# EPA Reg. No. 2517-134 part 2

# Materialto be added to an e-JacketorJacket Reg. No. 2 ')/7-i?C( Description: (."D,Jo

## flY 

## I1vVIJIX\chwM;(-

1.



## 2. 

# ¥ Placementwithin the e-Jacket/Jacket 

# 9tI Default: (chronological, top 

# =newest) 

# o File Location: (PDF page number) 

# 'rf Send to Data Extraction contractors this material:



# . 191 Newly stamped accepted label 

# Yo Notification 

# o NewCSF 

# o Other:
__________ _ Attach this coversheetto the top ofthe material orjacket. Itmust be well-organized and clipped together

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

# Reviewer's Name: Rosanna Louie Phone: 308.0037 Division: RD Date: 1\ fc'132-0ll

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

Sergeant's Pet Care Products, Inc. c/o lvIr. James Messina, Exponent, Inc. 1150 ConnecticutAvenue, NW Washington, DC 20036 

## FEB - 3 2011 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

Subject: Amendmentto Sergeant's Fipronil 

### +Methoprene Dog Squeeze-On EPA Reg. No. 2517-134 Submission dated January 19, 2011 DecisionNo: 443571 Dear Mr. Messina: The labeling referred to above, submitted inconnection

### with registrationunderthe Federal Insecticide, Fungicide, and Rodenticide Act, as amended, is acceptable. Two (2) copies ofthe finished labeling must be submitted prior to releasingthe product for shipment.
A stamped copy ofthe label is enclosed for your records. Ifyouhave any questions regardingthis action, please contact Rosanna Louie-Juzwiak at (703) 308-0037.
Sincerely,

Richard Gebken Product Manager 10, Insecticide Branch Registration Division (7505P) Enclosure: Sergeant's Fipronil 

### + Methoprene Dog Squeeze-On, Stamped

### Accepted

# Sergeant'sMasterLabel 28 January2011 Amendment Version 10.2 EPANo. 2517-134 Information in 1 of9 EPA SAL4 Nov 2010


### [Optionaltext appears in brackets

- the final product label may include some orall ofthe optionaltext on front, back or side labelpanels.**_~]** 

# Sergeant's Fipronil 

# +Methoprene Squeeze-On for Dogs [ABNs] [(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs] [(Sergeant's®) (Sentry®) Ectoadvance (Spot On) for dogs] 

# ACCEPTED [SentryProline (Spot On) for dogs] 

### FEB - 3 2011 [[SENTRY®] FIPROGUARDTM PLUS for dogs] [[Sergeant's®] PRONYL OTC'M PLUS for dogs] UndertheFederalInsecttctde, FungIcide. and Rodent1cldeAct, as amended, forthepest1c1de Regtstered under [Applyto puppies over 8 weeks old] [Apply to puppies 8 weeks or older] [Mosquitoes] ,. EPA**~Reg.** No. 

### Z$l7 I

### 34 

# I@>O,<>T I WEON i CATS 

# , [Kills mosquitoes] [within24hours forup to 7 days] [and within 48 hours for up to 28 days] [Adult Fleas] [[Kills [adult] Fleas [for up to three months]] [Kills newly emerged adultFleas before they lay eggs] [Kills Adult Fleas, which may be a source of[flea allergy dennatitis] [, flea bite anemia]] [Kills Fleas Up to [4 weeks] [1 month] [30 days]!] [Ifdog is at high risk for flea reinfestation a once month application may beneeded] 

### [Multiple Infestations] [Kills chewing lice [and controls mites thatmay cause sarcoptic mange]] [Flea [&] [and] Tick Control for Dogs [&] [and] Puppies 8 weeks old [&] [and] older] [Kills fleas, flea eggs, ticks, chewing lice [&] [and] [mosquitoes]] [Kills fleas, ticks, [mosquitoes,] chewing lice, flea eggs, flea larvae 

### [&] [and] [prevents the development offlea pupae]] [Kills Fleas, Ticks [&] [and] [Mosquitoes]] [Breaks the Flea Life Cycle [forup to three months]] [Monthly flea, tick, [mosquito,] chewing lice and flea eggprotection] [Monthly flea, tick, [mosquito] and chewing lice protection] [Kills fleas, ticks, [mosquitoes,] flea eggs, andchewing lice] [[Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing lice, flea eggs, flea larvae 

### [&] [and] prevent the development offlea pupae]] [[Six] [6] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing lice, flea eggs 

### [&] [and] flea larvae] [[4 Week] [1 month] [30 day] [Flea [and] 

### [&] Tick Treatment] [[Four (4) Week] [1 month] [30 day] [Flea, Tick, and Chewing Lice Control] [[Four [4] Week] [1 month] [Flea, Tick, [Mosquito] and Chewing Lice Control] [Use [brand name] monthlyto break the flea life cycle.] [Use [brand name] monthly to control ticks and chewing lice]

# Sergeant's Master Label 28 January 20ll Amendment Version 10.2 EPANo. 2517-134 Informationin 2 of9 EPA SAL4 Nov 2010



### [Monthly flea, tick, [mosquito,] flea egg, flea larvae and chewing lice pr<Jte(;tic,n.] [Once A Month Flea and Tick [Application][Treatment] 

### [[4 week] 

### [1 month] 

### [30 day] Flea and Tick [Application] [Treatment]!] [Kills Fleas, [and] Ticks for up to 

### [4 weeks] 

### [1 month] 

### [30 days]!] [Kills Fleas, [and] Ticks [and Mosquitoes] for upto 

### [4 weeks] 

### [1 month]!] [Kills Fleas, Ticks, FleaEggs & Flea Larvae for up to 

### [4 Weeks] 

### [1 month] 

### [30 days]] [Ticks] 

### [Kills Ticks including those that may transmit Lyme disease] [Kills Ticks for Up to 

### [4 weeks] [1 month] 

### [30 days]!] 

### [Kills (deer) ticks [including those that may transmit Lyme Disease] [for up to [4 weeks] [1 month] 

### [30 days] [per application]] [Kills all stages ofdeerticks] [Kills Ticks (Including Deer Ticks) for up to [4 weeks] [1 month] 

### [30 days]] [Kills [brown dogticks], [American dog ticks,] [and lone starticks] [and deerticks] 

### [(Rhipicephalus sanguineus)] [for up to 

### [4 weeks] 

### [1 month] 

### [30 days]] [Kills American Dog Ticks 

### [(Dermacentor variabilis)] for up to 

### [4 weeks] 

### [1 month] 

### [30 days]!] 

### [Flea Eggs 

### and Larvae[ [Controls flea reinfestation forup to [12 weeks] [3 months]] 

### [Kills adult fleas, flea eggs, flea larvae and prevents the development ofpupae for up to [three months] [12 weeks].] 

### [Effectively controls all stages ofthe 

### flea (including adult fleas, flea eggs, flea larvae and prevents the development offlea pupae)] [Effective against all stages ofthe 

### flea (including adult fleas, flea eggs, flea larvae and prevents the development offlea pupae)] [Ifdog is at high risk for flea reinfestation a once month application may be needed] [Prevents from developing, flea eggs [larvae] [pupae] forup to [3 months] [12 weeks]] [With (S)-methoprene Insect Growth Regulator [IGR] which Breaks the Flea Life Cycle] [With (S)-methoprene to Break Flea Life Cycle] [With Insect Growth Regulator [IGR] to Break Flea Life Cycle] [Dual Action [!]:Fipronil with (S)-methoprene IGR [insect growthregulator] Effectively Breaks the Flea Life Cycle] [Dual Action [I]: Effectively Breaks the Flea Life Cycle 

## [ill [Kills Flea Eggs & FleaLarvaefor [up to 3 months] [upto 12 weeks]!] 

### [Prevents Flea Eggs From Developing Into Biting Adults] [Prevents all stages ofthe flea life cycle from developing] [Controls reinfestation offleas for up to 3 months] [Effective against all stages ofthe 

### flea life cycle] [Effectively controls all stages ofthe 

### flea life cycle] [All Others] 

### [For Dogs and Puppies 8 weeks ofage or older] [Controls mites that may cause sarcoptic mange]

# Sergeant's Master Label 28 January 2011 Amendment Version 10.2 EPANo. 2517-134 Information in [ ] is optional. Page 3 of9 EPA SAL 4 Nov 2010 [For Dogs [up to 221bs.], [23-441bs.], [45-88 Ibs.], [89-1321bs.]

[FastActing] [Long Lasting] 

### [Prevents reinfestation oflisted pests for [4 weeks] [1 month]] [Easy to use [application]] [Applymonthly] [[A once monthly application required][Apply monthly to control] [for] chewing lice] 

### [Rapid elimination ofchewing lice infestations] [[Three] [3] Applications] andlor [3 Month Supply] or [12 Week Supply] 

### [Best 

### ifused 

### year round!] [(ICON Showing [4 week] [1 month] [30 day] Protection)] [4 WeekDose!] [1 Month Dose!] [30 Day Dose!] 

### [Specially Formulated for Dogs and Puppies 8 weeks ofage 

### or older] [[Free] Calendar Stickers Inside!] [Apply once every [4 weeks] [month] [30 days]!] [WaterproofJ [Can be used on breeding, pregnant and lactating [bitches] [female] [dogs]] [[Free with purchase] [Free inside] Monthly ApplicationReminder [Magnet][insidelJ 

### [Can be used on puppies 8 weeks ofage and older] [Convenient spot treatment] [Easyto Use [ApplicationlJ 

### [Effective after bathing and exposure to water and sunlight] [For year-round protection, apply [Brand name] monthly] [Fipronil (9.8%) 

### +(S)-methoprene (8.8%)] [Lift [here] for more information] 

### [Contains Fipronil and (S)-methoprene[,] [-] the active ingredients used in Frontline Plus®*] [*[Brand name] is not manufactured by or distributed by Merial. Frontline Plus® is a 

### registered trademark ofMerial.] [U.S. PatentNo. 5,567,429] [3 applications] 

### [For year-round protection, apply [Brand name] monthly] [Effective after bathing and exposure to water and sunlight] [Stops and prevents infestation oflisted

### pests for [4 weeks] [1 month]] [Stops existing infestation and prevents establishment ofadditional infestation oflisted pests]

# Sergeant's Master Label 28 January 2011 Amendment Version 10.2 EPANo. 2517-l34 Information in Iis 40f9 EPA SAL 4Nov 2010

[Foruse ONLY on dogs [Up to 22lbs] 123-44lbs] [45-88lbs] [89-l32lbs] [over 8weeks ofage

## II [ForDogs & 

### Puppies 8weeks orolder andllup to 22lbs.1 IFor Dogs 23-44lbs.1 [ForDogs 45-88 lbs.] IForDogs 89-132lbs.1

ACTIVE INGREDIENTS: Fipronil

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

### (S)-methoprene

............................................................8.80% OTHERINGREDIENT**:

....................................81.40% TOTAL 100.00% I**diethylene glycol monoethyl etherl 

### KEEP OUT OFREACH OF CHILDREN 

### CAUTION
See [Back][or][Side] [Label Panel[sll for Additional Precautionary Statements

NET CONTENTS:

{END

- FRONT PANEL} [3] [three] 0.023 fl 

### oz (0.67 mL) applicators [3] [three] 0.045 fl 

### oz (1.34 mL) applicators [3] [three] 0.091 fl 

### oz (2.68 mL) applicators [3] [three] 0.l36 fl 

### oz (4.02 mL) applicators 

# =""

# Sergeant'sMasterLabel 28 January 2011 Amendment Version 10.2 EPANo. 2517-134 Information in 50f9 EPA SAL 4 Nov 2010

[[brand name] 

### contains Fipronil and S-Methoprene (insect growth regulator) (lGR) to effectively kill fleas and ticks [(includingthose that maytransmitLyme Disease).] [The active ingredients in [brand name] 

### feature a sustainedrelease fonnula developed for fast acting [and long lasting] control offleas, ticks, [mosquitoes] and chewing lice for up to [1 month] [[4][four] weeks] on dogs.] [Brand name] 

### READ ENTIRE LABEL BEFOREEACH USE. USE ONLY ONDOGSAND PUPPIES OVER 8 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TOHUMANS. CAUTION. Harmful ifswallowed. Causes eye irritation. Avoid contact with skin, eyes or clothing. Washhands thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on puppies under 8 weeks ofage. Individual sensitivities, while rare, may occur afterusing any pesticide product. [Some dogs may experience temporary startle effectswhenany product is applied.] Dogs may experience some temporary irritation atthe site ofproduct application. Ifsigns persist, orbecome more severewithin a few days ofapplication, consult aveterinarian immediately. Ifyour dog has an unusual reactionto the initial application, consult a veterinarian before repeating treatment. Certain medications can interact withpesticides. Consult a veterinarian before using onmedicated, debilitated or aged dogs. Call 1-800-781-4738 for 24-hour assistance.
FIRSTAID Ifswallowed: Call a poison control center or a doctor immediately for treatment advice. Have person sip a glass ofwater ifable to swallow. Do notinduce vomiting unless told to do so by a poison control center or doctor. Do not give anything bymouthto an unconscious person. Ifineyes: Flush eyes withplenty ofwater. Call a doctor ifirritationpersists. Ifon skin: Washwith plenty ofsoap and water. Get medical attention ifirritation persists. HOTLINENUMBER Have the product container or label with you whencalling a poison control center or doctor, or going for treatment. You may also contact**1~800~78IA738** 

### for emergency medical treatment infonnation.

# Sergeant'sMasterLabel 28 January 2011 Amendment Version 10.2 EPANo. 2517-134 60f9 EPA SAL 4 Nov 2010

DIRECTIONS FORUSE It is a violation ofFederal lawto use this productih a manner inconsistent 

### with its labeling. DONOTALLOW CHILDREN TOAPPLY PRODUCT. TO PREVENT HARM TO YOU AND YOURDOG, READ ENTIRE LABEL BEFORE EACHUSE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOREXTERNAL USE ON DOGS ONLY. DONOT USE ON RABBITS. DONOT USE ON OTHERANIMALS. Do notuse on puppies under 8 weeks ofage. [Do not split onetube between dogs.] [Do notuse multiple tubes on one dog.] Weigh your dogto be sure you are applying the right dose fonnulated for the weight ofyourdog. Consult a veterinarian before using this product on debilitated, aged, or medicated dogs. Canbe used on breeding, pregnant, or lactating dogs. Consult a veterinarian beforeusing on dogs with known organ dysfunction. Dogs may experience some temporary irritation at the site ofproduct application. Certain medications can interact 

### with pesticides. Sensitivities may occur after using ANY pesticide product ondogs. Ifsigns ofsensitivity occur bathe your dog with a mild soap and rinsewith large amounts ofwater. Ifsigns continue, consult a veterinarian immediately. {OuterPackaging) How to open: Remove product tubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched endpointing up and away from the face and body, cut offthe narrow end at the notches with scissors.
How to apply: Inverttube over dog anduse open end to part dog's hair. Squeeze tube firmly to apply all ofthe solutionto the dog's skin, as directed below. Donot apply more oftenthan once every 4 weeks. [Optional drawings that mayormay not appear on finished label] FREQUENCY OFAPPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and mosquito] infestations. [Studies showthat] [brand name] kills adult fleas for up to three months. Apply monthly ifyour dog is at high risk for flea reinfestation [, or in a highly infested environment]. Apply monthlyto control ticks, [mosquitoes] and chewing lice. [Brand name] remains effective, even afterbathing, water immersion, orexposureto sunlight. Allowtreated areato drythoroughly. Do not reapply for 30 days.
ForDogs Weighingup to 221bs. [including small dogs and puppies, 8 weeks or older]: {For cartons containing 0.67 mL (0.023 fl oz) applicatortubes} Apply onetube (0.67 

### mL)(0.023 

### fl oz) [fromthe back ofthe neckto a point midway betweenthe neck and tail.] [as a spot on the dog's back betweenthe shoulder blades.]

# Sergeant's MasterLabel 28 January 2011 Amendment Version 10.2 EPANo. 2517-134 Infonuation in 7 of9 EPA SAL 4Nov 2010

ForDogs Weighing23

- 441bs. {For cartons containing 1.34 mL (0.045 fl 

### oz) applicatortube} Apply one tube (1.34 ml)(0.045 fl. 

### oz.) [from the back ofthe neck to a point midway betweenthe neck and taiL] [as a spot on the dog's backbetweenthe shoulderblades.]
ForDogs Weighing 45

- 881bs. {For cartons containing2.68 mL (0.091 fl 

### oz) applicatortube} Apply one tube (2.68 ml)(0.09I fl. 

### oz.) [from the backofthe neckto a point midway betweenthe neck andtail.] [as a spot onthe dog's back betweenthe shoulderblades.] ForDogs Weighing 89

- 1321bs. 

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

### oz) applicatortube} Apply one tube (4.02 ml)(0.136 fl. 

### oz.) [fTom the back ofthe neckto a point midwaybetweenthe neck and taiL] [as a spot onthe dog'sbackbetweenthe shoulderblades.] STORAGEAND DISPOSAL PESTICIDE STORAGE: Do notremove tube from the pack until ready to use. Store in a cool (below 77°F [25°C]) dry place inaccessible to children andpets. Do notrefrigerate. Protect from direct sunlight. CONTAINERDISPOSAL: If

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

### available. 

### Ifpartly filled: Call your local solidwaste agency for disposal instructions. Never place unusedproduct down any indoor or outdoor drain. [WARRANTY Read the entire Directions for Use and Warranty before using this Product. By using this product, user orbuyer accepts the following warranty. The directions for use ofthis product are believedto adequate and must be followed carefully. It is impossible to eliminate all risks associatedwiththe use ofthis product. Unintended consequences may result because ofunknown factors. All such risks shall be assumed by the user orbuyer. Sergeant's is committed to providing high quality products. To the extentconsistent with applicable law, Sergeant's makes no warranties, express or implied, ofmerchantability oroffitness for a particularpurpose orotherwise, that extendbeyond statements onthis labeL To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall notbe liable for indirect, special, incidental or consequential damages. To the extent consistent with applicable law, the exclusive remedy ofthe user or buyer shall not exceedthe purchase price paid.] [Ifyouhave questions or comments about thisproduct, please write: [Sergeant's] [SENTRY] 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) [Coupon(s) inside oron outside ofbox] [Made inUSA]

# Sergeant'sMasterLabel 28 January 2011 Amendment Version 10.2 EPANo. 2517-134 Information in· 8of9 EPA SAL 4 Nov 2010

Distributed by: Sergeant's Pet CareProducts, Inc. P.O. Box 540399 Omaha,NE 68154·0399 EPA Reg. No. 2517-134 EPAEs!.No. 25l7-TN-l [XXXXX-XX-XXX] [BAR CODE AREA]

u.S. PatentNo. 5,567,429



### [How to Apply

- May contain graphics illustratingproductuse, e.g., dogwith a drop falling onto its neck from a vial on front, side, orback carton label and/or applicator labeling.] [Application Instructions] [Directions for Use] 

### How to open 1. Remove producttubes 

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

### [vial] withnotched end pointingup and away from the face and body, cut offthe narrow end at thenotches with scissors. 

### How to apply 1. Invert tube over dog and use open end to part dog's hair. 2. Squeeze tube firmly to apply all ofthe solution to the dog's skin [as a spot to the dog's back between the shoulder blades.] [or] [from the back ofthe neck to a pointmidway between the neck and tail.] [Optional drawings that mayormaynot appear on finished label]

# ~ ........ . 

# ¥-t .......**~** . "
, ,

, " 

### ,"', ',' ,

. . . [Flea life cycle diagram] [Flea Life Cycle] ]Samplecoloring and layoutmay be different on final label] [Look at the Label (Look atthe Label icon) [Easy] 6 Step [Easy] [Spot On] [Squeeze·On] [Topical] Checklist] • Readthe label completely and follow directions • Weigh yourpet • DoNOTuse dog products on cats • Do NOTtreat with more than one pesticide product at a time • Separate animals after treatmentto avoid chance ofingestion • DoNOT splittubes between pets] FLEALARVAE

# Sergeant'sMasterLabel 28 January 2011 Amendment Version 10.2 EPANo. 2517-134 Information in 9 of9 EPA SAL 4Nov 2010

[Brand narne[ [3 Month [Treatment] [Application] Tracker] [For

### yearMfound protection, apply [Brand name] monthly.] 

### [Pet'sName (Empty blank for owner to fill in name)] [First] [1st] [Second] [2nd] [Third] [3rd] [Dose] [Treatment] [Application](Empty blank for owner to fill in date)(Date: MM/DD/YY)] 

### [calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapply [brand name] in 30 days.] [MonthlyApplication Reminder Magnet (image ofreminder magnet)] [Enclosed for yourconvenience is an applicationreminder magnet. Push the (reset) button, andthe reminder light will blink twice. Theremindertag is now set for 30 days. Atthe end of30 days the 

### reminder light will blink, reminding you to reapply [Brand name]. Press the button once and the blinking 

### lightwill stop. Press the button again and this will resetthe timer for another 30 days.]



## '" AdultFlea 

# @ AdultFlea

... flea eggs

# ~ flea eggs 

# ..., flea larvae

_ fleapupae Brown Dog

### Tick



## DeerTick American DogTick

chewing lice LoneStarTick -""" mosquIToes [Optional graphics above 

### -PACKAGE

Front Label 

# (3) flea larvae

# ~ fleapupae 

# ® Brown DogTick 

# ® DeerTIck 

# @ American DogTick 

# ® chewing lice 

# @ Lone StarTick

# ~ mosquIToes

Back Label {Brand Name}[catgraphicwith linethrough1 

### Fordogs [up

### to X][X-Y]lbs KEEP OUTOF REACH OF CHILDREN CAUTION: Read directions and precautions before using. Use scissors to open. Fiproni19.8% w/w, (S)Mmethoprene 8.8% w/w 

### 0.023 fl 

### oz (or) 0.045 fl 

### oz (or) 0.091 fl 

### oz (or) O.136floz llabelcode} 

### {END

- TUBENIAL COPY} EPA REG. 

