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# X

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### Is an Application Form (EPA Fom18570-1) Included in the

# ~ Suhmiss'ion Package, is it completely filled out and signed including package type?**~.-~----** 

### Is a Confidential StatementofFormula (EPA Fonn 8570- 

# I 29) Included in the Submission Package, is 

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### Is a Formulator's Exemption Statement (EPA Form 8570- 

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### Certification with Respect to Citation ofData (EPA 

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### a Data Matrix (EPA Form 8570-35) Included in the 

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# 'l Is a Label Included in the Submission Package?

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### Data Included in the Submission Package? 

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# Material to be added to an e-JacketorJacket 

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# r Default: (chronological, top 

## =newest)



## 2. D File Location: (PDF page number)

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# tflI Newly stamped accepted label D Notification 

# t1 New CSFQ.C\.)((. t

## Al~ I 

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## .&<.y-e D Other:__________ _ Attach this coversheetto the top ofthe material orjacket. It must be well-organized and clipped together
- NOT STAPLED. Then givethe material with this coversheetto**~staff** 

### in the Information Services Center (Room S-4900). 

# Reviewer's Name: Rosanna louie-Juzwiak Phone: 308-0037 Division: RD Date: 

# '2e M l\fL7P \ 

# 1

### REGISTRATION JACKET INTRA-TRANSFER REOUEST (PLEASE FILL OUT FORM COMPLETELY)**,~** ! 

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____ _ ReasonForTransfer:



# o RSB CHEMISTRY REVIEW 

# o CODING (Macfadden) 

# o ACTION COMPLETED 

# o PRECAUTIONARYLABELREVIEW 

# o WITHDRAWPENDING APPLICATION 

# o OTHER

________________________ ___
TRANSFERRED FROM: SenednAlemn <Macfadden) 

### Phone: 305-6178 DATE REQUEST: PMTEAM:

_____ _ (If

### Applicable)
REGISTRATIONNUMBER (S) OF JACKET (S) TO BETRANSFERRED (PLEASE INDICATE VOLUME NUMBER IF APPLICABLE) REGISTRATION

### # COMMENTS LOCATION OTHERINFORMATION 

### .2H?

- 11-2

SPECIAL COMMENTS: 

### FORFILE ROOM STAFF

### USE NOTIFYREQUESTOR:
DATE TIME 

### INITIALS

## ,

# ", PPIS DeficiencyNutice

## PMNUMBER:~ REGISTRATIONNUMBER: ').)'i'f

- 

### 19-2 Transferred from: SeneduAlemu (M:acfadden) DateProcessed: J 

### /2

## q/).Oll Thisjackethasbeenfoundto be deficient accordingto establishedEPA dataprocessing guidelines forthefollowingreasons: 1. Currentacceptedlabel dated 

### I 1 __ _

__ismissingfrom thejacket.

__ismlssmg acceptance stamp.

__Acceptance stamp ismissing date and/orregistrationnumber.

__Is missingthefollowinginformation:

_______________ _ 2. Acceptance 

### letter dated----1

__ 1 and associatedlabel areinconsistent concerning:

__Acceptance date.

__Productname.__Registration number. 3. 

### Conunents letter associated withlabel dated__ I __ I ___

### ismissingfrom thejacket. 4. Accepted (Basic 

### 1Alternate) CSF dated 

### 1 1 __ _ Ismissingfromthejacket.

__Is misfiled orhas wrongregistrationnumber.

__Sole activeingredient sourceproduct has beencancelled. 5. VActive andinert chemical percentages do not equal 100%. 6. Otherinformationmissing/ inconsistentwithinthejacket. Seebelow fordetails.U.S. ENVIRONMENTAL PROTECTION AGENCY Office ofPesticide Programs Registration Division (7504P) 1200 Pennsylvania Ave., N.W.

Washington. D.C. 20460 

### NOTICE OF PESTICIDE: 0' Registration 

## o Reregistration (under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended)
Name and Address ofRegistrant (include ZIP Code): Sergeant'sPetCareProducts,Inc. c/o Exponent,Inc. 2625 South 158'h Plaza Omaha,NE 68130 EPA Registration No. Date ofIssuance:
2517-142 

### MAR 23 2011

Term ofIssuance: Conditional Registration Time-limited: see conditions below
Name ofPesticide Product: Sergeant'sFipronil 

### +Cyphenothrin 

### + Methoprene Squeeze-on for Dogs

Note: Changes in labeling'differing in substance from that acceptedin connection withthis registration mustbe submittedto and accepted bytheRegistration Divisionpriorto use ofthe label in commerce. In any correspondence on this product always refer to the above EPA registration number.

.. . .' On the basis ofinformation furnished by the registrant, the above named pesticide is hereby registered underthe Federal Insecticide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation ofthis product by the Agency. In order to protect health and the environment, the Administrator, on his motion, may at any time suspend or cancel the registration ofa pesticide in accordance with the Act. The acceptance ofany name in connection with the registration ofaproduct under this Act is notto be construed as giving the registrant a right to exclusive use ofthe name or to its use ifit has beencovered by others. This product is conditionally registered in accordance with FIFRA §3(c)(7)(a) provided that: I. This registration is time-limited and expirestwo years from the date this product is first released for shipment. You must provide the Agency with a projected release for shipment date within 30 days ofthe date ofthis Notice ofRegistration. The Agency will calculate the expiration date based on the projected release for shipment date until an actual release for shipment date is provided in writing. 2. Consider limiting the formulations ofeach productto one basic confidential statement offormula. The Agency may require this in the future. It is possible that no additional alternate formulations orminor formulation amendments will be approved for this productin the future. 3. As a condition ofregistration for this product, within one year from the date ofthis registration, you must submit the results ofStorage Stability and Corrosion Characteristics studies, corresponding to OCSPP Guidelines 830.6317 and 830.6320, respectively, including interim reports made at 0, 3, 6, 9, and 12 month intervals. Page lof64. The approval ofthis registration is contingent on the Agency's review to determine that the study to fulfill OCSPP Guideline 830.1800

- Enforcement Analytical Method, is acceptableto support the registration. 5. Within one year ofthe date on this Notice ofRegistration, and priorto fonnulating this product, you must provide the Agency the following:

a. The registration number and establishment number ofthe manufacturing ortechnical product(s) from which the active ingredient is derived. b. The name and address ofthe entity from which the manufacturing product(s) was obtained; and c. A copy ofthe bill ofsale for this manufacturing product(s). 6. Within 30 days from the date ofthis registration, in accordance with FIFRA §3(c)(l)(F) and 3(c)(2)(B), you must submit a copy ofall offers to pay compensation and evidence oftheir delivery, used to support the data required for this product. 7. You must submit quarterly enhanced incident reports and quarterly sales infonnation in doses sold for this product for the quarter that begins onApril 1,2011. The quarterly reports are due two months after each quarter ends. Please flag any Confidential Business Infonnation as such. Enhanced incident reporting should be submitted to the Product Manager. Quarterly sales infonnation should be submitted to the Registration Division (7504P), to the Product Manager's attention. The following is a list ofinformation that must be iucluded iu the 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 on which incident occurred. (mm/dd/yyyy) State in which the incident occurred. (standard 2 letter abbreviation) Registrant case # Species: dog, cat, other (speciry) 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, other Major signs noted with separate column for each sign, using standard tenninology Timeto Onset: (hours, days) Treated byveterinarian: yes orno First time product used: yes orno Page 2 of6Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) Any known precondition EPA Severity Code: death, major, moderate, minor Outcome: died, recovered, still treated, unknown 8. Along with the enhanced incident reporting, you must submit an analysis ofthe incidents seen, to include the following details: All incidents should be reported including all minor dermal and ocular irritation reports. Summarytable for dogs showing number ofincidents ofeach severity code for each route ofexposure. Each incident should only be reported once. Ifone incident has several routes ofexposure, 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 incident with both ocular and oral exposure would be reported as ocular exposure. A similar summary table for cats (misuse or secondary exposure) showing number of incidents ofeach severity code for each route ofexposure. Summary table for dogs and table for cats showingnumber ofincidents that are believed due to secondary exposure (e.g., multi-pet households). A summary table for dogs 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, 7 yr, 8 yr, 9 yr, 10 yr, II yr, 12 yr, 13 yr, 14 yr, IS yr, >IS yr. A summary table showingthe number ofdog incidents for each severity code for each pet weight range on theproduct label. A summary table for dog weight showing number ofincidents for each product weight range. This table should show number ofincidents in dogs weighing less than that product weight range, number ofincidents in dogs in lower halfofweight range, number ofincidents in dogs in upper halfofweight range, and dogs weighing more than the product weight range. Table showing number ofincidents for each dog breed. Table showing number ofincidents in dogs for each clinical sign. Table showing number ofincidents in dogs for each organ system. Report aggregate incidents, but do not combine moderate and minor incidents. 9. You must submitand/or cite all data required for registration ofyour product under FIFRA §3(c)(5) whenthe Agency requires all registrants ofsimilar products to submit such data, and submit acceptable responses required for reregistration ofyour product under FIFRA §4.

Page 3 of6All labeling comments below are in reference to the proposed master label, dated March 4, 20II. These comments apply to all submitted draft labeling, including the master label, the color mock-up labels, and the proposed text and graphics for the stickers and magnet: 10. Throughoutthe entire label, add "starts killing" so that the claims read as follows: "Starts killing in as little as I hour" "Startskilling in as little as I hour." II. Throughout the entire label, per the Acute Toxicity and Companion Animal Safety review, change "up to 22 Ibs" to "4to 22 Ibs" to include a minimum dogweight. 12. On page I under the header Fleas, revise the following claims to add the underlined words, or delete struck-out words, as follows: "[Controls flea [einfestation fer HI' to [!6 weeks]]" "[Researeh aemonstrates that [brana name] kills aaHlt fleas (starts ill as little as I hOHr), flea eggs, ana flea laryae alla flrevellts flHflae for HI' to feHr months.]" "[[brana Ilame] flrevellts aeveloflment ofall flea stages fer Ufl to four mOllths.]" "[Prevents all flea stages (adult fleas (starts killing in as little as I hour), flea eggs, flea fluflae and flea larvae)]" "[Ki!!s flea eggs [larvae] [flre'o'ellts fluflae] fer HI' to 4months]" "[Kills Flea Eggs & Flea Larvae [for 2 months] [Ufl to 4mOllths]!]" "Kills a!! stages ofthe flea life eyeIe" 13. On pages I and 2 under Multiple Infestations, revise the following claims to add the underlined words, or delete struck-out words, as follows: "[Kills fleas (starts killing in as little as 1hour), flea eggs, ticks (starts killing in as little as I hour), chewing lice & mosquitoes][and prevents development offlea pupae]" "[Kills fleas (starts killing in as little as I hour), ticks (starts killing in as little as 1hour), mosquitoes, chewing lice, flea eggs, and larvae alla flrevents fluflae]" "[Kills fleas (starts killing in as little as 1hour), ticks (starts killing in as little as I hour), mosquitoes, flea eggs, and lice]" "[Kills Fleas (starts killing in as little as 1 hour) and Ticks [and mosquitoes](starts killing in as little as I hour) for up to 4 weeks!]" "[Ki!!s Fleas (starts ill as little as I hour), Tieks (starts ill as little as I hour), Flea Eggs & Flea Laryae for ufl to 16 Weeks]" "[Prevents and controls reinfestations oflisted pests for up to [I month] [4 weeks]]" 14. On page 2 under Ticks, revise the following claims to add the underlined words, ordelete struckout words, as follows: "[Kills ticks (starts killing in as little as 1 hour)]" "[Kills Ticks (starts killing in as little as 1 hour) for Up to [4 weeks]!]" "[Kills [all stages of] Deer Ticks (which may vector ofLyme Disease) for up to 4 weeks]" "[Kills Brown Dog Ticks (starts killing in as little as 1hour)]" 15. On page 2 under All Others, revise the following claims to add the underlined words, or delete struck-out words, as follows:
Page 4 of6"[OHee a mSHtR treatmeHt is feesmmeHaea]" "[[Free] BfseflHfe aHa Calendar Stickers Inside]" "[pfeveHts aHa eSHtrsls feiHfestatisHs sflisted pests]" "[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] 

### f£lif+[eaFdB" 16. On page 3 in the Ingredients Statement, all Inert ingredients must be identified when electingto list the inert ingredients. 17. On page 3, delete the optional statement "[Ingredient Statement may be on front orback label]" because the ingredient statement must be placed on the Front Panel. 18. On page 4 under the Back Panel, revise the first sentence to read as follows: "[brand name] contains fipronil, cyphenothrin, and the insect growth regulator (IGR) (S)- methoprene to effectively kill Fleas [(starts killing in as little as I hour)], Ticks [(starts killing in as little as 1 hour)], and kills mosquitoes and chewing lice." 19. On page 6 in the How to Apply section, correct the reapplication interval from "4 weeks" to "30 days" to be consistent with the interval stated under Frequency ofApplication. 20. On page 6 underthe Frequency ofApplication, add the underlined words in the following statements: "[Studies show that] [brand name] kills fleas (starts killing in as little as I hour) for up to three months. Ifyour pet is at high risk for flea reinfestation [, or in a highly infested environment], apply monthly." "[Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, then within 48 hours for up to 28 days." 21. On page 7 under the Storage and Disposal statement, replace "Container Handling" with "Container Disposal." 22. On page 7 in the Warranty statement, remove the brackets within the paragraph so that ifused, the Warranty statement is present in its entirety. 23. On page 9 under the End-back/side Panel section, delete the "Optional Insert or Package Copy" statement because the Agency has not reviewed the optional insert as part ofthe labeling for approval. 24. Note that should you wish to add a reference to the company's website on your label, then the website becomes labeling under FIFRA and is subject to review by the Agency. Ifthe website content is false or misleading, the product would be deemed misbranded and unlawful to sell or distribute under FIFRA §12(a)(I)(E). 40 CFR 156.l0(a)(5) list examples ofstatements EPA may consider false or misleading. In addition, regardless ofwhether a website is referenced on your product's label, claims made on the website may not substantially differ from those claims approved through the registration process. Therefore, should the Agency find or ifit is brought to our attention that a website contains false or misleading statements, or claims substantially differing from the EPA-approved registration, the website may be referred to the EPA's Office of Enforcement and Compliance Assurance. 25. Revise the EPA Re istration Number to read: "EPARe istration No. 2517-142." Page 5 of6[fthe Agency determines that future mitigation measures are necessary for all pet spot-on products, you will be informed, and be expected to comply. Ifmitigation measures are necessary, the Agency maytake appropriate regulatory actions. Two copies ofthe finished labeling must be submitted priorto releasingthe product for shipment. Ifthese conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA sec. 6(e). Yourrelease for shipment ofthe product constitutes acceptance ofthese conditions. A copy ofyour label stamped "Accepted with Comments" is enclosed for your records. Please contact Rosanna Louie-Juzwiak at (703) 308-0037 with any questions. Enclosure: Sergeant's Fipronil 

### + Cyphenothrin 

### +Methoprene Squeeze-on for Dogs Label, Stamped Acceptedwith Comments 

# s;?nZdL Date: 

# MAR 23 Richard Gebken, Product Manager (10) Registration Division, Insecticide Branch EPA Fonn 8570-6

Page 6 of6

# Sergeant's@ MasterLabel 4 March 2011 Version 10.1 EPA Reg. No. 2517-RUE Information in [ ] is optional. Page I of 10 

## )<];;..\,.;.,; .•, ..•..••.•.•..........•."....• •**.......}~g.(;'~Q y~E~~()l\l** **FIP~ONII,+GypHENQ:rH.R.IN:E~ETHQPRENE** [Option text appears in brackets-the final product label may include some or all ofthe optional text onfront, back or side panels. The CRP required text will not change.] 

