date: 

### 7 

## /:;1£ 

## 1-;:;

# eil Templateversion 02106 

# I DATA EVALUATION RECORD
STUDY TYPE: Companion animal safety study- cats!kittens

- OPPTS 870.7200 PC CODES: 129121: Fipronil; 105401: S-Methoprene; 128965: Etofenprox; 129032: Pyriproxyfen DP BARCODE: 385149

TEST MATERIAL (PURITYl: Cat Spot on Soup, containing Fipronil (9.83%), S-Methoprene (11.76% w/w), Etofenprox (15.78%) and Pyriproxifen (2.34%) TRADE NAME: Not provided CITATIONS: Delport, P. (2010) Companion Animal Safety Evaluation ofaSpot-On Containing Two Toxicants and Two Insect Growth Regulators On Kittens and Cats (Sergeant's Fipronil 

### + Etofenprox 

### + Methoprene Spot-On for Cats). ProjectNumber: CV/09/660, SERl1009/1. 

### July 13, 2010. Unpublished study prepared by Clin Vet International. 118 p. MRID 48302108. Miller, T. (2010) Companion Animal Safety Evaluation ofa Spot-On Containing Two Toxicants and Two Insect Growth Regulators on Kittens and Cats (Sergeant's Fipronil 

### + Etofenprox 

### + Methoprene Spot-On for Cats). ProjectNumber: CV/09/660. April 13,2010. Unpublished study prepared by Thomas A. 

### Miller. 13 p. MRlD 48302109. Hoskins, K. (2011) SUppOlt Datato Upgrade the Study "Companion Animal SafetyEvaluation ofa**Spot~On** 

### Containing Two Toxicants and Two Insect Growth Regulators on Kittens and Cats" From Supplemental to Acceptable. ProjectNumber: CV/09/660/SUPPLEMENT. June 16, 20II. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 41 p. MRID 4851320I. SPONSOR: Sergeant's Pet Care Products, Plano, Texas EXECUTIVE SUMMARY: In a companion animal safety study (MRID 48302108), three groups, each containing 3 male and 3 female adult

# c::: 1year ofage) cats (body weights: males: 2.98-4.92 kg; females: 1.92-3.06 kg; source: ClinVet cattery) and three groups, each**contai~ing** 

### 3 male and 3female kittens (12-16 weeks ofage; body weights: males: 1.08-1.84 kg; females: 0.82-1.68 kg) were treated with either 0.5 mL (1X) or 2.5 mL (5X 0.5 mL) ofCat Spot on Soup (containing Fipronil: 9.83%; SMethoprene: 11.76%; Etofenprox: 15.78%; and Pyriproxyfen: 2.34%) or with 1.45 mL (5X 0.29 mL) ofthe control substance orplacebo. The groups and the amounts oftest material orplacebo administered to each cat orkitten are given below:

4Kittens AdultCats Group Al (n 6) Kitlens (12-16 weeks old);siugle (0.5 mL)**a~nlieation** ofCat Snot on So'up

. Group B I (n 6) Aduli cats (> I year old) Single (0.5

# mi;'application ofCat Spot on Soup Group A2 (n 6) Kittens (12-16 weeks old); five 0.5 mL Group 82 (n 6) Adult cats (> I year old); five 0.5 mL applications ofCal Spot on Soup adminislered at one hour applications ofCal SpOI on Soup administered at one hour intervals iutervals Group CI (n-6) Kittens (12-16 weeks old); five 0.29 mL Group C2 (n-6) Adults (> 1year old); five 0.29 mL aDolieations ofPlacebo administered at one hour intervals aODlicaIions ofPlaeebo administered at one hour intervals 

### The test and control substances were applied by syringe along the back ofeach animal, starting onthe neck behind the ears and thenextendingtowards the base ofthe tail. Accordingto the reportthe objective was to limit application ofthe test material to areas where it would be difficult for the animal to "lick off' (and presumably ingest) the substances, although any material at the base ofthe tail (oreven along part ofthe back) would be accessible for groomingpurposes. Cats and kittens receiving 0.5 mL Cat Spot on Soup received a single application; cats and kittens receiving 2.5 mL received five 0.5 mL applications, with approximately one hourbetween applications. Cats and kittens receiving 1.45 mL control substance received five 0.29 mL applications, with approximately one hourbetween applications. The animals were observed daily for general health. Clinical examinations (which included pulse rate, respiratory rate, rectal temperature, and examination ofmucous membranes, eyes, motility, lymph nodes, abdominal palpation, thoracic auscultation and evaluation ofskin condition) were performed on days -14, -7, -1, +1, +7, and +14, and the animals were also weighed onthese days. Blood samples were collected for clinical chemistry and hematology on days -6, +1, +7 and +14. All animals were sedated (Rompun 2%,0.12 mLlkg 1M) to facilitate blood specimen collection. All animals survived to the end ofthe study, andthere were no indications ofany systemic toxicity. No effects were observed in the hematology orblood chemistry results or body weight values. Most cats and kittens showed no dose-related changes in food consumption, although one Group A2 (5X) female kitten scored 2 for meat consumption onDay +2 (kittens received pellets and meat, with separate scoring for their consumption ofthesetwo items). Of522 observations for the consumption ofmeat, there were 518 "4's" (>75 to 100% consumption); 3 "3's" (>50-75% consumption), and one "2" (>25-50% consumption). Remarkably, the score of"2" involved the 5X albino kitten (CC2 ABI) observed to have a "hotspot on side ofneck behind ear" starting onDay +3 which necessitated treatment. On every otherpre- and post-treatment day ofthe study this kitten scored "4" for meat consumption. There were dermal effects. Two adult cats in group Bl (1

### X) scratchedthe application site and lost hair after application, and the report states that these lesions were consideredto be a result ofexposure to the testmaterial. One ofthese cats (963 FE5) had preexisting alopecia (measuring 3 mm x 3mm onthe dorsal neck, between the ears) on days -7 and -1, andthen had a scratch mark (20 mm x 10 mm) on days +1 and +7 at the application site, "moving anterior." The second (966 2C7) had no preexisting condition, but thenhad a scratch mark at the application site on study days +1, +7, and + 14. In the discussion onp. 38 ofMRID48513201 it is stated that: "The de novo 

### hairloss and local sensory irritation (scratch marks) recorded for cat 966 2C7 mustbe assumed to be a consequence of the application ofSergeant's test substance. However, its immediate onset (v.rithin 24 hours) suggests thatthis was not an irritant but rather an allergic reactionto a component, or components, ofthe test substance to whichthis cat may have beenpreviously exposed. Although the history ofthis cat inthis test facility is not available, it is known that

...this facility was active in the testing offipronil5

### containing me-too products, including spot-ons (that may have also contained the same or similar inerts)

....there is a substantial possibility that cat 966 2C7 had been previously used in such testing and recycled into Sergeant'sprotocol." None ofthe adult cats in the 5X group had any dermal effects. One kitten (CCO 

### F92) in the IX (AI) group had scabs on the back ofthe head from day 7to 14 

### and scabs between the shoulder blades on days 7 and 8; this kitten was an albino. One kitten (female CC2 ABl) in the 5Xgroup (also an albino) had acute wet eczema onthe neck and shoulders from day 3 to 14, and this required treatment with Dermavet Cream. It 

### is stated (p. 36) thatthis lesion: "

...was considered to be related to the application ofthe test substance." From page 37 ofMRID 48513201 both ofthe albino kittens were littermates, and there were no other kittens (albino or otherwise) from this litter in this study. As noted on p. 37 ofMRID 48513201: "It 

### is unforttmate that albino kittens, a comparative rarity in the cat population, were included in a companion animal safety study. The literature on defects or susceptibilities associated with albinism in cats describes a propensity for deafness, but no references to dennatologic effects. However, one must suspect thatthe unique skin reactions inthe area oftest substance application to thesetwo albino kittens may not properly be extrapolated to what will occur in the US cat population when this product may be released onto the market." TRB has concluded thatthe most probable explanation for the observed effects in the albino kittens is that the toxicitywas due to a fipronil photodegradate (MB465l3, also known as fipronil-desulfinyl) which is more toxic than the parent compound. Ithas been established that fipronil accumulates in sebaceous glands. The dose-related response observed inthe albino kittens (which lack melanin, which would nonnally block light from reaching fipronil) is consistent with fonnation ofthis photodegradate (particularly as effects appeared on day 3 in the 5Xkitten and on day 7 in the IX kitten). The possibility also exists that the presence ofone or more ofthe other ingredients in this formulation may have enhancedthe formation ofthis photodegradate inthe albino kittens. Hourly observations for adult cats and kittens for the four hours after last application are reported in MRID 48513201. 

### For adults (fromp. 11 

### ofMRlD 48513201) 

### one B2 

### female (8B 1C65) 

### showed restless rolling with a duration of**~**

### 10 minutes after the third application (this observation was unique, as it was made before the series of5 applications oftest material had been completed), but had calmed down one hourlater, then (from p. 9 ofMRlD 48513201) was restless at the first hourly observation post-application, and was showing signs ofestrus at the next observation, but showed no signs at the nexttwo observations. Two B2males showed crystals (presumably from evaporation at the application site), one atthe 2 hourobservation, and both atthe 3 and 4-hour observations. The crystals were still present on one male onDays 1 and 2. For kittens, no signs were observed in the four hours following the last application, and the only signs that were observed were dermal effects in 5X albino kitten CC2 AB 1 (first noted onDay 3) and scabs behind head and between shoulderblades in 1 X albino kitten CCO F92 (first observed on Day 7). From the confidential attachment to MRID 48513201, ithas been confirmed that the solvent(s) and/or inerts present in the test material are the same as those in the products which will be supported by this study. This companion animal safety study in adult cats and kittens is upgraded to Acceptable and does satisfy the guideline requirement for a companion animal safety study (OPPTS 870.7200) in cats 

### 6

### and/or kittens with the stipulation that labeling indicates that this product is notto be used on albino cats or kittens. COMPLIANCE: Signed and dated GLP, Quality Assurance and [No] Data Confidentiality statements were provided for ClinVet International. According to the GLP statement, Pathcare Veterinary Laboratory (Bloemfontein), which conducted the hematology and clinical chemistry analyses is an ISO 15189 accredited facility and their clinical veterinary department is GLP accredited.



### 71. 

### MATERIALS AND METHODS A. MATERIALS: 1. Test material:

Cat Spot on Soup Description: Batch #: Purity: Storage: Compound Stability: CAS#:
Control substance Description: Batch #: Purity: Storage: Compound Stability: CAS#: Not provided FPIO 12/09 Fipronil 9.83%; S.Mclhoprene 11.76%; Etofenprox 15.78%; Pyriproxyfen 2.34% At room temperature Expiration date: September 30, 20 10 Not provided

Not provided 012004-09 Transcutol CG 99.92% [identified on the Internet as Diethylene glycol monoethyl etherI At room temperature EXpiration date: Feblllary 2011 Not provided 

### 2. Vehicle control: See control substancedescribed above. 

### 3. Test animals: Species: Strain: Age/weight Source: Housing:

Diet: Water: Environmental conditions: Temperatllfe: Humidity: Air changes: Photoperiod: Acclimation period: Domestic Cat (adults**~** I year ofage; kittens: 12-16 weeks ofage) Not specificd (short to mediUm haired) Adult cats**~** I year ofage: males: 2.98-4.60kg; females: 1,92-3.06 kg Kittens 12-16 weeks old: males: 1,08-1.84 kg; females: 0.82-1.68 kg ClinVet cattery Individually housed in cages: [From p. 18 ofMRID 48302J08: adult cat cages: 0.74 m x 0.67 m x0.6 m; kitten cages: 1,5 m x 1.5 mx 1m (kittens were in larger cages than adults?)]. Adults (>I year) were fed IAlvIS Multi cat I+ cat food (Eukanuba) Kittens (12-16 weeks) were fed kitten andjunior 0-1 food and PurinaFriskies "

...supplied in stainless steel bowls."
20 ±4° C Notprovided 12-15 air changeS/hr 12 hours lightJI2 hours dark Fourteen days



### 8

### B. 

### STUDYDESIGN: 1. 

### In life dates: Adult: Acclimatization start (day**~14):** 

### October 27,2009; Experimental start (day 

### 0): November 10,2009; Experimental termination date: November 24, 2009. Kitten: Acclimatization start (day**~14):** December 15,2009; Experimental start (day 0); December 

### 29,2009; Experimental termination date: January 12,2010. 2. Animal assignment: Thirty-six animals were assigned to the study, with an additional four adults and four kittens enrolled on day -14 as possible replacements. For the adult cats, the genders were separated and the cats allocated to study groups withinthe age requirements using randomizationthrough minimization with bodyweight as the only criterion. Within each gender, animals were blocked into three blocks ofthree cats each. The three heaviest cats fonned block 1; the next three heaviest cats formed block 2 and the lightest cats formed block 3. \Vithin blocks, cats were allocated to one ofthree groups, 1,2 or 3. The first animal ofblock 1 was assigned to group 1, the second to group 2 and the third to group 3. The first animal ofblock 2 was assigned to group 3, the second to group 2 and the third to group 1. The first animal ofblock 3 was assigned to group 1, the second to group 2 andthe third to group 3. Groups 1,2 and 3 were then randomly assigned to the actual groups B 1, B2 and C2 using Excel randbetween. Kittens were similarly assigned to groups AI, A2 and CI.
Table 1. Dosagc Groups Kittcns Adult Cals Group Al (n 6) Killens (12-16 weeks old);single (0.5 mL) Group BI (n 6) Adult cats (> l year old) application ofCal Spol on Soup Sine:!e (0.5 mL) application ofCal Spot on Souo Group A2 (n 6) Kittcns**(l2~16** weeks old); five 0.5 mL Group B2 (n 6) AdulL cots (> I year old); five 0.5 mL applications orCal Spol on Soup administcred at one hour applications orCal Spot on Soup administered at one hour intervals intervals Group CI (n 6) Killens (12-16 weeks old); five 0.29 mL Group C2 (n 6) Adults (> I year old); five 0.29 mL applications orPlacebo adminislered alone hour intervals applications ofPlacebo**admjJl~stered** at onc hour intervals

3. Dose selection rationale: The IX dosage rate (0.017 fluid oz. or 0.5 mL) is consistent with the proposed labeling for the products that this study would be usedto support. 4. Preparation 

### and treatment: On Day 0 the cats were held by hand and the test and control substances were applied as measured doses from syringes (without needles) to a furrow in the

9hair on the back, statting high onthe neck behind the ears and extending caudally towards the base ofthe tail. Table 2: Doses Grouo Material applied Total dose administered A 1 (kittens) Cat Spot on Soup 0.5 mL (lX) A2 (kittens) Cat Soot on Soup 2.5 mL (5X 0.5 mL) Bl (adults) Cat Suot on SauD 0.5 mL (lX) B2 (adults) Cat Spot on SouP 2.5 mL (5X 0.5 mL) C 1 rkittens) Placebo 1.45 mL (5X 0.29 mL) C2 (adults) Placebo 1.45 mL (5X 0.29 mL) 

### " " Cat Spot on Soup contams Flprontl (9.83%), S-Methoprene (11.76% w/w), Etofenprox (15.78%) and Pynproxtfen (2.34Yo) Placebo IS Identified (p. 12 ofMRID 48302108) as Transcutol CO 99.92%. 5. Statistics: From p. 40 ofMRID 48302108: "All analyses and calculations were performed using SAS Version 8.2. Statistical significance was declared at a two-side p-value of0.05. The data from the adult cats and kittens were analysed separately and are presented as such

..." The emphasis ofthe statistical analyses was the change from baseline ofeach ofthe hematology and clinical chemistry parameters. Individual hematology and clinical chemistry values ontest days -6,1,7 and 14 were tabulated separately for each variable and each group, together with the following descriptive statistics: mean, standard deviation (SD), coefficient ofvariation (CV %), geometric mean, geometric SD, median, minimum, maximum andthe number ofobservations in the group. The individual changes andpercentage changes from baseline (test day -6) for each of the post-treatment days (1, 7 and 14) were calculated andtabulated for each variable and each group. The number ofpost-treatment values that fell outside the reference range was calculated. The post-treatment values were compared to the baseline values in an intra-treatment comparison bymeans ofan analysis ofvariance (ANOVA) with an animal and observation time as effects. An inter-treatment comparison with respectto the changes from baseline was also performed. The post-treatment values ofeach the two treatment groups for adult cats (BI and B2) were compared to their control group (C2). The post-treatment values ofeach ofthe two testtreatment groups (AI and A2) were comparedto the control group (CI) for kittens. An analysis ofcovariance (COANOVA) with a treatment effect andthe baseline values as covariate was used for the analyses. In addition, the change from baseline values ofeach ofthe two treatment groups were compared to those ofthe corresponding control group (e2) for dogs and the two test groups (AI and A2) were comparedto those ofthe control group for adult cats and kittens by means ofan ANOVA with a treatmenteffect. C. 

### METHODS: 1. Observations:

a. General health observations: The animals were observed daily for general health. Specific health observations were observed hourly on the day ofapplication until four hours after application ofthe test material and twice daily, thereafter, for the duration ofthe study. Observations included, but were not limited to, changes in skin and fur, eyes and mucous membranes, nervous signs and behavior pattern as well as vomiting and dialThea. 10b. Clinical examinations: Physical examinations were conducted by a veterinarian on Days -14, -7, -1, 

### +1, +7 and +14. The examinations included but were not limited to pulse rate, respiratory rate, rectal temperature, mucous membranes and skin,joints, eyes, ears, mouth and genital organs, and auscultation [using a stethoscope to listen to the sounds] ofthe heart and 

### lungs. 2. Body weight: Animals were weighed on Days -14, -7, -1, +1, +7 and +14. 

### 3. Food consumption: From p. 26 ofMRlD48302108: The amount offood offered was measured and the food consumption was recorded daily and scored using the following scoring system. Fc 1 - 0- 25% Fc 2 - >25- 50% Fc 3 - >50-75% Fc 4 - >75-100% 4. Hematology and clinical chemistrv: Blood was collected for hematology and clinical chemistry assessments on non-fasted animals on the following days:

- 6, +1, +7 and +14. The tests were conducted by Pathcare, Bloemfontein, South Africa, because ClinVet International did not have tile expertise and apparatus to perform the analyses. The CHECKED (X) parameters were examined.

a. Hematology
X Hematocrit (HCT)* X Leukocyte differenlial eount* X Hemoglobin (HGB)* X Mean corpuscular HGB (MCH)* X Leukocyte count (WBC)* X Mean eorpuse. HGB conc.(MCHC)* X Erythrocyte count (RBC)* X Mean corpusc. volume (MCV)* X Platelet eount*J Reticulocyte count Blood clotting measurements* X (Activated Partial Thromboplastin time) X (Prothrombin time)
*Reeommended for compamon aJlJmals safety evaluatIOn based on OPPTS 870.7200 IFrom p. 27 ofMRID 48302108: "In some cases the platelets were microscopically clumped and in Ihose cases the plalclet count relumed by the Celldyne 3500 was nOl correct, the actual count should have been higher and the pathologist had to commenl on the number ofplatelets on a blood smear. Theplatelet count was then indicated as "reduced", "adequate" or "increased". For the sake of consistency, a value was linked to these classes. However the variable was handled as a discrete variable and nOl as a continuous variable. The following criteria were used by the pathologist: Thehistorical control value for cats was 300-600 x 109/L Platelets appeared reduced: approximately 250 x 109 /L Platelets appeared adequate: approximately 350 x 109/L Platelels appeared increased: approximately 650 x 109 /L

II

### b. Clinical chemistry
ELECTROLYTES OTHER X Calcium* (Ca) X Albumin'" X Chloride'" (CI) X Creatinine'" Magnesium (Mg) X Urea nitrogen'" X Phosphorus'" CP) Total Cholesterol X Potassium* (K) X Globulins* X Sodium* (Na) X Glucose* ENZYMES (more than 2 hepatic enzymes, eg., *) X Total bilirubin 

### * X Alkaline phosphatase (AP)* X Total serum protein'" Cholinesterase (ChE) Triglycerides Creatinekinase X Albumin/Globulin ratio Lactic acid dehydrogenase (Lm·I) X Direct bilirubin* X Alanine aminotransferase (ALT/also SGPT)* Indirect bilirubin X Aspartate aminotransferase CAST/also SGOT)* BUN/Creatinine ratio Gamma glutamyl transferase (GGT) TC02 Bicarbonate Amylase Sorbitol dehydrogenase '" Recommended for a compamon ammal safety cvaluatlOn based on OPPIS 870.7200 

### 5. Urinalysis: Urinalysis was not conducted. 

### 6. Sacrifice and pathology: The study did not have a scheduled necropsy.

12

### II. RESULTS 

### A. ACTUAL DOSESADMINISTERED: The mg/kg doses ofactive ingredients were not calculated. From information in Table 1 ofMRID 48302109, the rnglkg doses to kittens were significantly higher than those to adults (refer to Tables 3 and 4).
Table 3. Dasa es ofFi ranil and Etofen rox for adult cats GROUP SEX ANIMAL AGE WEIGHT DOSAGE OF DOSAGE OF NUMBER (YEARS) (KG) FIPRONIL (mg/ke:) ETOFENPROX (mg/kg) 81 Male 9B3 D3A > I 4.60 10.7 17.2 81 Male 9847DC > I 4.26 11.5 18.5 81 Male 963 FE5 >1 3.26 15.1 24.2 81 Female 9662C7 > I 2.88 17.1 27.4 81 Female CC5325 > I 2.34 21.0 33.7 81 Female CDS 170 > I 2.00 24.6 39.5