### No. 2517-134 {label code}Trlllcking Crelllte Resubmission FFS Letters

Action Code History

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

## FEB - 3 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
Sergeant's Pet Care Products, Inc. c/o Mr. Kelly Hoskins 2625 South 158lli Plaza Omaha,NE 68130-1770
Subject: AcceleratedReview ofa MinorFonnulationAmendmentper PRNotice 98-10 to 

### Revise the Current Basic CSF for Sergeant's Fipronil 

### + S-methoprene SqueezeOn for Dogs EPA Reg. No. 2517-134 Your Submission DatedNovember23, 2010 DecisionNo: 443624 

### DearMr. Hoskins:
We have no objectionto the use ofthe proposed alternate fonnulations requested in your application submittedNovember 23, 2010. The amended alternate CSFsnos. 3 and 4, bothdated November 23, 2010, have been addedto the file for the subjectproduct. Ifyou have any questions regardingthis action, please contact Rosanna Louie-luzwiak at (703) 308-0037.

Richard Gebken Product Manager 10, Insecticide Branch Registration Division (7504P)

### DATA PACKAGE BEAN SHEET Date:**30~Dec~2010** Page 1 of 1
* 

### * * Registration Information 

### ** * Decision #: 443624 DP 

### #: (385167) NON PRIA Parent DP 

### #: Submission #: 888047 Registration:**~?:t7'**

### ..

### :1_3:04 ___**~**



### __**~_~_~_GJ:A_~T_~** 

### ___

FJf'.R.9NI_1,._ + METH.oPRENE SQUEEZE::9N**F9.~**

# ~c~tl~i Company: 2517

- SERGEANT'S PET CARE PRODUCTS, INC. Risk Manager:**~_1\I1** __1_0_**~_~ic_h_ar9**__**co_e_b_~E!n** __**-_F.?~)**

### __**~_5:_E3?~_1**__R(I_(Irn_1t PYI 5-7237 Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: 29-Dec-2010 Calculated Due Date: 21-Feb-2011 Type of Registration: Product**Regi~lration** :. Secli_on 3 Action Desc:**(~_~>"~C?_I3f.J!LJ_LA: C:_HANc:;~;:rEC::Hr.J_I_C:,ll,L_;** __

Ingredients:**~_O~_4_02,**__**i?_:_I>i1~t~opr,,_~e(8.8%)** 1_?_9_1_?I_,__**~_ipr.c>n_il(~:a%.l.**__ Edited Due Dale:



### * * * Data Package Information 

### * * *
Expedite: 

### 0 Yes. No DP Ingredient: 105402, S-Methoprene**1291~1.,** Fipr.oni! DP Title: A!ternate CSF Review Date Sent: 30-Dec-2010 Due Back:

CSF !ncluded: • Yes 

### 0 No Labe! !ncluded: 

## 0 Yes. No Parent DP#:

As.signed To Organization: RD f**TR~** Team Name: CHEM Reviewer Name: Conlractor Name: Date In Date Out



### * * * Studies Sentfor Review 

### * * *
No Studies 

# ;z.:-\1.(c"
Last Possible Science Due**Date:&-cp~lh2Q1J~** Science Due Dale: Sub Data Package Due Date:

## ~ \:\

## ~~l<) 

# "W,/\**\~** 

## rr5

* * * Additional Data Package for this Decision 

### * * *
No Additional Data Packages 

### * * * Data Package Instructions 

### * * 

### *
Attn CHEM: Please review the attached a!ternales #3 and #4 CSFs for approval. Contact Rosanna Louie-Juzwiak at 308.0037 with any questions. Attachments: Cover letter App!1cant-supp!ied CSFs uacket unavailable to retrieve paper copy of approved CSFs) draft AMernate #3 and #4 CSFsUNITED STATES ENVIRONMENTAL PROTECTION AGENCY OPPTSIOPP/RDfTRB/PRODUCT CHEMISTRY TEAM WASHINGTON, D.C. 20460

DATE OUT: January 19,2011 DP BARCODE No.: 385167 Company Name:SERGEANT'S PET CARE PRODUCTS, INC. REG. No.:**2517~134** Action Code: 345 Decision No: 443624

SUBJECT: Product ChemistryReview ofthe EP, "Sergeant's Fipronil +Methoprene Squeeze-On for Dogs" PC Code(s): 105402; 129121 .1, _;() Food Use: No. FROM: William Herald, Microbiologist, REHSIRS

# 1/~/' 

# , I

# "~:~ /71) 

# IG( 

# I )

TO: Product Chemistry Team ( I 

### '1**~ ~/(..f\./\**  I Technical Review Branch/RD (750SP) / Rosanna Louie I Richard Gebken, RM 13 Insecticide Branch I RD (7505P) With a fetter dated November23, 2010, registrant has submitted newly proposed alternates CSF 3 and 4(dated 11/23.10) for the end use product, " Sergeant's Fipronil 

### + Methoprene SqueezeOn for Dogs." The alternate formulations have been submitted to add a new sources for the active ingredients. TRB has been asked 10 evaluate the revised CSF alternate formulation and determine their acceptability. SUMMARY OF FINDINGS 

### 1.:. The proposed end use product contains Fipronil ) [Reg. No. and [Reg. No. ); or Reg. No. as the active ingredients with the product label claims of 9.8% and 8.8% respectively. LThe proposed two CSF(s), Alt. Nos. 3 and 4 (both dated 11/23/10) are filled out correctly and completely. The nominal concentrations ofthe active ingredients concurwith the product label in compliance with PR Notice 91-2, and Title 40 CFR 

### § 152.43. All the non-food use inert ingredients present in the formulation have been approved by the Agency (1/19/11). The certified upper and lower limits of the active and inert ingredients are in compliance with standard certified limit tables set forth in 40 CFR 

### § 158.350(b)(2).**~**The proposed alternate CSF(s), Alt. Nos. 3 and 4 (both dated 11123/10) are substantially similar in chemical composition and physical-chemical composition to the current basic CSF (dated 8/31/10). CONCLUSIONS: The TRB has reviewed the alternate CSF(s), Nos. 3 and 4 (both dated 11/23/10) and has determined them acceptable.

W. J. Herald 2011Please rear! inslructions on reverse before G leting form Form Approvel J1B No 2070-0060 Approval expires 05-31 98
. United States [.1Registration OPP Identifier Number 

# EPA Environmental Protection Agency D.Amendment Washington, DC 20460

### ~ Other Application for Pesticide**~** Section I



# - 1. Company/Product Number 2. EPA Product Manager 3. Prooul;eo t..;lassiflcation 2517-134 Richard Gebken 4. CompanyfProduct (Name) PM#10

### ~None DRestricted Sergeant's Pel Care Products, Inc.! Sergeant's Fiproni! + S-methoprenc Squeeze-On For Dogs 5. Name and Address ofApplicant (Include ZIP Code) 6. Expedited Review. In**accordanc~** ·/dt'l**F~FRA** S'Jctic.1'3(c)(3)(b)(I), my Sergeant's Pet Care Products, Inc. product is similar or identical in composillC'!' and labelhg to: 2625 South I58th Pla7..a Omaha, NE 68130-1770 EPA Reg. No.



# -- Product Name 

# o Check ifthis is a newaddress Section II
D Amendment

- Explain below. D Final printed labels in response to Agency letter dated XX-XX-XX D Resubmission in response toAgency letter dated D "Me Too' Application D Notification

- Explain below.

### ~ Other

- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section II.) Submission of an Alternate #2 CSF and Formulator's Exemption Statement as a minor formulation amendment pursuant to PR Notice 98-10. Section III 1. Material This ProductWill Be PackaQed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type ofContainer**~Yes·** 

### [g]

## y" Oy" 

# o Metal 

## ON' ON' [g] 

## N,**~** Plastic If"Yes" No. per If "Yes" No. per DGlass ·Certification must Unit Packaging wgt. Container Package wgt. Container DPaper be submitted 0.023 n oz (0.50 011) 3vials 0.04511 oz (1.34 ml) 

## I 

## I Dother (Specify) Plastic Bag 0.091 11 oz (2.68 ml) 0.13611 07.: (4.02 ml) 3 Location 01 Net Contents Information 4. Size(s) Retail Container 5. Location of label Directions**~Label** 

# o Container 0.023 n oz (0.50 ml). 0.04511 oz(I.34 ml), 0.091 n DOn Can oz (2.68 ml), 0.136 n oz (4.02 ml) {glOn Labeling accompanying product 6. Manner in Which Label isAffixed to Product**~lithOgraPh** cg]Other DPaper glued DStenciled Section IV 1. Contact Point (Complete items directly befow for identification ofindividuafto be contacted, ifnecessary, 10 process this application.) Name Title Telephone No. (Include Area Code) Kelly R. J·loskins Manager ofTcchnical Affairs 402-938-7079 Certification 6. Date Application I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. 1 Received acknowledge that any knowingly false or misleading statemenl may be punishable by fine or imprisonment or both (Stamped) under applicable law. 2.

### S;g",I"~ 

# to::**J;;//~** 3. Title BY, 

# )!:,

.. Manager ofTechnical Affairs
4. Typed Name: / Kelly R. Hoskins / / 5. Date: 11/23/2010Form approved. OM8 No. 2070-0060, 2070-0057, 20/0-0107, 2070-0122,2070-0164

. 