## Sergeant's Fipronil

# + Cyphenothrin 

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

### (Sentry®) EctoadvanceTM (Spot On) for dogs] 

### ACCEPTED with COMMENTS 

### InEPALetterDated: 

### MAR 23 [Apply to puppies over 12 weeks old] [Apply to puppies 12 weeks or older] Unde.theFederal Insecticide Fungicide,aDd ROdenticideAct: asamended, forthe pesticide registered underEPA Reg. No. 2.517-1q,?- 

### [Mosquitoes]

[Fleas] [-Kills mosquitoes] [within 24 hours for up to 7 days] [and within 48 hours for up to 28 days] [-Kills mosquitoes]
[-Cefltrels flea reinfestatien fer up te [16 weeks]] [-Researeh demenstrates that [brand name] kills adult fleas (starts in as little as 1MUr), flea eggs, and flea larvae andpreYents pupae fer up te feur menths.] [-[brand name] preYents dewlepment efall flea stages fer up te feur menths.] [-Prevents all flea stages (adult fleas (starts killing in as little as I hour), flea eggs, flea pupae and flea larvae)] [-Ifdog is a high risk for flea re-infestation a once month application may be needed] [-Kills flea eggs [larrae] [preyents pupae] fer up te 4 menths] [-With (S)-methoprene Insect Growth Regulator which Breaks the Flea Life Cycle] [-With (S)-methoprene to Break FleaLife Cycle] [-With Insect Growth Regulator to Break Flea Life Cycle] [-Triple Action [!]:Fipronil and Cyphenothrin with (S)-methoprene IGREffectively Breaks the FleaLife Cycle] [-Triple Action [I]: Effectively Breaks the Flea Life Cycler!]] [-Kills Fleas (starts in as little as I hour) up to [4 weeks]!] [-Kills FleaEggs & Flea Larvae [for 2 months] [up te 4 menths] 

### !] [-Prevents FleaEggs From Developing Into Biting Adults] [-Kills all stages efthe flea life eyele] 

### [Multiple Infestations] [-Flea & Tick Control for Dogs & Puppies 12 weeks old and older] [-Kills fleas (starts killing in as little as I hour), flea eggs, ticks (starts killinginas little as I hour), chewing lice & mosquitoes][and prevents development offlea pupae] [-Kills Fleas, Ticks and Mosquitoes]

# Sergeant's® Master Label 4 March 2011 Version 10.1 EPA Reg. No. 2517-RUE Infonnation in [ ] is optional. Page 2 of 10



### [Ticks] [-Kills fleas (starts killing in as little as I hour), ticks (starts killing in as little as 1hour), mosquitoes, chewing lice, flea eggs, and larvae and prevents pupae] [-Monthlyflea, tick, mosquito, chewing lice, and flea egg protection] [-Monthly flea, tick, mosquito and chewing lice protection] [-Kills fleas (starts killing in as little as 1hour), ticks (starts killing in as little as 1hour), mosquitoes, flea eggs, and lice] [-[Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing lice, flea eggs, flea larvae [&] [and] prevent the development offlea pupaelJ [-[Six] [6] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing lice, flea eggs [&] [and] flea larvae] [- [4 Week] [Flea and Tick & Treatment] [-[Four (4) Week] [Flea, Tick, Mosquito and Chewing Lice Control] [-When used monthly [brand name] completely breaks the flea life cycle and controls tick and chewing lice infestations.] [-4 week Flea and Tick Treatment!] [-Once A Month Flea and Tick Treatment] [-Kills Fleas (starts killing in as little as 1hour) and Ticks [and mosquitoes](starts killing inas little as 1hour) for up to 4 weeks!] [-Kills Pleas (starts in as little as 1hour), Ticks (starts in as little as 1hour), Plea Eggs & Plea LaFYae 

### fOF UjJ to 16 Weeks] [-Prevents and controls reinfestations oflistedpests for up to [1 month] [4 weekslJ
[-Kills ticks (starts killing in as little as I hour)] [-Kills ticks including those that may transmit Lyme disease] [-Kills Ticks (starts killing in as little as 1hour) for Up to [4 weeks]!] [-Kills [all stages of] Deer Ticks (whichmay vector ofLyme Disease) for up to 4 weeks] [-Kills Ticks (starts in as little as 1hour)] [-Kills Ticks including Deer Ticks for up to 4 weeks] [-Kills Brown Dog Ticks (starts killing in as little as 

### 1hour)] [-Kills [Brown], [American,] [and Lone Star] Dog Ticks for up to 4 weeks] [-Kills Rhipicephalussanguineus for up to 4 weeks] [-Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!] [All Others] [-ForDogs and Puppies 12 weeks ofage or older] [-For Dogs 

### [UJl-1 to 22Ibs], [23-44Ibs], [45-88Ibs], [89-132Ibs] [-FastActing] [-Waterproof] [-Effective afterbathing and exposure to water and sunlight] [-Long Lasting] ['Once a month treatment is recommended] [-Applymonthly] [-A once monthly application is required [apply monthlyto control] [for] chewing lice.] [-Rapid elimination ofchewing lice infestations] [Controls mites that may cause sarcoptic mange] [-Three Applications] and/or [3 Month Supply] or [12 Week Supply] [-Best ifused year round!]

# Sergeant's® Master Label 4 March 2011 Version 10.1 Information in [ ] is optional. Page 3 of 10 [-4 

### Week Dose!] [-(ICON Showing 4 Week Protection)] 

### [-I Month Dose!] [-Easy to Use Application] [-Specially Formulated for Dogs and Puppies Over 12 Weeks] [-[Free] Calendar Stickers Inside!] [-[Free] BroclHlre and Calendar Stickers Inside] [-Apply once every [4 weeks]!] EPA Reg. No. 2517-RUE

[-[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] 

## feHtJt [eartIH [-Effective after bathing and exposure to water and sunlight] ["Prevents and controls reiBfestatioBs oflisted pests] [" [Free vrith plH'chase] [Free iBside] Monthly l\flplicatioB RemiBder [Magaet] [clip] [card]] [-3 applications] [-Fiponil (9.8%) + cyphenothrin (5.2%) + s-methoprene (8.8%)] [-US 

### and Foreign patents pending] [-Lift [here] for more information] [-For yearround protection, apply (brand name) monthly] [3 Applications] [For use ONLY on dogs]**[~1** 

### to 221bs] [23-44Ibs] [45-88Ibs] [89-132 Ibs] [over 12 weeks ofage] [For Dogs & Puppies (12 weeks or older and) up to 22Ibs.] [ForDogs 23-44 Ibs.] [For Dogs 45-88 Ibs.] [For Dogs 89-132Ibs.] [ ] - Denotes Optional Statements and/orImages thatMaybeUsed on Front, Back or Side Label Panels 

### [IBgredieBt StatemeBt may he OB front or hack lahel] ACTIVE INGREDIENTS: 

### Fipronil

.......................................................................... 9.8% Cyphenothrin

................................................................. 5.2% (S)-methoprene

............................................................. 8.8% OTHER

### INGREDIENTS*:
...................................... 76.4% TOTAL: 

### 100.0% [*diethylene glycol monoethyl ether]

# Sergeant's@ Master Label 4 March2011 Version 10.1 EPA Reg. No. 2517-RUE Information in [ ] is optional. Page 4 of 10 KEEP OUT OF REACH OF CHILDREN 

### WARNING See [Back][or][Side] [Label Panel[s] for Additional Precautionary Statements
NET CONTENTS: Contains (3) [0.023 fl oz] [0.67 ml] applicators Contains (3) [0.045 fl oz] [1.34 ml] applicators Contains (3) [0.091 fl oz] [2.68 ml] applicators Contains (3) [0.136 fl oz] [4.02 ml] applicators

### J11{G~;P~i1';'··**·~J>k;P'~0\i··** 

# ••····..,X<?;,•..•>·· •.•**\./.:;~9~§~P];;~¢ ID,9N** **~IIlRP.JmIj-l;QX'Il.EIENPTIIRI~:+M$mOIll{EN1li** 

### [BACK/SIDE CARTON LABEL - MASTERLABEL] [brand name] contains fipronil, cyphenothrin, and the insect growth regulator (IGR) (S)- methoprene to effectively kill Fleas [(starts killing in as little as I hour)], Ticks [(starts killing in as little as I hour)], and kills mosquitoes and chewing lice. The active ingredients in [brand name] feature a sustained release formula developed for fast acting [and long lasting] control of fleas, ticks, [mosquitoes] and chewing lice for up to [ I month] [[4] [four] weeks] on dogs. READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ONDOGS AND PUPPIES OVER 12 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS. WARNING. Causes substantial buttemporary eye injury. Do not get in eyes oron clothing. Harmful ifswallowed. Harmful ifabsorbed through skin. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. Wash hands thoroughly with soap and water afterhandling and before eating, drinking, chewing gum, using tobacco, orusing the toilet. Remove and wash contaminated clothing before reuse. HAZARDS TO DOMESTIC ANIMALS. For external use only. Do notuse on puppies under 12 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 atthe site ofproduct application. Ifsigns persist, orbecome more severe within a few days ofapplication, consult a veterinarian immediately. Ifyour dog has an unusual reaction to the initial application, consult a veterinarian before repeating treatment. Certain medications can interact withpesticides. Consult a veterinarian before using on medicated, pregnant, nursing, debilitated or aged dogs. Call 1-800-781-4738 for 24-hour assistance.

# Sergeant's® Master Label 4 March 2011 Version 10.1 EPA Reg. No. 2517-RUE Information in [ 

## 1 is optional. Page 5 of 10
FIRST AID IfIn Eyes 

# • 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 poison control center or doctor for further treatment advice. IfOn Skin 

# • Take offcontaminated clothing. OrClothing 

# • Rinse skin immediatelywith plenty ofwater for 15-20 minutes. 

## • Call a poison control center or doctor for treatment advice. IfSwallowed 

# • Immediately call a poison control center or doctor. 

## • Do not induce vomiting unless told to do so by a poison control center or doctor. 

# • Have person sip a glass ofwater ifable to do so. 

## • Do not give anything by mouth to an unconscious person. HOT LINE NUMBER Have the product container or label with you when calling a poison control center or doctor, or going for treatment. Formore information on this pesticide product (including health concerns, medical emergencies or pesticide incidents), you may call 1-800-781-4738. NOTE TO PHYSICIAN ORVETERINARIAN Treat patient symptomatically



# ."Gi[;'ii.'.'"

..·.,.'.,.,·'·
...**:7};;;i"i'!>:(.i~$gME]l;Z;1!J9N****J!'I~~QNJ:I.-I-~¥PJIEN(>jmuN:*METH()PRENE** DIRECTIONS FORUSE Itis a violation ofFederal lawto use this product in a manner inconsistentwith its labeling. DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU AND YOURDOG, READ ENTIRE LABEL BEFOREEACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOREXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS. DO NOT USE ON CATS. Maybe toxic and potentially fatal ifapplied to oringested by cats. FOREXTERNAL USE ON DOGS ONLY. Do not use onpuppies under 12 weeks ofage. Weigh your dog to be sure you are applying the right dose formulated for the weight ofyour dog. Do nottreat your dog with more than one pesticide product at a time. Over dosing your dog can result in serious illness and even death. Bestifused yearround. Certainmedications can interactwithpesticides. Consult a veterinarian before using this product on debilitated, aged, medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known organ dysfunction. DO NOT USE ON CATS or animals otherthandogs. Separate the treated dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that actively groom or engage in close physical contact withtreated dog may be at risk ofserious harmful effects. The most common signs ofingestion are excessive salivation and foaming at the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your pet for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats exhibiting these same symptoms from ingestion should be takento the veterinarian immediately.

# Sergeant's® Master Label 4 March20ll Version 10.1 EPA Reg. No. 2517-RUE Infonnation in [ 

### I is optional. Page 6 of 10 Ifyour dog is exhibiting signs ofand/or are being treated for skin dennatitis, talk to your vet before applying any topical flea and tick control product. Sensitivities may occur afterusing ANY pesticide producton dogs. Dogs may experience some temporaryirritation atthe site ofproduct application. If

### signs ofsensitivity occur batheyour dogwith a mild soap and rinsewithlarge amounts ofwater. If

### signs continue, consult a veterinarian immediately by calling 1-800-781-4738. [{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 off the narrow end atthe notches with scissors. How to apply: Inverttube over dog and use open end to part dog's hair. Squeeze tube firmly to apply all ofthe solutionto the dog's skin, as directed below. Repeat application may be made if necessary, but do not apply more often than once every 30 ,

# ..3 "-..

. days 4 weeks. 

# -n n- [Optional drawings that mayormay not appear on finished label] FREQUENCY OFAPPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill mosquitoes] [infestations]. [Studies showthat] [brand name] kills fleas (starts killing in as little as 1hour) for up to three months. Ifyour pet is at high risk for flea reinfestation [, or in a highly infested environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, then within48 hours for up to 28 days. [Brand name] remains effective, even after bathing, water immersion, or exposure to sunlight. Allowtreated area to dry thoroughly. Do not reapply for 30 days.

# Sergeant's® Master Label 4 March 20II Version 10.1 EPA Reg. No. 2517-RUE

# ~~~~~~page70f10~~~iI~~~~~~~~~ ForDogs Weighing**~:!.** 

### to 22 Ibs. [including smalldogs and puppies, 12weeks orolder] {For cartons containing .67 ml (0.023 fl. 

### oz.) applicatortubes} Apply one tube (.67 ml)(O.023 fl. oz.) [as a spotto the dog's back between the shoulder blades] [from the back ofthe neckto a point midway between the neck and tail]. ForDogs Weighing Between 23

- 44 Ibs. {Forcartons containing 1.34 ml (0.045 fl. 

### oz.) applicatortube} [Apply one tube (1.34 ml) (0.045 fl. oz.) as a spot to the dog's backbetweenthe shoulder blades.] [from the back ofthe neckto a pointmidwaybetweenthe neck andtail]. ForDogs Weighing Between 45

- 88 Ibs. {Forcartons containing 2.68 ml (0.091 fl. 

### oz.) applicatortube} Apply one tube (2.68 ml)(0.091 fl. oz.) [as a spot onthe dog's back between the shoulderblades] [from the back ofthe neckto a point midwaybetweenthe neck and tail]. ForDogs Weighing 89

- 1321bs. {For cartons containing4.02 ml (0.136 fl. 

### oz.) applicatortube} Apply one tube (4.02 ml)(O.l36 fl. oz.) [as a spot onthe dog's back betweenthe shoulder blades] [from the back ofthe neck to a point midway between the neck and tail]. STORAGE AND DISPOSAL PESTICIDE STORAGE: Do notremove tube from the packuntil ready to use. Store in a cool [below nOF 

### (25°C)] dry

### place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight. CONTAINERDISPOSAL 

### Hf.NDLlNC: If

### empty: Non-refillable container. Do notreuse or refill this container. Offer for recycling ifavailable. If

### partlyfilled: Callyour local solid waste agencyfor disposal instructions. Neverplace 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. HThe directions for use ofthis product are believed to adequate and must be followed carefully. It

### is impossible to eliminate all risks associated withthe use ofthis product. Unintended consequences may result because of unknown factors. All suchrisks shall be assumed bythe user or buyer.H Sergeant's is committed to providing high qualityproducts. To the extent consistentwith applicable law, Sergeant's makes no warranties, express or implied, ofmerchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this label. To the extent consistentwith applicable law, Sergeant's, the manufacturer, orthe Seller shall notbe 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.] [Ifyouhave questions orcomments about this product, please write: Sergeant's Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.]

# Sergeant's® Master Label 4 March 2011 Version 10.1 EPA Reg. No. 2517-RUE Information in [ ] is optional. Page 8 of 10 In Case ofEmergency, call: 1-800-781-4738 [For more information] [Visit us at:] [www.sergeants.com] Non-Emergency call1-800-224-PETS (7387) [Made in USA] Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-RUE EPA Est. No. XXXXX-XX-XXX [BAR CODE AREA]

[How to Apply

- May contain graphics illustratingproductuse, e.g., dogwith a drop falling onto its neckfrom a vial on front, side, orbackcarton label and/or applicatorlabeling.] [{Outer Packaging}] [Application Instructions] [Directions for Use] Howto 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 atthe notches 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.]

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

[Look at the Label (Look atthe Label icon) [Easy] 6 Step [Spot On] [Squeeze-On] [Topical] Checklist • Read the label completely and follow directions

# Sergeant's® Master Label' 4March2011 Version 10.1 EPA Reg. No. 2517-RUE Information in [ ] is optional. Page 9 of 10 • Weigh yourpet • Do NOT use Dog products on Cats • Do NOT treat with more than one pesticide product at a time • Separate animals after treatmentto avoid chance ofingestion • Do NOT split tubes between pets] [Brand Name] [3] [Month [Treatment] [Application] Tracker] [For year-round protection, apply [Brand name] monthly.] [Pet's Name (Emptyblank for owner to fill in name)] [First] [1st] [Second] [2nd] [Third] [3rd] [Dose] [Treatment] [Application](Empty blank for ownerto fill in date)(Date: MM/DDIYY)] 

### [calendar stickers with brand name] [Place stickers on your calendar as a reminder to reapply [brand name] [in 30 days.] [Monthly ApplicationReminder Magnet (image ofreminder magnet)] [Enclosed for your convenience is an applicationreminder magnet. Pushthe (reset) button, and the reminder lightwill blinktwice. The reminder tag is now set for 30 days. Atthe end of30 days the reminder light will blink, reminding youto 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.]