Mean values for GrOll 81 > I 3.22 16.7 26.8 82 Male 965009 > I 4.44 55.3 88.9 B2 Male BSD BID > I 4,44 55.3 88.9 82 Male 6DC GeC >1 2.98 82.5 132.4 82 Female CD4302 > I 2.62 93.8 150.6 82 Female 881 C65 > I 2.46 99.9 160.4 82 Female 984080 > I 1.92 128.9 205.5

Mean values for Group B2 > I 3.14 86.0 137.8 C2 Male 6D6 BEB > I 4.92 0 0 C2 Male 700 A83 > I 3.96 0 0 C2 Male 70D F55 > I 3.40 0 0 C2 Female CD3 D77 > I 3.06 0 0 C2 Female 6BD 8B8 > I 2.28 0 0 C2 Female CD3 E61 > I 2.20 0 0

Mean values for GrOll C2 > I 3.30 0 0
Table 4. D GROUP SEX ANIMAL AGE WEIGHT DOSAGE OF DOSAGEOF NUMBER (DAYS) (KG) FIPRONIL (m!!lke) ETOFENPROX(m!!lke) Al Male E4653D 112 1.76 27.9 44.8 Al Male CCI D85 92 1.34 36.7 58.9 Al Male CCOF92 92 1.22 40.3 64.7 Al Female CCO 4A8 92 1.48 33.2 53.3 AI Female CCI26E 84 1.34 36.7 58.9 Al Female CCI COA 84 1.00 49.2 78.9

Mean values for Group Al 92.7 1.36 37.3 59.9 A2 Male E9F FD4 112 1.84 133.6 214.4 A2 Male CCO B97 100 1.32 186.2 298.9 A2 Male CC2 DI3 84 1.22 201.4 323.4 A2 Female CCI EED 113 1.68 146.3 234.8 A2 Female CCO 38A 92 1.30 189.0 303.5 A2 Female CC2 ABI 92 1.12 219.4 352.2

Mean values for Grou A2 98.8 1.41 179.3 287.9 CI Male CC06CC 84 1.52 0.0 0.0 CI Male CCO D09 100 1.48 0.0 0.0 CI Male CC3 AEO 84 1.08 0.0 0.0 CI Female EAI63C 113 1.42 0.0 0.0 CI Female CCO F9D 92 1.38 0.0 0.0 CI Female CCI7F8 92 0.82 0.0 0.0

Mean values for GrOll CI 94.2 1.28 0.0 0.0



### 13

# 1 

# 1 1 1 1 1 

# 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

# 1 1 1 1 1 

# 1 1 1 1 1 1 1

### B. OBSERVATIONS: 1. 

### Clinical signs and application site effects: For the adult cats, two animals in group Bl (IX) scratched the application site and lost hair after application. One ofthese cats (966 2C7) had preexisting alopecia (days**~**7 and -1) measuring 3 mm x 3 mm on dorsal neck (between ears) atthe time ofapplication. For group B2 (5X) there were no abnormal signs, although one cat (CD4 302) had hair loss (5 mm x 5 mm) on the right ear and neck ondays -7 and -1. One cat came into 

### estrUs on day 

### +1. For the controls ee2), one cat had tongue ulcers on days +7 and 

### +14 (improving on day 

### +14), confirmed as a case ofmycoplasmosis. For the kittens, one group Al (IX) kitten (CeO F92, an albino) developed scabs behind the head and between the shoulder blades on day +7, which were still present on day +14. For group A2 (5X) one kitten (CC2 AB1, an albino) had acute wet eczema on the neck and shoulders on day 3, and this was still present on day +14. This required treatmentwith Dermavet Cream, 

### It is stated (p, 10 ofMRID 48302108) that: "The test substance caused scabs and eczema in two albino kittens." Oue control kitten (CCO F9D) had loose feces on day +9.

Table5a

- Signs in Group BI (adults IX)

AnimallO Sex Study Days Siens 9B3 D3A M No abnormal SigJ1S 9B470C M No abnormal signs (p, 30, 32) [but, from p. 29, treated on days +2 through +6 with Lincomycin HCI50 mg by injection for mucopurulent nasal discharge (left)1' 963 FE5 M +1, +7, +14 Scratch mark (20 mm x 10 mm) on application site, moving anterior (p. 30) +1 to +14 Local hair loss on application site (p. 33) 9662C7 F -7, -1 Alopecia 3 mm x 3mm on dorsal neck (between ears) +1, +7 Scratch mark (20 mm x 10 mm) on application site, moving anterior +1 to +13 Local hair loss on application site (from p. 33) +610+12 Scratch mark (from·p. 33) CC5325 F -I Scratch mark anterior to ri ht ear ( .30) CD5 170 F No abnormal si ns
Table Sb

- Signs in Group B2 (adulls 5X)

AnimallD S" Study Days Signs

965009 M No abnormal si ns B80 BID M No abnormal signs 60C OCC M No abnormal si 

## " C04302 F -7, -I Hair loss ri tear&neck5 mmx5mm .31) 8BI C65 F -14, -7 Alopecia left lateral neck (p. 31) +1 Estrus (p. 31) 984080 F No abnormal si ns
Table Sc

- Signs in Group C2 (adulls -OX)

AnimallD S" Study Days Signs 606 BEB M No abnormal signs 700 A83 M +7, +14 Ton ue ulcers Om rovin onda l +14 ( .31 700 F55 M -7 Thinning ofhair iJmcr thighs (p. 31) C03077 F -7, -I, +1, +7 Wound left lateral neck; estrus day +7 (p. 31) 6BO 8B8 F No abnormal si ns CD3 E61 F No abnormal signs

15Table 6a

- Signs in GroupAl (kittens IX) AnimallD So< Study Days Signs

E4653D M No abnormal signs CCI D85 M No abnormal signs CCO F92 M +7, +14 Scabs behind head and between shoulderblades (p, 32) +7 to +14 Seabs behind the head (p. 34) +7 to +8 Scabs between shoulder blades (p. 34) CCO 4A8 F No abnormal signs CCI26E F No abnormal si 

# , CCI COA F No abnormal si ns
Table 6b

- Signs in Group A2 (kittens 'X)

AnimallD Sex Study Days Signs E9FFD4 M No abnormal si ns CCO B97 M +1 Lacrimation in the ri ht eye (p. 31) CC2 Dl3 M No abnormal si ns CCIEED F No abnormal si ns CCO 38A F No abnormal signs CC2ABI F +3 to+14 Acute wet eczema (p. 32, 34
Table 6c

- Signs in Group CI (kittens OX)

AnimallD So< StudyDays Signs CC06CC M No abnormal si 

# , CCO D09 M No abnormal signs CC3 AEO M No abnormal signs EAI63C F No abnormal si ns CCO F9D F +9 Loose feces CCl7F8 F No abnormal signs 

### From p. 33 ofMRlD 48302108 (for adult cats): "Cats 963 FES and 966 2C7 (group BI) lost hair on the application site and the lesions were visible from day 

### +1till the end ofthe study

... A scratch markwas visible in this lesion ofcat 966 

### 2C7 from day +6 to 

### +12. These lesions were considered to be a result ofthe application ofthe test substance

... In group B2, two cats (965 009 and BSD BID) developed crystals on the hairtips after application. On cat 965 009 it was visible on day 0 at the +2 hour and +3 hour observations, while the crystals were visible from +1 hour till day +2 on BSD BID. These were considered to be cosmetic changes. SBI 

### C65 was restless and came into oestruS on day 0

... No abnonnal signs were recorded amongstthe cats in group 

### C2." From p. 34 ofMRlD 48302108 (for kittens): 

## "cco F92 (group AI) developed scabs behind the head [that were detected?] on day +7 that lasted to the end ofthe study and scabs between the shoulder blades that disappeared by the end ofday +8

... CC2 ABI (albino kitten in group A2) developed wet eczema on day +3, it became infected on day +7 and was bleeding on day +S. After therapy [fromp. 29: Derrnavet topical once or twice a day on days +8 to 

### +I0] the lesions started to heal towards the end ofthe study

..." From p. 36: "CC2 AB 1 (albino kitten in group A2) developed wet eczema behind the ear on day +3. On day +5 it had spread to the shoulder blades, the sides ofthe neck and belowthe chin. This lesion was improving by day +14 and was considered to be related to the applicationofthe test substance." 2. 

### Mortality: All adult cats and all kittens survived to the end ofthe study. 16B. BODYWEIGHT AND WEIGHT GAIN: Body weight data for adults are presented in Table 7, and for kittens 

### in Table 8. There are no indications ofany significant differences between the different adult dosage groups, orthe different kitten dosage groups.
Table 7: Mean bod wei ht and bod wei htchan es for adult cats" Body weiebt (k Bod wei htchan es (k Group N Day -1 Day +1 Day +7 Day +14 Day wI Day-1 to Day -1 to to +1 +7 +14 Bl (adult males) IX 3 4.04 4.01 3.99 4.01 -0.03 -0.05 -0.03 81 (adult females IX 3 2.41 2.41 2.47 2.51 0.00 +0.06 +0.10

81 (combined IX 6 3.22 3.21 3.23 3.26 -0.01 +0.01 +0.04 82 (adult males 5X 3 3.95 3.88 3.92 4.02 -0.07 -0.03 +0.07 82 (adult females 5X 3 2.33 235 2.28 2.27 +0.02 -0.05 ·0.06

8? (combined) 5X 6 3.14 3.12 3.10 3.15 -0.02 -0,04 +0.01 C2 (adult males OX 3 4.09 4.08 3.98 3.99 -0.01 ·0.11 -0.10 C2 adult females OX 3 2.51 2.52 2.53 2.55 +0.01 +0.02 +0.04

C2 (combined) OX 6 3.30 3.30 3.25 3.27 0.00 -0.05 -0.03 'Calculoted by the reviewer from dota on page 37, MRlD 48302108

Table 8: Mean body weight and body weight changes for kittens' Bod wei ht k Bod weight chan " k Group N Day-l Day +1 Day+7 Day +14 Day -1 Day -1 to Day-Ito to +1 +7 +14 Al (male**kitten~11X** 3 1.44 1.43 1.51 1.72 -0.01 +0.07 +0.28 Al (female kittens) IX 3 1.27 1.27 1.37 1.55 0.00 +0.10 +0.28

Al (combined IX 6 1.36 1.35 1.44 1.64 -0.01 +0.08 +0.28 A2 (male kittens 5X 3 1.46 1.45 1.53 1.68 -0.01 +0.07 +0.22 A2 female kittens 5X 3 1.37 1.37 1.47 1.61 0.00 +0.10 +0.24

A2 (combined) 5X 6 1.41 1.41 1.50 1.65 0.00 +0.09 +0.24 CI (male kittens OX 3 1.36 1.33 1.43 1.59 -0.03 +0.07 +0.23 CI (female kittens OX 3 1.21 1.21 1.25 1.39 0.00 +0.04 +0.18

CI (combined) OX 6 1.28 1.27 1.34 1.49 -0.01 +0.06 +0.21 'Caleulated bythe reviewer from·data on pages 37-38, MRlD 48302108 C. 

### FOOD CONSUMPTION: No treatment-related effects were reported. Most cats and kittens showed no dose-related changes in food consumption, although one Group A2 (5X) female kitten scored 2 for meat consumption on Day +2 (kittens received pellets and meat, with separate scoring for their consumption ofthese two items). Of522 observations for the consumption ofmeat, there were 518 "4's" (>75-100% consumption); 3 "3's" (>50%-75% consmnption) andone "2" (>25- 50% consumption. Remarkably, the score of"2" involved the 5X albino kitten (CC2 ABI) observed to have a "hotspot on side ofneck behind ear" starting onDay +3 which necessitated treatment. On every otherpre- and post-treatment day ofthe study, this kitten scored "4" for meat consumption.

17

### The following Tables are from p. 39 ofMRID48302108:
Table 9. Mean daily and weekly food consumption values for the adultgroups Study Day Group Bl (IX) -13 3.67 -12 3.17 -11 3.67 -10 3.83 -9 3.83 -8 3.83 -7 3.67 Mean days -13 to-7 week 1 3.67 -6 3.83 -5 3.00 -4 3.50 -3 3.67 -2 3.83 -1 3.83 0 3.67 Mean days -6 to 0 (week 2) 3.62 +1 4.00 +2 3.33 +3 3.83 +4 3.83 +5 3.33 +6 4.00 +7 3.33 Mean da s+lto+7 week 3 3.67 +8 3.33 +9 3.67 +10 3.83 +11 3.50 +J2 4.00 +13 3.67 +14 3.83 Mean da s +8 to +14 weck4 3.69
Food consumption was scored daily using the following scoring system. 1 = 0-25% 2 = >25· 50% 3 = >50-75% 4=>75-100% Groull 82 5X) Group C2 (OX) 3.33 3.33 3.67 117 3.67 3.33 3.83 3.33 3.83 3.50 3.50 3.33 3.50 3.50 3.62 3.36 3.33 3. J7 2.67 2.83 3.17 4.00 3.33 3.67 3.33 3.83 3.67 3.67 3.50 3.50 3.29 3.52 3.33 3.50 2.67 2.83 3. J7 3.83 3.33 4.00 3.50 3.17 3.67 3.17 3.50 3.17 3.31 3.38 3.00 2.83 3.33 3.17 350 3.83 333 3.67 3.67 3.17 3.33 3.33 3.17 3.50 3.33 3.36

Individual daily food consumption scores for adult cats from day -14 to +14 arc reported on p. 6 ofMRID 4851320I.



### 18Table 10. Mean daily and weekly food consumption values for the kitten groups Stndv Day Group Al IX) Group A2 (5X) Pellets Meat Pellets Meat ·13 3.42 4.00 3.50 4.00 ·12 3.92 4.00 4.00 4.00 ·11 4.00 4.00 3.92 4.00 ·10 3.92 3.83 3.92 4.00 ·9 4.00 4.00 3.92 4.00 ·8 3.83 4.00 3.92 4.00 ·7 4.00 4.00 4.00 4.00 Mean da s M13 to-7 week I 3.87 3.98 3.88 4.00 ·6 3.92 4.00 4.00 4.00 

# ., 3.83 4.00 3.92 4.00 ·4 3.92 4.00 4.00 4.00 ·3 4.00 4.00 4.00 4.00 ·2 3.83 4.00 4.00 4.00 ·1 3.83 4.00 4.00 4.00 0 3.83 4.00 4.00 4.00 Mean da s -6 to 0 week2 3.88 4.00 3.99 4,00 +1 3.92 4.00 4.00 4.00 +2 3.83 4.00 3.58 3.67 +3 4.00 4.00 3.83 4.00 +4 3.58 4.00 3.67 4.00 +5 3.92 4.00 4.00 4.00 +6 3.92 4.00 3.75 4.00 +7 4.00 4.00 3.92 4.00 Mean days +1 to +7 (week 3). 3.88 4.00 3.82 3.95 +8 4.00 4.00 3.92 4.00 +9 3.83 4.00 4.00 4.00 +10 3.58 4.00 4.00 4.00 +11 3.83 4.00 3.58 4.00 +12 4.00 4.00 3.83 4.00 +13 4.00 4.00 4.00 4.00 +14 3.83 4.00 3.83 4.00 Mean days +8 to +14 (week 3.87 4.00 3.88 4.00 4l
Food consumption was scored daily using the following scoring system. 1 = 0·25% 2 = >25· 50% 3 =>50-75% 4=>75-100%
1 ndividual daily food consumption scores for kittens are reported 011 p. 20-21 ofMRID4851320I. 

### D. CLINICAL PATHOLOGYANALYSES: Group CI Pellets

3.42 3.83 3.83 3.92 3.92 3.75 3.83 3.79 3.75 3.75 3.92 3.58 3.67 3.92 4.00 3.80 3.75 3.67 4.00 3.50 3.83 3.75 3.42 3.70 3.67 3.50 3.67 3.75 4.00 4.00 3.67 3.75 OX Meat 4.00 3.83 3.83 4.00 4.00 4.00 4.00 3.95 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00



### 1. 

### Statistical 

### considerations: From p. 43 ofMRID 48302108: "The statistical analysis was designed to screen the results in order to point out differences between each ofthe 2 test treatment groups 

### eBI and 

### B2 in the case ofadult cats and Al and A2 for kittens) and the corresponding control groups 

### eC2 for adult cats and 

### CI for kittens) that should be considered more closely from a clinical and safety point ofview. The following strategywas followed to point out these differences for further review:

a. 

### Ifthere were any values on either test days 1,7

### or 14 in at least one animal in a particular test group that were outside the reference range, and 19b. Ifthe difference inthe mean values for a particular parameter between a specific test group and the control group was statistically significant from the**between~group** comparison (from either the ANOVA or CO-ANOVA analysis) and

c. Ifthe within-group comparison for the particular test group from test day**~6** (baseline) to the post-treatment day was statistical[ly] significant." 2. Hematology: From p. 44 ofMRID48302108 no**treatment~related** changes were observed in adult cats. For kittens: "Themean prothrombintime [for group AI, the IX kittens] decreased from 8.52 to 7.03

...from baseline (day -6) to day +7, with 5 ofthe 6 kittens (CCO 4AS, CCO F92, CCI 26E, CCI COA and CC DS5) having values 6.S, 6.S, 6.1, 7.2 and 7.5 respectively, all ofwhich were belowthe reference range of7.8 to 8.9." The group A2 kittens also had significantly reduced prothrombin times for days 7 and 14. For group A2 (5X kittens): "The mean aPTT [activated partial thromboplastic time] decreased from 15.33 to 13.25

...from baseline (test day -6) to test day -I, with I ofthe 6 kittens (CCO B97) having a value ofll.O, which was belowthe reference range of12.7 to 17.9." However, pathology for PT and aPTT generally involves increased values.
Table II. Statistically significantchanges from baseline in hematology parameters for kitten groups Hematology Kitten Day -6 Day+1 p-value Day +7**p~value** Day +14 p-value Parameter Group Mean Mean Mean Mean Prothrombin

Time**(se~)-** AI(IX) 8.52 8.22 0.0913 7.03 0.0048 7.22 0.0006**prothro~~~n** A2(5X) 8.43 8,58 0.6560 7.85 0.0127 7.57 0.0048 Time (sec

Partial A2(5X) 15.33 13,25 0.0375 13.97 0.1629 13.48 0.1259thromboplastin time (sec)



### 2. Clinical Chemistry; For adult cats, from p. 44 ofMRID48302108: "The mean albumin value [ofgroup BIl decreased from 30.0 to 29.0

...from baseline (test day -6) to test day 7, with I of the adult cats (963 FE5) having a value of24, which was below the reference range of25 to 34." For group B 1: "Themean total bilirubin value increased from 7.17 to 8.0

...from baseline (test day -6) to test day 14, with 1ofthe 6 adult cats (CC5 325) having a value of 12, which was above the reference range of4 to 11

... At no other days in any ofthe two groups were all three ofthe conditions set out.
.. [see statistical considerations, above] met for any other clinical chemistry parameters in the adult cats." For kittens, from p. 45 ofMRID 4830210S for group AI (IX): "The meantotal chloride value increased :fi:om 121.2 to 125

...from baseline (test day -6) to test day 7, with 1ofthe 6 kittens (CC 1COA) having a value of 126, which was above the reference range of 117 to 125

..." Also for group AI: "Themean total protein value increased from 59.3 to 62.0

.. ,from baseline (test day -6) to test day 14, with I ofthe 6kittens (CCI COAl having a value of6S, which was above the reference range of56 to 67

..." 20

### These findings appear to be sporadic, and unrelatedto exposure to the test material. III. DISCUSSION AND CONCLUSIONS A. INVESTIGATORS' CONCLUSIONS: The study author concluded [po 116 ofMRlD48302108J that two adult cats developed minor lesions after application ofa single dose ofthe test substance, butno signs were recorded in the group that received five times the dose. In group B2 (5X) two cats developed crystals on the hair tips after application. On one cat these were visible on day 0 at the 2- and 3-hour observations, while they were visible from 1hour until day 2 on the other. These were considered to be cosmetic changes. One kitten developed scabs after application ofa single dose ofthe test substance and one kitten developed wet eczemaafter receiving five times the dose (both were albino kittens). According to the discussion onp. 7 ofMRID 48302109: "It is not apparent ifthe delayed appearance ofeczema and scabs was coincidentally unrelated, or a direct consequence ofthe application ofthe test substance. An earlier CASS study repmi (MRID 46161309) in which cats and kittens were also treated at IX and 5X but with largeruntil dose volumes (0.7 and 1.4 mL, instead of0.5 mL) and with an etofenprox-Nylartest substance containing a much higher level of etofenprox (55% vs. 15%) did not describe any dermatopathology

... However, the present CASS test substance also contained fipronil, a different class ofactivethat has been very widely used now for years, apparently without gathering a reputation for inducing significant delmatopathology." Fromp. 37 ofMRlD 48513201; "Kitten CC2 AB1 (group

### A2, 5x dose) had "hot spots" on the side ofits neck and between its shoulder blades, first observed on the third day after treatment and persisting through day 14, reported as starting to resolve on day 9

... Kitten CCO F92 (group AI, Ix dose) had scabs onthe back ofits head recorded from days 7 to 14 and between its shoulder blades on days 7 and 8 (resolved on day 9)

... Both ofthese kittens were littermate albinos and there were no other kittens (albino or otherwise) from this litter enrolled in the study. There were no other dermatologic reaction reports for any ofthe other kittens in any group in the study. 