# .sEPA
United States Environmental Protection Agency Washington, DC 20460 

### Formulator's Exemption Statement (40 CFR 152.85)

Applicant's Name and Address EPA File SymboJlRegistration Number Sergeant's Pet Care Products, Inc. 2517-134 2625 South 158th Plaza Product Name Omaha, NE 68130-1770 Sergeant's Fipronil 

### + S-methoprene Squeeze-On II Date of Confidential Statement of Formula (EPA Form 857()-4)



### 11/23/2010 As an authorized representative ofthe applicant for registration ofthe product identified above, I certify that; (1) This product contains the following active ingredient(s): Fipronil (9.8%) S-methoprene 01.8%)

(2) Ofthese, each active ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat aci,ve ihgri-dient if' t'le rnnufacturing, formulation or repackaging enother productwhich contains that ective ingredient which is registered under FIFRA Sectioj, 3;i::- ,'lurchased by usfrom another person and meets the requ·,rements of40 CFR section 158.50(e)(2)or (3). ' ' , ' ,**~** (3) Indicate by checking (A) or (8) belowwhich paragraph applies:

11 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to thiss:;.h,r,lf..nt. Thatformula statement indicates, by company name, registration number, end product name, the source ofthe ective ingrepir-r;t(s) listed in paragreph (1). OR 

# , (8) The Confidentiel Statement of Formula (CSF)(EPA Form 8570-4) referenced above end on file with the EPA is complete, current, an accurate and contains the information required on the current CSF. (4) The following active ingredients in this product qualifyfor the formulator's exemption.

Source Active Ingredient Product Name Registration Number Fipronil Technical Fipronil Technical S-methoprene S-methoprene 

# S7Z;,)LIck Name and Title Date Kelly R. Hoskins, Manager of II 

### 11/23/2010 EPA Form**85~-27** (Rev.**06-2~** I Copy 1 EPA Copy 2 - Applicant copyTracking Create Resubmission FFS Lettet'$

Action Code History

# EXponent

January 19, 2011

Richard Gebken, PM10 Office ofPesticide Programs (7504P) (AMEND) U.S. Environmental ProtectionAgency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Sergeant'sFipronil 

### +Methoprene Dog Squeeze-On EPA Registration Number2517-134 Dear Mr. Gebken: Exponent 1150 Connccr;cut Avenue, NW Suite 1 100 Washington, DC 2003(, telephone 202-772-4-900 ),nimile 20:2-772-4979 www.cxponent.com

In response to the Agency letter dated December 22, 2010, Sergeant's Pet Care Products, Inc. (Sergeants, EPA Company Number 2517) is responding to the Agency-initiated Required Label Amendment by submitting the following documents: (1) Cover letter; (2) Applicationfor Pesticide Form (8570-1); and (3) Revised product label (five copies). Sergeant's has reviewed EPA'srequested label comments and either incorporated them or revised them to include appropriate language to clarify the supported efficacy claim. Further, the revised label includes EPA's comments in theNotice ofRegistration datedNovember4, 2010. Please find enclosed a revised label for EPA'sreview and approval. Ifyouhave any questions, please contact me at202-772-4932.

# rsJ!L·~ey \

- "J!mIes Messina Mthorized Representative for

Sergeant's Pet Care Products, Inc. Enclosures

cc: Kelly R. Hoskins, Sergeant's Pet Care Products, Inc.Please read instructions on reverse before comp/et1ng form. Form Aporoved. OMB No. 2070-0060. Aooroval eXIlires 05-31-98 United States 

# W _Registration OPP Identifier Number 

# EPA Environmental Protection Agency 

### D.Amendment Washington, DC 20460

### ~other Application for Pesticide**~** Section I 1. Company1Product Number 2. EPA Product Manager 3. Proposed Classification 2517-134 Richard Gebken 4. Company1Product (Name) PM#10 [gINone DRestricted Sergeanfs Fipronll + Methoprene Only Squeeze-On For Dogs 5. Name and Address ofApplicant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3)(b)(I), my Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling to: 2625 South 15Sth Plaza Omaha, NE6S130 EPA Reg. No. Product Name D Check ifthis is a new address Section II

### ~ Amendment

- Explain below. 

# D Final printed labels in response to Agency letterdated XX-XX-XX

### ~ Resubmission in response to Agency letter dated 12-22-2010 

### D "Me Too" Applicalion D Notification

- Explain below. 

# o Other

- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section II.) Submission ofaresponse to EPA letter dated December 22, 2010 regarding an Agency-initiated labelingamendment. 

## I PRIA 

### .. . Section III 1. Malerial This ProductWill Be Packaaed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container [gJ Yes* [gJ Yes 

## Dy" DMetal 

## DNo D No**~** 

## No [gj Plaslic If"Yes" No. per If"Yes" No. per DGlaSS *Certification must Unit Packagingwgt. Container Packagewgt. Container DPaper be submitted 0.023 fl OZ (0.50 ml) 3 vials 0.045 floz (1.34 ml) 

## I I DOther(Specify) Plastic Bag 0.091**flo:;~.68ml)** 0.136 fl oz 4.02 mt) 3. Location of Net Contents Information 4. Size(s) Retail Container 5. Location of Label Directions [gJLabel D Container 0.023 fl oz (0.50 ml). 0.045 fl oz I 1.34 m)), 0.091 fl DOn Can oz (2.68 mt), 0.t36 fl oz (4.02 mt) DOn Labelino accompanying product 6. Manner in Which label is Affixed to Product DLithograph [gJOther


# -- DPaper glued DStenciled Section IV

. 1. Contact Point (Comple/e items directlvbelow foridentifICation ofindividual 10 be contacted ifnecessaJY. to c.'DCEs;:;·:his ap;'licat:G.1.l 

### -,- Name Title I'Telephore No. ('nclude Area Code) James Messina Authorized Represcntative .1. 202-772-4932 Certification 

# ,. Date Application I certify**th!~iitments** I have made on this form and all attachments thereto are true, accurate and complete. I Received**/CK.~~=ge** t ny knowinglyfalse or misleading statement may be puniShable by fine or imprisonment or both (Stamped) under a Ii Ie aw.

# ~~tul 

# h 3. Title


# - BY: Authorized Representative
4. TYPed/Nre: James Messina 5. Date: 0111912011 

### V

# Sergeant'sMasterLabel 19 January 2011 Amendment Version 10.2 EPA No. 2517-134 Information in [ ] is optional. Page I of9 EPA SAL 4 Nov 20I 0 FRONTPANEL

..DOGSQUEEZE ON FIPRONIL+METHOPRENE 

### [Optionaltext appears in brackets

- the final productlabel may include some or all ofthe optional text on front, back or side label panels. The'cRPrequiredtext

### will not change.] 

# Sergeant's Fipronil 

# +Methoprene Squeeze-On for Dogs [ABNs] [(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs] [(Sergeant's®) (Sentry®) Ectoadvance (Spot On) for dogs] [SentryProline (Spot On) for dogs] [[SENTRY®] FIPROGUARDTM PLUS for dogs] [[Sergeant's®] PRONYL OTCTM PLUS for dogs] [Apply to puppies over 8 weeks old] [Apply to puppies 8 weeks orolder] ]MosquitoesJ [Kills mosquitoes] 

### rwithin 24 hours for up to 7 days] [and within 48 hours for up to 28 days] [Adult Fleas] [[Kills [adult] Fleas [for up to three months]] [Kills newly emerged adult Fleas before they lay eggs] [Kills Fleas, which may be a source of[flea allergy dermatitis] [, flea bite anemia] [and] [tapeworm infestations]] [Kills Fleas Up to [4 weeks] [I month] 

### [30 days]'] [Ifdog is a high risk for flea reinfestation a once month application may be needed] [MultipleInfestationsj [Kills chewing lice [and controls mites that may cause sarcoptic mange]] [Flea [&] [and] Tick Control for Dogs [&] [and] Puppies 8 weeks old [&] [and] older] [Kills fleas, flea eggs, ticks, chewing lice [&] [and] mosquitoes] [Kills fleas, ticks, mosquitoes chewing lice, flea eggs, flea larvae 

### [&] [and] [prevents flea pupae]] [Kills Fleas, Ticks 

### [&] [and] Mosquitoes] [Breaks the Flea Life Cycle [for up to three months]] [Monthly flea, tick, mosquito, chewing lice and flea egg protection] [Monthly flea, tick, mosquito and chewing lice protection] [Kills fleas, ticks, mosquitoes, flea eggs, and chewing lice] [[Seven] [7] Way Protection to kill fleas, ticks, mosquitoes, chewing lice, i1eh eggs, flea'larvae 

### [&] [and] prevent flea pupae]] [6 [Six] Way Protection to kill fleas, ticks, mosquitoes, chewing lice, flea eggs [&] Ear_oJ r1ea larvae] [[4 Week] [I month] 

### [30 day] [Flea [and] 

### [&] Tick Treatment] [[Four (4) Week] [I month] 

### [30 day] [FleaTick, Mosquito and Chewing Lice Control] [Use [brand name] monthly to break the flea life cycle.] [Use [brand name] monthly to control ticks and chewing lice]

# Sergeant's Master Label 19 January 20II Amendment Version 10.2 EPANo. 2517-134 

### Information in [ ] is optional. Page 2 of9 EPA SAL 4 Nov 20I 0 

### FRONT PANEL DOGSQUEEZE ON FIPRONIL+.METHOPRENE [Monthly flea, tick, mosquito, flea egg, flea larvae and chewing lice protection.] 

### [Once A Month Flea and Tick Treatment] [[4 week] [I month] [30 day] Flea and Tick Treatment!] [Kills Fleas, [and] Ticks [and mosquitoes] for up to [4 weeks] [I month] [30 days]!] [Kills Fleas, Ticks, Flea Eggs & 

### Flea Larvae for up to [4 Weeks] [I month] [30 days]] 

### [[Images ofthe 

### different kinds ofbugs 

### killed with a line drawn through each bug]] (Ticks] 

### [Kills Ticks including those that may transmit Lyme disease] [Kills Ticks for Up to [4 weeks] [I month] [30 days]'] [Kills [all stages of] (deer) ticks [before they can] [that] [transmit Lyme Disease,] [for up to [4 weeks] [I month] [30 days] [per application]] [Kills Ticks (Including Deer Ticks) for up to [4 weeks] [1 month] [30 days]] [Kills [brown dog ticks], [American dog ticks,] [and lone starticks] [and deerticks] [(Rhipicephalus sanguineus)] 

### [for up to [4 weeks] [1 month] [30 days]] [Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to [4 weeks] [I month] [30 days]!] {Flea Eggs and Larvae( [Controls [flea] reinfestation [for upto [12 weeks] [3 months]]] 

### [Kills adult fleas, flea eggs flea larvae and prevents pupae for up to [three months] [12 weeks].] [Effectively protects against all stages ofthe flea (including adult fleas, flea eggs, flea larvae and prevents f1

### ea pupae)] [Ifdog is a high risk for flea reinfestation aonce month application may be needed] [Prevents from developing, flea eggs Darvae] [pupae] for up to [3 months] [12 weeks]] [With (S)-methoprene Insect Growth Regulator [IGR] which Breaks the Flea Life Cycle] [With (S)-methoprene to Break Flea Life Cycle] [With Insect Growth Regulator [IGR] to Break Flea Life Cycle] [Dual Action [!]:Fipronil with (S)-methoprene IGR [insect growth regulator] Effectively Breaks the Flea Life Cycle] [Dual Action I!]: Effectively Breaks the Flea Life Cycle 