## '" AdultFlea 

# @ AdultFlea



# .". flea eggs

# ~ fleaeggs 

# .., flea larvae

# ~ flea larvae 

# .. flea pupae

# ~ flea pupae 

# ,. ticks 

# @ ticks 

# + Brown Doglick 

# ® Brown DogTick 

# + DeerTick 

# ® Deerlick

# ~ American Dog lick 

# @ American Dog lick



# f' chewing lice 

# @ chewing lice

# ~ LoneStar

## lick 

# @ Lone Star

## lick**~** 

## mosquIToes 

# @ mosquIToes [Optional graphics above mayor may not appear on finished label] (END OPTIONAL INSERT ORPACKAGE COPY)

# Sergeant's® Master Label 4 March 2011 Version 10.1 EPA Reg. No. 25l7-RUE Information in [ 

## I is optional. Page 10 of 10
Front Label 

# l@o<)NorJ 1 U'JII! ot< 

### {Brand Name}: CPT. 

### Fipronil 9.8% w/w, Cyphenothrin 5.2% w/w, (S)-methoprene 8.8% w/w 0.023 fl 

### oz (or) 0.045 fl 

### oz (or) 0.091 fl 

### oz (or) 0.136 fl 

### oz {label code} Back Label KEEP OUT OF REACH OF CHILDREN WARNING: Read directions and precautions before using. Use scissorsto open. EPA REG. No. 2517-RUE {label code}J 

# 3**~** I , J

"] <) 

# Brand Y" fordogs

# ~~ READ ENl1RELABEL BEFORE EACH USE.USEONLYON DOGSAND PUPPIESOVER 12WEeKSOFAGE. PRECAUTIONARYSTATEMENTS HAZARDS TO HU\1ANS,WARNING:GaI.IsesSI.IbsliiI'ltia!oot !tmporarytqei$l'f.Do rot getineyes oroncklIhillg. HimIfuI**~**swalowed. HamifulltaimrOOdthrough skill.1'lWJnged CffrfqJeolIy**~ed**skin cootactmaycauseaIler9ic reactions m some indMcIuaIs.WiUh hands**thorough~with** soapandwalei'aile!'Imding Md beforeootlng. ooniing, chewiflg gxn, using toboccQ, orusingthetoilet Re!oove andwash contaminatlld clo!hill9boNre!'Me. HAZARDS TO DOMESl1CN4MAl$.Forexterml useooly.Oo not I.ISeOO puppieslJ'ldl:r t2we-eksofage.lntlNiduai swsM'rt\es,lIillle rare, may 0CC\Ifafterusingarll pesllcm**~**Somedogs may**~~ !€ffl~ary** slaJileeffocts whef'lany productis**a~ied**Dogs ma'/,exp<fiencesometemi»"!ryirritationatthesite01 product**a~icatioo.**n signs persist, OfbecomamOleseverewithin afewda'J'Sof application, COM!AIauetefinariaoimmooa/etj.II)\1I.Irdoghas an unusualreaction lo!he**init~** applicatloo, coosultaveterirlariMbaItte repootingtreatment, Cer!aH1 medicallonscan interact,..ilh**~tickles. COflSU~** avetl!finarian before uslngon medicated, pregflarlt, nursing, detiliialed**or~eddll9S.GaH** 1-8(1).78/-4738lor24-hotx assistance. FIRSTAID IIInEyes I
-Hold eyeopen andrinseslowlyandgentlyvAlhwatedortS:2-o;nrnutes.

-RemoV<! contactlenses, ilpresent, afterthefirst 5milutes, then continuerinsing eye.

-Calla p050ncontrol cenlerordoctorlorfurthertreatmenladvict!. liOn SkinOrCIothin9 I
- Tilke offconlarninaledclothing.

-Rinseskinimmediatelywith plentyofwalerlort5-2O minutes.

-Call apoisoncontrol centerordoctortortreatmenladuice. ItSwalowed \

-Callap;lisoncontrolct!nterordoctorimmediatolylortreatmenladvice. •Havepersonsipaglass otwalerffable10swallow.

-Donotinduce**\'OfIl~ing** UI'I!essloidtodo so 'rJjapoison controlct!nterordoctor. •Do oot**g~~** anything 'rJjmouthtoanunCOIlSCKlUS pi1(SOIl. H01UHENUMBER Havethe productcontainerorlaOOlwithyouwhen caRingapcisoncontrol cenlerordoctor, orgoing tortreatmoot.Formore inlOl11latioo Of! !his pesticideproductIlflCWng health conC€l!ls,medical**OOl~g.llfICles** orpestlcio'e**Incide~),_youmay**call t-80()"78t-4718. NOTE TO PHYSICIAN ORVETERINARlI.H Treat**patiantS)'ll1~maticaGy.**

DIRECTIONS FOR USE Itis aviolation otFed€filllawto usathiS productinal!l3I'I!'l«incons!stefllv.ithttsIllbeling. DO NOTALLOWCHILDRENTOAPPLYPRODUCT.TO PREVENTHARMTOYOUANOYOOR OOG, READENTIRElABElBEFOREEACH USE FOLLOWALLDIRECTIONSANDPRECAUTIONARYSTATEMENTSCAREFULLY. FOREXTERNALUSEON COGSONlY, 00NOT USE ONRABBITS. DO NOTUSE ONOTtiERANIMAlS. 00 NOTUSEONCATS.May betOl(ic andpotenfuJlylatalit appt«!tooringestedbycats. FOR EXTERNAlUSEON DOGSOOLY. t::crot US€onpuppiesundert2weeks01age.Weighyourdogto besurel'011ltn aWfiroatheright doseIomlulatedtortheweightotyourdog. Do not !reatyourdog With morethan one pesticideproductatatme.**~dosing**yourdo;!canresultinseriousill!lessand e\'e(ldealh.Bestif usedyearround.CIlfI81nmedications canInleractWithpesticides. COI'IS\Atal'eleOOarianbeforeusing this prodJJcton!!ebiMa!1ld, aged, medicatoo, pregnant, ornursingdogs.Coosuft aue{ffinailanbeloreusingOIldogsv.ilhknownorgan dysfuncflOll. 00 NOTUSEONCATS 0( animals otherthan dogs. Separatethetreatoodog !romallotherdogs and cats tor24hoorsaftertrealmeot lias boon**a~**CatsaMdcqs that activelygroomorengage in closephysical contactwithtreatoo dog may be atrisk01 seriOliSMtmfuleffects.ThemostCOIllmOO**~** 01 ingeslionare excessiuesalivatlOil andImngatthe mouth.**~**the$(! symplomsoccurimmediatolyleedy(llll'dogand cootiml!to**moo~Of** y(lurdogtorthe next 24 hOLlrn.ltsymptoms**~sl**call t-800-781-4738totalktoaVillerinariM. Catse.xnbltlngthesesames;mplom$lrom infrastIonshouldbetaken tothevetl!finalY'aIlImmediately. I!I'ourdogisemitif!ngsigns01and/oris beingtreated forsk1ndetmali1is, t:i&to yourvetiletoreapp.'ying any lopicall\ea amtickcontrolproduct. Semltil'ities mayoccuralterusingIJjYpesticideprodocton dogs. Dogs mayexperience someterrrporaryirritation at\hesite of productapplication. H signsoisensitil'ityoccurbatIi&yourdogwith amild soapandrinse with largeaJ!fO\R1ts01walel',l1signs continue,consuH aw!ef'inaria!!immedi;tely bycall!ng 1-8011-78t-me. Howtoopen: Remove producttubestromthe**~.**Separateooe tube fromthe othen. Holding the lubewith notched end pdntlng up &ld away IfOOlthetaceand body, cutoNlhe narrowendal thenotctles**w~h**scissors. Howtoapply: InverttubeOI'efdog anduseope!!endto partdog'shair. Squeezetube firmlyto apply**a~**01the solutiontothedog's skin,as directed below. Repeat applicalioo may 00made itnecessary, OO!do not**a~**moreoftenthanonct!**~ery**4wooks. FREQUENCYOF**APP~K:ATKlN** Use BrandY'MmOlithlylorcompleteCOIltroi 01 1m,tickandchewingkeinlestations. Studies showthatBrand**Y'~**killsaduft fie,ru; torupto threemonths. Ityourpetis at high risklorI\eareintestation, apptymOfithly.**Ap~**monthlytocontrol ticks,**mosqu~oes,** andchewing tce. Brnnd yrn kmsmosquitoeswitrun 24 hoofslortile first 7daysaftertreatment, thenw1hin48 hourstorupto28days. BrandY"" remains eftectiveeven aftll( bathing,waterill'l1lersion, 01e};.posureto sunlight.JIJIow !reatoo areatodl'fthoroughly.00 ootreapply tor30days. ForDogs WeighingUpto22Ibs,:Apply onetube(U.B7ml)(O.023fl 01,\ I!youhaw'!queslioos orCOIIlmentsaboutthis**produc~** as aspoltothedog'sbackbetweenthe shou!derthdes. pleasawrite: SENTRYConsumerResp:lllse, U.S. andForeignPatentsPendiflg MadeIn USA InCase ofEmergency, call: t-8oo·781-4738 Non-Emergencycall t..goo.224-PETS (7387) P.O. Box540399, Omaha, NE 58t54·0399. Distributedby: Sergeant's PetCare Products,Inc., P.O. Box540399,Omaha, NE6!1t54-0399. EPAReg. No.25t7-RUE EPAEst. No. 25tHN·j POOXXXX. ACRR 

# OJ**O~** 

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OFREACH OFCHILDREN 

### WARNING SeeBa<klabelPanelforAdditionalPrecautiooaryStatements 

### NetContents: Three 0.023 II oz (0.67 mL) applicators 

## KILLS 

## ""fleas fA

## flea eggs**~ticks** 

## Jr 

## chewing lice**~mosquitoes** -'.- Controls mites thatmay cause sarcoptic mange • Waterproof

ACTIVE tNGREDtENTS: Fipronil.........

.....9.80% Cyphenothrin

................................5.20% (S)-melhoprene

...........................8.80% OTHER**INGREDIENTS~:** ......... 76.40% TOTAL:

................................... 100.00%, 'Diethylene Glycol Monoethyl Ether, Vitamin E Nicotinate

EPA Reg # 2S17-RUE 

# , 

# >- (f) 

# "00)



# c:-8 cal.- ,-Q 

# CO**~** 2

## ~**~ ~** **~=<: (j)go~** **~ti** t.:i**~** 

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### B5:**~~8** !£r:.:**8~-a**Front Whitetube IBlacktext on awhite labelIColored Strip

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# - Additional Notes:

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# --

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### WARNING 

## KILLS 

## '"fleas '41. 

## flea eggs**~ticks** 

## 't chewing lice**~mosquitoes** -tf: Controls mites thatmay causesarcoptic mange • Waterproof

ACTIVE INGREDIENTS: Fipronil

..........................................9.80% Cyphenothrin

................................5.20% {S)-methoprene

...........................8.80% :R**INGREOIENTS~:** .... 76.40% 'OiethyleneGlycol Monoethyl Ether, Vitamin E Nicotinate

SeeBacklabelPanelforAdditional PrecautionaryStatements c,**c_=~--,** 

### NetContents: Three 0.045 11 oz 

### (1.34 mL) applicatorsFront White tube/Blacktext on awhite label/Colored Strip

ART INSTRUCTION FORTHE PRINTER 

# -- Prinler/Vendor:

BlACK PMS J6J Additional Notes:
Labels adhere to White Tubes Dale sent: 8mm



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# 3000 Applications 

## SENTRY. 

# Brand yTM fordogs

REACH OFCHILDREN 

### ING 

### Net Contents: Three 0.091 Iloz (2.68 mL) applicators 

## KILLS 

## '"fleas 'I\. 

## flea eggs**~ticks** 

## 't chewing lice**~mo5quitoe5**

--.Controls mites thatmay causesarcoptic mange • Waterproof

ACTIVE INGREDIENTS: Fipronil............

...........9.80% Cyphenothrin

......."

......................5.20% (S)-methoprene

............ .......8.80% OTHER INGREDIENTS·:

......... 76.40% TOTAL:
.................................... 100.00% 'DiethyleneGlycol Monoethyl Ether, Vitamin E NicotinateFront Whitetube IBlacktexton awhite label IColored Strip

ART INSTRUCTION FORTHE PRINTER Printer/Vendor: 

# --

BLACK PMS 200 Additional Notes: Labels adhere to White Tubes 38,1mm

Date sent: 8mm



# --

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### Net Contents: Three 0,136 II oz (4,02 mL) applicators 

## KILLS 

## '"fleas '4L 

## flea eggs**~ticks** 

## Jr chewing lice**~mosquitoes ,,~**  Controls mites thatmay cause sa(copticmange • Waterproof

ACTIVE INGREDIENTS: Fipronil...................

................9.80% Cyphenothrin

........ .......5.20% (S)-methoprene

.....:......................8.80% OTHER INGREDIENTS·;

........ 76.40% TOTAL:
.................................... 100.00% *Diethylene Glycol Monoethyl Ether, Vitamin E NicotinateFront White tube/ Blacktexton awhite label/Colored Strip

ART INSTRUCTION FOR THE PRINTER 

# --

SlACK PMS 2945 Printer/Vendor: Additional Notes:
Labels adhere to White Tubes 38.1mm

Date sent: 8mm



# --

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.**WARNJN~:** Read**dir~ctions** and prec3unons**~~~~E~~I~~. ~~~7~~~orsP=** 

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# --

10mmART INSTRUCTION FOR THE PRINTER Printer/Vendor: Dote sent: 

# -- Additional Notes:

BlACK PMS 2738



### 3Tracking Create Resubmission



## u**w~,** 

# t\. lJ\h(L-

## ~~fY1

### DATA PACKAGE BEAN SHEET Date: 05·0ct·2010 Page 1013



### ••• Registration Information' •• Decision #: 

### 438361 DP #: 

### (382788) PRIA Parent DP #: 

### Submission #: 

### 880182 Registration: 2517·RUE· SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI 

# \ Company: 2517
- SERGEANT'S PET CARE PRODUCTS, INC. Risk Manager: RM 10
- Richard Gebken
- (703) 305-6701 Room# PY1 S-7237 Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Date:**23~Mar-2011 ~~~~**  Type of Registration: Product Registration
- Section 3 Edited Due Date:

Action Desc: (R310) NEW PRODUCT;.i'l0N-FAST TRACK (INCLUDES REVIEWS OF P_RODUCT CHEMISl

Ingredients: :oSe,..e ___p"'a"'g-::;e-=3 ________________________ _



### ••* Data Package Information 

### * * * ExpedITe: 

### 0 Yes. No Date Sent 05-0ct-2010 Due Back: DP Ingredient: See page 3**~~~~~~-**
DP Title: #2517-RUE: Product Chemistry**R~-:v,,"ie.:.:w** ______ _ CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP #:

--**~~~~**

Assigned To Date In Date Out / 

## -===- Last Possible Science Due Date: 21-Feb-2011 Organization: :.cRo:D-'-/-'T"Ro:B ________**~** Team Name: c:C"H=E:.::M'--- ________**~** Reviewer Name:

### ~ Q,lv'-A

### Mc,,--\-t~ 

# 'L-.f**I~** Contractor Name: 

### * • * Studies Sentfor Review' 

### * * Printed on Page 2 Science Due Date: Sub Data Package Due Date: ____ _



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

### * * * No Additional Data Packages 

### • * • Data Package Instructions 

### * * • Attn TRB/CHEM: Please conduct a product chemistry review ofthe attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 with any questions. Attachments:

- cover letter

- basic CSF

- draft label

- MRIDs 48189201, -02DATAEVALUATION RECORD FIPRONIL CYPHENOTHRIN S-METHOPRENE (Sergeant's Fipronil

### + Methoprene Squeeze-On forDogs) STUDY TYPES: ProductIdentity and Composition (OPPTS 830.1550)

Primary Reviewer: Description ofMaterials Used to ProducetheProduct (OPPTS 830.1600) Description ofProduction Process (830.1620) Discussion ofFormationofImpurities (OPPTS 830.1670) PreliminaryAnalysis (OPPTS 830.1700) Certified Limits (OPPTS 830.1750) EnforcementAnalyticalMethod (OPPTS 830.1800) Physical and Chemical Characteristics (OPPTS 830.6302-830.7950) MRlDs 481892-01 and 481892-02 Prepared for Registration Division Office ofPesticide Programs U.S. Environmental Protection Agency One Potomac Yard 2777 South Crystal Drive

Arlington, VA 22202 Prepared by Toxicology and Hazard Assessment Group Environmental Sciences Division

Oak Ridge National Laboratory OakRidge, TN 37831

Task OrderNo. 1-43

Eric B. Lewis. M.S. Signature: Date: 

## dAN 1 1 

## 281 J Secondary Reviewers: SylviaMilanez. Ph.D., D.A.B.T. Signature: Date: 

## JAN 1 I 

## 2011 Robert H. Ross, M.S., Group Leader Signature: Date: Quality Assurance: Kimberly G. Slusher, M.S. Signature: Date: 

## ,JAN 11



# - " Disclaimer This review may have been altered subsequent to the contractor's signatures above. Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC., for the U.S. Department ofEnergy under ContractNo. DE-ACOS-000R2272S.DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; PC Code(s): 129013. 129121. 105402; Action Code: R 310; FOOD Use: No DATE OUT: March 1. 2011
SUBJECT: End Use Product Chemistry Review Product Name: Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs Shyam Mathur 

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# _~.. . Product Chemistry Team**u\'p~** 

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# 1\**~_** Technical Review Branch 1Registration Division (7505P) Z> \ 