### Itis unfortunate that albino kittens, a comparative rarity inthe cat population, were included in a companion animal safety study

....However, one must suspect that the unique skin reactions in the area oftest substance application to these two albino kittens may not properly be extrapolated to what will occur 

### in the US catpopulation when this product may bereleased onto the market."

B. REVIEWER'S COMMENTS AND CONCLUSIONS: Fromthe confidential attachmentto MRlD 48513201, it has been confirmed that the solvent(s) 

### andlor inerts present in the test material are the same as those in the products which will be supported by this study. All animals survived to the end ofthe study, and there were no indications ofany systemic toxicity. There were no effects on body weights. Most cats and kittens showed no dose-related changes in food consumption, although one Group A2 (5X) female kitten scored 2 for meat consumption on Day +2 (kittens received pellets and meat, with separate scoring for their consumption ofthese two items). Of522 observations for the consumption ofmeat, there were 21518 "4's" (>75 to 100% conswnption); 3 "3's" (>50-75% consumption), and one "2" (>25-50% consumption). Remarkably, the score of"2" involved the 5X albino kitten (CC2 AB1) observed to have a "hotspot on side ofneck behind ear" starting on Day +3 which necessitated treatment. On every other pre- and post-treatment day ofthe studythis kitten scored "4" for meat consumption. Hourly observations for adult cats and kittens for the four hours after last application are reported in MRID 4851320!. For adults (from p. 11 ofMRlD 48513201) one B2 female (8Bl C65) showed restless rolling with a duration of**~**10 minutes after the third application (this observation wasunique, as it was made before the series of5 applications oftestmaterial had been completed), but had calmed down one hour later, then (from p. 9 ofMRID 48513201) was restless atthe first hourly observation post-application, and was showing signs ofestrus at the next observation, but showed no signs atthe next two observations. Two B2 males showed crystals (presumably from evaporationatthe application site), one atthe 2 hour observation, and both at the 3 and 4-hour observations. The crystals were still present on one male on Days I and 2. For kittens, no signs were observed in the four hours following the last application, andthe only signs that were observed were dermal effects in 5X albino kitten CC2 AB1 (first noted on Day 3) and scabs behind head and between shoulder blades in 1X albino kitten CCO F92 (first observed on Day 7). There were dennal effects. Two adult cats in group Bl (IX) scratchedthe application site and lost hair after application, and the report states that these lesions were considered to be a result of exposure to the test material. One ofthese cats hadpreexisting alopecia (measuring 3 mm x 3 mm on the dorsal neck, betweenthe ears) on days -7 and -1, and then had a scratch mark (20 mm x 10 mm) on days +1 and +7 at the application site, "moving anterior." The second had no preexisting condition, but then had a scratch mark atthe application site on study days +1, +7, and +14. None ofthe adult cats in the 5X group showed any dermal signs. One kitten in the IX group had scabs on the back ofthe head from day 7 to 14 and scabs between the shoulder blades on days 7 and 8; this kitten was an albino. One kitten in the 5X group (also an albino) had acute wet eczema onthe neck and shoulders from day 3 to 14, andthis required treatment with Dermavet Cream. 

### Itis stated (p. 36) that this lesion: "

...was considered to be related to the application ofthe test substance." From page 37 ofMRlD 48513201 both ofthe albino kittens were littermates, and there were no other kittens (albino or otherwise) from this litter in this study. As noted on p. 37 ofMRID 48513201: "Itis unfortW1ate that albino kittens, a comparative rarity in the catpopulation, were included in a companion animal safety study. The literature on defects or susceptibilities associated with albinism in cats describes a propensity for deafness, but no references to dermatologic effects. However, one must suspect thatthe unique skin reactions inthe area oftest substance application to these two albino kittens may not properly be extrapolated to what will occur in the US cat population when this product may be released onto the market." TRB has concluded that the most probable explanation for the observed effects inthe albino kittens is thatthe toxicitywas due to a fipronil photodegradate (MB46513, also known as fipronildesulfinyl) which is more toxic than the parent compound. 

### It has been established that fipronil accumulates in sebaceous glands. The dose-related response observed in the albino kittens (which lack melanin, which would normally block light from reaching fipronil) is consistent with 22

### formation ofthis photodegradate (particularly as effects appeared on day 3 in the 5X kitten and on day 7 in the IXkitten). The possibility also exists that the presence ofone or more ofthe other ingredients inthis formulation may have enhanced the fonnation ofthis photodegradate in the albino kittens. The registrant should provide the Agency with any additional information available from this study relevant to the formation ofthe fipronil degradate, including (ifpossible) the fur coloration ofthe animals at the application site and the level and type oflightingthat the cats and kittens were exposed. This information should be received within 6 months ofthe issuance ofa registration. This companion animal safety study in adult cats and kittens is upgraded to Acceptable and does satisfy the guideline requirement for a companion animal safety study (OPPTS 870.7200) in cats and/or kittens with the stipulationthat labeling indicates that this product is not to be used on albino cats or kittens.



### 231. DP BARCODE: 385149 2. PC CODES: 129121 (Fipronil); 105401: (S-Methoprene); 128965: (Etofenprox); 129032 (Pyriproxyfen) 3. CURRENT DATE: July 26, 2011 

### 4. TEST MATERIAL: Cat Spot on Soup, containing Fipronil (9.83%), S-Methoprene (11.76% w/w), Etofenprox (15.78%) and Pyriproxifen (2.34%) Study/SpeciesiLab MRID Results Tax. Core Studv# I Date Cat. Grade Companion Animal Safety 48302108 Three groups, each containing 3M N/A A Study/AdultCats & Kittens 48302109 & 3F adult cats, and 3 groups, each 48513201 containing 3M & 3F kittens (12-16 ClinVet International; weeks ofage) were treated (along Bloemfontein, South Africa the back ofeach animal) with either 0.5 mL (IX) or 2.5 mL (5X) StudyCV 09/660 1July 13, 2010. oftest material or with 1.45 mL (5 x 0.29 mL) ofthe control material. Dermal effects occurred in two IX adults (but none ofthe 5X adults) and in one IX and one 5X kitten. Both affected kittens were albino. No indications ofany effect involving hematological, clinical chemistry, or body weights. Food (meat) consumption data indicates a possible effect on the 5X albino kitten on Day2, shortly before the appearance (Day 3) ofdennal effects. TRB has concluded that the most probable explanation for the observed effects in the albino kittens is that the toxicity was due to a photodegradate offipronil. Labeling should stipulate that this product is not to be used on albino cats orkittens. Core Grade Key: A

- Acceptable, S

- Supplementary, U

- Unacceptable, W - WaIved

24/**"~** FW: Sergeant's Cat Labels

# ~**~:::::~n:inlOSotu** 07/14/2011 02:01 PM Cc: MarionJohnson, BeWandaAlexander Hide Details From: "James Messina" <jmessina@exponent.com> To: Bonaventure Akinlosotu/DCIUSEPA/US@EPA Page 1 of2

Cc: Marion Johnson/DCIUSEPA/US@EPA, BeWandaAlexanderlDCIUSEPA/US@EPA

4 Attachments

# ~ 25I7-RUTFinal Label vIO.3.docx 25l7 HRUL Final Label VIO.3.docx 25I7-RUI Final Label vlO.3.docx

### 6~'l 

## 3J 25I7-RUA Final Label vIO.3.docx B.A., These are the !abels I mentioned during our call today. Best Regards, James Messina Exponent 202.772.4932 office 301.908.1181 mobile From: James Messina Sent: Wednesday, July 06, 2011 4:02 PM To: Akinlosotu.Bonaventure@epamail.epa.gov

file:IIC:\Documents and Settings\BAkinlos\Local Settings\Temp\notes87944B\-web6892.... 8116/2011

### Page 2 of2

Cc: Mary Hunt Subject: Sergeant's Cat Labels Bonaventure, Please find attached updated labels (per EPA efficacy reviews and minor language corrections) for the following four pending registration applications:

• Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats (2517-RUT) • Sergeant's Fipronil + Nylar Spot-On for Cats (2517-RUA) • Sergeant's Fipronil + Etofenprox + Methoprene Spot-On for Cats (2517-RUL) • Sergeant's Fipronil + Etofenprox Spot-On for Cats (2S17-RU!) Please confirm the new PRIA due date for the above pending applications as I have not received any official correspondence related to the date change. My calculations have it atJuly 13, 2011. Can you please let me know ifwe are on track to meetthis date? Best Regards, James Messina Principal 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 301-908-11B1 cell
CONFIDENTIALITY NOTICE: This electronic transmission (including any files attached hereto) may contain information that is privileged, confidential and protected from disclosure. The information is intended only forthe use ofthe individual or entity named above and is subjectto any confidentiality agreements with such party. Ifthe reader ofthis message is not the intended recipient or- any employee or agent responsible for delivering the message to the intended recipient, you are hereby notified that any disclosure, dissemination, copying, distribution, orthe taking of any 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

0"""...""Efficacy Review Date: May 25, 2011 Efficacy Reviewer: Clayton Myers, Ph.D.,

## )Oiiiomoloo;"'~~iJ, mvers.clavlOn(a:!epa.gov ' 703-347-8874 '

### ,_~----;**~-** 

## 1\ '- S-,-' Risk Manager Rev.: Rosanna Louie Products: Sergeant's Fipronil 

### +Etofenprox 

### +Nylar Spot-on for Cats EPA Reg. #: 25I7-RUT A.L's: Fipronil (9.8%), Etofenprox (15.0%), Pyriproxyfen (2.2%) Decision #s: 442431 DP#s: 385137 Submission: R31 0, New Products, RD Science Review MRIDs: Submitted: 48302110,48302111,48302112,48302113,48302114 Cited: Selective Cite-All for efficacy (Merial) 

### GLP: No

MRID 48302110 Title: Immediate Efficacy ofaCombined Application ofFrontline Plus with Etofenprox as a Squeeze-on against Fleas (Ctenocephalidesfelis) and Ticks (Dermacentor variabilis) on Cats. Guideline: OPPTS 810.3300 Materials 

### and Methods: A laboratory study was conducted with an experimental fonnulation, with etofenprox (12.6%) added to aregistered fipronil 

### + s-methoprenepetproduct. Etofenprox technical was added to Merial's Frontline Plus (65331-4), with dosages applied in accordance with the parent product label. Cats receiving the experimental fonnulation received a 0.58 mL dosage, regardless ofcat body weight. 18 cats, provisioned with cone collars, were allocated to 3 groups (control, experimental formulation, and positive control). One day priorto treatment, cats were infested with 100 fleas and 50 ticks (Dermacentor), with subsequent weekly reinfestation on days 8, 15, 22, and 28 after treatment. Flea and tick counts were taken at I and 4 hours after application on the day oftreatment, and similarly afterreinfestation on days 8, 15,22, and 28 to measure speed ofkill, as evidenceofrepellency. COl.mts were also made at 24 and48

### hours after treatment and after each re-infestation on days 1, 2, 9, 10, 16, 17, 23, 24, 29, and 30. Fleas and ticks were not removed or destroyed until the last count ineach re-infestation cycle, which was done by comb removal. Effiacy was calculated using Abbott's fonnula. StudySummary ofthe Results: 1. Efficacy against both fleas and ticks exceeded 90% for the duration ofthe efficacy study, 30 days after treatment. Entomologist's ObservationslDiscussion: 1. 

### The 1-4 hour efficacy evaluations are suitable for evaluating claims of'quick acting', but are not appropriate for evaluating repellence. Forrepellence to be demonstrated, a study would have to be done to demonstrate 90%reduction in tick attachmentlretention. 2. I hour efficacy data indicates that the fonnula containing etofenprox starts killing fleas and ticks within one hour at a higher level thanthe fonnula with fipronil alone.

MRID48302111 Title: Immediate Efficacy ofa Combined Application ofFrontline Plus with Etofenprox as a Squeeze-on against Fleas (Ctenocephalis felis) 

### and Ticks (Dermacentor variabilis) 

### on Cats. Guideline: OPPTS 810.3300 

### Materials and Methods: Etofenprox was added to Frontline plus at 12.6% for immediate efficacy evaluations. Etofenprox technical was added to Merial's Frontline Plus (65331-4), with dosages applied in accordance with the parentproduct label. Cats receiving the experimental formulation received a 0.58 mL dosage, regardless ofcat body weight. 9 cats, provisioned with cone collars, were allocated to 3 groups (control, experimental fonnulation, and positive control). One daypriorto treatment, cats were infested with 100 fleas and 50 ticks (Dermacentor), 

### with subsequent weekly reinfestation on days 8, 15,22, and 28 after treatment. Fleaand tick counts were taken at 1and 4 hours after application on the day oftreatment, and similarly after reinfestation on days 8,15,22, and 28 to measure speed ofkill, as evidence ofrepellency. Counts were also made at 24 and 48 hours aftertreatment and after each re-infestation on days 1, 2, 9, 10, 16, 17, 23, 24, 30, and 31. Fleas andticks were notremoved or destroyed until the last count ineach re-infestation cycle, which was done by comb removaL Effiacy was calculated using Abbott's fonnula. Study Summary ofthe Results: 1. Fleaefficacy on day oftreatment was significantly higher for the treatment including etofenprox than fipronil alone (25% vs. 0% at 1hourpost-treatment, and 88% vs. 14% at 4 hours post-treatment). Tickefficacy onthe day oftreatment wassignificantly higher for the etofenprox treatment at 4 hours after application (53% vs. 0%). 2. Mean efficacy against fleas exceeded 90% when assessed at 1-2 days after treatment or reinfestation with parasites, through 17 days aftertreatment. 3. Mean efficacy against ticks exceeded 90% when assessed at 1-2 days aftertreatment or reinfestation withparasites through 31 days after treatment. Entomologist's ObservationslDicussion: 1. The 1-4 hour efficacy evaluations are suitable for evaluating claims of'quick acting', but are not appropriate for evaluating repellence. For repellence to be demonstrated, a study would have to be done to demonstrate 90% reduction intick attachment/retention. 2. 1-4 hour efficacy dataindicates thatthe formula containing etofenprox starts killing fleas andticks within four hours at a higher level than the fonnula with fipronil alone. MRID48302112 Title: Dose Titration with S-Methoprene Squeeze-On Cats Measuring Flea Egg Sterilization 

### Guideline: OPPTS 810.3300 Materials and Methods: A laboratory dose titration study was conducted to evaluate (and project) the residualprotection time for cats treated with varying dosages ofs-methoprene. Prevention oflarval development,pupation, and adult flea emergence was evaluated, with dose rates ranging from 2.1 to 130.8 mg/kg body weight. Six treatment groups were established with 2 cats each, and 6 additional cats were assignedto an untreated control group. Cats were fitted with Elizabethan collars to prevent grooming and pest removal Cats were infested with fleas 1 day after treatment, and reinfested once weekly thereafter. Drop pans were used to collect flea eggs on the 2nd and 6th day after each infestation. Eggs were sorted and incubated for 3 days to measure fertility. Other eggs were incubated on a flea growing medium for 21-35 days to evaluate flea emergence. 

### %hatch and % adult development were calculated for each cat. Efficacy (compared to controls) was calculated using Abbott's fonnula. Efficacy was plotted against dosage to develop a regression equation, used to detenninethe relationship between dosage and duration ofresidual flea ovisterilant efficacy using regression analysis. StudySummary oftheResults:

1. Progressive failures in preventing egg hatch occurred after the 14th day, with the lowest rates. 2. Based on inhibition ofadult flea emergence, the analysis supports a claim for up to 4 months for smaller cats, and no less than 1 month for large cats. Entomologist's ObservationslDiscussion: 1. This data is supplemental in tenns ofsupporting s-methoprene claims, as existing data already support claims for breaking ofthe flea life cycle for up to 3 months.

### Because this product does not contain s-methoprene, this citation is not relevantto supporting any claims beyond those already supported by cited pyriproxyfen data. MRID 48302113 Title: Comparative efficacy evaluation ofSergeant's squeeze-on and Frontline Plus for the treatment ofadult cat flea 

### (Ctenocephalisfelis) and Tick 

### (Haemaphysalis elliptica, Rhipicephalus turanicus, and 

### Dermacentor variabilis) infestations on cats. Guideline: 

### OPPIS 810.3300 Materials and Methods: Etofenprox was added to Frontline plus at 15.0% for efficacy evaluations on cats. 7 treatment groups were evaluated, including an untreated control, and 2 rates each ofFrontLine Plus (Fipronil 

### + S-methoprene), Sergeant's 1 (Fipronil 

### + S-methoprene), and Sergeant's 2 (Fipronil 

### + S-methoprene 

### + Etofenprox). The 2 rates ofthe experimental treatments were 0.5 mL and 0.055 mL ofeach treatment. 42 cats, ranging in weight from 5-15 lbs, were provisioned withcone collars, and allocated randomlyto the 7 groups (6 cats per group) Cats were all qualified for health and parasite retention. 50 ticks were placed atvarious times during the study. 

### D. variabilis were used on days -6, -1, 21, and 28. 

### R. turanicus were used on day 7. 

### H elliptica were used on day 14. Infestations of 100 fleas were made on days -6, -1,7,14,21, and 28. 1and 4 hour in situ assessments were made on the day ofplacement for each parasite. 24 and 48 hour assessments were made one and two days after the placement for all parasites. Fleas and ticks were not removed or destroyed until the last count ineach reinfestation cycle, which was done by comb removal. Effiacy was calculated using Abbott's formula. Study Summary ofthe Results: 1. Mean efficacy against ticks exceeded 90% when assessed at 1 day after reinfestation at 28 days post treatment, with the exception of

### H elliptica, but efficacy exceeded 90% for all species when evaluated at 2 days afterreinfestations. The lowerrates did not demonstrate adequate efficacy. 2. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment and reinfestations, for both treatmentrates. 3. Immediate efficacy onfleas (i.e. kill!repellence within 4 hours oftreatment) ranged from 0-75% for 1-4 hours immediately after treatment. With reinfestations after 7, 14,21,28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for reinfestations on days 14,21,28, or 35 days after treatment. 4. Immediate efficacy on ticks ranged from 11-71 % for 1-4 hours immediately after treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy exceeded 90% within4 hours for only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for reinfestations on days 14,21,28, or 35 days after treatment. Entomologist's ObservationslDicussion:

### 1. Efficacy against fleas and ticks was adequate to support controls claims through 30 days for the squeeze-onproduct containing etofenprox, applied at a label rate of0.5 mL per cat. MRID 48302114 Title: Comparative efficacy evaluation ofSergeant's Squeeze-on and Frontline Plus for the treatment ofadult cat flea (Ctenocephalidesfelis) and tick (Haemaphysalis elliptica, Rhipicephalus turanicus, andDermacentor variabilis) infestations on cats. Guideline: OPPTS 810.3300 Materials andMethods: Etofenprox was added to Seargeant's Fipronil-Methroprene fonnulation Frontline plus atthe rate of 15% for efficacy evaluations. This treatmentwas compared to a 2 positive controls, Merial's Frontline Plus and a Sergeant's Fipronil 

### + smethoprene combo, and an untreated control. The 3treatments were split whereby one group received a fulllabe1 dose, while ther second group received a dosage based on atitrationfrom the largest animal (20lbs cat) dose, to 

### simulate the lightest possible dosage accordingto label directions. Each group consisted of6 animals. These treatments were evaluated for efficacy against pre-existing fleas and ticks (Dermacentor var;abilis). Residual efficacy was measured againstR. turanicus, H. 

### elliptica, andD. variabilis over 30 days following treatment. Cats were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14, 21, and 28 days after treatment. Counts were made at 1 and 4 hours post treatment and also after every**reinfestation~this** 

### was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours afterinitial infestation and all re-infestations. Flea counts were only made at 48 hours after treatment and eachre-infestation. Mortality was calculated using Abbott's fonnula. For speed ofkill/repeUence, the number ofkilled/repelled fleas onthe liner below each treated cat was divided by the total number offleas placed on the cat (all x 100), adjusted for 'normal' attritionon control dogs. Study Summaryofthe Results! 1. Mean efficacy against fleas exceeded 90% when assessed at all assessment times up to 30 days after treatment. Entomologist's ObservationslDiscussion: 

### 1. Efficacy against fleas and ticks was adequate to support controls general claims through 30 days (one month) after treatment. 2. No immediate efficacy claims (i.e., within 1-4 hours ofapplication or reinfestation by parasites) are supported by this data.