## [ill [Kills Flea Eggs & 

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

### [Prevents Flea Eggs From Developing Into Biting Adults] [Prevents all stages ofthe flea life cycle from developing] [Controls reinfestation [for up to 3 months]] [Effectively protects against all stages ofthe flea life cycle] [All Others] 

### [For Dogs and Puppies 8 weeks ofage or older] [Controls mites that may cause sarcoptic mange] [For Dogs [up to 22Ibs.], [23-44Ibs.], [45-88Ibs.], [89-132Ibs.( [Fast Acting( [Long Lasting]

# Sergeant's Master Label 19 January 201 1

### Amendment Version 10.2**EPANo.2517~134** Infonnation in 1 

## I is optional. Page 3 of9 EPA SAL 4 Nov 2010



### FRONT PANEL DOG SQUEEZE ON [Prevents reinfestation oflisted 

### pests for [4 weeks] [1 month]] [Easy to use [application]] 

### [Once month treatment recommended] [A once monthly application is recommended for chewing lice] [Rapid elimination ofchewing lice infestations] 

### FIPRONIL+METHOPRENE

[[Three] 13] Applications] and/or 

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

### [Best 

### ifused year round!] I(ICON Showing 14 week] 

### [1 month] [30 day] Protection)] 14 Week Dose'] II Month Dose'] [30 Day Dose!] 

### [Specially Fonnulated for Dogs and Puppies 8 weeks ofage 

### or older] [[Free] Calendar Stickers Inside!] [Apply once every [4 weeks] [month] 130 days]!] IWaterproof] [Canbe used on breeding, pregnant and lactating [bitches] [female]ldogs]] [[Free with purchase] [Free inside] Monthly Application Reminder IMagnet]linside]] 

### [Can be used on puppies 8 weeks ofage and older] [Fipronil (9.8%) 

### + (S)-methoprene (8.8%)] 

### [Lift [here] for more infonnation] [Contains Fipronil and (S)-methoprene[,] [-] the active ingredients used in Frontline Plus®*] [*[Brand name] is not manufactured by or distributed by Merial. Frontline Plus® is a registered trademark ofMerial.] [U.S. PatentNo. 5,567,429] 

### [[3] applications] 

### [For year-roW1d protection, apply [Brand name] monthly] [Effective after bathing and exposure to water and sunlight] [Stops and prevents infestation oflisted pests for [4 weeks][l month]] [Stops existing infestation and prevents establishment ofadditional infestation oflisted pests]

# Sergeant'sMasterLabel 19 January 2011 Amendment Version 10.2 EPANo. 2517-134 Information in [ [isoptional. Page 4 of9 EPA SAL 4Nov 2010

FRONTPANEL

. ..' DOG SQUEEZE ON '..

. FIPRONIL+METHOPRENE [For use ONLY on dogs [Up to 22 lbs] [23-44 lbs] [45-88Ibs] [89-132Ibs] [over 8weeks of

### age]] [ForDogs & 

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

### lbs.[

ACTIVE INGREDIENTS: Fipronil

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

.......... n .',. 'n •••••••• " •••••••••••• , •• , •••••••••••••••8.800/0 

### OTHER INGREDIENT**:

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

### KEEP OUT OF REACH OF CHILDREN CAUTION
See [Back][or][Side] [Label Panel[slJ [or] [insert] for Additional Precautionary Statements

NET CONTENTS:

{END

- FRONT PANEL} [3] [three] 0.023 fl 

### oz (0.67 mL) applicators [3] [three] 0.045 fl 

### oz (1.34 mL) applicators [3] [three] 0.091 fl 

### oz (2.68 mL) applicators [3] [three] 0.136 fl 

### oz (4.02 mL) applicators

# Sergeant's MasterLabel 19 January 2011 Amendment Version 10.2 EPANo. 2517-134 Information in 

## I ]is optional. Page 5 of9 EPA SAL 4Nov 2010 BACKISIDEPA,NEL .' '. '. ,DOGSQUEEZEON FIPRONIL+.METHOPRENE [[brand name] contains Fipronil and S-Methoprene (insect growth regulator) (IGR) to effectively kill 

### fleas and ticks [(including those that maytransmit Lyme Disease).] [The active ingredients in 

### [brand name] feature a sustained release formula developed for fast acting [and long lasting] control offleas, ticks, mosquitoes and chewing lice for up to 30 days on dogs.] 

### [Brand name] READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ONDOGS AND PUPPIES OVER 8 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TOHUMANS. CAUTION. Harmful ifswallowed. Causes eye irritation. Avoid contact with skin, eyes or clothing. Wash hands thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. 

### HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on puppies under 

### 8 weeks ofage. Individual sensitivities, while rare, may occur after using any pesticide product. [Some dogs may experience temporary startle effects when any product is applied.] Dogs may experience some temporary irritation at the site ofproduct application. Ifsigns persist, or become more severe within a few days ofapplication, consult a veterinarian immediately. Ifyour dog has an unusual reaction to the initial application, consult a veterinarian before repeating treatment. Certain medications can interact with pesticides. Consult a veterinarian before using on medicated, debilitated Or aged dogs. Call 1 w800w 781-4738 for 24-hour assistance.


### FIRST AID Ifswallowed: Call a poison control center or a doctor immediately for treatment advice. Have person sip a glass ofwater ifableto swallow. Do not induce vomiting unless told to do so by a poison control center or doctor. Do not give anything bymouth to an unconscious person. Ifin eyes: Flush eyes with plenty ofwater. Call a doctor ifirritation persists. Ifon skin: Wash with plenty ofsoap and water. Get medical attention ifirritatiOlt, 

### .. persists.



### - - --- HOTLINE NUMBER



## - Have the product container or label with you when calling a poison control cel1tf!r9r doc1or, or going for treatment You may also contact 1-800w 781w4738 for emergency medicd'treatment information. ' 

### ..

# Sergeant's MasterLabel 19 January 2011 Amendment Version 10.2 EPANo. 2517-134 Information in 

## I I is optional. Page 6 of9 EPA SAL4 Nov 2010 

### BACK/SIDEPANEL DOG SQUEEZE ON FIPRONIL+METHOPRENE DIRECTIONS FOR USE It is a violation ofFederal lawto use this product in a manner inconsistent with its labeling. DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU AND YOUR DOG, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DONOT USE ON OTHER ANIMALS. Do not use on puppies under 8 weeks ofage. [Do not splitone tube between dogs.] [Do not use multiple tubes on one dog.] Weigh your dogto be sure you are applying the right dose formulated for the weight of your dog. Consult a veterinarian before using this product on debilitated, aged, or medicated dogs. Can be used onbreeding, pregnant, or lactating dogs. Consult a veterinarian before using on dogs with known organ dysfunction. Dogs may experience some temporary irritation at the site ofproduct application. Certain medications can interact with pesticides. Sensitivities may occurafter using ANY pesticide product on dogs. Ifsigns ofsensitivity occur bathe your dog with a mild soap and rinse with large amounts ofwater. Ifsigns continue, consult a veterinarian immediately. {Outer Packaging} How to open: Remove product tubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cut offthe narrow end at the notches with scissors.
How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to apply all ofthe solution to the dog's skin, as directed below. Do not apply more often than once every 4 weeks. [Optional drawings that mayor may not appear on finished label] FREQUENCY OFAPPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and mosquito] infestations. [Studies showthat] [brand name] kills adult fleas forup to three months. Apply monthly ifyour dogis at high risk for flea reinfestation [, or in a highly infested**environment~.** Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] remains effeC'dVe, even after bathing, water immersion, or exposure to sunlight. Allowtreated area to dry**thGr~"'J.gl:ly.** Do not reapply for 30 days.
ForDogs Weighing up to 22 lbs. [including small dogs and puppies, 8 weeksu'r older]: {For cartons containing 0.67 mL (0.023 fl oz) applicator tubes} Apply onetube (0.67 mL)(O.023 

### fl oz) [from the back ofthe neck to a point midv.!.lj between the neck and tail.] [as a spot on the dog's back between the shoulder blades.]

# Sergeant's MasterLabel 19 January 2011 Amendment Version 10.2 EPA No. 2517-134 Information in I 

## I is optional. Page 7 of9 EPA SAL 4 Nov 2010 

### BACK

### ISIDEPANEL DOG SQUEEZE ON FIPRONIL+ME'j'HOPRENE For Dogs Weighing 23

- 441bs. 

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

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

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

- 881bs. 

### {For cartons containing2.68 mL (0.091 fl 

### oz) applicatortube} Apply one tube (2.68 ml)(0.091 

### fl. oz.) [from the back ofthe neck to a point midway between the neck and taiL] [as a spot on the dog's back between the shoulder blades.]
ForDogs Weighing 89

- 132 Ibs. {For cartons containing 4.02 mL (0.136 11 oz) applicatortube} Apply one tube (4.02 ml)(0.136 

### fl. oz.) Ifrom the back ofthe neck to a point midway betweenthe neck and tail.] [as a spot on the dog's back between the shoulder blades.] STORAGEAND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the pack until ready touse. Store in a cool (below 77°F [25°C]) dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight. CONTAINERDISPOSAL: 

### Ifempty:**Non~refillable** container. Do not reuse orrefill this container. Offer for recycling ifavailable. Ifpartly filled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. [WARRANTY Read the entire Directions for Use and Warranty before using this Product. Byusing this product, user or buyer accepts the following warranty. [[The directions for use ofthis product are believed to adequate andmust be followed carefully. Itis impossible to eliminate all risks associatedwith the use ofthis product. Unintended consequences mayresult because ofunknown factors. All such risks shall be assumed by the user or buyer.J] Sergeant's is committed to providing high quality products. To the extent consistent with applicable law, Sergeant's makes no waHanties, express or implied, ofmerchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this label. To the extent consistent with applicable law, Sergeant's, the manuf3::urer, or the Seller shall not be liable for indirect, special, incidental or consequential damages. Tu ttle extent consistent with applicable law, the exclusive remedy ofthe user or buyer shall not**e;~..:;(!cd** the purchase price paid.] [Ifyou have questions or comments about this product, please write: [Sergeant;s]' [SENTRY] Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.]
In Case ofEmergency, caU: 1-800-781-4738 Non-Emergency, call: 1-800-224-PETS (7387) [Coupon(s) inside or on outside ofbo'<] [Made in USA

## 1

# Sergeant's MasterLabel 19 January 2011 Amendment Version 10.2 EPA No. 2517-134 Information in [ ] is optional. Page 

### 8 of

### 9 EPA SAL 

### 4Nov 

### 20I 0 

### BACK

### ISIDE PANEL DOG SQUEEZE ON

Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-134 EPA Est. No. 2517-TN-I [XXXXX-XX-XXX]
{END

- HACKl SIDEPANEL} 

### FIPRONIL+METHOPRENE [BAR CODE AREA]

U.S. PatentNo. 5,567,429



### OUTERPACKAGING ORINSERT COPY "'DOG SQUEEZE ON FIPR()NIL+METHOPRENE [How to Apply

- May contain graphics illustrating product usc, e.g., dog with a drop falling onto its neck from a vial on front, side, or back carton label and/or applicator labeling.] lAppIication Instructions] [Directions for Use] How to open 1. Remove product tubes [vial} from the package. 2. Separate one tube from the others. Holding the tube 

### {vial} with notched end pointing up and away from the face and body, cut offthe narrow end at the notches with scissors. How to apply [Optional drawings that mayormay not appear on finished label] 1. Invert tube overdog and use open end to part dog's hair. 2. Squeeze tube firmly to apply all ofthe solutionto the dog's skin [as a spot to the dog's back between the shoulderblades.] [or] [from the back ofthe neckto a point midway between the neck andtail.]