# 3j;r)11 FROM:

TO: Rosanna Louie 1Richard Gebken, PM 10 Insecticide Branch 1Registration Division (7505P) Company Name: Sergeant's Pet Care Products, Inc. Formulation Type: Insecticide
A. INTRODUCTION: The applicant submitted an application for registration of a new non-food use end use product. In support of the application, the applicant submitted product chemistry data corresponding to guideline 830 series, group A & group B (MRIDs 481892-01 and 481892-02). A CSF for a basic formulation (dated 8/11/2010) was submitted along with the product label. On the advice ofthe Agency, the registrant submitted a revised basic CSF and an alternate CSF #1 (both dated 02-28-11) bye-mail on February 28,2011. The primary review of the product chemistry data was performed by Oak Ridge National Laboratory, Oak Ridge, TN, USA.TRB has been asked to determine the acceptability of the product chemistry data and the proposed CSF's.
B. SUMMARY OF FINDINGS: 1. Name ofActive Ingredient(s): Fipronil (9.8%), S-Methoprene (8.8%), Cyphenothrin (5.2%) 2. All the source materials for the active ingredients are derived from registered sources: [Xl Yes; [l No 3. All inert ingredients have been screened by IIAB and found to be approved for the proposed labeled uses [Xl Yes; [ 1No. 4. Confidential Statement of Formula(s): [Xl Basic
- Dated: August 11, 2010; Re-submitted (email 02-28-11)
- Dated: 28 February, 2011 [Xl Alternate # 1 - Dated: 02-28-11 Is the alternate CSF in compliance with 40CFR§152.43? [Xl Yes; [l No; [l NA



### 2 DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; PC Code(s): 129013. 129121. 105402; Action Code: R 310; FOOD Use: No DATE OUT: March 1. 2011
SUBJECT: End Use Product Chemistry Review Product Name: Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs Shyam Mathur 

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# _~.. . Product Chemistry Team**u\'p~** 

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# 1\**~_** Technical Review Branch 1Registration Division (7505P) Z> \ 

# 3j;r)11 FROM:

TO: Rosanna Louie 1Richard Gebken, PM 10 Insecticide Branch 1Registration Division (7505P) Company Name: Sergeant's Pet Care Products, Inc. Formulation Type: Insecticide
A. INTRODUCTION: The applicant submitted an application for registration of a new non-food use end use product. In support of the application, the applicant submitted product chemistry data corresponding to guideline 830 series, group A & group B (MRIDs 481892-01 and 481892-02). A CSF for a basic formulation (dated 8/11/2010) was submitted along with the product label. On the advice ofthe Agency, the registrant submitted a revised basic CSF and an alternate CSF #1 (both dated 02-28-11) bye-mail on February 28,2011. The primary review of the product chemistry data was performed by Oak Ridge National Laboratory, Oak Ridge, TN, USA.TRB has been asked to determine the acceptability of the product chemistry data and the proposed CSF's.
B. SUMMARY OF FINDINGS: 1. Name ofActive Ingredient(s): Fipronil (9.8%), S-Methoprene (8.8%), Cyphenothrin (5.2%) 2. All the source materials for the active ingredients are derived from registered sources: [Xl Yes; [l No 3. All inert ingredients have been screened by IIAB and found to be approved for the proposed labeled uses [Xl Yes; [ 1No. 4. Confidential Statement of Formula(s): [Xl Basic
- Dated: August 11, 2010; Re-submitted (email 02-28-11)
- Dated: 28 February, 2011 [Xl Alternate # 1 - Dated: 02-28-11 Is the alternate CSF in compliance with 40CFR§152.43? [Xl Yes; [l No; [l NA



### 2DP BARCODE No.: 0382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; PC Code(s): 129013, 129121, 105402; Action Code: R 310; FOOD Use: No
5. 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: Metallic equivalent: [ 1Yes [Xl NA; Soluble arsenic: [lYes [Xl NA Isomeric ratios: [lYes [Xl NA Acid equivalent: [lYes [Xl NA; {name} acid equivalent

## = xx % b. Health related sub statements: Product contains? Petroleum distillate at > 10%: 

### 1 Yes [Xl No 

### 1NA Methanol at > 4%: 1Yes [Xl No 1NA
c. Physical chemical hazard statement: Product label requires a statement per 40 CFR §156.78 for: fiammability, explosive potential or electric insulator breakdown? [ 1Yes [Xl No Is the sub statement in compliance with PR Notice 97-6? [ 

### 1 Yes, [Xl NA; [ 

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

### 1 Yes [Xl No; ifyes explain below:

3 DP BARCODE No.: 0382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; PC Code(s): 129013, 129121, 105402; Action Code: R 310; FOOD Use: No
5. 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: Metallic equivalent: [ 1Yes [Xl NA; Soluble arsenic: [lYes [Xl NA Isomeric ratios: [lYes [Xl NA Acid equivalent: [lYes [Xl NA; {name} acid equivalent

## = xx % b. Health related sub statements: Product contains? Petroleum distillate at > 10%: [l Yes [Xl No [ 1NA Methanol at > 4%: [ 

### 1 Yes [Xl No [ 

### 1 NA
c. Physical chemical hazard statement: Product label requires a statement per 40 CFR §156.78 for: fiammability, explosive potential or electric insulator breakdown? 

### [ 1 Yes [Xl No Is the sub statement in compliance with PR Notice 97-6? [ 

### 1 Yes, [Xl NA; [ 

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

### 1 Yes [Xl No; ifyes explain below:

3DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; PC Code(s): 129013. 129121. 105402; Action Code: R 310; FOOD Use: No 6. Group A: Product Chemistry Data TRB's determination ofthe acceptability ofthe data for the proposed product is listed in the tables below. Data submitted TRB's Guideline No. Study Title Assessment MRID Nos. Yes No of Data 830.1550 Product Identity & Composition X A 481892-01 Description of materials used to 830.1600 produce the product X A 481892-01 Description offormulation 830.1650 process X A 481892-01 Discussion on the formation of 830.1670 impurities X A 481892-01 830.1700 Preliminary analysis X NA Standard certified limits X A Certified limits Proposed Limits 481892-01 (158.350) Justification for wider limits 830.1750 Enforcement analytical method 830.1800 X G

A 

## = Acceptance, N

## =Not Acceptable, G

## =Data Gap, W 

## = Waiver Request, I

## =In Progress, NA

## =Not Applicable

4DP BARCODE No.: 0382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; PC Code(s): 129013. 129121.105402; Action Code: R 310; FOOD Use: No
7. Group B: Guideline Study Title Value or Qualitative TRB's No. Description Assessment of Data
830.6303 Physical State Liquid A 830.6315 Flammability Flashpoint >90'C A Does not contain explosive 830.6316 Explodability inQredients NA Not soluble/dispersible in 830.7000 JlH water NA 830.7300 Density (units) 1.00
- 1.05 g/cc A MRIDNos.

481892-02 481892-02 481892-02 481892-02 481892-02
A 

## = Acceptance, N

## =NotAcceptable, G

## =Data Gap, W 

## = Waiver request, NA

## =Not applicable, I 

### = In progress

5DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; PC Code(s): 129013. 129121, 105402; Action Code: R 310; FOOD Use: No C. CONCLUSIONS: The TRB has reviewed the CSF(s) and product chemistry data for the proposed end use product and has concluded: 1. The proposed revised CSF for basic formulation (dated 02-28-11) and the new CSF for alternate formulation #1 (dated 02-28-11) are acceptable. 2. The data submitted corresponding to guidelines 830.1600 (description of materials used to produce the product), 830.1650 (description ofthe formulation process), 830.1670 (discussion of the formation of impurifles), and 830.1750 (certified limits) are acceptable. 3. No data was submitted forthe guideline 830.1800 (enforcement analytical method), this was considered as a data gap. The registrant is advised to provide a validated enforcement analytical method forthe determination ofthe three active ingredients in the proposed product. This is a product specific data and is required to satisfy the product chemistry data requirements. 4. The product chemistry data submitted corresponding to guidelines 830.6302 (color), 830.6303 (physical state), 830.6304 (odor), 830.6315 (flammability), 830.7100 (viscosity), and 830.7300 (density) are acceptable. 5. No data were submitted for guidelines 830.6317 (storage stability) and 830.6320 (corrosion characteristics), The registrant states that these data will be submitted when the studies are completed. It is recommended that the observations should be made at 0, 3,6, 9, and 12 month intervals. 6. The proposed label was screened as it pertains to the product chemistry requirements. The final review ofthe proposed label and uses are the purview of the RM team. 7. The registrant is advised to revise the Ingredient statement on the product label to correct the product label claim for the active ingredient cyphenothrin from 5.0% to 5.2%, so that it concurs with nominal concentration in the revised basic CSF (dated 02-28-11).

6 DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; PC Code(s): 129013. 129121, 105402; Action Code: R 310; FOOD Use: No C. CONCLUSIONS: The TRB has reviewed the CSF(s) and product chemistry data for the proposed end use product and has concluded: 1. The proposed revised CSF for basic formulation (dated 02-28-11) and the new CSF for alternate formulation #1 (dated 02-28-11) are acceptable. 2. The data submitted corresponding to guidelines 830.1600 (description of materials used to produce the product), 830.1650 (description ofthe formulation process), 830.1670 (discussion of the formation of impurifles), and 830.1750 (certified limits) are acceptable. 3. No data was submitted forthe guideline 830.1800 (enforcement analytical method), this was considered as a data gap. The registrant is advised to provide a validated enforcement analytical method forthe determination ofthe three active ingredients in the proposed product. This is a product specific data and is required to satisfy the product chemistry data requirements. 4. The product chemistry data submitted corresponding to guidelines 830.6302 (color), 830.6303 (physical state), 830.6304 (odor), 830.6315 (flammability), 830.7100 (viscosity), and 830.7300 (density) are acceptable. 5. No data were submitted for guidelines 830.6317 (storage stability) and 830.6320 (corrosion characteristics), The registrant states that these data will be submitted when the studies are completed. It is recommended that the observations should be made at 0, 3,6, 9, and 12 month intervals. 6. The proposed label was screened as it pertains to the product chemistry requirements. The final review ofthe proposed label and uses are the purview of the RM team. 7. The registrant is advised to revise the Ingredient statement on the product label to correct the product label claim for the active ingredient cyphenothrin from 5.0% to 5.2%, so that it concurs with nominal concentration in the revised basic CSF (dated 02-28-11).

6RE: 2517-RUE James Messina to: Shyam Mathur 02/28/2011 04:49 PM Shyam, Good point. We have spoken with the PM and are planning to send updated labels to them this week. Regards, Jim -----Original**Message~----** From: Mathur.Shyam@epamail.epa.gov [mailto:Mathur.Shyam@epamail.epa.gov] Sent: Monday, February 28, 2011 3:50 PM To: James Messina Subject: Re:**2517~RUE** Thanks James. You may have to revise the product label also for cyphenothrin to 5.2% and adjust the amounts of Other ingredients. shyam Shyam Mathur, Ph.D Product Chemistry Team Leader Technical Review Branch/Registration Division opp / USEPA**703~308~9374**

From: To: Cc:
Date: Subject:
Shyarn, "James Messina rr <jrnessina@exponent.cotn> Shyam Mathur/DC/USEPA/US@EPA "Kelly Hoskins" <KHoskins@SERGEANTS.cotn>, "Matthew Feinberg n <mfeinberg@exponent.com>, IIPaulina Do" <pdo@exponent.cotn>, IIRyan Weidling" <rweidling@exponent.cotn>

02/28/2011 03:36 PM**2517~RUE**

As reqeusted today, please find attached updated CSF's (Basic and Alternate #1) for 2517-RUe (Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs. We have separated the CSF into a Basic and Alternate #1 as per EPA policy. Additionally, we have updated the percentage of cyphenothrin from 5.0% to 5.2%. This change was already approved by EPA for 2517-140 and should also be acceptable for**2517~RUG.** If you have any questions, please contact me. Best Regards, James Messina Senior Managing Regulatory Consultant Exponent Center for Chemical Regulation and Food Safety 1150 Connecticut Avenue, N.W. Suite 1100 RE: 2517-RUE James Messina to: Shyam Mathur 02/28/2011 04:49 PM**~~~~~~~~,~~,~~~~~,:~:~~~~,~,~~:~~~~,~~~~,~,~~~:~"~~"'**..**'~""~'."~~'~~~.~".,.,~.,.,**..**~**..,..**~.** Shyam, Good point. We have spoken with the PM and are planning to send updated labels to them this week. Regards, Jim -----Original**Message~----** From: Mathur.Shyam@epamail.epa.gov [mailto:Mathur.Shyam@epamail.epa.gov] Sent: Monday, February 28, 2011 3:50 PM To: James Messina Subject: Re:**2517~RUE** Thanks James. You may have to revise the product label also for cyphenothrin to 5.2% and adjust the amounts of Other ingredients. shyam Shyam Mathur, Ph.D Product Chemistry Team Leader Technical Review Branch/Registration Division opp / USEPA**703~308~9374**

From: To: Cc:
Date: Subject:
Shyarn, "James Messina rr <jrnessina@exponent.cotn> Shyam Mathur/DC/USEPA/US@EPA "Kelly Hoskins" <KHoskins@SERGEANTS.cotn>, "Matthew Feinberg n <mfeinberg@exponent.com>, IIPaulina Do" <pdo@exponent.cotn>, IIRyan Weidling" <rweidling@exponent.cotn>

02/28/2011 03:36 PM**2517~RUE**

As reqeusted today, please find attached updated CSF's (Basic and Alternate #1) for**2517~RUe** (Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs. We have separated the CSF into a Basic and Alternate #1 as per EPA policy. Additionally, we have updated the percentage of cyphenothrin from 5.0% to 5.2%. This change was already approved by EPA for**2517~140** and should also be acceptable for**2517~RUG.** If you have any questions, please contact me. Best Regards, James Messina Senior Managing Regulatory Consultant Exponent Center for Chemical Regulation and Food Safety 1150 Connecticut Avenue, N.W. Suite 1100

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page 1 of 3 

### * * * Registration Information 

### * * * Decision #: 438361 DP 

### #: (382790) PRIA Parent DP 

### #: Submission 

### #: 880182 Registration: 2517-RUE
- SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI Company: 25t7
- SERGEANT'S PET CARE PRODUCTS, INC

.. _________ _ Risk Manager: RM 10
- Richard Gebken
- (703) 305-6701 Room# PYt S-7237 Risk Manager Reviewer:**:cR:.:c0s",accnccna=--=L:co~ui:.:ce-,-R=L=O-=UccIE,--**______________ _ Sent Date: -'----- Calculated Due Date: 23-Mar-20t t Edited Due Date: Type of Registration: Product Registration
- Section 3 Action Desc: (R31 0) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients: "'S"ee=pa"'gc:e-=3'-- ________ _ 

### * * * Data Package Information 

### * 

### * * Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient: See page 3**-~'-------**
DP Title: #25t7-RUE Companion Animal Safety Review CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP#:

Assigned To Date In Date Out Organization: RD / TRS



### ---------- Team Name: TOX**~~------------** Reviewer Name:

-------- Contractor Name:



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

### * * * Studies Sent for Review 

### * * 

### * Printed on Page 2 ----
/ Last Possible SCience Due Date: 21-Feb-201 t / Science Due Date: ____ _ Sub Data Package Due Date:



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

### * 

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

### * 

### * * Data Package Instructions 

### * 

### * * Attn TRSrrOX: Please conduct a companion animal safety review of the attached package in support of the proposed product. Contact Rosanna**Louje~Juzwiak** at 308.0037 with any questions. Attachments;**~** cover letter

- basic CSF

- draft label**~** data matrixOP#: (382790)

43121110

43121111

46166108

43863802

47849609

43577711

48129614

43121111

43121110

43444905

43863802 Page 2 * * * Studies Sentfor Review * * * Decision#: (438361)
Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab Project Number: 94423: PS-232DAS. Unpublished study prepared by White Eagle Toxicology Labs. 171 p. Arnaud, J.: Consalvi, P. (1993) Assessment of Tolerance of a 0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 ml/kg WhenApplied 6 times to the Haircoat at 28 Day Intervals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Arnaud, J.: Consalvi, P. (1993) DomesticAnimal Safety: Assessment of the Tolerance of a 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a 28 Day Interval at a Dose Rate of 6 ml/kg: Revised: Lab Project Number CLI 180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Kuhn, J. (2003) Companion Animal Safety Study in Dogs: Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project Number: 7650/03. Unpublished study prepared by Stillmeadow, Inc. and Miller, Thomas A. 53 p. Powell, L.; Pallett, R. (1995) DomesticAnimal Safety study by Topical Administration to Dogs: Fipronil Spot Treatment (RM 1601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Research Centre, Ltd. 219 p. Delport, P. (2009) Companion Animal Safety Evaluation on Dogs of Spot-On Products Containing Multiple Toxicants and Insect Growth Regulators: Final Report. Project Number: 2517FEGEN, CV/08/551. Unpublished study prepared by Clin Vet Intemational. 129 p. Walker, K. (1995) Discussion in Support of Bridging Domestic Animal Safety Data on Frontline Spray Treatment to Frontline Spot Treatment Data Package. Unpublished study prepared by Rhone Merieux, Inc. 6 p. Hoskins, K. (2010) Companion Animal Safety for Sergeant's 870.7200/Companion animal safety Fipronil + Cypheno1hrin Squeeze-On for Dogs. Project Number: SERGEANTS/06/10/06. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 39 p. Arnaud, J.; Consalvi, P. (1993) DomesticAnimal Safety: 870.7200/Companion animal safety Assessment ofthe Tolerance of a 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a 28 Day Interval at a Dose Rate of 6 ml/kg: Revised: Lab Project Number CLI 180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Arnaud, J.; Consalvi, P. (1993) Assessment ofTolerance of a 870.7200/Companion animal safety 0.25% RM 1601 Spray Formulation in Dogs at 3,9, and 15 ml/kg When Applied 6 times to the Haircoat at28 Day Intervals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Schwartz, E. (1994) DomesticAnimal Safety Study of RM1601 C 870.7200/Companion animal safety Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab Project Number: 94423: PS-232DAS. Unpublished study prepared by White Eagle Toxicology Labs. 171 p. Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by 870.7200/Companion animal safety Topical Administration to Dogs: Fipronil Spot Treatment (RM 1601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Research Centre, Ltd. 219 p. OP#: (382790)