OverallReview ofLabelClaims and Directions:

### -killing claims against flea pupae are unsupported and thus, unacceptable -repellence claims againstticks are unsupported and thus, unacceptable Based upon submitted efficacy data, claims for the product to start working within I hour, or within hours are acceptable. Claims supported by selective and cite-all methods: -kill claims against fleas, flea eggs & 

### larvae, ticks, including those that may transmit Lyme disease, chewing lice, and mosquitoes -fast acting -long-lasting -waterproof wdescription ofproduct spread over pet's skinlhair -prevents all flea stages (eggs, larvae, pupae) from developing wstops existing infestations and prevents establishment ofnew infestations -kills fleas which may cause flea allergy dermatitis -kills all stages ofticks (larva, nymph, and adult), including deer ticks, brown dog tick, American dog tick, and Lone Startick. -kills ticks thatmay transmit Lyme disease, Rocky Mountain spotted fever, erlichosis, and other tick-borne diseases -rapidly minimizes chewing lice infestations -kills mosquitoes w When used monthly, xxxx breaks the flea life cycle and controls ticks and chewing lice infestations. Do not reapply for 30 days. -Controls fleas for up to 6 weeks. -Kills mosquitoes within 24 hours for up to 14 days, andwithin 48 hours for up to 28 days with a monthly application wkeeps working even ifthe cat gets wet -fleas, ticks, and chewing lice are killed quickly after corning into contact with a treated cat. Fleas and ticks do not needto bite the cat in orderto die. Line by Line Review ofLabel Claims Mosquitoes. Kills mosquitoes: Acceptable Adult Fleas. Studies show that [brand name] kills adult fleas for up to six weeks: Acceptable, but strike the statement "studies show". Kills Fleas [Up to[4][6J weeks]!: Acceptable Kills Fleas that mav cause flea allergy dermatitis, flea bite anemia, and tapeworm infestation: Acceptable Stops and prevents reinfestation: Acceptable

### Controls flea reinfestation for up to [six weeks]: Acceptable [brand name] kills adult fleas for up to six weeks: Acceptable Ifcat is a high risk for flea reinfestation a once month application may be needed: Acceptable Dual Action 

### [!l: Fipronil and Etofenprox Effectively Breaks the Flea Life Cvcle: Unacceptable, as the life cycle claim is driven byNylar efficacy. Prevents and controls reinfestations: Acceptable FleaEggs and Larvae: Acceptable Stops and prevents infestations: Acceptable Controls flea reinfestation for up to 6 weeks: Acceptable Research demonstrates that [brand name] kills adult fleas. flea eggs. flea larvae and pupae for up to six weeks: Pupae claim is unacceptable. Pupal development is prevented by treatment, but the product was not shown to actually kill pupae directly. [brand name] prevents development ofal! flea stages for up to 6 weeks: Acceptable Prevents all flea stages (adult fleas, flea eggs, flea pupae, and flea larvae): Acceptable Ifcat is a high risk for flea reinfestation a once month application mav be needed: Acceptable Kills flea eggs [larvae][pupaeJ for up to [3 monthslfI2 weeks]: Pupae claim is unacceptable. Pupal development is prevented bytreatment, but the productwas not shown to actually kill pupae directly. rSeven][7] Way protection [kills fleas. ticks. mosquitoes. lice, flea eggs, flea larvae and flea pupae]: Pupae claim is unacceptable. Pupal development is prevented by treatment, but the product was not shown to actually kill pupae directly. WithNylar Insect Growth Regulator which Breaks the Flea Life Cycle: Acceptable With Nylar to Break Flea Life Cycle: Acceptable With Insect Growth Regulator to Break Flea Life Cycle: Acceptable Triple Action [!]: 

### Effectively Breaks the Flea Life Cycler!]: Acceptable Kills all stages ofthe flea life cycle: Acceptable Kills Flea Eggs & 

### Flea Larvae for [(up to 3 months)!]: Acceptable

### Prevents Flea Eggs From Developing Into Biting Adults: Acceptable Prevents and controls reinfestations: Acceptable Ticks: Acceptable Kills Ticks includingthose that may transmit Lyme disease: Acceptable Kills Ticks for Up to [4 weeksl!: Acceptable Kills Deer Ticks (vector ofLyme Disease) for up to 4 weeks: Change parenthetical statement to "which may transmit Lyme Disease". Kills Ticks (Including DeerTicks) for up to 4 weeks: Acceptable Kills rand repelslfAmerican Dog Ticks for up to 4 weeks): Repels statement is unacceptable, kill claim is acceptable Kills [Brown]. fAmericanl[and Lone Star} dog ticks for up to 4 weeks: Acceptable Kills 

## r& Repels] American Dog Ticks [(Dermacentor variabilis)] 

### for up to 4 weeks: Repels statement is unacceptable, kill claim is acceptable Multiple Infestations: (Brand Name) provides convenient and effective flea, tick. chewing lice and mosquito control for cats and kittens: Acceptable Controls reinfestation for up to 4 weeks: Acceptable Flea & 

### Tick Control for Cats & 

### Kittens 12 weeks old and older: Acceptable Kills fleas, ticks. chewing lice & 

### mosquitoes: Acceptable Kills fleas. ticks. mosquitoes. and (chewing) lice: Acceptable Monthly flea. tick. mosquito and lice protection: Acceptable Kills fleas. ticks. mosquitoes. and lice: Acceptable [Fourl[4] WayProtection: Acceptable [4 Week] [Flea and Tick & 

### Treatment!]: Acceptable [Four (4) WeeklfFlea. Tick. Mosquito and Lice control]: Acceptable

### When used monthly [brand name] completely breaks the life cycle and controls tick and chewing lice infestations: Acceptable 4 week Flea and Tick Treatment!: Acceptable Once A Month Flea and Tick Treatment: Acceptable Kills Fleas and Ticks for up to 4 weeks!: Acceptable Starts to kill fleas and ticks in an hour. continues to kill for a month: Acceptable Kills [93% offleas] in 4 hours [and] [98 to 100% oftick] in one hour: Explicitpercentage claims are unacceptable and must be removed. Research shows that [Brand Name] kills 93% offleas in 4 hours and 98% to 100% of Demmcentorticks in one hour: Explicit percentage claims are unacceptable and must be removed. Kills more than 50% ofticks in 1hour: Explicit percentage claims are unacceptable and must be removed. Kills 100% offleas and ticks in [24 hoursl[1 day]: Explicit percentage claims are unacceptable and must be removed. Starts killing fleas and ticks in as little as 1hour: Acceptable Stops and prevents infestations: Acceptable Fast Acting: Acceptable Cats can be bathed 24 hours after treatment: Acceptable Waterproof: Acceptable Long Lasting: Acceptable Once a month treatmentrecommended: Acceptable A once monthly application is recommended for chewing lice: Acceptable Fast Action against chewing lice infestations: Acceptable
[brand namel contains FiproniL Etofenprox and the insect growthregulator OaR)Nylarto effectively kills fleas. ticks. mosquitoes and chewing lice. The active ingredients in [brandname] work by collecting in the hair follicles and skin oils. This product features a sustainedrelease fonnula that discharges from the cat's hairfollicles 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. Etofenprox and Nvlar IGR collecting and being released from hair follicle]: Acceptable 

### FREQUENCYOFAPPLICATION Use [brand name] monthly for complete control offlea. tick [and] chewing lice [and mosquito] infestations. [Studies showthat]fbrand namel kills fleas for up to six weeks. and flea eggs. flea larvae. and flea pupae for up to 12 weeks. Ifyour pet is highrisk for flea reinfestation [. or in ahighly infested environment]. apply monthly. Apply monthly to control ticks. mosquitoes and chewing lice. [BrandName] kills mosquitoes within 24 hours forup to 14 days. and within 48 hours for up to 28 days. (Brand name] remains effective. even after bathing, water immersion. orexposure to sunlight. Allow treated areato drythoroughly. Do not reapply for 30 days: The statement "studies show" and claim against 'fleapupae' must be removed. The remainder ofthe claim is acceptable.

### May 24, 201 I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM 

### Subject: Name 

### ofPesticide Product: 

### EPA Reg. No. !File Symbol: DP Barcode: Decision No.: 

### Action Code: 

### PC Codes: SERGEANT'S FIPRONIL 

### +ETOFENPROX 

### + NYLAR SPOT-ON FOR CATS 2517-RUT DP 385135 442431 R310 129121 (Fipronil: 9.8%); 128965 (Etofenprox: 15.0%); 129032 (Nylar: 2.2%) 

### From: Byron T. Backus, Ph.D., Toxicologist 

# 0

# ~7 r 0

# -~**o~,** ..

# ~ Technical Review Branch**,,,~** 

### __ <-- \ -.-- ,-, '" Registration Division (7505P) 

# r-//11 _ Richard Gebken RM 

### 10

# ~.f",;y./COI-0Gl'( 

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

### Registrant: SERGEANT'S PET CARE PRODUCTS FORMULATION FROM LABEL: Active Ingredient(s): 

### 129121 Fipronil 128965 Etofenprox 129032 Nylar Other Ingredient(s): 

### TOTAL ACTION REQUESTED: 

### The Risk Manager requests: bywt. 9.80% 15.00%

2.20% 

### 73.00% 100.00%

"Attn TOX please conduct a companion animal safety review 

### ofthe attached studies in support ofanew cat spot-on product containing fipronil, pyriproxyfen and etofenprox..."

Page 1of2BACKGROUND: The material received for review includes a cover letter dated 11118/2010, and a data matrix which cites a numberofcat and kitten companion animal safety studies, a proposed label, and a CSF (dated 11116/2010). The citations include a recently reviewed companion animal safety study (in MRID 48302108) titled: "Companion animal safety evaluation ofa**spot~on** containingtwo toxicants andtwo insect growthregulators onkittens and cats," as well as a data analysis report onthis study (in MRID 48302109). In addition, the registrant is citing a numberofadditional studies (MRIDs 46161309 [Kuhn, J. (2003) Companion Animal Safety Study for an Etofenprox-IGR Spot-On Kittens and Cats: Final Report. ProjectNumber: 

### 7652/03. Unpublished study prepared 

### by Stillrneadow, Inc. 70 p.]; 43577711 [Walker, 

### K. (1995) Discussion in Support ofBridging Domestic Animal Safety Data on Frontline Spray Treatment to Frontline Spot Treatment Data Package. Unpublished study prepared 

### by Rhone Merieux, Inc. 6 p.]; 43577713 [Everett, R; Cunningham, 1.; Tanner, P. (1995) Positive Referenced and Untreated Controlled Dose Confirmation Trial ofRM1601E 10% SPOT-ON Fonnulation Applied to Cats for Control ofthe Cat Flea Ctenocephalides [elis: Lab ProjectNumbers: RM VSR-250LT: ARC #RMC194: P-250LT. Unpublished study prepared by AgResearch Consultants, Inc. 30p.]; 43577716 [Villageliu, J.; Lopez, S.; Genna, M.; et 

### aI. (1994) Percutaneous Absorption and Distribution ofRadioactivity in Hair, Skin, and Fat After Spot-On Applicationof(Carbon 14)-RM1601 in Cats: Lab ProjectNumbers: CD-93/3748F. Unpublished study prepared 

### by Centro de Investigacion 

### y Desarrollo Aplicado, S.A.L. 42 p.]; 43444904 [Schwartz, E. (1994) Domestic Animal Safety Study ofRM1601C Topical Spray (Frontline Spray Treatment) in Juvenile Cats: Lab ProjectNumber: 94424: PS-234DAS. Unpublished study prepared by White Eagle Toxicology Labs. 168 p.]; 43272401 [Schwartz, E. (1994) Domestic Animal Safety Study ofRM1601C 0.25% Topical Spray in Juvenile Cats: Interim Report: Lab ProjectNumber: 94424. Unpublished study prepared by White Eagle Toxicology Lab. 112 p.]; and 43121112 [Arnaud, J.; Consalvi, P. (1993) Domestic Animal Safety: Assessment ofthe Tolerance ofa0.25% RM 1601 Spray Formulation in Cats at 3, 9, and 15 mllkg When Applied 6 Times to the Haircoat at 28 Day Intervals: Revised: Lab Project Number: eLI 137. Unpublished study prepared by Rhone Merieux, Inc. 62 p.]. COMMENTSAND RECOMMENDAnONS: 1. TRB hasrecently (May 16, 2011; Review for 2517-RUA under DP 385149) reviewed the cited companion animal (adult cats and kittens) study in MRID 48302108 with the accompanying data analysis report (MRID 48302109). 2. As stated in the TRB reviewdated May 16,2011, the study in MRID 48302108 for adult cats and kittens is currently classified as Supplementary data and does not currently satisfy the guideline requirement for a companion animal safety study (OPPTS 870.7200) in cats andlor kittens. The study can be upgraded to acceptable and can be used to supportthe proposed registration(s) ifthe additional information indicated inthe May 16 review is provided and there are no indications ofsignificant adverse effects. Until then, it cannot be used to support the registration of2517-RUTand similar products.

Page 2 of2Sergeant's Pet CareProducts, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.709t • www.sergeants.com


### May 18,2011

Richard Gebken, PMlO 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: Offerto Pay Compensationin Support ofPending Registration Sergeant's Fipronil 

### +Etofenprox 

### +Nylar Spot-On for Cats EPA File Symbol Number25 1 7-RUT Dear Mr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th 

### Plaza, Omaha, NE 68130- 1770, EPA CompanyNumber2517) is submitting the following infonnation in accordance with FIFRA 3(c)(l)(F) and 3(c)(2)(B) to support the required data for the subjectproduct, Sergeant's Fiproni1 

### + Etofenprox 

### +Nylar Spot-On for Cats (2517-RUT). Please find enclosed the following support documents:

• A copy ofthe offerto pay letterdated March 1, 2011 to Merial Limited; and • A copy ofthe USPS certified mailing receipt and deliveryconfilmation dated March 3, 2011. Ifyou have anyquestions regardingthis submission, please contact me at 402-938-7079. Sincerely,

Kelly R. Hoskins Manager ofRegulatory Affairs Sergeant's Pet Care Products, Inc. Enclosures

cc: Bonaventure Akinlosotu, EPAPet Care products, Inc, 2625 South 100th Plaza • Omaha, NE**68130~1770** • Telephone 402.938.7000 • Fax402.938.7091 • www.sergoants.com



### U.S. RegisteredMail March 1,2011 Merial Limited Amention: Regulatory Manager 3239 Satellite Blvd., Bldg 500 LOC 106B Duluth, GA 30096 Subject: Offerto Pay CompensationUnder FIFRA Section 3(c)(1)(F) 

### Sergeant's Pet Care Products, Inc. Proposed Product Sergeant's Fipronil + 

### Etofenprox 

### +Ny1ar Spot-On for Cats ("Product'') 

### To 'Nhom It May Concern: As required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 3(c)(1)(F), and implementing regulations at 40 CFR Part 152 Subpart E, Sergeant's Pet Care Products, Inc. ("Sergeant's") hereby notifies Merial Limited, EPA Company Number 65331 ("CaMP ANY")that it intendsto cite dataregarding fiproni1 onfile withtheU.s. Environmental 

### Protection Agency ("DSEPA" or "Agency") related to your end-use products containing fipronil to support the USEPA registration ofan end-use Product containing the active ingredient. According to the USEPA's Listing ofPesticide Data Submitters (dated March 31, 2010), 

### Sergeant's has identified COMPANY as an Original Data Submitter who has end-use product data on file with the Agency for the active ingredientfipronil. Sergeant's herebynotifies COMPANY: 

### 1. that it is the intent ofSergeant's to submit to the USEPA an application for pesticide registration forthe Product containing the active ingredient fipronil; 2. that Sergeant's offers to pay compensation regarding data, as appropriate, to COMPANY, with regard to the approval ofthis registration application, to the extent required byFIFRA Section 3(c)(l)(F); and 

### 3. Sergeant's offers to commence negotiations to detennine the amount and tenns of compensation, ifany, to 

### bepaid fortheuseofany 

### data. IfCOMPANY intends to request compensation for the use ofCOMPANY's dare, with regard to the approval ofSergeant's registration application, Sergeant's**respectfunY'~~quests** 

### that COMPANY indicate, by return correspondence, the amount and tenns of suth req'le'stec compensation and the following infonnation for each Study for which**c(,mp~nsation** 

### is requested:
1sargeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE68130-1

### no • Telephone 402,938.7000 • Fax402.938.7091 • www.sergeants.com



### I. the MRID number, 2. the StudyTitle, 3. the date ofStudy submission, and 

### 4. the amount ofany compensation previously received by COMPANY forthe use of these data from other parties. Sergeant's requests a response from COMPANY within 90 days from the date ofthis 

### letter. IfSergeant's does not receive a response within 90 days, it will understand that no data compensation is requestedby COMPANY. Ifyouhave any questions, please contactme at 402-938-7079. 

### Sincerely, 

# Jkit;iUIJ-- Kelly Hoskins Manager ofTechnical Affairs 

### Sergeant's Pet Care Products, Inc.
cc: Larry

### Nouvel, Sergeant's Pet Care Products, Inc.

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# Confirm Search Results Label/Receipt Number: 7010 1670 0000 7307 8209 Status: Delivered Your item was delivered at 10:43 am on March 03, 2011 in DULUTH, GA 30096. A proof ofdelivery record may be available through your local Post Office for a fee. Additional information for this item is stored in Illes offline.

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5/17/201 IDATE OUT: SUBJECT:
FROM:

TO: Company Name: Formulation Type: INTRODUCTION: 0385133; FILE SYMBOL No.: 2517-RUT; PRODUCT NAME: Sergeant's Fipronll + DECISION No.: 442431; PC Code(s): 128965, 129121, 129032;
May 12, 2011 End Use Product Chemistry Review Product Name: Sergeant's Fipronil + Etofenprox +Nylar Spot-On for Cats

, U 

## ,V'I--1\' \) I Shyam Mathur,

.

### <\~V'd**-~**

# \

Product Chemistry Team Leader 

# 'is <. 

### r Technical Review BranchlRD (7505P) 

# 9 C,;)9-
Rosanna Louie I Richard Gebken, RM 10 Insecticide Branch I RD (7505P) Seargent's Pet Care Products Incorporation Spot-On for Cats 

## S-

# It

# 1/ 1 ')

The registrant has submitted an application for the registration of the new end use product "Sergeant's Fipronil + Etofenprox+Nylar Spot-On for Cats". In support ofthe registration application, the registrant has submitted 830 series group A & group B data with MRID Nos. 483026-01 & 483026-02.The registrant has also submItted CSF's for basic & alternate formulations (both dated 11-16-10) and the product label. TRB has been asked to detennine the acceptability of product chemistry data submitted to support the proposed basic and alternate CSF's. SUMMARY OF FINDINGS: 1. Name ofActive Ingredient(s): Fipronil (9.8%), Etofenprox (15.0%) & Pyriproxyfen (2.2%; Nylar) 2. Has the registrant claimed substantial similarity to a registered product? IIYes; [Xl No; [ 1NA; if yes, provide the registration number ofthe cited product. EPA Reg. No: 3. All of the source materials ofthe active ingredient are derived from registered sources- [Xl Yes; [ 1No 4. All inert ingredients have been screened by IIAB (11-29-10) and found to be approved for the proposed labeled uses. 5. Confidential Statement of Formula(s): [Xl Basic
- Dated: 11-16-10; Re-submitted
- Dated: [Xl Alternate CSF #1- Dated: 11-16-10; Re-submitted
- Dated: Alternate CSF(s) complies with 40CFR§152.43: [Xl Yes; [ 1No; [ 1NADP BARCODE No.: D385133; FILE SYMBOL No.: 2517-RUT; PRODUCT NAME: Sergeant's Fipronil + Etofenprox +Nylar Spot-On for Cats; DECISION No.: 442431; PC Code{s): 128965, 129121. 129032; ACTION CODE: R 310; FOOD Use: No
6. Product label
a. Ingredient statement: Nominal concentration ofAI listed on CSF{s) concurs with product label (PR Notice 91-2).

[Xl Yes, if not, explain below: Is the sub statement in compliance with PR Notice 97-6 (inert ingredient vs other ingredient) [Xl Yes; [ 1No; if not, explajn below: Metallic equivalent: [ 

### 1 Yes [Xl NA; Soluble arsenic: [l Yes [Xl NA Isomeric ratios: [[Yes [Xl NA Acid Equivalent: [[Yes [Xl NA; acid equivalent

## = b. Health related sub statements: Product contains? Petroleum distillate at > 10%: Methanol at > 4%: Sodium nitrate/Sodium nitrite [ [Yes [XI No [ [ NA [ [Yes [XI No [ [ NA [ [Yes [XI No [ [NA
c. Physical chemical hazard statement Product label requires a statement per 40 CFR §156.78 for: flammability, explosive potential or electric insulator breakdown? [[Yes [X] No Is the sub statement in compliance with PR Notice 98-6 (Total Release Fogger)? 