[Flea life cycle diagram] [Flea Life Cyele] [Sample coloring and layoutmay be different on finallabelJ
[Look at the Label (Look at tile Label icon) [Easy] 6 Step [Easy] [Spot On] [Squeeze-On] [Topical] Chccklist] • Read the label completely and follow directions • Weigh your pet • Do NOTuse dog products on cats • Do NOT treat withmore than one pesticide product at a time • Separate animals aftertreatment to avoid chance ofingestion • DoNOT split tubes between pets]

# Sergeant'sMasterLabel 19 January 2011 Amendment Version 10.2 EPANo. 2517-134 Information in [ ] is optional. Page 9 of9 EPA SAL 4 Nov 2010 

### OUTERPACKAGING ORINSERT.COPY DOG SQUEEZE ON

, " " " ' '--.,

, "'" , " [Brand name] [3] [Month [Treatment] [Application] Tracker] [Foryear-round protection, apply [Brand name] monthly.] [Pet'sName (Empty blank for ownerto fill in name)] [First] 

### [Ist] [Second] [2nd] [Third] [3rd] 

### FIPRONIL+M.ETHOPRENE

[Dose] [Treatment] [Application](Empty blank for owner to 

### lilI in date)(Date: MM/DDIYY)] [calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapply [brandname] in 30 days.] [Monthly Application ReminderMagnet (image ofreminder magnet)] [Enclosed for your convenience is an application reminder magnet. Push the (reset) button, and the reminder light

### wiJ1 blink twice. The reminder tag is now set for 30 days. At the end of30 days the reminder light will blink, reminding you to reapply [Brand name]. Press the button once and the blinking light will stop. Press the button again and this will reset the timer for another 30 days.] 

## @**Adulf~' ~**  Adult Flea

### ~ filaEg<jS



# ... ReaEggs 

# e§J filal""" 

# .., Rea larvae 

# S f",Pupae 

# - Rea

### f'l4>ae 

# @ ErovmDog

### Ti~k 

# "" Brown Dog TICk 

## @ LoneStarTlCk 

# .,. Lone StarT tel< 

# ®OeffTick 

# "" DeerTick 

## @**Arntt~aIlDoq** id 

### ,,t ArnericanDogTICk



### , 

## @ CIYJIMngLice 

# '" O1eoNing Lice**~,** Mosquito

### ~ Mosquito


### {END

- OPTIONAL INSERT OR PACKAGE COPY} TUBE/VIALLABEL DOG SQUEEZE ON FIPRONIL.,.METHOPRENE Front Label {Brand Name}fcat graphic with line through] For dogs [up to Xj[X-Yjlbs FiproniI 9.8% w/w, (S)-methoprene 8.8% w/w 0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 mL {label code

## I [END

- TUBENIAL COPY} Back Label KEEP OUT OF REACH OF CHILDREN CAUTION: Read directions and precautions before 1lsing. Use scissors to open. EPA REG. No. 2517-134 (label code)

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

December 22, 2010 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

Sergeant's Pet Care Products, Inc., c/o Exponent Mr. James Messina 1150 Connecticut Avenue, NW Suite 1100 Washington, D.C. 20036 Subject: Agency-initiated Required Label Amendment Sergeant's Fipronil + Methoprene Dog Squeeze On, EPA Reg. No. 2517-134
DearMr. Messina: During a recent review ofthe Sergeant's Fipronil 

### +Methoprene Dog Squeeze On product, EPA Reg. No. 2517-134, the Agency detenllined that certain pest efficacy claims are unacceptable and must be removed fro111 the label. To date, there is no acceptable data on file to support any pest repellency, kills pupae claim, and other certain orunqualified efficacy claims. Therefore, the struck-out text must be deleted from the label and the bolded text must be added as described below: Page 2: [Mosquitoes] [Kills mosquitoes] [within 24 hours] [Kills ([and] [&] repels)**mos~Hitoes** that maytransmit heartwonn] [Adult Fleas] [Kills [adult] fleas [for up to three months.] [Kills newly emerged adult Fleas before they lay eggs] [Kills [and Fcpels] Fleas, source of[flea allergy dennatitis] [, flea bit anemia] [and tapewonn infestations]] [Kills [&] [aIld] [Repels] Fleas Up to [4 weeks] [I month] [30 days]!] [Ifdog is at high risk for flea reinfestation a once a month application may be needed] Multiple Infestations [Kills fchewingllice and controls mites 

### that may cause sarcoptic mange] [Flea [&] [and] Tick Control for Dogs [&] [and] Puppies 8 weeks old [&] [and] older] [Kills [aIld] 

### [&] repels] fleas, flea eggs, ticks, fchewing:l-lice [&] [and] mosquitoes] [Kills [and] [&] [repels] fleas, ticks, mosquitoes, fchewingJlice, flea eggs, and flea larvae [&] [aHd] [flea pupae] [Kills [&] [and] [Repels] Fleas, Ticks [&] [and] Mosquitoes]

Page I of3[Monthly flea, tick, mosquito, 

### chewinglice, and flea egg protection] [Monthly flea, tick, mosquito and 

### chewinglice protection] Page 3:

[Ticks] [Kills fleas, ticks, mosquitoes, flea eggs, and 

### chewing lice] [ [Seven3 [73 Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea larvae [&] [aad] flea**~llflaell** 

### [6 [Six] Way**Protection~** 

### to Kills fleas, ticks, mosquitoes, 

### chewing lice, flea eggs 

### [&] [and] flea larvae] [[Four (4) Week] [I month] [30 day] [Flea Tick, Mosquito and Chewing Lice Control] [Kills [&] [and]**Re~els** Fleas, [and] Ticks [and mosquitoes] for up to [4 weeks] [I month] [30 days]'] [Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to [4 Weeks] [1 month] [30 days]] [Images ofthe different kinds ofbugs killed with a line drawnthrough each bug]]
[Kills [and3 [&3 repels] Ticks includingthose that may transmit Lyme disease] [Kills [and] [&]**re~els]** Ticks for Up to [4 weeks] [1 month] [30 days]!] [[Kills [and R"J'els] [all stagesofJ (deer) ticks [before they can] [that] [transmit Lyme disease,] [for up to [4 weeks] 

### [1 month] [30 days] [per application]]] [Kills [aad] 

### [&] repels] Ticks (Including Deer Ticks) for up to [4 weeks] [1 month] [30 days]] [Kills [and] [&]**re~els]** [brown dog ticks,] [American dogticks,] [and lone star ticks] [and deer ticks] 

### [(Rhipicephalus sanguineus)] [for up to [4 weeks] [1 month] [30 days]] [Kills [&] [and] Repels] American Dog Ticks 

### [(Dermacentor variabilis)] for up to [4 weeks] [1 month] [30 days]!] [Flea Eggs and Larvae]

Page 4: [Controls [flea] reinfestation [for up to [12 weeks] [3 months]]] [Kills adult fleas, flea eggs, 

### and flea larvae and pupae for up to [three months] [12 weeks].] [Kills all stages ofthe flea (including adultfleas, flea eggs, flea larvae and flea pupae)] [Ifdog is a high risk for flea reinfestation a once month application may be needed] [Kills flea eggs [larvae] [pHpae] for up to [3 months] [12 weeks]]

[Kills all stages o[the flea life eycle] [Complete protection against all stages ofthe flea life cycle] [All Others] [Dogs canbebathed 24 hours aftertreatment] [Prevents reinfestation] [Fast Action against [chewing] lice infestations] [Dogs can be ba-thed 24 hours after Spot on is applied]

Page 2 of3Page 6: [[brand name] contains Fipronil and S-Methoprene (insect growth regulator) (lOR) to effectively kill [and repel] fleas (all stages) and ticks [(including those that may transmit Lyme Disease)]. Within 30 calendar days from the date ofthis letter, you mustrespond by submitting updated draft labels that addressesthe comments above, as well as incorporating the comments from the November 4, 2010 Notice ofRegistration. Ifthese conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA Section 6(e). lfyou have any questions concerning this action, you may contact Rosanna Louie-luzwiak at 703-308- 0037 or email her at louie-juzwiak.rosanna@epa.gov.

# ~~&:-L -\'.<" Richard Gebken Product Manager 10, Insecticides Branch Registration Division

Page 3 of3Karen C, Cunningham, DVM, DABVP Head, Regulatory Affairs Lifecycle Management US Merlal Limited Tel: 678-638-3138 Fax: 678-638-3707
December 17, 2010 Richard Gebken, Product Manager 10 Registration Division Office of Pesticide Programs (7505P) U.S, Environmental Protection Agency Room 5-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 SUBJECT: Sergeant's Pet Care Products, Inc" EPA Reg. No. 2517-134 Dear Mr. Gebken: 3239 Satellite Blvd Duluth, GA 30096 Tel: 678.638.3000

Merial submits this letter as a follow-up to our telephone conversation on December 3, 2010 regarding Sergeant's Pet Care Products, Inc., EPA Reg. No. 2517-134 (Sergeant's Fipronil 

### + Methoprene Squeeze-On for Dogs),The purpose of Merial's call was to understand some ofthe claims listed in the newly approved labeling for the aforementioned Sergeant's product, including claims of repellency. You indicated that Sergeant's cited Merial data to support the registration of this product. I painted out that repellency is not consistent with the known mode of action of fipronil and none of Merial's fipronil-based products have repellency claims. We also discussed the fact that Frontline Plus does not kill flea pupae, yet the Sergeant's label includes claims such as "kills flea pupae" and "kills all stages of the flea," You committed to following up with the EPA entomologists and suggested that Merial submit a formal challenge to the Sergeant's label. To that end, please find in Attachment 1 a table highlighting Merial's specific objections to claims in the Sergeant's Fipronil 