43121110

43121111

46166108

43863802

47849609

43577711

48129614

43121111

43121110

43444905

43863802 Page 2 * * * Studies Sentfor Review * * * Decision#: (438361)
Topical Spray Spray Treatment) Dogs: Lab Project Number: 94423: PS-232DAS. Unpublished study prepared by White Eagle Toxicology Labs. 171 p. Arnaud, J.: Consalvi, P. (1993) Assessment of Tolerance of a 0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 ml/kg WhenApplied 6 times to the Haircoat at 28 Day Intervals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Arnaud, J.: Consalvi, P. (1993) DomesticAnimal Safety: Assessment of the Tolerance of a 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a 28 Day Interval at a Dose Rate of 6 ml/kg: Revised: Lab Project Number CLI 180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Kuhn, J. (2003) Companion Animal Safety Study in Dogs: Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project Number: 7650/03. Unpublished study prepared by Stillmeadow, Inc. and Miller, Thomas A. 53 p. Powell, L.; Pallett, R. (1995) DomesticAnimal Safety study by Topical Administration to Dogs: Fipronil SpotTreatment (RM 1601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Research Centre, Ltd. 219 p. Delport, P. (2009) Companion Animal Safety Evaluation on Dogs of Spot-On Products Containing Multiple Toxicants and Insect Growth Regulators: Final Report. Project Number: 2517FEGEN, CV/08/551. Unpublished study prepared by Clin Vet Intemational. 129 p. Walker, K. (1995) Discussion in Support of Bridging Domestic Animal Safety Data on Frontline Spray Treatment to Frontline SpotTreatment Data Package. Unpublished study prepared by Rhone Merieux, Inc. 6 p. Hoskins, K. (2010) Companion Animal Safety for Sergeant's 870.7200/Companion animal safety Fipronil + Cypheno1hrin Squeeze-On for Dogs. Project Number: SERGEANTS/06/10/06. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 39 p. Arnaud, J.; Consalvi, P. (1993) DomesticAnimal Safety: 870.7200/Companion animal safety Assessment ofthe Tolerance of a 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a 28 Day Interval at a Dose Rate of 6 ml/kg: Revised: Lab Project NumbereLi 180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Arnaud, J.; Consalvi, P. (1993) Assessment ofTolerance of a 870.7200/Companion animal safety 0.25% RM 1601 Spray Formulation in Dogs at 3,9, and 15 ml/kg When Applied 6 times to the Haircoat at 28 Day Intervals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Schwartz, E. (1994) DomesticAnimal Safety Study of RM1601 C 870.7200/Companion animal safety Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab Project Number: 94423: PS-232DAS. Unpublished study prepared by White Eagle Toxicology Labs. 171 p. Powell, L.; Paffett, R. (1995) DomesticAnimal Safety Study by 870.7200/Companion animal safety Topical Administration to Dogs: Fipronil Spot Treatment (RM 1601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Research Centre, Ltd. 219 p.Page 3 uP#: (382790) * * * Product and Data Package Ingredients * * * Decision#: (438361)

1129121 1120068-37-3 Wipronil 1129121 1120068-37-3 IFipronil(9.8%) 1105402**~5733-16-6** /S-Methoprene(8.8%) 1129013 139515-40-7 ICyphenothrin(5%)

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page 1013 

### * * * Registration Information 

### * 

### * * Decision #: 438361 DP #: (382789) PRIA Parent DP #: Submission #: 880182 Registration: 2517-RUE - SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI Company: 2517
- SERGEANT'S PET CARE PRODUCTS, INC. Risk Manager: RM 10
- Richard Gebken
- (703) 305-6701 Room# PY1 S-7237 Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Da1e: 23-Mar-2011

---- Type of Regis1ration: Produc1 Registration - Section 3 Edited Due Da1e:

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

Ingredients: S"e::;e:.'p'-'a""g':ce-'3 ____**~** _______________________ _ 

### * * * Data Package Information 

### * * * Expedne: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient: "S"'ee::..c.Pa"g"e.c3'---- __ . _____ _
DP Tnle: #2517-RUE Acule Toxicity Review CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP #:

----

Assigned To Date In Date Out /

_____ Last Possible SCience Due Date: 21-Feb-2011 Organization:**:.:R~D-,-I.:.T~R:--B** _____**~** __ _ Tearn Name: TOX**-------~** Science Due Da1e: ____ _ Reviewer Name: ________ _ Sub Data Package Due Da1e: _____ _ Contractor Name: __________ _ 

### * * * Studies Sentfor Review 

### * * * Printed on Page 2 

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

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

### • * • Data Package Instructions' 

### * • Attn TRBITOX: Please conduc1 an acute toxicity review of the attached package in support of the proposed product. Contact Rosanna Louie-Juzwiak at 308.0037**w~h** any questions. Attachments:

- cover letter

- basic CSF

- draft label

- data matrix48129603

48129608

48129606

48129607

48129604

48129605 Page 2

p. Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with 870.11 aD/Acute Oral Toxicity Dog Products (in Rats): Final Report. Project Number: 100137B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 45 p. Stelter, D. (2010) Test for Sensitization (Guinea Pig Maximisation 870.2600/Skin sensitization Test) with Dog Products (in Guinea Pigs): Final Report. Project Number. 100141B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 41 p. Ahuja, V. (2010) Acute Eye Irritation/Corrosion with Dog Products 870.2400/Acute eye irritation On Rabbits): Final Report. Project Number: 1001408. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 33 p. Ahuja, V. (2010) Acute Dermal Irritation/Corrosion with Dog 870.2500/Acute dermal irritation Products (in Rabbits): Final Report. Project Number: 100139B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 29 p. Leoni, A. (2010) Acute Dermal Toxicity (Limit Test) with Dog 870.1200/Acute dermal toxicity Products (in Rats): Final Report. Project Number: 100138B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 34 p. Hoskins, K. (2010) Waiver Request of Requirementfor Further 870.1300/Acute inhalation toxicity Testing for Acute Inhalation Toxicity for Following Sergeant's Products: Sergeant's Fipronil + Cyphenothrin**Squeeze~On** for Dogs, Sergeant's Fipronil + Cyphenothrin + Methoprene**Squeeze~On** for Dogs, Sergeant's Fipronil + Cyphenothrin + Nylar**Squeeze~On** for Dogs, Sergeant's Fipronil + Nylar**Squeeze~On** for Dogs, Sergeant's Fipronil + Etofenprox**Spot~On** forCats, Sergeant's Fipronil + Etofenprox + Methoprene**Spot~On** for Cats, Sergeant's Fipronil + Etofenprox + Nylar**Spot~On** for Cats, Sergeant's Fipronil + Nylar**Spot~On** for Cats. Project Number: SERGEANTSI06110105. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. 48129603

48129608

48129606

48129607

48129604

48129605 Page 2

p. Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with 870.11 aD/Acute Oral Toxicity Dog Products (in Rats): Final Report. Project Number: 100137B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 45 p. Stelter, D. (2010) Test for Sensitization (Guinea Pig Maximisation 870.2600/Skin sensitization Test) with Dog Products (in Guinea Pigs): Final Report. Project Number. 100141B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 41 p. Ahuja, V. (2010) Acute Eye Irritation/Corrosion with Dog Products 870.2400/Acute eye irritation On Rabbits): Final Report. Project Number: 1001408. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 33 p. Ahuja, V. (2010) Acute Dermal Irritation/Corrosion with Dog 870.2500/Acute dermal irritation Products (in Rabbits): Final Report. Project Number: 100139B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 29 p. Leoni, A. (2010) Acute Dermal Toxicity (Limit Test) with Dog 870.1200/Acute dermal toxicity Products (in Rats): Final Report. Project Number: 100138B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 34 p. Hoskins, K. (2010) Waiver Request of Requirementfor Further 870.1300/Acute inhalation toxicity Testing for Acute Inhalation Toxicity for Following Sergeant's Products: Sergeant's Fipronil + Cyphenothrin**Squeeze~On** for Dogs, Sergeant's Fipronil + Cyphenothrin + Methoprene**Squeeze~On** for Dogs, Sergeant's Fipronil + Cyphenothrin + Nylar**Squeeze~On** for Dogs, Sergeant's Fipronil + Nylar**Squeeze~On** for Dogs, Sergeant's Fipronil + Etofenprox**Spot~On** forCats, Sergeant's Fipronil + Etofenprox + Methoprene**Spot~On** for Cats, Sergeant's Fipronil + Etofenprox + Nylar**Spot~On** for Cats, Sergeant's Fipronil + Nylar**Spot~On** for Cats. Project Number: SERGEANTSI06110105. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p.Page 3 LlP#: (382789) * *

.. Product and Data Package Ingredients ""

.. Decision#: (438361)

1120068-37-3 IFipronil 1120068-37-3 IFipronil(9.8%)**~5733-16-6** IS-Methoprene(8.8%) 1129013**~9515-40-7** ICyphenothrin(5%)

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

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### February 15,2011 MEMORANDUM 

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

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

### Symbol: 2517-RUE DP Barcodes: DP 382789, 382790 Decision No.: 438361 Action Code: R310 PC Codes: 129121 (Fipronil: 9.8%) 129013 (Cyphenothrin: 5.0%) 105402 (S-Methoprene: 8.8%) From: Byron T. Backus, Ph.D., Toxicologist 

# n**~:** (l

# -~-~Q-""I Technical Review Branch 

# f <L-'" 

# -l5'

- 1.-<> \.\ 

# r/IJ _ 0 "- Registration Division (7505P) 

# l**~** To: Rosanna Loiue-JuzwiaklRichard Gebken RM 10 Insecticide Branch Registration Division (7505P) Registrant: SERGEANT'S PET CARE PRODUCTS, INC. FORMULATION FROM LABEL: Active Ingredient(s): 129121 Fipronil 129013 Cyphenothrin 105402 (S)-methoprene Other Ingredient(s): TOTAL
ACTION REQUESTED: 

### The Risk Managerrequests: bywt. 9.8% 5.0% 8.8% 76.4% 100.0%

For DP 382789: "
...Please conduct an acute toxicity review ofthe attached package in support of the proposed product.

.." Pagelof4

### For DP 382790: "
...Please conduct a companion animal safety review ofthe attachedpackage in support ofthe proposedproduct

..." BACKGROUND: The material received for review includes a data matrix, a CSF (dated 8111120I0) and a proposed label for this product, indicating use on adult dogs and puppies 12 weeks old and older. COMMENTS AND RECOMMENDATIONS: 1. The five cited acute toxicity studies (48129603, 48129604, 48129606

- 48129608) were conducted on a formulation containing as active ingredients: Fipronil (9.8%), (S)-Methoprene (8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as acceptable (TRB memorandum dated November 23, 2010 for 2517-RUN), and can be used to support the registration of25l7-RUE. The signal word is WARNING, based on the eye irritation potential (MRID 48129606). 2. The material in the inhalation waiver request in MRID 48129605 is applicable to 2517-RUE. Referto the TRB memorandum dated November 23, 2010 for 2517-RUN which states: "Based onthe amount offormulation applied (0.5-4.5 mL), the packaging ofthese products (single-use containers or ampoules), the non-volatile nature ofthe formulations, and the application method (directly to the skin ofthe dog or cat) which does not result in any respirable particles, TRB concludes that a waiver for the acute inhalation study requirement is appropriate, and that these products can be assigned to EPA Toxicity Category IV by this exposure route." 3. The proposed label dosage rates for 2517-RUE are 0.67 mL for dogs up to 22 lbs; 1.34 mL for dogs 23-44 lbs; 2.68 mL for dogs 45-88 lbs; and 4.02 mL for dogs 89-132 lbs. The cited companion animal safety studies include MRID 47849609, in which six Group A2 puppies were treated with 5 applications ofsubstance IA (containing 8.2% cyphenothrin and 9.8% fipronil) and 5 applications ofsubstance II (55.16% etofenprox, 8.78% methoprene and 2.31 % pyriproxyfen). The meantotal dose was 1.84 (range: 1.79-1.88) mLlkg for test substance IA and 6.88 (range: 6.69-7.05) mLlkg for substance II. Group B2 adults were treated with 5 applications ofsubstance IA and 5 applications ofsubstance III (8.90% methoprene, 2.43% pyriproxyfen). The mean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance IA and 0.395 (range: 0.352-0.443) mLlkg for substance III. The proposed label dosage rates for 2517-RUE are 0.67 mL for dogs up to 22 lbs; 1.34 mL for dogs 23-44 lbs, 2.68 mL for dogs 45-88 lbs; and 4.02 mL for dogs 89-132 lbs. Assuming that the test substances and proposed product have a specific gravity = 

### 1.0, the puppies were treated with means of 151 mg cyphenothrinlkg, 180 mg fipronil/kg, and 604 mg methoprene/kg. Dividingthese values by 5 would give 30.2 mg cyphenothrinlkg, 36 mg fipronil/kg 

### and 120.8 mg methoprene/kg. 

### In terms ofthe formulation for 2517-RUE these values would be 0.604, 0.367, and 13.73 mLlkg, respectively, indicating that 0.67 mL would be acceptable for puppies weighing 1.83 (0.67 mL divided by 0.367 mLlkg) kg ormore. 1.83 kg is 4.03 lb, so (applying a 5X safety factor) we can accept the data for dogs weighing4 pounds or more. The cited companion animal safety studies adequately support the use ofthis product on dogs and puppies 12 weeks old or older. Labeling should indicate a minimum weight of4 Ibs for dogs or puppies. Page2of4 

### For DP 382790: "
...Please conduct a companion animal safety review ofthe attachedpackage in support ofthe proposedproduct

..." BACKGROUND: The material received for review includes a data matrix, a CSF (dated 8111120I0) and a proposed label for this product, indicating use on adult dogs and puppies 12 weeks old and older. COMMENTS AND RECOMMENDATIONS: 1. The five cited acute toxicity studies (48129603, 48129604, 48129606

- 48129608) were conducted on a formulation containing as active ingredients: Fipronil (9.8%), (S)-Methoprene (8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as acceptable (TRB memorandum dated November 23, 2010 for 2517-RUN), and can be used to support the registration of25l7-RUE. The signal word is WARNING, based on the eye irritation potential (MRID 48129606). 2. The material in the inhalation waiver request in MRID 48129605 is applicable to 2517-RUE. Referto the TRB memorandum dated November 23, 2010 for 2517-RUN which states: "Based onthe amount offormulation applied (0.5-4.5 mL), the packaging ofthese products (single-use containers or ampoules), the non-volatile nature ofthe formulations, and the application method (directly to the skin ofthe dog or cat) which does not result in any respirable particles, TRB concludes that a waiver for the acute inhalation study requirement is appropriate, and that these products can be assigned to EPA Toxicity Category IV by this exposure route." 3. The proposed label dosage rates for 2517-RUE are 0.67 mL for dogs up to 22 lbs; 1.34 mL for dogs 23-44 lbs; 2.68 mL for dogs 45-88 lbs; and 4.02 mL for dogs 89-132 lbs. The cited companion animal safety studies include MRID 47849609, in which six Group A2 puppies were treated with 5 applications ofsubstance IA (containing 8.2% cyphenothrin and 9.8% fipronil) and 5 applications ofsubstance II (55.16% etofenprox, 8.78% methoprene and 2.31 % pyriproxyfen). The meantotal dose was 1.84 (range: 1.79-1.88) mLlkg for test substance IA and 6.88 (range: 6.69-7.05) mLlkg for substance II. Group B2 adults were treated with 5 applications ofsubstance IA and 5 applications ofsubstance III (8.90% methoprene, 2.43% pyriproxyfen). The mean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance IA and 0.395 (range: 0.352-0.443) mLlkg for substance III. The proposed label dosage rates for 2517-RUE are 0.67 mL for dogs up to 22 lbs; 1.34 mL for dogs 23-44 lbs, 2.68 mL for dogs 45-88 lbs; and 4.02 mL for dogs 89-132 lbs. Assuming that the test substances and proposed product have a specific gravity = 

### 1.0, the puppies were treated with means of 151 mg cyphenothrinlkg, 180 mg fipronil/kg, and 604 mg methoprene/kg. Dividingthese values by 5 would give 30.2 mg cyphenothrinlkg, 36 mg fipronil/kg 

### and 120.8 mg methoprene/kg. 

### In terms ofthe formulation for 2517-RUE these values would be 0.604, 0.367, and 13.73 mLlkg, respectively, indicating that 0.67 mL would be acceptable for puppies weighing 1.83 (0.67 mL divided by 0.367 mLlkg) kg ormore. 1.83 kg is 4.03 lb, so (applying a 5X safety factor) we can accept the data for dogs weighing4 pounds or more. The cited companion animal safety studies adequately support the use ofthis product on dogs and puppies 12 weeks old or older. Labeling should indicate a minimum weight of4 Ibs for dogs or puppies. Page2of44. The following is the acute toxicity profile for Sergeant's Fipronil 