### [ 1

Yes; [ 

### 1 No; [Xl NA; if not, explain below d. Label requires,an additional Storage and Disposal statement: [ [Yes [Xl No; if yes explain below:



### 2DP BARCODE No.: 0385133; FILE SYMBOL No.: 2517-RUT; PRODUCT NAME: Sergeant's Fipronil + Etofenprox +Nylar Spot-On for Cats; DECISION No.: 442431; PC Code(s): 128965. 129121. 129032; ACTION CODE: R 310; FOOD Use: No

7. Group A: Product Chemistry Data TRB's determination of the acceptability for the proposed product is listed in the tables below. Data submitted TRB's Guideline No. Study Title Assessment MRID Nos. of Data Yes No Product Identity & Composition 830.1550 X A 483026-01 Description of materials used to 830.1600 produce the product X A 483026-01 Description offormulation 830.1650 process X A 483026-01 Discussion on the formation of 830.1670 impurities X A 483026-01 830.1700 Preliminary analysis NA Standard certified limits X A Certified limits Proposed Limits (158.350) Justification for 830.1750 wider limits 830.1800 Enforcement analytical method X A 481226-01 A 

## = Acceptance, N = Not Acceptable, G = Data Gap, W 

## = Waiver Request, I = In Progress, NA = Not Applicable; U

## =Upgradeable.



### 3DP BARCODE No.: D385133; FILE SYMBOL No.:**2517~RUT;** PRODUCT NAME: Sergeant's Fipronil + Etofenprox +Nylar**Spot~On** for Cats; DECISION No.: 442431; PC Code(s): 128965, 129121. 129032; ACTION CODE: R 310; FOOD Use: No

8. Group B: Guideline Study Title Value or Qualitative TRB's MRID Nos. No. Description Assessment of Data
830.6303 Physical State Liquid A 483026-02 830.6315 Flash point >90'C (194'F) A 483026-02 830.6316 Explodabilitv None A 483026-02 Not soluble or dispersible in 830.7000 pH water A 483026-02 830.7300 Density (units) 1.03-107 glee A 483026-02 A 

## = Acceptance, N

## =Not Acceptable, G 

## =Data Gap, W 

## = Waiver request, NA

## =Not applicable, I

## =In progress; U = Upgradeable.

4DP BARCODE No.: D385133; FILE SYMBOL No.: 2517-RUT; PRODUCT NAME: Sergeant's FiproniJ + Etofenprox +Nylar Spot-On for Cats; DECISION No.: 442431; PC Code(s): 128965. 129121, 129032; ACTION CODE: R 310; FOOD Use: No

CONCLUSIONS: The TRB has reviewed the product chemistry data submitted for the proposed end-use product and has concluded that 1. The proposed CSF for basic formulation & the CSF for alternate formulation #1 (both dated 11-16-10) are acceptable. 2, The data submitted corresponding to guidelines 830.1600 (description of materials used to produce the product), 830,1650 (description of formulation process), and 830.1670 (discussion on the formation of impurity), 830.1750 (certified limits) for the basic & altemate formulations are acceptable. 3. The data cited for the guideline 830.1800 (enforcement analytical method) is acceptable. 4. The product chemistry data submitted corresponding to the guidelines 830.6303 (physical state), 830.6314 (oxidation/reduction), 830.6315 (flammability), 830,6316 (expJodabllity), 830.6319 (miscibility), 830.7000 (pH), 830.7100 (viscosity), and 830 7300 (density) are acceptable, 5, The registrant has not submitted the productchemistry corresponding to the studies for one year storage stability (830,6317) and corrosion characteristics (830.6320). The registrant has stated that these two studies are in progress and the results will be submitted to the Agency when the studies are completed. It is recommended that the observations should be made at 0, 3, 6, 9, and 12 month intervals and the result must be submitted to the Agency at the end of the studies



### 5

### April 22, 2011 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Subject:

From:

To:

Registrmlt: 

### Name ofpesticide Product: SERGEANT'S FIPRONIL 

### + ETOFENPROX 

### + NYLAR SPOT-ON FOR CATS EPA Reg. 

### No.lFi1e Symbol: 25I7-RUT DP Barcode: DP 385134 DecisionNo.: 442431 Action Code: R310 PC Codes: 129121 (Fiproni1: 9.8%); 129032 (Pyriproxyfen: 2.2%); 128965 (Etofenprox: 15%) Byron T. Backus, Ph.D., Toxicologist 

# 0**~rr-.** '(1 **_ ...** 11 .,... Technical Review Branch

### Af<~

## t _ ""L"\..- 1....0 l \ , Registration Division (7505P)**~.' ~**  

### Rosanna Louie-IuzwiakIRichard Gebken RM 10 **"r** Insecticide Branch Registration Division (7505P) 

### SERGEANT'S PET CARE PRODUCTS FORMULATION FROM LABEL: Active Ingredient(s): 

### 129121 Fipronil 128965 Etofenprox 129032 Pyriproxyfen Other Ingredient(s): 

### TOTAL ACTION REQUESTED: The Risk Managerrequests: bywt. 9.80% 15.00%

2.20% 

### 73.00% 100.00%

"Attn TOX please conduct an acute toxicity review on the attached studies in support ofa new cat spot-on product containing fipronil, pyriproxyfen and etofenprox..."

Page 1(lOBACKGROUND: The material received for reviewincludes a cover letter dated 11/18/20I0, a datamatrix which references 5 acute toxicity studies (MRIDs 483021-03 through 483021-07), a proposed label, and aCSF(dated 11116/2010). COMMENTS AND RECOMMENDATIONS: I. All five ofthe acute toxicity studies have been previously reviewed (TRB memorandum dated 04/22/11 for DP 385123) and classified as acceptable. After comparingthe CSF for 2517-RUTwith the material that was tested, TRB concludes that these studies satisfy all acute toxicity datarequirements for the registration ofEPA File Symbol 2517-RUT except for acute inhalation. Itis noted thatthe test material contained S-Methoprene in addition to the active ingredients present in 2517-RUT. 2. Given the product use (a spot-on for cats), and the lack ofany significant potential inhalation exposure, TRB recommends for a waiver ofthe acute inhalation toxicity study requirement. 3. The following is the acute toxicity profile for EPA File Symbol 2517-RUT (SERGEANT'S FIPRONIL 

### + ETOFENPROX 

### +NYLAR SPOT-ON FOR CATS), based on the results ofthe citedtoxicity studies: Acute oral toxicity 

### III Cited MRID 48302103 Acute dermal toxicity 

### III Cited MRID 48302104 Acute inhalation toxicity IV Waived Primary eye irritation 

### III Cited MRID 48302105 Primary dennal irritation IV Cited MRID 48302106 Demlal sensitization Negative Cited MRID 48302107 4. Based on the acute toxicityprofile above, and taking into consideration the proposed uses specified on the label and infonnation in the 

## esp, the following is the precautionary and first aid labeling for EPA File Symbol 2517-RUT (SERGEANT'S FIPRONIL 

### + ETOFENPROX 

### +NYLAR SPOT-ON FOR CATS) as obtained from the Label Review System: PRODUCT 10#: PRODUCT NAME: 002517-00147 SERGEANT'S FIPRONIL 

### + ETOFENPROX 

### + NYLAR SPOT-ON FOR CATS PRECAUTIONARY STATEMENTS SIGNAL WORD: CAUTION Hazards to Humans and Domestic Animals: Harmful ifabsorbed through skin. Harmful if swallowed. Causes moderate eye irritation. Avoid contact with skin, eyes or clothing, Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco Or using thetoilet. Remove and wash contaminated clothing before reuse. [Wear protective eyewear.]* *[Protective eyewear may be specified, ifappropriate]. Page 2 of3First Aid: Ifon skin: -Take off contaminated clothing. -Rinse skin immediately with plenty ofwater for 15-20 minutes. -Call a poison control center or doctor for treatment advice. Ifswallowed: -Call a pOison control center or doctor immediately for treatment advice. -Have person sip a glass ofwater ifable to swallow. -Do not induce vomiting unless told to by a poison control center or doctor. -Do not give anything to an unconscious person. If in eyes: -Hold eye open and rinse slowly and gently with water for 15-20 minutes. -Remove contact lenses, if present, after the first 5 minutes, then continue rinsing, -Call a poison control center ordoctorfor treatment advice. NOTE TO PHY5IOAN: Note to PMjCRMjRegistrant: The proposed label should contain a "Note to Physician". The following statements are suggested types of information that may be included, if applicable:
- technical information on symptomatology;
- use of supportive treatments to maintain life functions;
- medicine that will counteract the specific physiological effects ofthe pesticide;
- company telephone number to specific medical personnel who can provide specialized medical advice. Have the product container or label with you when calling a poison control center or doctor or going for treatment. You may also contact 1-800-xxx-xxxx for emergency medical treatment information. 

### 5. The CSF (dated 11/16/2010) 

### for 25I7-RUT should also be reviewed and accepted by the TRB Chemistry Team. 6. This review does not address the requirements for companion animal safety studies (or citations for such studies) to support the registration of2517-RUT.

Page 3 00

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

NOTE TO RM 10 Richard Gebken OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

SUBJECT: Certification to Compliance with Child-Resistant Packaging Regulations EPA FILE NO: 2517-RUT (147) DP 386764, Decision: D442431 DATE: 

## APR 1 1 "1

Please note that EPA FILE NO: 2517-RUT certification for the 9.8% fipronil-containing spot-on catproduct (0.50 ml) regarding child-resistantpackaging (CRP) has beenreviewed, and is acceptableregarding compliance with the standards of40 CPR 157.32. The submitted CRP Self-Certification sununary, dated March 7, 2011, in support ofthe subject proposed product cited a previously-submitted study, Wlder MRlD 48279601. 

### Itis noted that although there is an additional active ingredients (etofenprox and pyriproxyfen) in this proposed product, the applicantnotes that there is no significant increase in fonnulation toxicity withregards to CRP. A failure to marketthese products with the identical size and colorpackages and fill weight colors as were tested for each size will result in the requirementto submit additional data for theseproducts to establish that they are CRP. Should any human experience/epidemiological evidence indicate a problem once the product is in the marketplace, the Agency reserves the right to reexamine this datacomprehensively andto questionthe childresistance ofthe package involved. Please place a copy ofthis note in the registrationjacketforthe above named product. Please advise the registrantthatthis CRP certification is acceptable. Ifyouhave any questions, please contact me at (703) 308-0037.

Rosanna Louie-Juzwiak, R

# ~L%eo14 

# 'ti«Jr Rosalind L. Gross, Secondary ReviewerSergeant's Pet Care Products, 

### Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanlS.com



### March 7, 2011 Richard Gebken, PMIO Office ofPesticide Programs (7504P) U.S. Environmental ProtectionAgency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 

### Subject: Child Resistant Packaging Certification Sergeant's Fipronil 

### + Etofenprox 

### +Nylar Spot-On for Cats EPA File Symbol 2517-RUT Dear Mr. Gebken: I certifY thatthe packaging used for the following product meets the standards of40 CFR 157.32, includingthe revised standards in 16 CFR 1700.l5(b), whentested by therevised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21,1995):

• Sergeant's Fipronil 

### +Etofenprox

### +Nylar Spot-On for Cats (EPA File Symbol 2517- RUT). Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158'" Plaza, Suite 100, Omaha, NE 68130-1703, EPA Company Number 2517) submitted a child resistantpackaging study under EPA Reg. No. 2517-137, MRID 48279601 (Perritt study 1746-01). The submitted data comply with current CRP regulations. Theresults from this CRP study 0.5 mL applicator are being submitted to supportthe pending productregistration for Sergeant's Fipronil 

### +Etofenprox 

### +Nylar Spot-On for Cats (EPA File Symbol 2517-RUT). CRP data are required for the above-referenced pending registration because ofthe inclusionofthe active ingredient fipronil (9.8%) in the spot-onproduct. The submitted CRP testing for the catproduct was conducted on a standard package size and white color configuration containing 0.5 mL fill volume for a product containing fipronil (9.8%). For children opening the applicators, opening ofone applicator was considered an individual failure. The above-referenced Sergeant's cat product can rely upon the same CRP data because it contains fipronil at 9.8%, and consequently requires CRP packaging. Althoughthe product also contains etofenprox andpyriproxyfen as active ingredients, they do not significantly add to the toxicity ofthe formulation. Additionally, Sergeant's or Pet Logic LLC (EPA Company Number 69332, owned by Sergeant's), already have cat spot-onproducts registered by EPA containing etofenproxand pyriproxyfen, and none ofthem are subject to CRP.

### The fill size for eachproductis 0.5 mLjustas the fill size ofthe catproducttested inMRlD 

### 48279601.**fl/7ple5~** 

### When this new cat product is marketed, it

# withave the same applicator color (white), 

### same fill 

### volume (0.5 mL), 

### and same fill

### weight color as forthe catproductusedinthe submitted and referenced CRP testing. Therefore, Sergeant's is relying onMRlD 48279601 to address the CRP testing requirements. 

### Ifyou have any questions, please contactme at402-938-7079. Sincerely, 

# il

.00, 

# ,fWl!to} 

# LA.b**K~~ns** ManagerofTechnical Affairs Enclosure

cc: Larry

### Nouvel



### 2• Identify which package is associated with the CRP test data; MRID number48279601 was conducted on a three-pack of0.5 mL white applicator tubes with a purple stripe connected to each other. The applicator consists ofthree parts, which are an applicatortip, a cap, and a main chamberbody. The applicatorlooks like a tube in a rectangle of plastic. Atthe top area ofthe applicator extending from the cap there is a narrow (needle like) applicatortip. In the rectangle ofplastic surrounding the applicatorin the narrowtip areathere is a notch onthe 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 purple colored stripe on each applicatorlabel connectedto each other. The colorofthe stripe is associated with the applicator size. The applicator, which is filled withwateras a placebo, comes inone size, 0.5 ml.

• A description ofthe package tested including a photograph ofthepackage; The testpackage was the cat spot-on 0.5 ml white applicator (base color) with a purple label indicator. Each applicatorcontains a single applicationandthe applicators were tested in a three pack configuration. The following outlines the detailed specifics ofthe spot-on applicator: Material Specifications: Opaque White PVClHigh Barrier HDLDPE with EVOH 240175Yield 

## I(;'ominal) 1665 sa. inllb., 3670 sa. inlh. OuterLayer: FDA grade opaque White PVC (Poly Vinyl Chloride), colour code 035, 240 micron (:0096") +/- 5%. Adhesive Layer: Novacote pre-polymer two component cross linked system

- 1.5 Ibs. per ream. 

### Inner (Sealant/Barrier) HOPE (High Density Polyethylene)

- EVOH (Ethyl Vinyl Acetate/Ethyl Layer-Non-Peelable: Vinyl Alcohol Copolymer)

- LLDPE (Linear Low Density Polyethylene) LDPE'(iow Densltv'Polvethvlene)blend 75 micron-;:003") +/- 5%. -PVC comphes wIth FDA Code ofFederal RegulatiOns, Title 21, sections 178.2010, 178.2650, 178.3297, 178.3690, and 178.3790. -Adhesive comp!ies with FDA Code ofFederal Regulations, Title 21, section 175.105. -PE complies with FDA Code ofFederal Regulations, Title 21, section 177.1520. -EVOH !ayercomplies with FDA Code ofFederal Regulations, Title 21, sections 175.105 and 177.1360.

A photograph ofthe package (front and back) is shown below:



### 3

### • Thedirections on the packageused for SeniorAdult Use Effectiveness (SAVE) 

### Testing alongwith any additional directions provided to the Seniors during SAVE 

### Testing; Directions on a label on the back ofthe applicator stated "Use scissors to open." Additional directions to openthe package, whichwill appear on the label, were used for SAUE Testing. These directions read: "How to open: Remove product tubes [vial] from the package. Separate one tube from the others. Holding thetube [vial] with notched end pointing up and away from the face and body, cut off the narrow endatthe notches with scissors."

• If

### the package is considered unitpackaging- (answerthe next three bullets) Sergeant's cat spot-onproduct is considered unit packaging. The CRP testing was conducted on a three-count (3) of0.5 mL applicators connectedto each other.

4

### o Define the number ofunits that represent a child failure; The toxicity ofany cat product containing 9.8% fipronil is based onthe toxicity ofthe active ingredient fipronil. The toxic orharmful amount offipronil for an 11.4 kg child is 2.5 kglkg times 11.4 kg, which equals 28.5 mg. Access to a toxic or harmful amount = 

### 28.5 mg divided 

### by [1025 mg/ml x 0.098 fipronil]**~** 

### 0.284 ml**~** 

### 0.28 ml for fipronil catproducts. 

### Access to one applicatorrepresents a failure for a child for all applicator sizes equal to or greater than 0.28 m!.



### o Statethe number ofunits a child receives atthe beginning ofthe test; Each child was provided one three-count (3) package ofapplicators connected to eachother at the beginning ofthe CRP test.



### o The number ofchildren opening/accessing a toxic orharmful amount or opening orgaining access to more than 8 individual units, whichevernumber is lower during the full 

### to minutes oftesting. The CRP dataresulted in zero (0) childrenbeing successful at opening or gaining access to the contents ofthe Sergeant's 0.5 mL applicator; therefore, the child-resistanteffectiveness is 100.0%

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### UNITE])

### STATESENVIRONMENTALPROTECTIONAGENCY 

# s!< 401 M Street,S.W. WASHINGTON,D.C. 20460 Paperwork Redm:tion AdNotice: Thepublic reportingburden forthis C(Il1edion ofllformation isestimated to average 0.25hoursper response forregistration activities and0.25 hoursperresponse for reregistration and special review activities.includingtime for readingthe instruction and C(Impletingthe necesslUy forms. Sendcomments regardingtheburden estimate orany otheraspeltofthis C(Illcction of infurmation, including suggestionsfor reducingtheburdentoDirector; OPPEInfurmatkmManagement Division (2137) U.S. Environmental Prole(:tionAgency,401 MStreet, S.W .•Washington, OC 20460. Do notsend the form tothis address. 

### DATAMATRIX Date: Febru 17,2011 EPARe**No.lFile~ol 2517~RlIT**  Page I of3 Applicant'slRegistrant's Name & Address Product: Sergeant'sFipronil +Etofenprox+ Sw!eant'sPctCare Products., Inc. 2625 South 158thPlaza, Omaha, NE**68130~1770** Nylar**Spot~On** For Cats I edients: Fi ronil, Etofen rox, and ri ro 

## ,n GuidelineReference Number Guideline Stud Namc MRIDNumber Submitter Status Note 830.1550, 830.1600, 830.1620, Product Properties Data for Sergeant'sFipronil +Etofenprox + 48302601 Sergeant's Pet Care Products, Inc. OWN 830.1650,830.1670, 830.1750**~ylar ~t~On** For Cats 830.1800 Enforcement anal 'cal method 48122601 Se eant'sPet Care Products Inc. OWN 830.6302, 830.6303, 830.6304, Product chemistry of Sergeant's Fipronil + Etofenprox +Nylar 48302602 Sergeant's Pet Care Products, Inc. OWN 830.6313, 830.6314. 830.6315. Spot-On For Cats 830.6316, 830.6317, 830.6319, 830.6320,830.6321,830.7000, 830.7100,830.7300,830.7520 830.6317,830.6320 Storage stability and corrosion characteristics To be conducted Sergeant's Pet Care Products, Inc. OWN 870.1100 Acute Oral Toxicity Up and Down Procedure with CatProducts 48302103 Sergeant's Pet Care Products, Inc. OWN 870.1200 Acute Dennal Toxicity (Limit Test) with Cat Products 48302104 Sergeant's Pet Care Products, Inc. OWN 870.]300 Waiver RequestofRequirement for Furthcr Testingfor Acute 48129605 Sergeant's PetCare Products, Inc. OWN Inhalation Toxicity 870.2400 Acute Eye Irritation/Corrosion with Cat Products 48302105 Sergeant's Pet Care Products, Inc. OWN 870.2500 Acute Dermal Irritation/Corrosion with Cat Products 48302106 sergeant's Pet Care Products, Inc. OWN 870.2600 Test for Sensitization (Guinea Pig Maximisation Test) with Cat 48302107 Sergeant's PetCare Products, Inc. OWN Products 870.7200 Companion animal safety evaluation ofaspot-on containing two 48302108 Sergeant's Pet Care Products, Inc. OWN toxicants andtwo insect**gr~wth** rel!Ulators on kittens and cats 870.7200 Companion animal safctyevaluation ofa spot-on containing two 48302109 Sergeant's Pet Care Products, Inc. OWN toxieants and two insectgrowth regulators on kittens and cats. Executive SUmmary ofDataand Conclusions. 870.7200 Companion Animal Safety Study for an Etofenprox-IGR Spot-On 46161309 Pet Logic, L.L.C. OWN Kittcns andCats 870.7200 Domestic Animal Safety: Assessmentofthe Tolerance ofa 0.25% 43121112 Mcrial Limited OLD RM 1601 Spray Fonnulation in Cats at 3, 9, and 15 ml/kg When**j\ppiied.~**Times to the Haircoat at28Day Intervals: Sig",tu<'

### K{~ ,f,L

### ~ Name and Title Date Kelly R. Hoskins, ManagerofTechnical Affairs 02/17/2011 EP"FomoSS10--l5(9- ecttooio.u>lP.pe,v**~bl._ sub",~onlyP.l"fversion.**  "S-qbl..-..al.U

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### UNITED STATES ENVIRONMENTALPROTECTIONAGENCY**,~** 

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

### WASHlNGTON,D.C. 20460 Paperwork ReductionActNotice: The public reportingburden for this collection ofnfonnationis estimated toa'Yerage 0.25hours perresponse forregistration aclivities and 0.25 hours perresponsefor reregistration and special review actiuties, includingtime forreadingthe in2eregistrationcompletingthenecessary foons. Sendcomments regarding the burdenestimate orooyotheraspectofthis collection ofinfonnation, including suggestionsforreducing theburdento Director: OPPE InfonnationMlUlagementDivision(2137) U.S. Environmental ProtectionAgency, 401 MStreet, S.W., Wa91ingmn, DC 20460: Do not**sen~~** form todtis address, 

### DATAMATRlX Date; Febru 17,2011 EPA Reg No,/File Symbol 2517-RUT Paj!;e 2 of3 Applicant'slRegistrant'sName & Address Product: Sergeant'sFipronil +Etofenprox + Seri!:eant's Pet Care Products, [nc. 2625 South. 158th Plaza, Omaha, NE 68130-1770 Nylar Spot-On For Cats In ients: Fi roni!, Etofenprox, andPyriproxyfen Guideline ReferenceNumber Guideline Study Name MRID Number Submitter Status Note 870.7200 DomesticAnimal Safety Study ofRMI601C 0.25%Topical 43272401 Merial Limited OLD Spray in Juvenile Cats 870.7200 DomesticAnimal Safety Study ofRMI601CTopical Spray 

## I (Frontline Spray Treatment) in Juvenile Cats 43444904 Merial Limited OLD 870.7200 Discussion in Support ofBridging Domestic Animal Safety 43577711 MerialLimited OLD Data**on:~~tIine** SprayTreatment to Frontline SpotTreatment Data Pae e. 870.7200 Positive Referenced and Untreated Controlled Dose 43577713 Merial Limited OLD Confirmation Trial ofRMl601E I()I'A. SPOT-ON Fonnulation Applied to Cats for Control of the Cat Flea Ctenocephalides felis 870.7200 Percutaneous Absorption and Distribution ofRadioactivity in 43577716 MedalLimited OLD Hair, Skin, and FatAfter Spot-On Application of(Carbon 14)- RMI601 in Cats 810.3300 Immediate Efficacy ofa CombinedApplication ofFrontline 48302110 Sergeant's Pet Care Products. Inc. OWN Pluswith Etofenprox as a Squeeze-on against Fleas (Ctenocephalidesjelis) and Ticks (Dermacentor variabilis}) on Cats. Studv ID 185C 810.3300 Immediate Efficacy ofa Combined Application ofFrontline 483021 II Sergeant's Pet Care Products, Inc. OWN Pluswith Etofenprox as a Squeeze-on against Fleas (Ctenocephalidesjelis) and Ticks (Dermacentor variabilis) on Cats. Studv lD 181C 810.3300 Comparative efficacy evaluation ofSergeant's Squeeze-on and 48302113 Sergeant'sPet Care Products, Inc. OWN FrontlinePlus for the treatment ofadult cat flea (Ctenocephalides/elis) and tick (Haemaphysalis elliptica, Rhipicephalus turanicus and Dermacentorvariabilis) infestations on cats. 810.3300 Comparativeefficacy evaluation ofSergeant's Squeeze-on and 48302114 Sergeant'sPet CareProducts, Inc. OWN Frontline Plus for the treatmentofadult cat flea (Ctenocephalidesfelis) and tick (Haemaphysalis elliptica, Rhipicephalus turanicus and Dermacentorvariabilis) 

## l**~~estations** on cats. Executive Summary ofData and onc1usions

# ~~~::~:Mg{L.**~€ rZ?subm;.omyp.~rv~M'**  Nameand Tille Date Kelly R. Hoskins, ManagerofTcchnical Affairs 02/1712011 A..tJleviJIl

.....o.IU••C

...., ___• _" • __ '

___ •• _____•• __• _____ • __0

____• " '_'

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.... _ , __ ..___ ". •• • • __ •• """ •• ____ • _ • , __ '

....... _**.~_.** _ ••_ • __••• __ 'M F_APllnwedOMBN•.lt7'- 

### UNITED STATESENVIRONMENTALPROTECTIONAGENCY


# .. 401 M Street, S.W. £ 

### WASHINGTON,D.C. 20460 Paperwork Reduction ActNotice:Thc public reportingburden forthis collection ofilfonnation is estimated to avcragc 0.25hours per7esponse forregistrationactivities and 0.25 hoursperresponsefor reregisttatioo and special review activities, includingtimeforreadingthe inJeregislratioocompletingthenecessaryforms. Sendcomments regardingthe burdcnestimateorany otheraspectofthis collection of information, including suggestionsfurreducingthe burdento Director: OPPEInformationManagementDivision(2131) U.S. Environmental ProtectionAgency,401 MStreet, S.W.,Washington, IX::20460. Do notsend the form tothis address. 