### + Methoprene Squeeze-On for Dogs labeling dated November 4, 2010, Merial respectfully requests a complete and thorough review of the label for the me-too product Sergeant's Fipronil 

### + Methoprene Squeeze-on for Dogs (EPA Reg. No. 2517-134) to ensure that all label claims comport with the label for Frontline® Plus for Dogs (EPA Reg, No, 65531-5). Merial believes that the Sergeant's product labeling approved November 4, 2010 would give Sergeant's an unfair competitive advantage if it were distributed, Merial requests that appropriate regulatory action be taken quickly to prevent distribution or sale of the product with this labeling and to ensure that the label is revised prior to consideration by the States. If you have any questions or require additional information, please contact rT)t;! py telephone at 678-638-3138 or email at karen.cunningham@meriaLcom, Sincerely,
_**~'**

# .~~~/~**"-'~e~** Cunningham, DVM, DABVP Head, Regulatory Affairs Lifecycle Mgmt US Merial Limited

M

..riallimit

..d is thE AnimO!I HEO!lth subsidiary of s1Inofi-av"-ntis A

campanyumiledbysharesI'1!gi!tel'1!din EIlgIand**~nd**WilesIl'1!gillendnwnoor3J3r1511 wilhaf1igi!tef1idoffiCI! atPII Box3rI SllndringhamHOlm. SandringhamAv!fJIle.HallowBminessPir\(. Harlow.EssexCMI95Q4.England. iIlddame!ticalotlin DulaWin!. USAisMerialllCAttachment 1 Table highlighting Merial's specific objections to claims In the Sergeant's Fipronil 

### + Methoprene Squeeze-On for Dogs labeling dated November 4, 2010Page Section Label Claim Rationale # (objectional portion highlighted) 2 Mosquitoes [Kills mosquitoes] [within 24 hours] Based on the efficacy review (MRID 45866902), mosquito labeling language for Frontline Plus for Dogs reads: "Kills mosquitoes within 24 hours for up to 7 days and within 48 hours for up to 28 days." 2 Mosquitoes [Kills ([andJ [&J repels) mosquitoes Repellency is not consistent with the that may transmit heartworm] known mode of action offipronil and none of Merial's fipronil-based products have repellency claims. 2 Adult Fleas [Kills [and repels] Fleas, source of Repellency is not consistent with the [flea allergy dermatitis] [, flea bite known mode of action offipronil and anemia] [and tapeworm none of Merial's fipronil-based products infestations]] have repellency claims. 2 Adult Fleas [Kills [&J [andJ Repels Fleas Up to [4 Repellency is not consistent with the weeksJ [1 monthJ [30 daysJ!J known mode of action of fipronil and none of Merial's fipronil-based products have repellency claims. 2 Multiple Bugs [Kills [andJ [&J [repelsJ fieas, flea Repellency is not consistent with the eggs, ticks, [chewingJ lice [&J [andJ known mode of action of fipronil and mosquitoes] none of Merial's fipronil-based products have repellency claims. 2 Multiple Bugs**[I@J~** ([andJ [&J [repelsJ fieas, ticks, Repellency is not consistent with the mosquitoes, [chewing] lice, flea known mode of action of fipronil and eggs, flea larvae [&J [andJ**tij~~** none of Merial's fipronil-based products 

## [l.lpifeJ have repellency claims. "Kills

...f1ea pupae" does not comport with the Frontline Plus label 2 Multiple Bugs [Kills [andJ [&J [RepelsJ Fleas, Ticks, Repellency is not conSistent with the [&] [and] Mosquitoes known mode of action of fipronil and none of Merial's fipronil-based products have repellency claims. 3 Multiple [SevenJ [7J Way Protection**r~HI.~** "Kills

...f1ea pupae" does not comport with Infestations fleas, ticks, mosquitoes, lice, flea the Frontline Plus label eggs, flea larvae [&] [and]**f(~'S** 

## pUpae 3 Multiple Bugs [Kills [&J [andJ Repels Fleas and Repellency is not consistent with the Ticks for up to [4 weeks] [1 month] known mode of action of fipronil and [30 daysJ!J none of Merial's fipronil-based products have repellency claims. 3 Ticks [Kills [andJ [&J [repelsJ Ticks Repellency is not consistent with the including those that may transmit known mode of action of fipronil and Lyme disease] none of Merial's fipronil-based products have reDellencv claims. 1 of 2Page Section Label Claim Rationale # (ob;ectional Dortion hiahliahtedl 3 Ticks [Kills [and] [&] [repels] Ticks [for Up Repellency is not consistent with the to] [4 weeks] [1 month] [30 days]!] known mode of action offipronil and none of Merial's fipronil-based products have repellency claims. 3 Ticks [Kills [and] [&] [repels] [all stages Repellency is not consistent with the of] deer ticks [before they can] known mode of action offipronil and [that] [transmit Lyme Disease,] [for none of Merial's fipronil-based products !**~~,**to [4 weeks;N month] [30 days] er aDolication have repellency claims. 3 Ticks [Kills [and] [&] [repels] Ticks Repellency is not consistent with the (Including Deer Ticks) for up to [4 known mode of action offipronil and weeks] [1 month] [30 days]] none of Merial's fipronil-based products have repellency claims. 3 Ticks [Kills [and] [&] [repels] [brown dog Repellency is not consistent with the ticks], [American dog ticks.] [and known mode of action offipronil and lone star ticks] **[(Rhipicephalus** none of Merial's fipronil-based products **sanguineus)]** [for up to [4 weeks] [1 have repellency claims. month] [30 days]]] 3 Ticks [Kills [&] [and] [Repels] American Repellency is not consistent with the Dog Ticks **[(Dermacentor variabilis))**  known mode of action offipronil and for up to [4 weeks] [1 month] [30 none of Merial's fipronil-based products days]!] have repellency claims. 3 Flea Eggs and**r~lIr~** adult fleas, flea eggs, flea "Kills
...f1ea pupae" does not comport with Larvae larvae and**pbj)~\~** for up to [three the Frontline Plus label months] [12 weeks].] 3 Flea Eggs and**iJl:jll[£~m~lf:ge~K<:if£~l1:eLlle~** (including "Kills all stages ofthe flea" and Larvae adult fleas, flea eggs, flea larvae and "Kills
...f1ea pupae" do not comport with 

## llei4"u"'"e)] the Frontline Plus label pp 3 Flea Eggs and 

### mUll/I''' [I ]**r~'N"'l** f ' "",,5.j,,&!.?1 eggs arvae**'PJl_R~t~,** or "Kills f1ea
... pupae" does not comport with Larvae up to [3 months] [12 weeks]] the Frontline Plus label 4 Flea Eggs and**[15U1~jJiiJlr~~'iies** of the fiea life cycle] "Kills all stages" does not comport with Larvae the Frontline Plus label 4 Flea Eggs and**[Cioilr~ete:"fdtection~a"arns!tall** "Complete protection against all stages" Larvae

## $I~;G~~Z9f{t[e:~ij~~:iti,~,~~~f~" _m_'" does not comport with the Frontline Plus label 6 BACK PANEL [[brand name] contains Fipronil and Repellency is not consistent with the S-Methoprene (insect growth known mode of action of fipronil and regulator) (IGR) to effectively 

## k!1J none of Merial's fipronil-based products [and**repel]lIe:al>iCam~g:e~j** and have repellency claims. ticks [(including those that may transmit Lyme Disease)]. "Kill...fleas (all stages)" does not comoort with the Frontline Plus label



### 2 of

### 2Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE**68130~1770** • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com

November 23, 2010

Rosanna**Louie~Juzwiak** Document Processing Desk Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Room SA900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 Subject: Response to EPANotice ofRegistration for**~** Sergeant's Fipronil 

### + S-Methoprene**Squeeze~on** for DogS:(2.2

..!7-LL4})
Dear Ms. Louie-Juzwiak: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 1581h Plaza, Omaha,NE 68130-1770, EPA Company Number 2517) is submitting a response to EPA'sNotice ofRegistration dated November4, 2010 for Sergeant's Fipronil 

### +**S~Methoprene** Squeeze-On for Dogs (EPA Registration Number 2517-134). Please find enclosed the following support documents:

• 8570-1 fonn; • A copy ofthe offerto pay letter dated December21,2009 to Merial Limited and delivery confirmation; • A copy ofthe FedEx tracking receipt (8673 4197 3765) and delivery confirmation; and • A copy ofresponse correspondence from Merial Limited acknowledging receipt (dated March 3, 2010). Sergeant's is responding to the following requests made by the Agency: 1. You must provide the Agency with a projected release for shipment date within 30 days of the date ofthisNotice ofRegistration. The Agencywill calculate the expiration date based on the projected release for shipmentdate until an actual release for shipment date is provided in writing. a. Sergeant's projectsthe anticipated release for shipment date to be March 1,2011. 2. Within 30 days from the date ofthis registration, in accordance with F1FRA §3(c)(1)(F) and 3(c)(2)(B), you must submita copy ofall offers to pay compensation and evidence oftheir delivery, used to supportthe data required for this product. a. Please find enclosed a copy ofthe offer to pay letter to Merial Limited and delivery confirmation.Sergeant's PetCare Products, Inc. 2625 Soutl1158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • W1Nw.sergeants,com Ifyotl have any questions, please contact me at 402-938-7079. 

# STil' / / /J'

# ~ 

# lUuj lI15X--/1
__ Kelly Hoskins Manager ofTechnical Affairs Sergeant's Pet Care Products, Inc. Enclosures cc: Richard Gebken, EPAPIease read' t 1'0 rns rue r nson reverse b " re

### c .0 feting" 

### 0=. Form A prove p 

## , .....,8 No 2070 0060 Approval expires 05-31 98 , , United States 

### [lRegistration opp Identifier Number 

# EPA Environmental Protection Agency 

### D,Amendment Washington, DC 20460 

## [g] Other Application for Pesticide

w Section I 1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification 2517-134 Richard Gebken 4. Company/Product (Name) PM#10

### ~"Jone DRestncted Sergeant's Pet CareProducts, Inc. / Sergeanl's Fipronil + S-mcthoprenc Squeeze-On For Dogs . 5. Name and Address ofApplicant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA 51>6[0'n'3\c)(3)(b)(l), my Sergeant's Pet Care Products, Inc. product is similar or identical in compositio,n and labeling IQ: 2625 South lS8th Plaza Omaha, NE 68130-1770 EPA Reg. No. . Product Name D Check ifthis is a newaddress Section II 

# D Amendment

- Explain below. 

# D Final printed labels in response to Agency letter

### u~I~;I 

### xx·xx-xx 

# o Resubmission in response to Agency leiter dated 11f4f2010 

# D "Me Too"Application 

# o Notification

- Explain below. 