### + Cyphenothrin 

### + Methoprene Squeeze-Onfor Dogs (EPA File Symbol 25I7-RUE), based on the results ofthe acute toxicity studies: Acute oral toxicity III Cited MRID 48129603 Acute dermal toxicity III Cited MRID 48129604 Acute inhalation toxicity (IV) Waived (MRID 48129605) Primary eye irritation 

### II Cited MRID 48129606 Primary dermal irritation IV Cited MRID 48129607 Dermal sensitization Positive Cited MRID 48129608 5. Based on the acute toxicity profile above, and taking into consideration theproposed uses specified onthe label and information in the CSF, the following would be the precautionary and first aid labeling for EPA File Symbol 2517-RUN [Sergeant's Fipronil + Cyphenothrin SqueezeOn for Dogs] as obtained from the Label Review System: PRODUCT ID #: 002517-00142 PRODUCT NAME: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN SQUEEZE-ON FOR DOGS PRECAUTIONARY STATEMENTS SIGNAL WORD: WARNING Hazards to Humans and Domestic Animals: Restricted Use Pesticide due to toxicity categories. For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's certification. Child Resistant Packaging Required. Causes substantial but temporary eye injury. Harmful ifabsorbed through skin. Harmful if swallowed. Do not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses). Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin. Wear longsleeved shirt and long pants, socks, shoes, and gloves. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. First Aid: If in eyes: -Hold eye open and rinse slowly and gently with water for 15-20 minutes. -Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. -Call a poison control center or doctor for treatment advice. Ifon skin: -Take offcontaminated 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. Page 3 of4 4. The following is the acute toxicity profile for Sergeant's Fipronil 

### + Cyphenothrin 

### + Methoprene Squeeze-Onfor Dogs (EPA File Symbol 25I7-RUE), based on the results ofthe acute toxicity studies: Acute oral toxicity III Cited MRID 48129603 Acute dermal toxicity III Cited MRID 48129604 Acute inhalation toxicity (IV) Waived (MRID 48129605) Primary eye irritation 

### II Cited MRID 48129606 Primary dermal irritation IV Cited MRID 48129607 Dermal sensitization Positive Cited MRID 48129608 5. Based on the acute toxicity profile above, and taking into consideration theproposed uses specified onthe label and information in the CSF, the following would be the precautionary and first aid labeling for EPA File Symbol 2517-RUN [Sergeant's Fipronil + Cyphenothrin SqueezeOn for Dogs] as obtained from the Label Review System: PRODUCT ID #: 002517-00142 PRODUCT NAME: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN SQUEEZE-ON FOR DOGS PRECAUTIONARY STATEMENTS SIGNAL WORD: WARNING Hazards to Humans and Domestic Animals: Restricted Use Pesticide due to toxicity categories. For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's certification. Child Resistant Packaging Required. Causes substantial but temporary eye injury. Harmful ifabsorbed through skin. Harmful if swallowed. Do not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses). Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin. Wear longsleeved shirt and long pants, socks, shoes, and gloves. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. First Aid: If in eyes: -Hold eye open and rinse slowly and gently with water for 15-20 minutes. -Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. -Call a poison control center or doctor for treatment advice. Ifon skin: -Take offcontaminated 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. Page 3 of4-Do not induce vomiting unless told to by a poison control center or doctor. -Do not give anything to an unconscious person. NOTE TO PHYSICIAN: Note to PM/CRM/Registrant: 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. 

### According to the LRS, this product is a candidate for restricted use because it is in Toxicity Category II for eye exposure. However, TRB concludes that, based on the packaging (in ampules) and proposed product use (direct application to the skin ofdogs orcats), the risk ofeye exposure is adequately reduced, and a restricted use classification is not necessary. 6. The CSF (dated 8/11/2010) for 2517-RUE should also be reviewed and accepted by the TRB Chemistry Team.

Page 4 of4 -Do not induce vomiting unless told to by a poison control center or doctor. -Do not give anything to an unconscious person. NOTE TO PHYSICIAN: Note to PM/CRM/Registrant: 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. 

### According to the LRS, this product is a candidate for restricted use because it is in Toxicity Category II for eye exposure. However, TRB concludes that, based on the packaging (in ampules) and proposed product use (direct application to the skin ofdogs orcats), the risk ofeye exposure is adequately reduced, and a restricted use classification is not necessary. 6. The CSF (dated 8/11/2010) for 2517-RUE should also be reviewed and accepted by the TRB Chemistry Team.

Page 4 of4

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page 1013 

### * * * Registration Information 

### * * * Decision #: 

### 438361 DP #: 

### (382791) PRIA Parent DP #: 

### Submission #: 

### 880182 Registration: 2517-RUE
- SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI Company: 2517
- SERGEANT'S PET CARE PRODUCTS, INC. Risk Manager: RM 10
- Richard Gebken
- (703) 305-6701 Room# PY1 S-7237 Risk Manager Reviewer: "R"'os:"a."n'"na"-'=L:"o':"ui"e"R'":L"O':'U

.. IE'- __________**~** ___ _ Sent Date:**_~** __ _ Calculated Due Date: 23-Mar-2011 Edited Due Date: Type of Registration: Product Registration
- Section 3 Action Desc: (R310) NEW PRODUCT;NON-FASTTRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients:**~S"ee"J:'Pa"'g!"e,,3'--** _______________________**~** 

### * * * Data Package Information 

### * * * Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Sack: DP Ingredient:**~S":ee"J:'pa",g!,,e,,3,--** ____ _
DP Title: #2517-RUE: CRP Review CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP #: __ _
Date In Date Out Organization: ':R":D"I-'T"R":B'-- ______**~**

### ~'3

### \ \0 Last Possible Science Due Date: 21-Feb-2011 Team Name: Child Resistant Packaging Science Due Date: Reviewer Name: __________**~** Sub Data Package Due Date: Contractor Name: __________**~** 

### * * * Studies Sentfor Review 

### * * * Printed on Page 2 

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

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

### * * * Data Package Instructions 

### * * * Attn TRB/CRP: Please conduct a CRP Packaging review ofthe attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 with any questions. Attachments:

- cover letter -letterfor CRP certification (including cited studies) -letterfor CRP information

- basic CSF

- draft label

- data matrix
NOTE: with regards to CRP review, there is no greater toxicity from cyphenothrin or s-methoprene exposure (i.e., does not trigger need for CRP) that would exceed that offipronil.DP#: (382791)

48059804

48059805

48059806 Page 2 * * * Studies Sentfor Review *,. * Dog Squeeze on Applicator with Orange Label Indicator (3x), Scissors to Open F=1 as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746/002. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation olthe Dog Squeeze on 1.34ml White Applicatorwith Green Label Indicator (3x), Scissors to Open**~** F= t as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: t746/003. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation ofthe Dog Squeeze on 2.68ml White Applicator with Red Label Indicator (3x). Scissors to Open**~** F=1 as a Poison Prevention Package for Sergeant's Pet Care Products. Inc.: Final Report. Project Number: t746/004. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation 01 the Dog Squeeze on 4.02ml Whtte Applicatorwith Blue Label Indicator (3x), Scissors to Open F= t as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746/005. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Decision#: (43836t)

### ~ DP#: (382791)

48059804

48059805

48059806 Page 2 * * * Studies Sentfor Review *,. * Dog Squeeze on Applicator with Label Indicator (3x), Scissors to Open F=1 as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746/002. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation olthe Dog Squeeze on 1.34ml White Applicatorwith Green Label Indicator (3x), Scissors to Open**~** F= t as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: t746/003. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation ofthe Dog Squeeze on 2.68ml White Applicator with Red Label Indicator (3x). Scissors to Open**~** F=1 as a Poison Prevention Package for Sergeant's Pet Care Products. Inc.: Final Report. Project Number: t746/004. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation 01 the Dog Squeeze on 4.02ml Whtte Applicatorwith Blue Label Indicator (3x), Scissors to Open F= t as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746/005. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Decision#: (43836t)

### ~Page 3 DP#: (382791) * * * Product and Data Package Ingredients * * * Decision#: (438361)

1129013 139515-40-7 ICyphenothrin 1129121**1120068~37~3** IFipronil 1129121 1120068-37-3 IFipronil(9.8%) 1105402**~5733-16-6** is-Methoprene(8.8%) 1129013 

### 139515-40-7 iCyphenothrin(5%);'\y-D S7."'1,€ ::fi'a' "\;, 

### !P

### ~J 

### " 

## '" :n !! q;' 

### 't
. .{**~** A'

### V~';i.**pR01~** UNITED STATES ENVIRONMENTALPROTECTIONAGENCY WASHINGTON, D.C. 20-160

NOTE TO RM 10 Rosanna Louie-Juzwiak**OFFICl~** OF CHI<:l\IICAL SAFETY .-\1'H} POLLFfJON PREYENTJON December 23,2010

SUBJECT: Certification to Compliance with Child-Resistant Packaging Regulations EPA FILE NO: 2517-RUE, DP 382791, Decision 

### # 438361 The August 11, 2010 CRP certification and bridging letter (indicating the same size and color package as package tested) for EPA Registration No. 2517-RUE are acceptable. The August 11, 2010 label for EPA Registration No. 2517-RUE has the same CRP directions as were used in the CRP testing. All the requirements for CRP have been metfor EPA Registration No. 2517- RUE. The directions on opening the package given to consumers must be identical to those given to the seniors during testing. Should any human experience/epidemiological evidence indicate a problem once the product is in the marketplace, the Agency reserves the right to reexamine this data comprehensively and to question the child resistance ofthe package involved. Thank you for your cooperation in this matter. Ifyou have any questions please contact me at (703)-308-7368.

# ~~J/~ Rosalind L. Gross UNITED STATES ENVIRONMENTALPROTECTIONAGENCY WASHINGTON, D.C. 20-160

NOTE TO RM 10 Rosanna Louie-Juzwiak**OFFICl~** OF CHI<:l\IICAL SAFETY .-\1'H} POLLFfJON PREYENTJON December 23,2010

SUBJECT: Certification to Compliance with Child-Resistant Packaging Regulations EPA FILE NO: 2517-RUE, DP 382791, Decision 

### # 438361 The August 11, 2010 CRP certification and bridging letter (indicating the same size and color package as package tested) for EPA Registration No. 2517-RUE are acceptable. The August 11, 2010 label for EPA Registration No. 2517-RUE has the same CRP directions as were used in the CRP testing. All the requirements for CRP have been metfor EPA Registration No. 2517- RUE. The directions on opening the package given to consumers must be identical to those given to the seniors during testing. Should any human experience/epidemiological evidence indicate a problem once the product is in the marketplace, the Agency reserves the right to reexamine this data comprehensively and to question the child resistance ofthe package involved. Thank you for your cooperation in this matter. Ifyou have any questions please contact me at (703)-308-7368.

Rosalind L. GrossSergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com


### August 11,2010 Richard Gebken, PMIO Office ofpesticidePrograms (7504P) 

## u.s. Environmental Protection Agency DocumentProcessingDesk Room S-4900, One PotomacYard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child Resistant Packaging Certification Sergeant's Fipronil 

### + Cyphenothrin

### +Methoprene Squeeze-On for Dogs EPAFile Symbol 25I7-NEW

### R-v-fC DearMr. Gebken: I certifythat thepackagingused for the following productmeets the standards of40 CFR 157.32, includingtherevised standards in 16 CFR 1700.15(b), when testedbytherevised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July21,1995):

• Sergeant's Fipronil 

### + Cyphenothrin 

### +Methoprene Squeeze-On for Dogs (EPA File**Symbo12517~ ~J)E.**  

### Sergeant'sPet Care Products, Inc. (Sergeant's, 2625 South 158th 

### Plaza, Omal1a, NE 68130-1770, EPA CompanyNumber 2517) is submittingthis child resistantpackagingcertificationto support for the new end-useproduct for Sergeant'sFipronil 

### + Cyphenothrin

### +Methoprene Squeeze-On for Dogs (EPAFile Symbol 25I7-NEW). All product labels have language specifying the use of scissors to open theproduct container and label language statingtheproductis notto be applied bychildren. Ifyouhave any questions, please contactme at402-938-7079. Sincerely, 

# J21b 'e. 

# t-l%**~** 

# !btl**K~ll; R~oskins**  Manager ofTechnical Affairs

cc: LarryNouvel

### Sergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha. NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com August 11,2010
Rosalind Gross c/o Richard Gebken RegistrationDivision Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Document ProcessingDesk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child Resistant Packaging Support Sergeant's Fipronil 

### + Cyphenothrin 

### +Methoprene Squeeze-On for Dogs (EPA File Symbol: 2517-NfiW) 

## (Zv.-"" DearMs. Gross: Sergeant's Pet Care Products, Inc. (EPA CompanyNumber 2517) is submitting a request to rely onpreviously submitted ChildResistant Packaging (CRP) studies to supportthis new registration. The CRP datawere submittedto EPA onApril 12, 20lOin support ofthepending registration applications under EPAFile Symbols: 2517-RGT, 2517-RGA, 2517-RGL, and 2517-RGU (all ofwhich contain Fipronil at 9.7-9.8%). Sergeant's generated CRP data on a standard white applicatorin sizes 0.5, 0.67, 1.34,2.68, and 4.02 mL. The following is a sununarytable ofthe applicators that weretested and submitted to EPAinthe CRP data: Use ApplicatorBase Color FillWeight (mL) Color DogUp to 22 Ibs White 0.67 Orange V Dog 23-44 Ibs White 1.34 Green V Dog45-88 Ibs White 2.68 Red 

### V Dog 89-132 Ibs White 4.02
. Blue 

## V Cats All Weigbts White 0.50 Purple \/ CRP datais required for this newproduct because ofthe inclusionofthe active ingredient fipronil (9.8%) inthepet squeeze-onproduct. The CRP testing was conducted on a standard package size and color configuration for a product containingfipronil (9.8%). The Sergeant's Fipronil + Cyphenothrin 

### +Methoprene Squeeze-On for Dogs productbeingsubmitted today also contains fipronil at 9.8%. Additionally, Sergeant's alreadyhas dog squeeze-onproducts approvedbyEPA containing20-30% cyphenothrin (EPARegistration Numbers 2517-127 through 2517-132) that arenot subjectto CRP. This newproduct contains 5% cyphenothrin and
1Sergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 8.8 % methoprene. Additionally, there are EPAregistered products containing s-methoprene, none ofwhich are subject to CRP. Furthermore, Sergeant's does not anticipate any additional toxicitythrough the combination of fipronil, cyphenothrin and methoprene. When Sergeant's Fipronil 

### + Cyphenothrin 

### +Methoprene Squeeze-On for Dogs is marketed,it will havethe same applicator color (white) and fill weight colors permL fill weight as was used inthe submitted and referenced CRP testing. Based on available information, the density range ofthependingproducts onwhichthe CRP data were generated is the sarqe as**t~1** newprod1!9t (1.0-1.5 

### gr/J;c). Therefore, Sergeant'sisrelying on MRID's: 4805980)1, 48059804, 480598'05, and

### 480~9806 to fulfill the CRP datarequirements for Sergeant's Fipronil 

### + Cyphenothrin

### + Methoprene Squeeze-On for Dogs. Ifyouhave anyquestions, please contactme at 402-938-7079. Sincerely,

# ~ 

# '8-.**~glu0-:)** 

# !**C-~T** Kelly R. Hoskins ManagerofTechnical Affairs

cc: LarryNouvel

2

### DATA PACKAGE BEAN SHEET Date: 05-0ct-2010 Page 1 of 3 

### * * * Registration Information * * * Decision #: 438361 DP#: (382792) PRIA Parent DP 

### #: Submission 

### #: 880182 Registration: 2517-RUE
- SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI Company: 251<7
- SERGEANT'S PET CARE PRODUCTS, INC< Risk Manager: RM 10
- Richard Gebken
- (703) 305-6701 Room# Pyt S-7237 Risk Manager Reviewer:**:.:Rc::os::.:a::cn",n~a-=L"o=ui:::e-,-R::::L:::O=U~IE=---**____________**~** ___ _ Sent Date: Calculated Due Date: 23-Mar-2011 Edited Due Date: ____**~** Type of Registration: Product Registration
- Section 3 Action Desc: (R310) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients: ::S"-ee=--"'pa::;g"e-=3'- _____**~**____________________ _ 

### * * * Data Package Information * * * Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back:

---- DP Ingredient: See page 3**-~~---------------------** DP Title: #2517-RUE: Efficacy Review CSF Included: 

### 0 Yes. No Label Included: • Yes 

### 0 No Parent DP #:

----

Assigned To Date In Date Out Organization: "R:::D.:.'-.:Tc.R:::B _______ _ _ ____ Last Possible Science Due Date: 21-Feb-2011 Team Name: ::E:::ffi:::ca"'c"y..;("'IB:!.) ______ _ Science Due Date:

---- Reviewer Name:



### --------- Sub Data Package Due Date: Contractor Name:



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

### •• • Studies Sentfor Review * * • Printed on Page 2 

### ** * Additional Data Package for this Decision • • * Can be printed on its own page 

### * * • Data Package Instructions • • • Attn Efficacy Reviewer: Please conduct an efficacy review ofthe attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 with any questions. Attachments:

- cover letter

- draft label

- data matrix 

### (; 

# ('1/ \ 

## 'D ,(DP#: (382792)

43121114

45612701 46298501

43121115

43121116

48129610

43121117

45620505

48189203

48129611

43121118

45620504

45866902 Page 2 * * * Studies Sentfor Review * * *

Frontline Top Spot, and IVlL.-<,U",',."O the and Control ofTrichodectes canis in the Dog: Report: Lab Project Number: PR&D 0022101, PR&D 00221. Unpublished study prepared by Centro Veterinario Oriola. 24 p. {OPPTS 810.3300} Everett, R.; Cunningham, J. (1993) A Dose Titration Study to Determine the Optimal Spray Concentration of RM 1601 for Long Term Control of the Cat Flea Ctenocephalides felis and the Brown Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab Project Number: RMD 292: P/214LT. Unpublished study prepared by Agresearch Consultants. 53 p. Ahmed, Z. (2002) Study Summaries: Frontline Plus For Dogs. Unpublished study prepared by Merial. 40 p. Miller, T. (2003) Effect of ShampooAfter Treatmentwith Cyphenothrin Squeeze-on on Efficacy against Adult Cat Flease (Ctenocephalides felis), Adutt Brown Ticks (Rhipicephalus saguineus) on Dogs: Analysis of Data and Conclusions. Project Number: MS/20D. Unpublished study prepared by Sharp Veterinary Hospital and Vetoquinol N.A., Inc. 15 p, Cruthers, L. (1993) Product Performance: A Dose Confirmation StudytoVerify the Optimal Spray Concentration of RM 1601 for Long Residual Control of the Cat Flea (Ctenocephalides felis) and the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog: Revised: Lab Project Number: 9251: P/215LT. Unpublished study prepared by Professional Labs and Research Services, Inc. 51 p. Everett, R; Cunningham, J. (1993) A Comparative Evaluation of Two Treatment Regimes Using RM 1601 Sprayfor Control ofthe Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project Number: RMD 692: P/222LT. Unpublished study prepared by Agresearch Consultants, Inc. 40 p. Decision#: (",R'O"

810.3300fTreatments to control pests of humans and pets

Sharp, M, (2009) Immediate Efficacy of a Combined Application of 81 0.3300fTreatments to control Frontline Plus with Cyphenothrin as a Squeeze-On Against Fleas pests of humans and pets (Ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on Dogs: Analyses of Data Conctusions, Project Number: MS/164/D. Unpublished study prepared by Sharp Veterinary Research. 24 p. McCall, J.; McTier, T. (1993) Laboratory Evaluation of RM 1601 Sprayfor Control Dermacentor variabitis and Rhipecephalus sanguineus on the Dog: Lab Project Number: RMfTKS/93/1 L: PS/229LT. Unpublished study prepared by TRS Labs, Inc. 18 p. Gaxiola, S.; Alva, R.; IlWin, J. (2001) PR & D 0052301: Frontline Spray/Frontiine Spot-On/ML-2, 095, 988 509TIDogs/SolutionfTopical: Final Report Lab Project Number: PR&D 0052301, PR&D 00523. Unpublished study prepared by University of Sinaloa. 40 p. {OPPTS 810.3300} Miller, T. (2009) Dose Titration with S-Methoprene Squeeze-On on 81 0,3300fTreatments to control Dogs Measuring Flea Egg Sterilization: Analyses of Data and pests of humans and pets Conclusions, Project Number: MS/172D. Unpublished study prepared by Sharp Veterinary Research, 42 p, Sharp, M. (2010) Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze-On Against Fleas (Ctenocephalides fells) and Ticks (Rhipicephalus sanguineus) on Dogs: Analyses of Data Conclusions, Project Number: MS/183D. Unpublished study prepared by Sharp Veterinary Research. 29 p, Everett, R.; Cunningham, J. (1993) An Investigation Study to Evaluate the Effect of Bathing of Laboratory Dogs on the Efficacy of RM1601 Spray: Revised: Lab Project Number: RMD 592: P/220LT. Unpublished study prepared by Agresearch Consultants, Inc. 43 p. Marchiondo, A. (2001) PR & D 0024101: Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509T/Dogs/Solution/Topical: Final Report: Lab Project Number: PR&D 0024101: PR&D 00241. Unpublished study prepared by Stillmeadow, Inc. 29 p. {OPPTS 810.3300} McCall, J.; Alva, R.; IlWin, J.; et al. (2002) A Study to Evaluate the Efficacy of Frontline Plus for Control of Mosquitoes, Aedes aegypti, on Dogs: Final Report: Lab Project Number: PR&D 0055201. Unpublished study prepared by TRS Labs, Inc. 24 p. {OPPTS 810.3300} 810.3300fTreatments to control pests of humans and pets DP#: (382792)

43121114

45612701 46298501

43121115

43121116

48129610

43121117

45620505

48189203

48129611

43121118

45620504

45866902 Page 2 * * * Studies Sentfor Review * * *

Frontline Top Spot, and IVlL.-<,U",',."O the and Control ofTrichodectes canis in the Dog: Report: Lab Project Number: PR&D 0022101, PR&D 00221. Unpublished study prepared by Centro Veterinario Oriola. 24 p. {OPPTS 810.3300} Everett, R.; Cunningham, J. (1993) A Dose Titration Study to Determine the Optimal Spray Concentration of RM 1601 for Long Term Control of the Cat Flea Ctenocephalides felis and the Brown Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab Project Number: RMD 292: P/214LT. Unpublished study prepared by Agresearch Consultants. 53 p. Ahmed, Z. (2002) Study Summaries: Frontline Plus For Dogs. Unpublished study prepared by Merial. 40 p. Miller, T. (2003) Effect of ShampooAfter Treatmentwith Cyphenothrin Squeeze-on on Efficacy against Adult Cat Flease (Ctenocephalides felis), Adutt Brown Ticks (Rhipicephalus saguineus) on Dogs: Analysis of Data and Conclusions. Project Number: MS/20D. Unpublished study prepared by Sharp Veterinary Hospital and Vetoquinol N.A., Inc. 15 p, Cruthers, L. (1993) Product Performance: A Dose Confirmation StudytoVerify the Optimal Spray Concentration of RM 1601 for Long Residual Control of the Cat Flea (Ctenocephalides felis) and the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog: Revised: Lab Project Number: 9251: P/215LT. Unpublished study prepared by Professional Labs and Research Services, Inc. 51 p. Everett, R; Cunningham, J. (1993) A Comparative Evaluation of Two Treatment Regimes Using RM 1601 Sprayfor Control ofthe Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project Number: RMD 692: P/222LT. Unpublished study prepared by Agresearch Consultants, Inc. 40 p. Decision#: (",R'O"

810.3300fTreatments to control pests of humans and pets

Sharp, M, (2009) Immediate Efficacy of a Combined Application of 81 0.3300fTreatments to control Frontline Plus with Cyphenothrin as a Squeeze-On Against Fleas pests of humans and pets (Ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on Dogs: Analyses of Data Conctusions, Project Number: MS/164/D. Unpublished study prepared by Sharp Veterinary Research. 24 p. McCall, J.; McTier, T. (1993) Laboratory Evaluation of RM 1601 Sprayfor Control Dermacentor variabitis and Rhipecephalus sanguineus on the Dog: Lab Project Number: RMfTKS/93/1 L: PS/229LT. Unpublished study prepared by TRS Labs, Inc. 18 p. Gaxiola, S.; Alva, R.; IlWin, J. (2001) PR & D 0052301: Frontline Spray/Frontiine Spot-On/ML-2, 095, 988 509TIDogs/SolutionfTopical: Final Report Lab Project Number: PR&D 0052301, PR&D 00523. Unpublished study prepared by University of Sinaloa. 40 p. {OPPTS 810.3300} Miller, T. (2009) Dose Titration with S-Methoprene Squeeze-On on 81 0,3300fTreatments to control Dogs Measuring Flea Egg Sterilization: Analyses of Data and pests of humans and pets Conclusions, Project Number: MS/172D. Unpublished study prepared by Sharp Veterinary Research, 42 p, Sharp, M. (2010) Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze-On Against Fleas (Ctenocephalides fells) and Ticks (Rhipicephalus sanguineus) on Dogs: Analyses of Data Conclusions, Project Number: MS/183D. Unpublished study prepared by Sharp Veterinary Research. 29 p, Everett, R.; Cunningham, J. (1993) An Investigation Study to Evaluate the Effect of Bathing of Laboratory Dogs on the Efficacy of RM1601 Spray: Revised: Lab Project Number: RMD 592: P/220LT. Unpublished study prepared by Agresearch Consultants, Inc. 43 p. Marchiondo, A. (2001) PR & D 0024101: Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509T/Dogs/Solution/Topical: Final Report: Lab Project Number: PR&D 0024101: PR&D 00241. Unpublished study prepared by Stillmeadow, Inc. 29 p. {OPPTS 810.3300} McCall, J.; Alva, R.; IlWin, J.; et al. (2002) A Study to Evaluate the Efficacy of Frontline Plus for Control of Mosquitoes, Aedes aegypti, on Dogs: Final Report: Lab Project Number: PR&D 0055201. Unpublished study prepared by TRS Labs, Inc. 24 p. {OPPTS 810.3300} 810.3300fTreatments to control pests of humans and petsPage 3 DP#: (382792) * * * Product and Data Package Ingredients *

.. </< Decision#: (438361)

20068-37-3 1129121 1120068-37-3 IFipronil(9.8%) 1105402**~5733-16-6** IS-Methoprene(8.8%) 1129013**~9515-40-7** jCyphenothrin(5%)

### Efficacy Review Date: December 6, 2010 Efficacy Reviewer: Clayton Myers, Ph.D., En 

# cp tom010gist RD-IB ,,\11 

### myers.c1ayton@epa.gov \tV,V 

### 703-347-8874 RiskManager Rev.: Rosanna Louie Products: EPAReg. #: A.I.'s: Decision #s: DP#s: Submission: MRIDs:

GLP:

MRID 

### 48129609 

### Sergeant's Fiproni1 

### + Cyphenothrin 

### +Methoprene Squeeze-on for Dogs 2517-RUE Fipronil (9.8%), Cyphenothrin (5.0%), S-Methoprene (8.8%) 438361 382792 R310, New Products, RD Science Review Submitted:
Cited:
No 48129609,48129610,48129611,48129612,48129613, 48189203 43121114,43121115,43121116,43121117,43121118, 43121122,43577712,45612701,45620501,45620504, 45620505,45620506,45628201,45866902,46298501

Title: Overview and Summary ofFipronillCyphenothrin Dog Efficacy for Sergeant's Fiproni1 

### + Cyphenothrin Squeeze-On for Dogs (Overview ofother submissions). Guideline: 

### OPPTS 810.3300 Study Summary ofthe Results: This submission is an overall summary and clarification ofthe other submitted MRIDs associated withthis application Entomologist's ObservationslDiscussion: Supplementary Information Efficacy Review Date: December 6, 2010 Efficacy Reviewer: Clayton Myers, Ph.D., En 

# cp tom010gist RD-IB ,,\11 

### myers.c1ayton@epa.gov \tV,V 

### 703-347-8874 RiskManager Rev.: Rosanna Louie Products: EPAReg. #: A.I.'s: Decision #s: DP#s: Submission: MRIDs:

GLP:

MRID 

### 48129609 

### Sergeant's Fiproni1 

### + Cyphenothrin 

### +Methoprene Squeeze-on for Dogs 2517-RUE Fipronil (9.8%), Cyphenothrin (5.0%), S-Methoprene (8.8%) 438361 382792 R310, New Products, RD Science Review Submitted:
Cited:
No 48129609,48129610,48129611,48129612,48129613, 48189203 43121114,43121115,43121116,43121117,43121118, 43121122,43577712,45612701,45620501,45620504, 45620505,45620506,45628201,45866902,46298501

Title: Overview and Summary ofFipronillCyphenothrin Dog Efficacy for Sergeant's Fiproni1 

### + Cyphenothrin Squeeze-On for Dogs (Overview ofother submissions). Guideline: 

### OPPTS 810.3300 Study Summary ofthe Results: This submission is an overall summary and clarification ofthe other submitted MRIDs associated withthis application Entomologist's ObservationslDiscussion: Supplementary Information

### MRID 48129810 Title: Immediate Efficacy ofa Combined Application ofFrontline Plus with Cyphenothrin as a Squeeze-on against Fleas (Ctenocephalis felis) and Ticks (Rhipicephalus sanguineus) on Dogs. Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was added to Frontline plus at 3 rates (5%, 10%, and 15%) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil dosage was slightly lower than that ofFrontline alone. 18 dogs were allocated to 6 groups 

### 00 dogs each. Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7 and 14 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also on day 14 at 1 and 4 hours post placement-this was to measure speed ofkiIl and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all reinfestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed ofkiU/repellence, the number ofkiIled/repelled fleas onthe liner beloweach treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after treatment or reinfestation with parasites, through 14 days after treatment. 2. Immediate efficacy onfleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-74% for 1-4 hours immediately aftertreatment. Withreinfestations after 14 days from treatment, efficacy exceeded 99% within 4 hours for all treatments that included cyphenothrin. 3. Immediate efficacy onticks ranged from 2-64% for 1-2 hours immediately after treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95% within 1hour, for the lowestpercentage ofcyphenothrin treatment, and exceeded 84% for all treatments. Entomologist's Observationsmicussion: 1. Efficacy against fleas and ticks was adequate to support controls claims through 14 days after treatment. 2. While immediate efficacy against fleas and ticks was enhanced when assessed at 1 and 4 hours aftertreatment (or reinfestation), the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately after treatment. However, after 14 days, this immediate efficacy was observed for reinfestations of both fleas and ticks. This is likely due to the more complete spread ofthe spot-on material throughout the animal coat at 14 days. Claims for killing (or 'starts killing') within hours would be supported bythis data, but not immediately after treatment of the animals. 

### MRID 48129810 Title: Immediate Efficacy ofa Combined Application ofFrontline Plus with Cyphenothrin as a Squeeze-on against Fleas (Ctenocephalis felis) and Ticks (Rhipicephalus sanguineus) on Dogs. Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was added to Frontline plus at 3 rates (5%, 10%, and 15%) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil dosage was slightly lower than that ofFrontline alone. 18 dogs were allocated to 6 groups 

### 00 dogs each. Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7 and 14 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also on day 14 at 1 and 4 hours post placement-this was to measure speed ofkiIl and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all reinfestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed ofkiU/repellence, the number ofkiIled/repelled fleas onthe liner beloweach treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after treatment or reinfestation with parasites, through 14 days after treatment. 2. Immediate efficacy onfleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-74% for 1-4 hours immediately aftertreatment. Withreinfestations after 14 days from treatment, efficacy exceeded 99% within 4 hours for all treatments that included cyphenothrin. 3. Immediate efficacy onticks ranged from 2-64% for 1-2 hours immediately after treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95% within 1hour, for the lowestpercentage ofcyphenothrin treatment, and exceeded 84% for all treatments. Entomologist's Observationsmicussion: 1. Efficacy against fleas and ticks was adequate to support controls claims through 14 days after treatment. 2. While immediate efficacy against fleas and ticks was enhanced when assessed at 1 and 4 hours aftertreatment (or reinfestation), the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately after treatment. However, after 14 days, this immediate efficacy was observed for reinfestations of both fleas and ticks. This is likely due to the more complete spread ofthe spot-on material throughout the animal coat at 14 days. Claims for killing (or 'starts killing') within hours would be supported bythis data, but not immediately after treatment of the animals.MRID 48129811 Title: Immediate Efficacy Following Application ofFrontline with Cyphenothrin Squeeze-on against Fleas 

### (Ctenocephalis felis) and Ticks 

### (Rhipicephalus sanguineus) onDogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrinwas added to Frontline plus at the rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was not takeninto account for the existing fipronil, therefore fipronil dosage was slightly lower than that ofFrontline alone. 18 dogs were allocated to 3 groups of6 dogs each. Group I, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone

.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21, and 28 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed of kill/repellence, the number ofkilled/repelled fleas onthe linerbelow eachtreated dog was divided bythe total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Stndy Snmmary ofthe Results: 1. Mean efficacy against fleas andticks exceeded 90% when assessed at 1-2 days after treatment orreinfestation withparasites, through 28 days after treatment. 2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-68% for 1-4 hours immediately aftertreatment. With reinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within4 hours for all treatments that included cyphenothrin, but did not exceed 90% within I hour after reinfestation. 3. Immediate efficacy on ticks ranged from 5-75% for 1-2 hours immediately after treatment. Withreinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all dates. For 21 and 28 days from treatment, adequate efficacy was observed within I hour ofreinfestation. Entomologist's ObservationslDicnssion: I. Efficacy against fleas andticks was adequate to support controls claims through 28 days (one month) after treatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately after treatment. However, after 7 days, this immediate efficacy was observed for reinfestations ofboth fleas and ticks. This is likely due to the more complete spread ofthe spot-onmaterial throughout the animal coat at 7+ days. Claims for killing (or MRID 48129811 Title: Immediate Efficacy Following Application ofFrontline with Cyphenothrin Squeeze-on against Fleas 