### DATA MATRIX Date: February 17,2011 EPA Re No.lFileS bol 2517-RUT P e300 Applicant'slRcgistrant'sName & Address Product: Sergeant'sFipronil +Etofenprox + Ser2eanfs PetCare Products, Inc. 2625 Soulh 158thPlaza, Omaha. NE 6813Q..1770 Nvlar Soot·On ForCats 1 redients: Fi ronil, Etofen rox, and ri roxyfen Guideline Reference Number Guideline Study Name MRlDNumber Submitter St,,", Note 810.3300 Selective Cite All Merial Limited OLD/PAY lHO.3300 Summary ofAnalyses ofEfficacy Data to SupportLabel Claims 46161310 Sergeant's Pet Care Products, OWN for an Etofenprox·Pyriproxyfen Spot..()n for Use on Cats and Inc. 0028. 810.3300 Dose Titration to Detennine the Relationship betweenDose Rate 46161316 Sergeant's Pet Care Products, OWN ofNylar(Pyriproxyfen) when Applied as a Spot-On to Kittens and Inc. the DurationofResidual Flea Ovisterillization. 40CFRPart 157.32 EvalUaiion ofthe Cat Squeeze On 0.5ml White Applicatorwith 48059503 Sergeant's Pet Care Products, OWN Purple Label Indicator(3x), scissors toopen·F=I as aPoison Joe Prevention Package for Sefgeant's Pet Care Products, Inc. 40 CFR Part 157.32 Amended Report: Evaluation ofthe Cat Squeeze On O.Sml White 48279601 Sergeant'sPet Care Products, OWN ApplicatorwithPurple Label Indicator(3x), scissors to open·F=I Inc. as aPoisonPrevention Package for Sergeant's Pet Care Products, 1"", / Signature: 

# KJJ{ ,.I/.. /**~** Name and Title Date Kelly R. Hosk.ins, ManagerofTcchnical Affairs 0211712011**''''''-,,~ .,,"-~,**  I<>-an ",

...._,**_~** ...**_"....;~. h.".~,** **~.** "

.....v ...__ ••,_ "-n_""T.'

.....'**n,,'-e~v**Care Products, Inc. 2625 Soulh 1581h Plaza • Omaha, NE 68130-1770 • relephone 402.938.7000 • Fax 402.938.7091 • www.sorgeants.com
January 17,2011 Richard Gebken, PMI0 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 Sergeant's Fipronil 

### + Etofenprox Spot-On for Cats EPA File Symbol 2517-RUT Dear 

### Mr. Gebken: 

### I certify that the packaging used for the following product meets the standards of40 CFR 157.32, including the revised standards in 16 CFR l700.15(b), when tested by the revised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995):



### • Sergeant's Fipronil + 

### Etofenprox Spot-On for Cats (EPA File Symbol 2517-RUT). Sergeant's PetCare Products, Inc. (Sergeant's, 2625 South 158"Plaza, Suite 100, Omaha, NE 

### 68130-1703, EPA Company Number 2517) submitted achild resistant packaging study under MRID 48279601 to support the pending product registration for Sergeant's Fipronil 

### + Etofenprox Spot-On for Cats. The submitted data comply with current CRP regulations to support anew product registration. We have enclosed asummary ofthe 

### requested study to supportthis certification statement. Ifyou 

### have any questions, please contact me at 402-938-7079. Sincerely,

# ;i!1~ Kelly R. Hoskins Manager ofTechnical 

### Affairs Enclosure

cc: Larry NouvelCRP Certification Study Summary
Sergeant's Pet Care Products, Inc. (Sergeant's) conducted a CRP study and submitted 

### itto EPA for review and comment. The study was assigned MRID number 48279601. The studywas conducted on a tltreeMpack of0.5 mL white applicator tubes. The following information is provided to EPAto summarizethe study results. Study Title: Amended Report: Evaluation ofthe Cat Squeeze On 0.5 mL "White Applicator with Purple Label Indicator (3x), scissors to open - F=l as a Poison Prevention Package for Sergeant's Pet Care Products, Inc. 

### MRID: 4827960I

• Identifywhich packageis associated with the CRP test data; Theresults from the CRP studyregarding Sergeant's Cat Spot-On 0.5 mL applicatoris being submitted to supportthe following pendingEPAregistration applications:

EPAFile Svmbol Product Name 2517-RUT Sergeant's Fipronil 

### +Etofenprox 

### +Nylar Spot-On for Cats 2517-RUA Sergeant's Fipronil

### +Nylar Spot-On for Cats 2517-RUL Sergeant's Fipronil 

### +Etofenprox 

### +Methoprene Spot-On for Cats 2517-RUI Sergeant's Fipronil 

### +Etofenprox Spot-On for Cats CRP data are required for the above-referenced pendingregistrations because ofthe inclusion of the active ingredient fipronil (9.8%) in the spot-on products. The submitted CRP testing for the catproduct was conducted on a standard package size and color configuration containing 0.50 mL fill volume for a productcontaining fipronil (9.8%). For children opening the applicators, opening ofone applicator was considered an individual failure. The aboveMreferenced Sergeant's catproductscanrely upon the same CRP databecause they each contain fipronil at 9.8%, and consequently require CRP packaging. Although each product listed above also contains etofenprox, pyriproxyfen and s-methoprene, these active ingredients do not significantly add tothe toxicity ofthe fonnulation. Additionally, Sergeant's or Pet Logic LLC (EPA CompanyNumber 69332, owned by Sergeant's). already has cat spot-on products registeredby EPA containing each ofthe listed active ingredients and none ofthem are subject to 

### CRP. The fill size for each product is 0.5 mLjust as the fill sire ofthe cat product tested in MRID 

### 48279601. "When each ofthe newcatproducts are marketed, they will have the same applicator color (white). same fill volume (0.5 mL), and same fill weight color as for the catproduct used in thesubmitted and referenced CRP testing. Therefore, Sergeant's is relying on MRID 48279601 to address the CRP testing requirement.

• A description ofthe package tested including a photograph ofthe packagej The testpackage was the cat**spot~on** 0.5 ml white applicator (base color) with a purplelabel indicator. Each applicatorcontains a single application and the applicators weretested in a three packconfiguration. The following outlines the detailed specifics ofthe spot-on applicator: Material Specifications: I Opaque White PVClHigh Barrier HDLDPE with EVOH 240175 Yield I (nominal) 1665 sq,In/lb., 3670 sq. Infkg. Outer Layer: FDA grade opaque White PVC (Poly Vinyl Chloride), colour code 035, 240 micron (0096") +/- 5%. Adhesive Layer: Novacote**pre~polymer**two component cross linked system**~** 1.5 lbs. per ream. Inner (SealantIBarrier) HDPE (High Density Polyethylene)**~** EVOH (Ethyl Vinyl AcetateiEthyl Layer-Non-Peelable: Vinyl Alcohol Copolymer)**~** LLDPE (Linear Low Density Polyethylene) LDPE (Low Dens'ity'Polyethylene) blend, 75 micron (.003")**+/~** 5%.**~PVC** complJes WIth FDA Code ofFederal RegulatIOns, TItle 21, secttons 178.2010, 178.2650, 178.3297, 178.3690, and 178.3790.**~Adhesive** complies with FDA Code ofFederal Regulations, Title 21, section 175.105. opE complies with FDA Code ofFederal Regulations, Title 21, section 177.1520. -EVOH layer complies with FDA Code ofFedera! Regulations, Title 21, sections 175.105 and 177.1360.

A photograph ofthe packageis shown below:• The directions on the package uscd for Senior Adult Use Effectiveness (SAUE) Testing alongwith any additional directions provided to the Seniors during SAUE Testing; Directions to open the package onthe label used for SAUE Testing read: "Howto open: Remove producttubes [vial] from the package. Separate one tube from the others. Holdingthe tube [vial] with notched end pointing up and away from the face and body, cut off the narrow end at the notches with scissors."

• The SAUE, the numberoffemales and males in each ofthe three age groups, the numberofSeniors tested for each tester, and the numberofSeniors obtained or tested at each test site (see checklist belowfor 16 CFR 1700.20 requirements); The SeniorAdult Use Effectiveness (SAUE) was determined to be 90.0%. The number offemale and male seniorsparticipating in each ofthe three age groups (50-54, 55-59, 60-70 years) is provided in Table I below. Tables 2 and 3represent a summary ofthe number ofseniors tested with each tester (notto exceed amaximum of35% ofsenior adults per tester) and the number of seniors tested at each test site (notto exceed amaximum of24% ofseniors pertest site). Please see report for full details.

Table I: Total number ofmale and female senior adults in each age group. 

# I Age in Males Females 

### Total Years 

### 50·54 7 18 25 55·59 8 17 25 60·70 15 35 50 Totals 

### 30 70 100 i This study componentis in compliance with 16 CFR 1700.20. Table 2: Total number ofsenior adults tested for each tester. 

### I Tester 

### No. Code Seniors



### 7 24 15 29 33 30 

### ! 37 17 I 

### Total 

### 100 

## ! This study component is in compliance with 16 CFR 1700.20 as the number ofseniors pertester never exceeded 35%.Table 3: Total numberofsenior adults obtained or tested at eachtest site. 

# I No. Testsite Seniors 

## I H726 I

, H902 24 H904 II H961 10 H967 20 H969 24 H975 I 

## I H980 9 

### i Total 100 This study component is in compliance with 16 CFR 1700.20 as the number ofseniors tested at each sitenever exceeded 24%.



### • FortheChild-Resistant Effectiveness (eRE) 

### the CRE, the numberofchildren tested, the number offemales and males in each ofthe three age groups, the number ofchildren tested for each tester, and the numberofchildren obtained ortested at each test site (see checklist below for 16 CFR 1700.20 requirements); The Child-resistanteffectiveness (CRE) was determined to 

### be 100.0% effective. A total of50 children were tested for child-resistant effectiveness andthe number offemales and males in each ofthe three test groups (42-44, 45-48, 49-51 months) is shown in table 4. Tables 5 and 6 represent a summary ofthe numberofchildrentested with eachtester (with a maximum of30% ofchildren in each group pertester) and the number ofchildren tested at eachtest site, (with a maximum of20% ofchildren in each group pertest site). Please see report for full details. Table 4: Total number ofmaleand female children in each test group i 

### l Age in Males Females Total 

### i Months 

# i 42-44 7 8 IS 45-48 10 10 20 , 49-51 8 7 IS 

# , Totals 25 25 50 

## I This study component is in compliance with 16 CFR 1700.20 as the age ofchildren for each group never exceeded 30%.40%, or 30%, respectively. Additionally, the difference between boys and girls in each age range never exceeded 10% ofthe number ofchildren in that age range.Table 5: Total number ofchildrentested for each tester. 

# I Tester 

### No. Code Children I 12 7 

### 4 i I 15 14 

# , i 

### I 33 14 37 6 Total 

### 50 This study component is in compliance with 16 CFR 1700.20 as the number ofchildren per tester never exceeded 30%. Table 6: Number ofchildren obtained or tested at each test site.
! 

### No. 

# l Test Site Children HI69 2 , I HI82 8 

### I H246 10 

## I H260 4 

### I H294 10 H321 10 H472 4 H634 2 Total 

### 50 This study component is in compliance with 16 CFR 1700.20 as the number ofseniors tested at each site never exceeded 20%.

• The number ofchildren opening/accessing the contents in the first 5 minutes, the numberofchildren opening/accessing the contents in thefull 10 minutes; No children were successful in opening or gaining access to the contents ofSergeant's Cat SqueezewOn Product during the first 5 minutes orfull 10 minutes ofthe CREtest.

• Ifthe packageis considered unit packaging- (answer the nextthree bullets) Sergeant's cat Spot-Onproductis considered unit packaging. The CRP testing was conducted on a three-count (3) of0.5 mL applicators in one unit.o Definethe number ofunits that represent a child failure; The tox'wity ofany cat product conta'1n'mg 9.3% flpronil isbased on the toxicity ofthe active ingredient fipronil. Thetoxic orhannful amount offipronil for an 11.4 kg child is 2.5 kg/kg times 11.4 kg, which equals 28.5 mg. Access to a toxic or hannful amount == 28.5 mg divided by [1025 mg/m! x 0.098 fiproni!J**~** 0.284 m!**~** 0.28 m! for Fipronil catproducts. Access to one applicator represents a failure for a child for all applicator sizes equal to orgreater 

### than 0.28 m!.

o Statethe number ofunits a child receives at the beginning ofthetest; Each child was provided one three-count (3) package ofapplicators at the beginning ofthe CRP test.

o The number ofchildren opening/accessing a toxic or harmful amountor opening orgaining access to more than 8 individual units,whichevernumber is lowerduring 

### the fuUIO minutes oftesting. The CRP data resulted in zero (0) children being successful at opening or gaining access tothe contents ofthe Sergeant's0.5 mL applicator; therefore, the child-resistant effectiveness is 100.0%.**~,** _D STATES ENVIRONMENTAL PR( C, .INAGENCY WASHINGTON, D.C. 20460

December 14, 2010

OPP DecisionNumber: D-442431 EPA File Symbol or RegistrationNumber: 2517-RUT OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

ProductName: SERGEANT'S FIPRONIL 

### +ETOFENPROX 

### +NYLAR SPOT-ON FOR CATS EPA Application Receipt Date: 23-Nov-20I0 EPA WaiverRequest Receipt Date: 23-Nov-201

# a EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CARE PRODUCTS, INC. KELLYR. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703 SUBJECT: Approval of50% Small Business WaiverRequest DearRegistrant: The Office ofPesticide Programs has approved your request for 50% waiver ofthe pesticide registration fee associated 

### vvith the action referenced above. The decision review period for this action will begin on the date ofthis letter. 

### The Action has been identified as Action Code: R310 NEW PRODUCT;NON-FASTTRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PESTEFFICACy); Ifyouhave any questions, please contactthe Pesticide Registration Service Fee Ombudsman, at (703) 308-9362.
Sincerely,

Oscar Morales, Director Information Technology & Resources Management Division Office ofPesticide ProgramsSergeant's Information to Address EPA Front-End Deficiencies James Messina 

### to: Rachel Metz 

### 12/03/201011:33 AM Cc: KHoskins, "Carrie Daniels", "Matthew Feinberg" Show Details

History: This message has been replied to. Ms. Metz, Page I ofI

In response to your email dated November 3D, 2010, please find enclosed the following information to upgrade the pending submissi90ns for 2517-RUI, 2517-RUT, 2S17-RUl and 2S17-RUA: 1. Sergeant's has cited MRID 48122601 in the support data matrixfor each ofthe pending products to address data requirement 830.1800 (Enforcement Analytical Method), The study is designed to identify the active ingredients fipronil, s-methoprene, etofenprox, cyphenothrin and pyriproxyfen in one analysis; therefore, Sergeant's can cite itto support each ofthe pending registrations as they contain various combinations of the listed active ingredients. 2. Corrected page 32 for volume 14 ofthe submission under 2S17-RUl. 3. Corrected Formulator's Exemption forms for 2S17-RUI and 2S17-RUT. We have listed all ofthe TGAI registrations and confirmed the typographical error. Please respond to this email to confirm your receipt ofit. Ifyou have any questions, please contact me. Best Regards, James Messina Senior Managing Regulatory Consultant Exponent Center for Chemical Regulation and Food Safety 1150 ConnecticutAvenue, N.W. Suite 1100 Washington, DC 20036 202-772-4932 202-772-4979 fax 301-908-1181 cell
CONFIDENTIALITY NOTICE: This electronic transmission (including any files attached hereto) may contain information that is privileged, confidential and protected from disclosure. The information is intended only for the 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 or any employee or agent responsible fordelivering 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:IDocuments and SettingslnnetzlLocal SettingsITemplnotesFCBCEEI-web5469.htm 

### 12/3/20I0Re: Following up on ourrecent phone call KHoskins to: Rachel Metz 

### 12/03/2010 09:29 AM Cc: 

### Aswathy Balan, Sree Nair, LNouvel, Inouvel, "Matthew Feinberg",jmessina Show Details

Ms. Metz, 

### Page 1of3

Thank you for the update, we did not discuss on Tuesday the 30th thatwe were on such a limited time frame. We will do our best to get them to you today by noon EST. Kelly R. Hoskins Manager of Regulatory Affairs Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza Omaha, NE 68130-1770 ph 402-938-7079 fx 402-938-7179 khoskins@sergeants.com

Metz.Rachel@epamail.epa.gov
12/03/201007:17 AM

Dear Mr. Hoskins: To KHoskins@SERGEANTS.com
cc Nair.Sree@epamaiLepa.gov,Balan.Aswathy@epamail.epa.gov Subject Re: Following up 011 our recent phone call

Unfortunately, with expedited processing I'm not able to hold on to your materials past noon (EST) today. If the corrections that we'd discussed are ready after that time they should be sent directly to the relevant PM. Thank you again for your cooperation. Sincerely, Rachel Metz Macfadden, EPA Contractor 2777 8. Crystal Drive, 84910B Arlington, VA 22202 Ph:**703~305-6177** Fax: 703-305-5060

From: KHoskins@SERGEANTS.com

file:IIC:\Documents and Settinl!s\nnetz\Local Settings\Temo\notesFCBCEE\-web3828.htm 12/3/2010khoskins@sergeants.com
Metz.Rache!@epamail.epa.gov

11/30/2010 11:00 AM

Dear Mr. Hoskins: To khoskins@sergeants.com cc Subject Following up on our recent phone call 

### Page 3 of3

I'm writing to follow up on our recent conversation regarding your submission in support of four products: Sergeant's Fipronil + Etofenprox Spot-On (2517-RUI) Sergeant's Fipronil + Eto£enprox + Nylar Spot-On (2517-RUT) Sergeant's Fipronil + Etofenprox + Methoprene Spot-On (2517-RUL) Sergeant's Fipronil + Nylar Spot-On (2517-RUA) We have found the following deficiencies; I} In the data matrix for all four submissions you cite another submission for the Enforcement Analytical Method guideline (830.1BOO). R310 End-use products must submit this (and all product chemistry data} for each proposed product. 2) The 13th study/14th volume in the 2517-RUL submission has contradictory confidentiality markings. Page 32 of Comparative Efficacy Evaluation of Sergeant's Squeeze-On and Frontline Plus for Treatment of Adult Cat Flea and Tick Infestation on Cats is marked as confidential. Please either resubmit with the confidentiality marking removed from this page or "This statement supersedes all other markings" added to the statement of non-confidentiality on page two of the study (PDF or fax is fastest)

. 3} Two of the submissions have discrepancies between the Confidential Statement of Formula and Formulator's Exemption pages that need to be corrected.

- Firpronil + Etofenprox's (2517-RUI) Formulator's Exemption Form lists the reg. numbers on the alternate formulation CSF for Fipronil but not the reg. number on the basic formulation CSF for this ingredient {in other words, assuming the basic formulation CSF is correct, needs to be added to the Formulator's Exemption}

.