# D Other

- Explain below. Explanation: Use additional page(s) if necessary, (Forsection I and Section 11.) Submission of a response to EPA Notice of Registration conditional requirements.
Section III 1. Material This ProductWill Be Packaaed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 

# 2. Type of Container 

### [g] Yes* 0yes DYes DMetal DNo D No 

# ISJ No 

### [gj Plaslic If''Yes'' No. per If "Yes' No. per DGlaSS "Certification must Unit Packaging wgt. Container Package wgt. Container DPaper be submitted 0.023 11 oz (0.50 ml) 3 vials 0.045 tloz(I.34ml)

## I I DOther (Specify) Plastic Bag 0.091 11 oz (2,68 ml) 0.13611 oz (4.02 ml) 3 Location 0/ Net Contents Information 4. Size(s) Retail Container 5. Location of Label Directions [glLabel D Container 0.023 11 oz (0.50 ml). 0.045 11 oz (1.34 ml), 0,091 11 oz (2.68 ml), 0.136 11 oz (4.02 ml) DOn Can**~On** Labeling accompanying product 6. Manner in Which Label is Affixed to Product b:!UthOgraPh IZlOther DPaper glued DStenciled Section IV 1. Contact Point (Comptete items direc/IYbelowloridentification ofindividuatto be contacted, ifnecessery, to process this applica/ion.) Name Title Telephone No. (IncludeArea Code) Kelly R. I-Ioskins Managcr ofTechnica! Affairs 402-938-7079 Certification 6. Date Application I certifythat the statements I have made on this torm and all altachments thereto are true, accurate and complete. I Received acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both (Stamped) under aoolicable law. 

# 2.Si'OU**jL/~h** 3. Title

. 

# , BY, '

## c;i Manager ofTechnical Affairs
4. Typed Name: I Kelly R. Hoskins 5. Date: 1112312010Sergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### U.S. Registered Mail December 21, 2009

Merial Limited 3239 Satellite Blvd., Bldg 500 LOC 106B Duluth, GA 30096 Subject: Offer to Pay CompensationUnder FIFRA Section 3(c)(l)(F) Sergeant's Pet Care Products, Inc. Proposed Product Sergeant's Fipror:iJ 

### + S-methoprene Squeeze-On for Dogs ("Product") To Whom It

### May Concern: As required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 3(c)(l)(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 ("COMPANY") that it intends to cite data regarding fipronil andlor (S)-methoprene on file with the U.S. Environmental Protection Agency ("USEPA" or "Agency") related to your end-use products containing fipronil andlor (S)·methoprel1e to support the USEPA registration of an end-use Product containing the same active ingredients. According to the USEPA's Listing ofPesticide Data Submitters (dated September 30, 2009), Sergeant's has identified COMPANY as an Original Data Submitter who has end-use product data on file with the Agency for the active ingredients fipronil andlor (S)-methoprene. Sergeant'shereby notifies COMPANY: 1. that it is the intent ofSergeant's to submit to the USEPA an application for pesticide registration for the Product containing the active ingredients fipronil and (S)- methoprene; 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 by FIFRA Section 3(c)(l)(F); and 3. Sergeant's offers to commence negotiations to determine the amount and tenns of compensation, ifany, to be paid for the use ofany data. IfCOMPANY intends to request compensation for the use ofCOMPANY's data, with regard to the approval of Sergeant's registration application, Sergeant's respectfully requestsPage 2



### that COMPANY indicate, by 

### return correspondence, the amount and terms ofsuch requested compensation and the following information for each Study for which cC?I11--rensation is 

### requested:
1. the MRlD number, 2. the Study Title, 3. the date ofStudy submission, and 4. the amount ofany compensation previously received by COMPANY 

### forthe use of these data from otherparties. 

### Sergeant's requests a response from CO:MPANY "vithin 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 requested by COMPANY. 

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

Kelly Hoskins Manager ofTechnical 

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

cc: LarryNouvel, Sergeant'sPet Care Products, Inc...D ['- 

### m

m ['- ..D QJ RETAIN THIS con FOR YOUR RECORDS,

### Page 1 of 1 

### @ Printpage Close

### €2J

Detailed Results

Tracking no.: 867341973765 Select time format 12H 

### Delivered Delivered Signed for by: J.SMARR Shipment Oales Deslinalion Ship date Dec 21, 2009 DULUTH, GA Delivery date Dec 22, 2009 10:04 AM Signature Proofof Delivery Shipment Options Hold at FedEx Location Hold at FedEx Location service is not available for this shipment.
Shipment Facts Service type Standard Overnight
Shipment Travel Hislory Select time zone: Local Scan Time
All shipment travel aclivily is displayed in local time for the location
DatelTima Activity Location Details Dec 22, 200910:04 AM Delivered OULUTH,GA



### http://www.fedex.com/TrackinglDetaiI7ftc_start _**url~&totalPieceNum~&backTo~&template** 

### _ty... 11/23/2010

# ~lllsDur~ Pillsbury Winthrop Shaw Pittman LLP 2300 N Street, t#'J ! Washington, DC 20037-1122 I Ie! 202.663.8000 I fax 202.663.8007

March 3, 2010 ByFederal Express 

### Ms. Kelly Hoskins Manager, Technical Affairs Sergeant'sPet CareProducts, Inc. 2625 South 158iliPlaza Omaha, NE 68130-1770 Warren U. Lehrenbaum leI 202.663.8754 warren.lehrenbaum@Pillsburylaw.com

Re: Demand for CompensationUnder Section3(c)(J)(F) oftheFederal Insecticide, Fungicide, and Rodenticide Act (UFIFRA").
Dear Ms, Hoskins: I 

### am writing

### on behalfofMerial Limited ("Merial"), inresponseto yourletters dated December21,2009 (which wereceived onJanuary 29, 2010). In those letters, you state 

### that Sergeant's PetCare Products, Inc. ("Sergeant's") offers to pay 

### compensationto Merial pursuantto FIFRA §3(c)(1)(F). forthe use ofMerial's data on file with Environmental ProtectionAgency ("EPA"). Weunderstand from your letters that Sergeant'shas applied to EPA to register four end-use pest control products that are intended for use on dogs and cats. The four products are identified in your letters as follows: (i) 

### Sergeant's Fipronil 

### + Smethoprene Squeeze-on for Dogs; (ii) Sergeant's Fipronil 

### + S-methoprene Spot-on for Cats; (iii) Sergeant's Fipronil'Only Squeeze-on forDogs; and (iv) Sergeant's Fipronil Only Spot On for Cats. According to your letters, these products contain either fipronil only or fipronil plus s-methoprene as the active ingredients. Your letters indicate, further, that Sergeant's is only citing data pertaining to Merial's enduse 

### products that contain fipronil or fipronil plus methoprene. Merial is prepared to enter into good faith negotiations aimed at reaching 'ag"etr.'1ent on the reasonable compensationthat is owedto Merial by Sergeant's. Inorder to facilitate this effort, and to detenninewhat constitutes reasonable compensa,;j'on for the data at issue, we request that you provideus with 

### the following items of

www.pllisburylaw.com 40173t680v1March 3, 2010 

### Ms. Kelly Hoskins Page 2

infonnation for each ofthe four Sergeant'sproducts that arethe subject afyaur 

### letters: • A copy ofthe proposedproduct label(s) submitted with 

### each registration application, as well as any proposed supplemental labeling forthe products; • A copyofthedatamatrix Sergeant's included with each registration application, and any subsequentrevisions; • A copyoftheFonnulators Exemption Statement(EPAFonn 

### 570-27) and a copyofthe Certification with

### Respect to Citation efData(EPAPenn 8570-34) that Sergeant's submitted with each of its registration applications; and

• Infonnationregardingthe date(s) on which Sergeant's 

### applications for registration were filed with

### EPA and the current status ofthose applications (in 

### particular, are the applications still pending orhavethe registrations alreadybeen granted). In addition, werequestthatyou provideus withwritten confinnationthat Sergeant's 

### is relying on the fannulators exemption for its fourproduct registrations, in lieu of citing orsupplyinggeneric safetydata for fipronil ormethoprene. IfSergeant's is

### not relying onthe formulators exemption,please explainwhy Sergeant's isnotciting any 

### generic safety data for fipronil ormethoprene in support ofits fourregistrations. Also, please confinn that: (i) Sergeant's is not citing anyproduct chemistrydata in EPA'sfiles (Le., theproductchemistrydata used to support Sergeant's productswere submitted

### by Sergeant's); and (ii) Sergeant'shas used the cite-all method to satisfy 

### the remaining datarequirements applicableto its products (other than 

### generic safety data for fipronil), includingproduct efficacy and/or acute toxicity. In

### orderto facilitate the promptresolution ofthis matter and to avoid unnecessary additional effort and expense, please provide us with this infonnationwithin 30 days ofthe date ofthis letter.

"""-W.pillsburylaw.COffi 401731680v1

### March 3, 2010 Ms. Kelly Hoskins Page 3

Ifyou have any questions regarding this letterplease feel free to 

### contactme at (202) 663-8754.



### cc: Selina Barnett, Esq. Karen C. Cunningham

www.pllisburylaw.com Sincer

## YO~' 

# j L-----**~~** ( 

### Warren U. 

### ehrenbaurn Pillsbury Winthrop Shaw Pittman Counsel for Merial Limited

40173168Ov1

# EXponent"

Submission to US EPADocumentProcessing Desk

Document Processing Desk 

### Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One Potomac Yard 

### 2777 South Crystal Drive Arlington, VA 22202

Date: November 23,2010 Company: Sergeant's PetCare Products, Inc. Submission List:

• Submission ofresponse to EPA conditions ofregistration for 2517-134.



### Confirmation ofreceipt by 

### US EPA DocumentProcessing Desk ExponenJ 1150 Connecticut Ave., NW Suite 1100 Washinglon, DC 20036 lciephone 202·293-5374 facsimile 202-293-5377 www.cxponclltcom



# /Ip?/!u 

# </.: c6 US EPA Document Processing Desk 

### Date/Time

# EXponent"

Submissionto US EPA OPP Document Processing Desk Office o[Pesticide Programs (7502P) U.S. Environmental Protection Agency Document Processing Desk Room s-4400, One Potomac Yard 2777 South Crystal Dr. Arlington, VA 22202
Date: 

### November 23, 2010 Exponent 1150 ConnecticutAve., NW Suite 1100 Washington, DC 20036 telephone 202·293·5374 facsimile 202-293-5377 www.exponentcom

Company: Sergeant's Pet Care Products, Inc. (EPA CompanyNumber 2517)
Submission List:

• Submission ofan updated CSF and Formulator's Exemption Statement for Sergeant's Fipronil 

### + S-methoprene Squeeze-On for Dogs (EPA Registration Number 2517-134)

Confirmation ofreceiptby US EPA OPP Document Processing 

## 1I(:J3i(O US EPA Document Processing Desk Date/Time