- Firpronil + Etofenprox + Nylar's (2517-RUT) Formulator's Exemption has the same problem with Fipronil. In addition, it lists as the reg. number for Etofenprox whereas the CSF (both basic and alternate formulation) lists Thank you for your cooperation, and have a great day! Sincerely, Rachel Metz Macfadden, EPA Contractor 2777 S. Crystal Drive, S4910B Arlington, VA 22202 Ph: 703-305-6177 Fax: 703-305-5060



### file:IIC:\Documents and Settings\rmetz\Local Settings\Temp\notesFCBCEE\-web3828.htm 12/3/2010UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

November 26, 2010

SERGEANT'S PET CARE PRODUCTS, INC. SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703
Report ofAnalysisfor Compliance with PRNotice 86-5 OFF!CEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

Thank you for your submittal of 19-NOV-IO. Our staffhas completed a preliminary analysis ofthe material. The results are provided as follows: Your submittal was found to be in full compliance with the standards for submission of datacontained in PRNotice 86-5. A copy ofyourbibliography is enclosed, annotated with Master Record ID's (MRlDs) assigned to each docwnent submitted. Please use these numbers in all future references to these documents. Thank you for yourcooperation. Ifyou have any questions concerningthis data submission, please raise them 

### with the cognizant Product Manager, to whom the data have beenreleased.ur..!rrt:D STATES ENVIRONMENTAL PROT
.... -,TlUN AGENCY WASHINGTON, D,C, 20460



### November 24, 2010

OPP DecisionNumber: D-44243I EPAFile Symbol orRegistration Number: 2517-RUT OFFICE OF PREVENTION, PESTICIDES Ai'JD TOXIC SUBSTANCES



### ProductName: SERGEANTS FIPRONlL 

### +ETOFENPROX 

### +NYLAR SPOT-ON FORCATS EPA Receipt Date: 19-Nov-2010 EPA CompanyNumber: 2517 CompanyName: SERGEANTS PET CARE PRODUCTS, INC.EPA File Symbol or Registration Number: KELLY 

### R. HOSKINS SERGEANTS PET CARE PRODUCTS, INC

.. 2625 SOUTH I58TH PLAZA OMAHA,NE 68130-1703

SUBJECT: Receipt ofApplication and 50% Small Business Waiver Request

- Correction DearRegistrant: The Office ofPesticide Programs has receivedyour application, 50% small business waiver request, and cerification ofpayment. Ifyou submitteddatawiththis application, the results ofthePRN-86-5 screen will be communicated separately. Duringthe administrative screen, the Office ofPesticide Programs has detenninedthatthis Action is subjectto a Pesticide Registration ServiceFee as defined in the Pesticide Registration Improvement Act. The Actionhas been identified as Action Code: R31 0 NEWPRODUCT;NON-FASTTRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PESTEFFICACY); Yourrequestfor waiverhas beenforwarded for review. Youwill be notified inwriting when a detenninationis made regarding yourrequest. Ifyourwaiver request is approved, the decision reviewtime period will start onthe date ofapproval. If

### yourwaiverrequest is denied, youwill receive aninvoice for the outstandingbalance. Ifyouhave any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362,483020-00 

### Sergeant's PetCare Products, Inc. 2625 South 1581h Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com November 18, 2010 Richard Gebken, PMlO Office ofPesticide Programs (7504P) (REGFEE) 

### u.s. Envirorunental Protection 

### Agency Document Processing Desk Room**S~4900,** One PotomacYard 2777 South Crystal Drive Arlington, VA 22202 Subject: Sergeant's Fipronil 

### + Etofenprox 

### +Nylar Spot-Onfor Cats EPA File Symbol 25l7-NEW /" 

## f':"f! DearMr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeants, 2625 South 158"Plaza, Omaha, NE 68130-1770, EPA CompanyNumber 2517) is submitting an EPA registration application for the new end-use product Sergeant's Fipronil 

### + Etofenprox 

### +Nylar Spot-On for Cats [containingthe EPA registered active ingredients Fipronil (9.8%), Etofenprox (15.0%), and Pyriproxyfen (Nylar) (2.2%)]. Please find enclosed the following documentation in support ofthis registration: (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) (14) (15) (16) (17) Transmittal Document; Application ForRegistration (EPA Fonn 8570-1); Basic Confidential Statement ofFonnula (EPA Fonn 8570-4) (Two Copies); Alternate#1 Confidential Statement ofFonnula (EPA Form 8570-4) (Two Copies); Formulator's Exemption Statement (EPA Fonn 8570-27); Certification With Respect to Citation ofData (EPA Form 8570-34); DataMatrix (EPA Fonn 8570-35)

- EPA And Public Versions; Product Label (Five Copies); LetterofAuthorization; Child Resistant Packaging (CRP) Certification Statement; : ' c**~** , ; Bridging Argumentto Cite CRP Data; , Submission ofEPA Pesticide Registration Improvement Act Inforillat!Qf:'; Voluntary Small Business Certification Form; , , : C' PRLA FeeWaiver Certification Statement; " , " , 

### ",,

,

, , , G L'

'" ' Recent EPA Approval Of50% Small Business Waiver Request (D-425455); ,.,' PRIA Category R31 0, Payment Confinnation Receipt; and Three Copies ofSuppomng Studies. The registration application for Sergeant'sFipronil 

### + Etofenprox 

### +Nylar Squeeze-On for Cats is a selective citation registration for a new end-use product.'Sergeant's is submitting new product chemistry studies in support ofthis end-useproduct. Additionally, Sergeant's is citing acute toxicity studies, companion animal safetydata and efficacy studies submitted to EPA on November 16, 2010 with theregistration application for Sergeant'sFipronil 

### + Etofenprox 

### + Methoprene Spot-Onfor Cats (MRID Numbers have notbeen assigned yet). The acute toxicitySergeant's Pet Care Products, Inc. 2625 SoU1h 158th Plaza • Omaha, NE 68130-1770 • Te!ephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com and companion animal safety studies were conducted on a "soup" that contains multiple active ingredients that can bebridged across multiple fonnulated**end~use** products. This registration application is considered a PRIA CategoryR310 (new end-use product) with a PRIA review time of6 months. Sergeant's submitted a PRIA Small Business Waiver Request under separate coveronApril 14, 2010, and itwas approved byEPA on May4,2010. A copy of this approval letter is enclosed. We look forward to working with the Agencyto register Sergeant's Fipronil 

### + Etofenprox 

### + Nylar Spot-On for Cats. Ifyouhave any questions or need additional infonnation regarding this registration application, please contact me at**402~938~**7079. 

# SkJ;IIlLvlifo
KellyR. Hoskins

# ~ Manager ofTechnical Affairs Enclosures

,( ('
" ( "

, ,,(

"< (

### TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Sergeant's Pet Care Products, Inc. 2625 South 158'h Plaza Omaha, NE 68130-1770 CONTACT PERSON (Return to) Kelly R. Hoskins Sergeant's Pet Care Products, Inc. 2625 South 158'hPlaza Omaha, NE 68130-1770 REGULATORYACTION SUPPORTEDBYTHIS PACKAGE: This submission is to supportthe EPA registration application for the new end-useproduct Sergeant's Fipronil 

### +Etofenprox 

### + Nylar Spot-Onfor Cats. SUBMITTAL DATE: November 16, 2010

Volume StudyTitle I 

### Administrative Materials 2 Group A Product Chemistry for Sergeant'sFipronil 

### +Etofenprox 

### + Nylar Spot-On for Cats 3 

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

### + Etofenprox 

### +Nylar Spot-On for Cats MRIDNo.
48302801
• • 

### ""', 48302802

. (' .



# . 

# .. .Please read instructions on reverse beforlo np/eting form Form Appro\ OMS No 20700060 Approval expires 05 31 98 . . . United States 

### c><:J.Registration OPP Identifier Number 

# EPA Environmental Protection Agency 

### D.Amendment Washington, DC 20460 

# o Other Application for Pesticide
- Section I 1.**companf:~ct** NRber.- 2. EPA Product Manager 3. Proposed Classification 2517- 

### Lt I Richard Gebken 4. Company/Product (Name) Sergeant's Pet Care Products, Inc.!Sergeant's Fipronil + 5.PM# 10

### ~None DRestricted Etofenprox + Nylar Spot-On For Cats 5. Name and Address ofApplicant (/nclude ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(I), my Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling to: 2625 South 1581h Plaza Omaha, NE 68130-1770 EPA Reg. No. PlOduct Name D Checkifthis is a newaddress Section II 

# o Amendment
- Explain below. 

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

# o Resubmission in response to Agency letter dated XX-XX-XX 

# o "Me Too" Application 

# o Notification
- Explain betow.

### ~ Other
- Explain below. Explanation: Use additional page(s) If necessary. (Forsection I and Section 11.) Submission of a new end-use product registration application.

Section III 1. Materiat This ProductWill Be Packaged In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container 

### [g] Yes' 

### [g] Yes DYes DMetal DNo D No 

## I3J No [2J Ptastic If"Yes" No. per If"Yes" No. per DGlaSS *Certification must Unit Packaging wgt. Container Package wgt. Container DPaper be submitted 0.Ot7 fl oz (O.5omli 3 vials 

## I DOther (SpeClfy)

### Pla~tiC Bag 3. location of Net Contents Information 4. Size(s) Retail Container 5. Location of label Direc,itA,s [2JLabel D Container 0.50 ml DOn Can IZJOn labe,;ng accomnanyiP2 product 6. Manner in Which label is Affixed to Product DUthograph [gJOther



# - DPaperglued DStenClled Section IV 1. Contact Point (Complete items directlybelowforidentificalion ofindividuaJ to be contacted, ifnecessary, toprocess this app/icetion.) ._ Name Titte Telephone No. (1'1:;l'ideArea Code) Kelly R Hoskins ManagerofTechnical Affairs 402-938-7079 Certification 6. Date Application I certify that the statements I have made on this form and att attachments thereto are true, accurate and complete. r Received acknowledge that any knowingly false or misleading statement may be punishable byfine or imprisonment or both (Stamped) under applicable law. 2. Signature 

# (etl2, 

# 1-./ rrfJ

# ~ 3. Title BY: ManagerofTechnical Affairs
4. Typed Name: {/ 

### I I 5. Date: 11/16/2010 Kettv R HoskinsPay.gov**~** OnlinePaymer

..

Online Payment Step 3: Confirm Payment Thank you. Yourtransaction has been successfully completed. Pay.gov Tracking Information Application Name: PRIA Service Fees Pay.gov Tracking 10: 25101L54 Agency Tracking 10: 74122351781 Transaction Date and Time: 06/1812010 14:30 EDT Payment Summary Account HolderSergean1's Pet Care Products, Name: Inc Payment Date: 06/21/2010 Decision Number: Payment Amount: $2.289.00 Registration Number:**2517~new** Page 1of1

11213

AccountType: Business Checking Routing Number: 1 Account Number:**~""5483** Company Name: Sergeant's Pet Care Produ Company Number: 2517 Action Code: R310

https:llwww.pay.gov/paygov/paymen1s/authorizeACHPayment.html 6/18/2010From: SCraft@SERGEANTS.com [mailto:SCraft@SERGEANTS.com] Sent: Thursday, November 18, 201010:48 AM To: James Messina 

### Subject: Fw:**P~y.Gov** 

### Payment Confinnation Susan Craft Regulatory Affairs Specialist Sergeant's Pet Care Products, Inc. 2625 S. 158thPlz. Omaha, NE 68130 (402) 938-7021 (402) 938-7121 (fax)**-~-~-** Forwarded by Susan Craft/SERGEANTS on II! 18/101 0 09:4g AM

----- 

### pavgovadmin@mail.doc.rn'aLgov 11/17/201001:37 PM To "scraft@sergeants.com" <scrafi@sergeants.com> cc Subject Pay.Goy Payment Confinnation

THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY. Yourtransaction has been successfully completed. Transaction Summary Application Name: PRIA Service Fees Pay.gOY Tracking ID: 251TL9QS AgencyTracking ID: 74152847197 Name On Account: Sergeants Pet Care Products Transaction Type: ACH Debit Transaction Amount: $114.50 Payment Date: Nov 18,2010 Account Type: Business Checking RoutingNumber: Account Number: ************5483 Transaction Date: Nov 17,20102:37:12 PM NumberofPayments Scheduled: 1 Frequency: OneTime DecisionNumber: Registration Number:**2517~New** CompanyName: Sergeants Pet Care Produc CompanyNumber: 2517 Action Code: R310Form approved. OM6 No. 2070-0060, 2070-0057. 2070·0107, 2070-0122, 2070.01$4.

Applicant's Name and Address Sergeant's Pet CareProducts, Inc. South 1 58thPlaza IOmaha,NE 68130-1770 United states Environmental ProtectionAgency Washington, DC 20460 Formulators Exemption Statement (40 CFR 152.85)

EPA File SymbollRegistration Number 25 1 7-RUT
Product Name

Date ofConfidential Statement ofFormula (EPA Fonn 8570-4)

(1) This product contains the following active Ingredient(s): Fipronil Etofenprox Pyriproxyfen 11/1612010

(2) Ofthese, each active ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat active ingredient in the manufactlJrlng, formulation or repackaging another productwhich conlain; that active ingredient which is registered under FIFRA Sedion 3, is purchased by us from another person and meets the requirements of40CFR section 158.50(e)(2) or (3). (3) Indicate by checking (A) or (6) belowwhich paragraph applies: '71 (Al An accurate Confidential statement of Formula (EPA FORM8570-4)forthe above identified product is attached to this**~atement.** That formula statement indicates, by company name, registration number, and product name, the source ofthe active ingredlenl(s) nsted in paragraph (1). OR
I (6) The Confidential Statement ofFormUla (CSF)(EPA Form 857Q-4) referenced above ,md on filewith the EPA is complete, current, an accurate and contains the information required on the current CSF. (4) The following active ingredients in this product quanfyfor the formulator's exemption.


## I FiF>ron.iI Technical 

### IP""n"lI Technical 

# I Etolfenprox

Kelly R. Hoskins, ManagerofTeehnical 12103/2010 Copy 2·Applicant copyForm Approved OMS Nos. 2070-0060; 2070 0 0 010 -0 57; 2 70- 7; 2070-0122; 2070-0t64
/"' ... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ,..no.. 

### ",lOlIIZ' 1200 Pennsylvania Avenue, N.W

.

.::7 WASHINGTON, p.C. 20460 Paperwork Reduction Act Notice: The pubtic reporting burden for this collection ofinformation is estimated to average t.25 hours per response for registration and 0.25 hours per response for reregistration andspecial review activities. inetuding time for reading the instructions andcompleting the necessary forlns. Send comments regarding burden estimate or any oihcraspect ofthis eolleetioll ofinforJnation. including suggestions for reducing the burden to: Direetor, Cotlection Strategies Division (2822T), U.S. Environmental Protection Agency, t200 Pennsytvania Avenue, N.W., Washington, DC' 20460. Do not send til.: completed t"onn 10 this address. Certifica1ion wi1h Respect to Citation ofData Applicant's/Re!Jistrant's Name. Address, and Telephone Number EPA Re!Jistration Number/File Symbol Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha, NE 68130-1770 2517-NEW Active Incredient(sl arld/or representative test compoundfs1 Date**Fiproni~** Etofenprox and Pyriproxyfen t11l6l20to General Use Pattern(s) (list all those claimed for this product usin!! 40 CFR Part 158) Product Name Domestic indoor non-food Sergeant's Flpronil oj. Etofenprox + Ny1ar Spot-On for Cats NOTE: Ifyour product is a 100% repackaging ofanother purchased EPA-registered product labeled for all the same uses on your label, you do not need to submit this form. You must submit the Formulator's Exemption Slatement (EPA Form 8570-27). 

# 0 Iam responding 10 a Data-Call-In Notice, and have included with this form a list ofcompanies sent offers ofcompensation (the Data Matrixfonn should be used for this purpose).

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

# 0 Iam using the cite-all method ofsupport, and have included with this fonn 

# 0 t am using the selective method of support {or cite-all option a list ofcompanies sent offers ofcompensation (Ihe Data MatriXform underthe selective method), and have included with this form a should be used for this purpose). completed list ofdata requirements (the Data Matrixform must be used). SECTION II: GENERAL OFFER TO PAY IRequired ifusing the cite-all method orwhen using the cite-all option under the selective method to satisfy one or more data requirements) 

# 0 I hereby offer and agree to pay compensation, to other persons, with regard to the approval ofthis applicallon, to the extent required by FIFRA.

SECTION til: CERTIFICATION I certify that this application for registration. this form for reregistration, or this Data-Call-In response is supported by all data Submitted or cited in the application for registration, the form for reregistration, or the Data--Call-In response. In addition, ifthe cite-all option or cite-all option under the selective method is indicated in Section I, this application is supported by all dala in the Agency's files that (1) concem the properties or effects ofthis product or an identical or subslanllally similar product, or one or more ofthe ingredients in this product; and (2) is atype ofdala that would be required to be submitted under lhe data requirements in effect on the date ofapproval ofthis application if the application sought the inilial registration ofa product of identical or Similar composition and uses. I certify that for each exclusive use study cHed in support ofthis registration or reregistration. that I am the original data submitter or that I have obtained the written permission of the original data submiller to cite that study. I certify thatlor each study cited in support ofthis registration or reregistration that is not an exclusive use study, either: (a) I am theoriginal data submiller; (b) I have obtained the permiSsion ofthe original data submiller to use the study in support ofthis applicallon; (c) all periods of**eligi~i::t;** 'y compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have offered (I) to pay compensation to the exlent required bysections 3(c)(1 )(F) and/or 3(c)(2)(S) of FIFRA; and (ii) to commence negoijations to c.eterm;,\e the amount and terms ofcompensalion, ifany, to be paid for the use of the study. (certifythat in all instances where an offer ofcompensation is required, copies ofall offers to pay compensation a!,d eli,de, ,ce oflheir delivery in accordance with seclions 3(c)(1 )(F) and/or 3{c)(2){B) of FIFRA are available and will be submilled to the Agency upon reques\, Should Ifail to p'C'd"f'e such evidence to the Agency upon request, I understand that the Agency may iniliate action to deny, cancel or suspend the regisvaU".J or my product in confonnity with FIFRA. I certifythatthe statements I have made on this form and all attachments to itaretrue, accurate, and cO,"!"!'l'etp. I acknowledge that any knowinglyfalse or misleading statement may be punishable byfine or Imprisonment or both underapplicable law.
S;g""ore

# k:JJ1 Q,ll

# f ' rM_ Date Typed or Printed Name and l1Ue 11/1612010 Kelly R. Hoskins, Manager ofTect:,':;,,1 Affairs EPA Form 8570-34

### (~3) Electronic and ,",aper versi available. Submit only Paperversion.

### R310
End Use (EP) or Manufacturing Use (MP) product or Technical Grade of the Active Ingredient (TGAI). Must submit Group A and B product chemistry data for each proposed product unless it's a 100% identical (repack): YES 

### or NO (circle one)

EP Data MP Data Guldeline Group A: Product Chemistry Data Submitted Submitted TGAI No. Study Title Yes No Yes No Yes No 

### 830.1550 Product Identity & Composition 

## X Description of materials used to 

## K 830.1600 

## I produce the product 

### 830.1650 Description offormulation orocess ;A 

## I 830.1670 Discussion on the formation of impurities 

# x.. 830.1700 Preliminary analysis 

### X 830.1750 Certified limits 

### (158.3451 

### X. 830.1800 Enforcement analytical method 

## X
EP Data MP Data Guideline Group B: Product Chemistry Data Study f-So;u",b",m"Titt"e"d'-t=:Su",b",m"Titt"e"d,-+-:-:TG,-,-,A:.-'

## r:--;--I No.Sergeant's Pet Care ProdlIC!S, Illc. ;.'ti2:i**~;()11111** 158111 filazi"l • Olnahn, NE 68130-1770 • TelellhOll1: 402.938 70UO • Fax 402.938 7099 • V,\Wv SI)I'Wflllls com

1{ldlanl Cichl,cII I'I-u(iIll'1**;VLlniJ)!.~:I·"''''** I)u:.:um<:ll( I'ro<.:es:-Ing. Desk ()me\: (11'1'1.':-1 i**~'idc** Pn)g.ra illS t!,S. En\'inllllllt'nial Pf(llcClion**AgLIl~'.\'** Roo!)) S-401l0, One**r\llollla~'** Yard 2777 Slllllil Crysl:'11 Drin; Arlingloll, VA**22~U2-'-l5(jl**

SL'rgcanl's I'd ('nrc PI"(l(IUClS, Inc. (SL'rgcmll"s. 2625 So\nh 15R1h**Pla~.o.** Onlilha, Nehraska**6~** 130-1770, EPA**C~1lllpony** N(1I11bcl" 2517), il\l!ilnrizes £xpoJlcnl. 1111.'. (115(J CUllllL'ClicUI A\"<.:'Il\I<:. NW, Soile 1100, W[lshinglon DC'. 20ll36) to act on o(lr bcbalC as our A 1I1ho**rl~,cd** RcprcSClllallvt::, Jill' illl necessary imertlctiollS regarding !If! ofollr pr()(hIcl reglslrali(lll upplic,ltillns (ind registrations. Plcnsl' notL' (his d()es nol**~'hange** the currelll Jiled /\ll(lwrizcd AgCll1 n.II'**Scrg~unl's.** The E.'(pllllcnt. IllC.**C~)jjl[l('l** IS ilS fllllo\\'s: .1nlllcs Messina :lnd/(ll" Rick Tinsworlh Exp(lilent Inc. 1150 ConnectlC\1I Ave

.. N\V Suite 1100 \\!'ushingtoll, DC 10()36 (201) 772-4932**(~02)** n::-4()79**J~LX** j**IIIC~~**i11;11:(( cxpOllenl.colll:rIIIIS\\'**(lr(h(;-(·~'.\P( 11l~'IlI.**  <':11111

Silll'Crch'.

# I~t:£? /1.

# ~-J£7~ tl l(l'lIy R. l'l()skill.<; tvlallag.cr ()rTcchniC'dl**Alfilir.~** CI.:: Junh:s Ml'SSIII'1Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### November 16,2010 Richard Gebken, PMlO Office ofpesticidePrograms (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 Sergeant's Fipronil 

### +Etofenprox 

### +Nylar Spot-Onfor Cats EPA File Symbol 25 1 7-NEW Dear Mr. Gebken: I certifythat the packaging used for the following productmeets the standards of40 CFR 157.32, including therevised standards in 16 CFR 1700.15(b), whentested bytherevised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995):

• Sergeant's Fipronil 

### + Etofenprox 

### + Nylar Spot-On for Cats (EPA File**Syrnbo12517~** 

### NEW) Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South l58'h Plaza, Omaha, NE 68130-1770, EPA Company Number2517) is submittingthis child resistantpackaging certificationto support for the new**end~use** 

### product for Sergeant's Fipronil 

### + Etofenprox 

### +Nylar Spot-Onfor Cats (EPA File Symbol 25l7-NEW). All product labels have language specifyingthe use ofscissors to open the product containerand label language stating the product is notto be applied by children. Ifyou have anyquestions, please contact me at**402~938~**

### 7079.

# sink~rJ~; KellyR. Hoskins Manager ofTeclmical Affairs

cc: LarryNouvelSergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com November 16, 2010

Rosalind Gross 

### clo Richard Gebken Registration Division Office o[PesticidePrograms (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 Support Sergeant's Fipronil 

### + Etofenprox 

### +Nylar Spot---On for Cats (EPA File Symbol: 25 1 7-NEW) Dear Ms. Gross: Sergeant's Pet Care Products, Inc. (EPA CompanyNumber2517) is supportingtheregistration ofSergeant's Fipronil 

### + Etofenprox 

### + Nylar Spot-On for Cats based upon a previously submitted Child Resistant Packaging (CRP) study. Theprevious CRP datawas submitted to EPA on April 12, 2010 in support ofthepending registration applications under EPA File Symbols: 2517-RGT and 25l7-RGL (all ofwhich contain Fipronil at 9.7-9.8%). The April 12, 2010 submission was Sergeant's generated CRP data with a standard white applicatorin size 0.5 mL. The following is a summary tableofthe applicator that was tested and submitted to EPA in the CRP data: Use A licatorBase Color Fill Wei ht mL Color Cats All Weiahts White 0.50 Pu Ie CRP datawas required for thependingregistrations under EPA File Symbols 2517

- RGT and 2517

- RGLbecause ofthe inclusion ofthe active ingredient fipronil (9.8%) in the squeeze-on products. The CRP testing for the catproduct was conducted on a standard package size and' color configuration containing 0.50 mL fill volume for aproduct containing fipronil**(9.~%).** For children openingthe applicators, openingofone applicatorwas considered an individua: -fdaure. The Sergeant's Fipronil 

### + Etofenprox 

### + Nylar Spot-Onfor Cats productbeirJg submitte;I,tQQ"y also contains fipronil at 9.8%, and consequentlyrequires CRP packaging. AlthougJthis new product also contains 15% etofenprox and 2.2% pyriproxyfen, these active il1£Tedients do )Jf)t significantlyadd to the toxicity ofthe fonnulation. Additionally, Pet Logic**LL~ ~£PA**  Cor.lpany Number 69332), owned by Sergeant's, alreadyhas a cat spot-onproductregistered by**E~t\.** containing55% Etofenprox and 2.2% Nylar (EPA RegistrationNumber 69332-3) that is not


### 1Sergeant's Pet Care Products, Inc. 2625 South 158111 Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com subject to CRP. The fill size for this new product will be 0.5 mLjust as the fill size ofthe cat product from theApril submission. TIle density ofthe new combination productis 1.03

- 1.07 glcc, whichis nearly identical to the densityrange for the previous cat products (1.00

- 1.05 

# glee).

When Sergeant's Fipronil 

### +Etofenprox 

### +Nylar Spot-On for Cats is marketed, it will have the same applicator color (white), same fill volume (0.5 mL), and same fill weight color as for the cat product used in the submitted and referenced CRP testing. Therefore, Sergeant's is relying on MRID specifically48059503 for the cat 0.5 ml size, to fulfill the CRP data requirement for Sergeant's Fipronil 

### + Etofenprox 

### +Nylar Spot-On for Cats. Ifyou have anyquestions, please contactme at402-938-7079.

# sine~R.#~ Kelly R. Hoskins 

# W

Manager ofTechnical Affairs

cc: LarryNouvel



### 2Sergeant's PetCare Products, Inc. 2625 Soulh 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com November 18, 2010 Richard Gebken, PMI0 Office o[Pesticide Programs (7504P) (REGFEE) 

## u.s. Environmental Protection Agency Document Processing Desk Room S-4900, OnePotomac Yard 2777 South Crystal Drive Arlington, VA 22202
Subject Submission ofEPA Pesticide Registration Improvement Act Infonnation U.S. EPA FIFRA Service Fees: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158"' Plaza, Omaha, NE 68130-1770, EPA CompanyNumber2517), is submitting PesticideRegistration Improvement Act Fees for the following newregistration application:

• Sergeant's Fipronil 

### + Etofenprox 

### +Nylar Spot-On for Cats R310, $4,578 (50% fee waiver $2,289), Pay.gov Tracking ID: 25101L54, Agency Tracking ID: 74122351781.

• To accountforthe FY 20IIIFY 2012 R310 increase to $4,807 (50% fee waiver $2,403.5), $1 14.50 was also submitted; Pay.gov Tracking ID: 25ITL9QS,Agency Tracking ID: 74152847197. This registration application is for a new end-use productwith supporting data and is considered an R310, new end-use product, requires review ofdatapackage within RD, PRIA review time frame 6 months, and a fee of$4,807. Sergeant's qualifies for a PRIA fee waiver/reduction of50% (refer to OPP Decision Number D-425455). Ifyou have any questions orneed additional infonnation regardingthis registration application, please contact me at 402-938-7079.

# sin~R.k~! Kelly R. Hoskins

# ~ ManagerofTechnical AffairsVoluntary Small Business Certification Formfor Pesticide Registration Fee WaiverlReduction Section 1: Business Identification CompanyName: Sergeant's Pet Care Products, Inc. Address: 2625 SOUtll 158m Plaza Omaha, NE 68130-1770 EPA Company Number: 2517 Contact Name: Kelly R. Hoskins Manager ofTechnical Affairs Phone Number: 402-938-7079 Fax Number: 402-938-7091 Email: KHoskins(a)SERGEANTS.com Section 2: EPA Pending Action Identification Product Name: Sergeant's Fipronil 

### + Etofenprox 

### +Nylar Spot-On for Cats Description ofAction Submitted to EPA: New end-use productwith product chemistry data EPA Identification 2517-NEW EPA Fee Category and Fee EPA PRIA fee category R310, 6 month review, $4,807 (50% fee waiver $2,403.50) Section 3: SmallBusiness Information/Documentation Fee Waiver Support as a Small Business (as Yes, 50%. applicable): Is the Applicant abusiness entitywith one or No. Refer to previously filed request ofDmore affiliates? 425455 (May 4, 2010) Business structure: include a chart or statement Referto previously filed request ofDdescribing the applicant's business entity, its 425455 (May4, 2010) relationships to parent/owner company(s) and/or affiliate company(s), and the percentage interest ofeach owner/affiliate. Includingparent and affiliate(s), the applicant's ( ) $10 million/year (75% fee waiver) average annual global gross revenue from (x) $60 million/year (50% fee waiver) pesticides for the last 3 years was less than or equal to: Documentation: Includerevenue statements for Refer to previously filed request ofDthe Applicant showing annual global gross 425455 (May 4, 20I0) revenue from pesticides for each ofthe three most recent completed fiscal ortax years. . Applicant's ( ) fiscal year (x) tax yearends on: September 30 Applicant's Audited Financial Statements are January 31 available on/about: Does the Applicant now employ 500 orfewer Yes employees? Documentation: include the most recent IRS 941 Refer to previously filed request ofDorW3 orotherofficial documentation 425455 (May4, 2010)



### ---FormApp,"ved OMII)'"o.2070·0060 

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

## _.,.,' 401 M Street, S.W. WASHINGTON, D.C. 20460 PlIpenvork Reductioo Aet Notice:**Th~** pubtic repunillg bunicil lor tJlis cn)lccli,lIl ofinfonnation is estiolatoo to average 0,25 hours**perre~pollse** lor n:gislnllillu ilctivitics and 0.25 hllUlS pn'**,,,.'pun~e** lor reregistration and spe<.:iat review activities. including**lilll~** fnr readillg the instruction and completing tJlC nccessary [onns, Send eommelllS regarding: llie hurtlell**estilllal~** (II' :lIIy ollieI'**a~p~'Ct** orlhiscllliceliOIl or infonnation. including suggestions for reducing thc**burd~n** tn Director. QPflE Infomlation Mallagcnlcnt Division (2137) U.S, Environlllcntni Protectiull Agmcy, 40) M**Str~~t.** S.W,.**Wa~hillghlll,** DC 20460. Du not send the form to this**addrc~s,** 

### DATA MATRIX Date: November 16, 20I0 EPA Re'No./FileS mhol 2517-l*E"WlZLl.T Pa'e) nf3 Applieant'slRcgistnmfs Name & Ad<hss Product: Sergeant"s Fipronil';- Etofcnprox + Ser,geant's Pet Care Products, Inc. 2625 South 158th Pla;.:a, Olnaha, NE 68130-1770 Nylar Spot-On For Cats Ingredients: Fipronil, EtotcnprOIl, and Pyriproxyfen Guideline Reference Number Gliidclinc Study Name MRlD Number Submittcr Status Note 830.1550, 830.I600, lBO.1620. Product Propcrtics Data tor Sergeant's Fipronil + Etofenprox + New submission Sergeant's Pet Care ProdUl:ts, 11Il:. OWN 830.1650,830.1670. 830.1750 Nylar Spot-On For Cats lte. '6u'"LwO\ 830.1800 Enforeclncnt analyticallnethod 48122601 Scrgeant's PetCare I'rodUl:ts, Inl:. OWN 830.6302, 830.6303, 83fl.6304, Product chcmistry of Sergcant's Fipronil + Etotcnprox + Nylar New submission Sergeant's Pct Care Products, Inc, OWN 830.63\3,830.6314,830.6315, Spo(-On For Cats 830.6316, 830.6317, 830.6319, 830.6320, 830.6321. 830.7000, '-I'03(t 2k,0"4 830.7100, 830,7300. 830.7520 830.6317, 830.6320 Storagc stability and COITosioll dUiracteristil:S To be submitted Sergeant's Pet Care Products, Inl:, OWN UDon completion 870.1100 Al:utl: Oral Toxicity Up and Dowil Prol:edure with Cat I'rndul:ts Submitted Sergeunt's Pd CareProducts, Ilic. OWN 'rB3CZ!O:; MRlD Pl:nding 870,1200 Al:utl: Dermal Toxil:ity (Limit Test) witll Cat Products Submitted Sergeant's I'd Care Produds. Inc. OWN up "1ol.t MRID Pelluin' ' ;,;""

.. t 870.1300 Waivl:r Rl:quest ofRequirclnl:nt for Further Testing for Acute Submitted Scrgeallt"s I'd Cllre ProtiUl:ts. Inl:. OWN .,<' Inhalation Toxkity MRlD Pending 870.2400 Acute Eye IrritatinnlCorTllsilln with Cat Products Submitted Sergl:ant" s Pd Cnrc Produds, Inl:, OWN 4'5'3007.10'::; MRID Pending 870.2500 Acute DennallrritationlCorrosinn with Cat Products Submitted Scrgl:ant"s Pet Care Produ(.:!s, InL OWN i+t)?v2tok> MRID Pending 870.2600 Tcst for Sellsitization (Guinea Pig Mallimisation T(,:$t) with Cat Submitted Sergl:allt"s Pet Care Prnducts, Inl:, OWN !fe30?w( Products MRID Pending 870.7200 COinpanion animal safety evaluatiOiI ofa spot-on containing two Submitted Sergelmt"s Pct CareProducts, Illc. OWN 49307tO'0 tuxkants and two inscct growth regulators onkittens and cats 

# - M,{ID'?cnding 870.7200 Companion animal satctyevaluatioll ofa spot-on containing two 

## - 3ubm;tted Sergeant's Pd Carl:**Producl~,** Ilic. OWN tnxil:ants and two insl:ct growth rcgulators on kittens and cats.**'M;~lD P~nding**  

### 4ft Executive Summw' ofData and Conclusions. 870.7200 Companion Animal Satety Study tor an Etofenprox-IGR Spot-On 46161309 Pct Logk, L.L.c. OWN Kittens and Cats , ", ,._._. __.r--:GI21 I 12"- 870.7200 Donlestil: Animal Satcty: Assessml:nt ofthe Tolerallcc',ofa**0.~:5%** ': Merial Limited OLD RM 160I Spray Formulation in Cats at 3, 9, alld 15 ml:kg'Wh'::l; Applied 6 Times tll tlleJiaircoat at 28 Day Intcrvals: 

## S;g""""

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## t."" 

# +-r Name andTitle Date Kelly R. Hoskins, Malla,ger ofTl:chnil:al Atlllirs 11/1612010**~I'A**fonn S570.)5?/,lt EI"""ook >d I'al'''' 'f,"s'",,,Ayailabl•. Sulti'**.m~'**'7'!(;iOO' Ag''''1' h"o,"ol Use COP)'Furm '\1'1,,",,<1IHIIl :"I». 2070·0060 

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

### 401 M Street, S.W

. 

# • WASHINGTON, D.C. 20460 PatlcrworkRed»etioll Act Notice: The puhlic reportillg burdCIi for tllis collcction ofilll'onnatiOiI is estimated to average 0.25 hours per responxe t'orregistl<llion activities nnd 0.25 Iiours pcr response tor reregistration allJ sllccial review activities, illcludillg time for n.'aJilig the in2eregistrationcolilpleting the necessary fonns, Send comments regaruing tho.'.' burdcll estimate orany otheraspL'Ct orthis collection ofinfonnation, iliciuJing suggesliolls lorreducing the bllruCIl to Director: OPPE Infomtation Managemcnt Division (2137) U.S. Ellvironmclltal Protcclion Agency, 40 I MStreet, S.W., Washillgtoll, DC 20460. Do not senJ the fOl1n to th'ls aJJn:ss, 

### DATA MATRIX Date: Novembcr 16, 201 0 EPA Re' Nlj)File Symbol 25I7-DU:o-W"RUT l'a"e20f3**Applicant's/Rcgi~trant's** Name & Address Product:**Scrgeant"~** Fiprnnil + Etofenprox + Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Nylar Spot-On Fnr**('at~** Ingredients: Fiprollil, Etofenprox, and Pyriprnxyfen Guideline Refcrence Numbcr Guidelinc Study Name MRID Number Submitter Status Note 870.7200 Domcstic Animal Safety Study ofRM 1601 C 0.25%Topical 43272401 Meriul Lim'llL'<I OLD Spray in Juvenile Cats 870.7200 Domestic Animal Safety Study ofRM 160lCTopical Spray 

## I (Frontline Sora Treatment) in Juvenile Cats 43444904 Merial Limiled OLD 870.7200 Discussion in Suppnrt ofBridging Domestic Animal Safety 43577711 Merial Limited OLD Data on Frontline Spray Treatmcnt to Frontline SpotTreatment Data Packa 'e, 870.7200 Positive Rdcrenced and Untreated Controlled Dose 43577713 Merial Limited OLD Contirmation Trial ofRM 1601 E 10% SPOT-ON Fonnulation Applicd to**Cal~** for Control nf the Cat Fica Ctenocephalides felis 870.7200 Percutaneous Absorption and Distribution ofRadioactivity in 43577716 Merial Limitcd OLD Hair, Skin, HIlII Fat Atler Spot-On Application of(Carbon 14)- RMI601 inCms 8103300 Immediate Efticacy ofa Combined Application ofFrontline Submitted Sergeant's Pet CarePruducts, Inc. OWN 4'6'"302.uO Plus with Etotenprox as a Squeeze-on againsf Fleas MRID Pending**(Cteno~'epltafides/eH:r)** and Ticks (Dermacewor**l'an'abifi~~)** on Cats. Study ID 185C 810.3300 Immediate Efficacy ofa Combincd Application ofFrontline Submitted Sergeant's Pet Care Prodw.:ts, Inc. OWN PIU!; with Etofenprox as a Squeeze-on against Fleas MRJD Pending (CtenocephalideS/dis) and Ticks (Dermacentar**mn'(fbili~~)** on Itt) il Cats. Study 10 181C 810.3300 CompHnltive ellicacy cvalwuinn nfScrgeant's Squeeze-on and Submitted Sergeant's Pet Care Frnduets, Inc, OWN Frnlltline Plus for the treatmellt ofadult cat tlea MRJD Pending (Ctelll!cepftllfides/elis) and tick (Haemapfly,w/i:r effipHca, '(; 3c'7, 1';4 Rhiplcep/w/II.'; (ffl'{lllicIIS and Dermacentor lIoriabllis) infestations on cats. 810.3300 Cnmparatlve elfleacy evaluation of Sergeant's Squeeze-on and Submitted Sergeant's Pet CW'e**Prnd(lct~,** Inc. OWN Frontline Plus for the treatment ofadult cat flea MRJD Pending (Ctellocep!w/idcsjefis) and tick (Haem(/pltpafis e//iptica, 4:rCO';oV I

### 3 RflipiCephaltls tllNmiclIs llfHI Demlr/celltar lIariabilis) infestations on**cat~.** EjCutive Summary ofDafa and C'nnclusions Signaturc: 

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# 19JiH Name ami Title Date Kelly R. Hoskins, Mannger ofTechnical Affairs IImi120 10 r.PA**~"** .,'0_" "_0,"**~I** M;" 0"_ P .•n"**\/M~;"'"** .,.**,.,bl,l~ ~** .."'m' nO P_",,, '. ,n '\",'nM ",.,·,,,.1 'he Com'

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W

.

.**~.** 

### WASHINGTON, D.C

.
• Tl

...**~**..**hJ:~ ."_~** .. ;,,.. ""-'''n forlhi, '" reregistration alKl"1JL>ciul review aCl;vilies, inchldi'ng lillie lor rCilding**lll~** I ofinfonnalioll, indllding5uggcsliOliS for reducing thebllrucn 10 Director 20460. Do no! selld the fonn 10 (his address. 11 is(

...., '"vu,.,**!'~' '~0l'""oe**  for**regi~!rmioll ac(ivi!ic~**  lIlid 0.25 houriS per**:c~~ons~_**ror y fOl1l1s. Send commcills regardillg die burden cslilllmcor,IllY nUlL'!'**aW~Cl** 01 \III>; eOIlL"CIiOIl

_ .. ,.., t37) U.S. Envirolimenl,1I Prolcclion Agency, 4t)] M Sln."CI, S.W

.. Washillgton, DC 

### DATA MATRIX Date: I

s Pet Care I
I 810.3300
I 81 0.3300 s Name &**I.~~,~_** "":, Lnc. 2625 South 158th Pla;l-U, Omalm, NE 68130-1770 ;, and l'yriproxykl**~?tudy** Nalile. A Prciililinary Study to Evnluatc Illitiul and RC!\idual Efficacy of Two RM ](i])1 Spray Fonnulllliull Topieully Applied Jor Control uftllc Cat Flc;1 in tile CUI A Do'Se COllfirtll<ltion Study to Verify the**Optim~l** "mnv

- -,**-.r:l~~** Coneclltration ofRM 16J1 ICfor COlltrol ofthe Cll -/-;,I:Sin the COl 810.3300 Dose-Titratioll (Volume) ofRM 160I Spray for Co Cat Flea Ctenoee Imlides felis in the Cat: Revised ofthc 810.3300 An Efficacy Study ofFrontIilie Top Spotfor tile Tp Control ofFelieola subro'Stratus in the Cat 

## I 810.3300 

## I 8J 0,3300 

## I 810.3300 An Efficacy Study ofFrontline Spray, Frontline Top**~** ML-2,095,988 50SQ Jor tile Treatment alld COlilrol ofFclieola subrostratus ill lile Cat :onHrm the Efficacy ofFipronil Against Lice in Cats 

## I**Und(;rField('--,J:·:~·-··**

Studies to ASL');s the Eftieney ofFrolitline Spot-Oil (J 0% w/y Fipronil) in tile Treatmellt ofFc1ille Flea Allergy Dermatitis FAD) llilder Field COllditions EPA I},

.. c SYlllbol s Fiprollil + J .0,
MRIDNulllber 43121119 

# IMcrial

43121120 

## I Merial Lilllitcd

43121121 I Merial Limited 4562810J 

## I Merial" 45628J02 

## I Merial Limited

45628103 

# I Merial Limited 45628104 \ Merinl Limited

810.3300 A Study to Determinethe EJfeet ofTreatment with Frontline 45628J05 Merial Limited**T_"C'~'lt** on the PreVlllellee and Severity ofFlea Allergy "n Cuts + 

### I

### status

OLD 

## IOLD 

# IOLD 

## I PAY 

# IPAY 

## I PAY 

## I PAY

810.3300 t sPetCareProducts, IIIC, \ OWN 

## I 810.3300 s Pet Care I ",1m;, 

## I OWN



# . . the Duratioll {IfResiduul t-tea UVlstentllzmlOl1. Pnge30f3

140 CFR Part 157.32 jEValUmion**oftll~** Cnt Squeeze.On 0.5ml Wllite**Apprleato~** witll 48059503 Sergeant's Pet Care Producls, Ilic. OWN [Y\C.Q,d i"V Purple Lubel Indlcutor (3x), selSS(lrs to orell

- F=I as a POison IJ,Y\ {)(.qnyd'.a\€. C 

### ',L -,t-""e f{li" Scrgc,lllt''S Pet Care ProcLu.(;t.s, Inc." t1'&17'7b oj

## J .L**~:** Name andTitle Dule Kell R. Hoskins, M<IIla 'crofTeclillical Amlir" I Iil6i2JlI0 EPA f"nn 85**,\"~.,,').** 1",,,,",,,,1\:," Cup)"