### (Ctenocephalis felis) and Ticks 

### (Rhipicephalus sanguineus) onDogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrinwas added to Frontline plus at the rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was not takeninto account for the existing fipronil, therefore fipronil dosage was slightly lower than that ofFrontline alone. 18 dogs were allocated to 3 groups of6 dogs each. Group I, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone

.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21, and 28 days aftertreatment. Counts were made at 1 and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed of kill/repellence, the number ofkilled/repelled fleas onthe linerbelow eachtreated dog was divided bythe total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Stndy Snmmary ofthe Results: 1. Mean efficacy against fleas andticks exceeded 90% when assessed at 1-2 days after treatment orreinfestation withparasites, through 28 days after treatment. 2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-68% for 1-4 hours immediately aftertreatment. With reinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within4 hours for all treatments that included cyphenothrin, but did not exceed 90% within I hour after reinfestation. 3. Immediate efficacy on ticks ranged from 5-75% for 1-2 hours immediately after treatment. Withreinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all dates. For 21 and 28 days from treatment, adequate efficacy was observed within I hour ofreinfestation. Entomologist's ObservationslDicnssion: I. Efficacy against fleas andticks was adequate to support controls claims through 28 days (one month) after treatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately after treatment. However, after 7 days, this immediate efficacy was observed for reinfestations ofboth fleas and ticks. This is likely due to the more complete spread ofthe spot-onmaterial throughout the animal coat at 7+ days. Claims for killing (or

### 'starts killing') within hours would be supported by this data, butnot immediately after treatment ofthe animals.

MRID 48129812 

### Title: 

### Immediate Efficacy Following Application ofFrontline Plus with Cyphenothrin Squeezeon against Fleas (Ctenocephalisfelis) 

### and Ticks (Rhipicephalus sanguineus) 

### on Dogs. Guideline: 

### OPPTS 810.3300 Materials and Methods: 

### Cyphenothrin was added to Frontline plus at the rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil dosage was slightly lowerthanthat ofFrontline alone. 18 dogs were allocated to 3 groups of6 dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone

.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21,28, and 35 days after treatment. Counts were made at 1 and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed of kill/repellence, the number ofkilled/repelled fleas onthe linerbelow eachtreated dog was divided by the total number offleas placed onthe dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 

### I. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after treatment or reinfestation with parasites, through 35 days after treatment. 2. Immediate efficacy on fleas (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. 3. Immediate efficacy onticks 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% within 4 hours for onlythe 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 ObservationsIDicussion: 

### I. Efficacy against fleas and ticks was adequate to support controls claims through 35 days (one month) after treatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at I and4 hours after treatment (or reinfestation) compared to fipronil alone, 'starts killing') within hours would be supported by this data, butnot immediately after treatment ofthe animals.

MRID 48129812 

### Title: 

### Immediate Efficacy Following Application ofFrontline Plus with Cyphenothrin Squeezeon against Fleas (Ctenocephalisfelis) 

### and Ticks (Rhipicephalus sanguineus) 

### on Dogs. Guideline: 

### OPPTS 810.3300 Materials and Methods: 

### Cyphenothrin was added to Frontline plus at the rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil dosage was slightly lowerthanthat ofFrontline alone. 18 dogs were allocated to 3 groups of6 dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone

.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14,21,28, and 35 days after treatment. Counts were made at 1 and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/or repellency. Counts were also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed of kill/repellence, the number ofkilled/repelled fleas onthe linerbelow eachtreated dog was divided by the total number offleas placed onthe dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 

### I. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after treatment or reinfestation with parasites, through 35 days after treatment. 2. Immediate efficacy on fleas (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. 3. Immediate efficacy onticks 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% within 4 hours for onlythe 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 ObservationsIDicussion: 

### I. Efficacy against fleas and ticks was adequate to support controls claims through 35 days (one month) after treatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at I and4 hours after treatment (or reinfestation) compared to fipronil alone,the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days after treatment. This data does not support any claims for faster kill orrepellence due to the addition ofcyphenothrin.



### MRID 48129813 Title: Comparative efficacy evaluation ofSergeant's Squeeze-on and Frontline Plus for the treatment ofadult cat flea 

### (Ctenocephalides felis) and tick 

### (Haemaphysalis elliptica, Rhipicephalus sanguineus, and

### Dermacentor variabilis) infestations on dogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was added to Seargeant's Fipronil-Methroprene formulation Frontline plus at the rate ofapproximately 5% for efficacy evaluations. This treatment was compared to fipronil-methoprene alone, and a positive control, Merial's Frontline Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mLlkg body weight, to simulate the dosing at the high end ofeach respective weight class. Dogs were subgrouped by weight class with 6 dogs in each subclass (split over time to 3 dogs ofeach class in 2 consecutive studies). Group 1, untreated control; Group 2, Fipronil+Methoprene, Group 3, Fipronil+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs 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 after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed ofkill/repellence, the number of killed/repelled fleas onthe liner below each treated dog was dividedbythe total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment or reinfestation withparasites, through 28 days after treatment. 2. Immediate group mean efficacy onticks (all species) overall means were all below 90%. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls general claims through 35 days (one month) after treatment. 2. No immediate efficacy claims (i.e., within 1-4 hours ofapplication orreinfestationby parasites) are supported bythis data. the immediate efficacy did not exceed 90% with any consistency for the treatments evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days after treatment. This data does not support any claims for faster kill orrepellence due to the addition ofcyphenothrin.



### MRID 48129813 Title: Comparative efficacy evaluation ofSergeant's Squeeze-on and Frontline Plus for the treatment ofadult cat flea 

### (Ctenocephalides felis) and tick 

### (Haemaphysalis elliptica, Rhipicephalus sanguineus, and

### Dermacentor variabilis) infestations on dogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was added to Seargeant's Fipronil-Methroprene formulation Frontline plus at the rate ofapproximately 5% for efficacy evaluations. This treatment was compared to fipronil-methoprene alone, and a positive control, Merial's Frontline Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mLlkg body weight, to simulate the dosing at the high end ofeach respective weight class. Dogs were subgrouped by weight class with 6 dogs in each subclass (split over time to 3 dogs ofeach class in 2 consecutive studies). Group 1, untreated control; Group 2, Fipronil+Methoprene, Group 3, Fipronil+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs 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 after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculated using Abbott's formula. For speed ofkill/repellence, the number of killed/repelled fleas onthe liner below each treated dog was dividedbythe total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. Study Summary ofthe Results: 1. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment or reinfestation withparasites, through 28 days after treatment. 2. Immediate group mean efficacy onticks (all species) overall means were all below 90%. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls general claims through 35 days (one month) after treatment. 2. No immediate efficacy claims (i.e., within 1-4 hours ofapplication orreinfestationby parasites) are supported bythis data.MRID 48189203 Title: Dose Titration with S-Methoprene Squeeze-Ons with Dogs Measuring Flea Egg Sterilization 

### Guideline: OPPTS 810.3300 Materials and Methods: 18 dogs were allocated to this study, with 6 in an untreated control group, and 2 each into 6 groups that received s-methoprene spot-on treatments at various dose rates based on weights ofthe 2 dogs, and designed to provide a range ofdose rates from 3 mg/kg to 48 mg/kg. Dogs were infested with fleas 24 hours after treatment, and again weekly thereafter. Flea eggs were collected overnights from pans below each dog 1-2 times during the week after eachre-infestation. Flea eggs were sorted into 2 aliquots ofapproximately 25 eachone incubated to measure fertility ofthe eggs, and the other incubated in a flea-growing medium to determine the number offleas that developed from the eggs after 35 days. % hatch was calculated. % hatchreduction efficacy was calculated using Abbott's formula. Less than 90% on 2 or more successive collections was a criteria for treatment failure. Data was analyzed for correlationbetween dose and the duration ofefficacy, to enable prediction ofthe duration of adequate efficacy at various doses. Study Summary ofthe Results: 1. Application ofthe regression equationpredicts residual efficacy in sterilizing female fleas andkilling their eggs at a duration of57 days for the largest heaviest dogs inthe treatment regime to 122 days for the smallest dogs. 2. The adult emergence efficacy was terminated at 108 days with 100% efficacy for the five highestrates and >63 days for the lowest Entomologist's ObservationslDiscussion I. Forthe largest dogs (i.e., the lowest dosage ofa.i. per kg dog weight), egg sterilization lasted 57 days and inhibition ofadultemergence lasted 63 days. Therefore claims against flea eggs, larvae, and breaking ofthe flea life cycle is supported for 2 months (8 weeks). Claims must be revised to reflect this supported duration. OverallReview ofLabel Claims and Directions: Based upon submitted efficacy data, claims are supported for fleas and ticks through 35 days. Claims for immediate efficacy are not supported exceptto state "starts killing within hours" or "starts killing in as little as one hour". RepeUence claims for fleas and ticks are not supported andmust be removed from the label. Kill claims against flea eggs or larvae, are supported. Control claims against flea eggs or larvae, or claims against breaking the flea life cycle are supported for up to 2 months after treatment, however claims of'upto 4 months' are acceptable, as this efficacy was supported for some dogs. MRID 48189203 Title: Dose Titration with S-Methoprene Squeeze-Ons with Dogs Measuring Flea Egg Sterilization 

### Guideline: OPPTS 810.3300 Materials and Methods: 18 dogs were allocated to this study, with 6 in an untreated control group, and 2 each into 6 groups that received s-methoprene spot-on treatments at various dose rates based on weights ofthe 2 dogs, and designed to provide a range ofdose rates from 3 mg/kg to 48 mg/kg. Dogs were infested with fleas 24 hours after treatment, and again weekly thereafter. Flea eggs were collected overnights from pans below each dog 1-2 times during the week after eachre-infestation. Flea eggs were sorted into 2 aliquots ofapproximately 25 eachone incubated to measure fertility ofthe eggs, and the other incubated in a flea-growing medium to determine the number offleas that developed from the eggs after 35 days. % hatch was calculated. % hatchreduction efficacy was calculated using Abbott's formula. Less than 90% on 2 or more successive collections was a criteria for treatment failure. Data was analyzed for correlationbetween dose and the duration ofefficacy, to enable prediction ofthe duration of adequate efficacy at various doses. Study Summary ofthe Results: 1. Application ofthe regression equationpredicts residual efficacy in sterilizing female fleas andkilling their eggs at a duration of57 days for the largest heaviest dogs inthe treatment regime to 122 days for the smallest dogs. 2. The adult emergence efficacy was terminated at 108 days with 100% efficacy for the five highestrates and >63 days for the lowest Entomologist's ObservationslDiscussion I. Forthe largest dogs (i.e., the lowest dosage ofa.i. per kg dog weight), egg sterilization lasted 57 days and inhibition ofadultemergence lasted 63 days. Therefore claims against flea eggs, larvae, and breaking ofthe flea life cycle is supported for 2 months (8 weeks). Claims must be revised to reflect this supported duration. OverallReview ofLabel Claims and Directions: Based upon submitted efficacy data, claims are supported for fleas and ticks through 35 days. Claims for immediate efficacy are not supported exceptto state "starts killing within hours" or "starts killing in as little as one hour". RepeUence claims for fleas and ticks are not supported andmust be removed from the label. Kill claims against flea eggs or larvae, are supported. Control claims against flea eggs or larvae, or claims against breaking the flea life cycle are supported for up to 2 months after treatment, however claims of'upto 4 months' are acceptable, as this efficacy was supported for some dogs.

### Line by Line Review ofLabel Efficacy Claims 

### Kills fleas (in as little as I hour), flea eggs, ticks (in as little as one hour), chewing lice & 

### mosquitoes: Unacceptable unless revised to 'starts killing' for fleas and ticks. Kills (and Repels) Fleas, Ticks, and Mosquitoes: Repels claim must be deleted. Controls flea reinfestation for up to [16 weeksl: Acceptable Fast Acting: Unacceptable Kills ticks (in as little as I hour): Acceptable only ifrevised to say 'starts killing' Kills ticks including those that may transmit Lyme disease: Acceptable Dogs can be bathed 24 hours after treatment: Unacceptable Waterproof: Acceptable Long Lasting: Acceptable Research demonstrates that [brand namel kills adult fleas (in as little as I hour), flea eggs, larvae and pupae for up to four months: Acceptable only ifrevised to 'starts' killing. Claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposed to residue. [brand namel prevents development ofall flea stages for up to four months: Acceptable Kills fleas (in as little as I hour), ticks (in as little as 1hour), mosquitoes, (chewing) lice, flea eggs, larvae, and pupae: Acceptable only ifkills claims are revised to 'starts killing'

j 

### U- "Prevents all flea stages (adult fleas (in as little as 1hour), flea eggs, flea pupae, and flea larvae}:
J

### Acceptable except claim against 'pupae' must be deleted, as no data was submitted indicating the

productkills flea pupae exposed to residue. Ifdog is a high risk for flea re-infestation once a month application may be needed: Acceptable. Once a month treatment is recommended: Acceptable. A once monthly application is recommended for chewing lice: Acceptable. Rapidly eliminates infestations with chewing lice: Acceptable; Monthly flea, tick, mosquito, lice, and flea egg protection: Acceptable. Monthly flea, tick, mosquito, and lice protection: Acceptable. Line by Line Review ofLabel Efficacy Claims 

### Kills fleas (in as little as I hour), flea eggs, ticks (in as little as one hour), chewing lice & 

### mosquitoes: Unacceptable unless revised to 'starts killing' for fleas and ticks. Kills (and Repels) Fleas, Ticks, and Mosquitoes: Repels claim must be deleted. Controls flea reinfestation for up to [16 weeksl: Acceptable Fast Acting: Unacceptable Kills ticks (in as little as I hour): Acceptable only ifrevised to say 'starts killing' Kills ticks including those that may transmit Lyme disease: Acceptable Dogs can be bathed 24 hours after treatment: Unacceptable Waterproof: Acceptable Long Lasting: Acceptable Research demonstrates that [brand namel kills adult fleas (in as little as I hour), flea eggs, larvae and pupae for up to four months: Acceptable only ifrevised to 'starts' killing. Claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposed to residue. [brand namel prevents development ofall flea stages for up to four months: Acceptable Kills fleas (in as little as I hour), ticks (in as little as 1hour), mosquitoes, (chewing) lice, flea eggs, larvae, and pupae: Acceptable only ifkills claims are revised to 'starts killing'

j 

### U- "Prevents all flea stages (adult fleas (in as little as 1hour), flea eggs, flea pupae, and flea larvae}:
J

### Acceptable except claim against 'pupae' must be deleted, as no data was submitted indicating the

productkills flea pupae exposed to residue. Ifdog is a high risk for flea re-infestation once a month application may be needed: Acceptable. Once a month treatment is recommended: Acceptable. A once monthly application is recommended for chewing lice: Acceptable. Rapidly eliminates infestations with chewing lice: Acceptable; Monthly flea, tick, mosquito, lice, and flea egg protection: Acceptable. Monthly flea, tick, mosquito, and lice protection: Acceptable.

### Kills flea eggs [larvae] [pupae] for up to 4 months: Acceptable except claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposed to residue. Aids in control ofsarcoptic mange: Acceptable. Kills fleas (in as little as I hour), ticks (in as little as 1hour), mosquitoes, flea eggs, and lice: Acceptable only ifkills claims are revised to 'starts killing'. [Seven] [7] 

### Way Protection! Kills fleas (in as little as 1hour), ticks (in as little as I hour), mosquitoes, lice flea eggs, & 

### flea larvae: '7-way' is an unacceptable nebulous claim. Kills claims must be revised to 'starts killing' 6 [Six] Way Protection! Kills fleas (in as little as I hour), ticks (in as little as 1hour), mosquitoes, lice, flea eggs & 

### flea larvae: '6-way' is an unacceptable nebulous claim. Kills claims must be revised to 'starts killing' [4 Week] [Flea and Tick & 

### Treatment]: Acceptable Four (4) Week Flea, Tick, Mosquitoe and Lice Control: Acceptable With (s)-methoprene Insect Growth Regulator which Breaks the Flea Life Cycle: Acceptable With (s)-methoprene to Break Flea Life Cycle: Acceptable With Insect GrowthRegulator to Break FleaLife Cycle: Acceptable Triple Action [I]: 

### Fipronil and Cyphenothrinwith (s)-methoprene IGREffectively Breaks the Flea Life Cycle: Acceptable Triple Action [!]: 

### Effectively Breaks the Flea Life Cycle [I]: 

### Acceptable Best ifused year round!: Acceptable Kills & 

### Repels Fleas (in as little as I hour) Up to [4 weeks]!: Kills must be revised to 'starts killing' and 'repels' claim must be deleted. (ICON showing 4 week protection): Acceptable 4 Week Dose!: Acceptable 1Month Dose!: Acceptable Specially Formulated for Dogs and Puppies: Acceptable Kills flea eggs [larvae] [pupae] for up to 4 months: Acceptable except claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposed to residue. Aids in control ofsarcoptic mange: Acceptable. Kills fleas (in as little as I hour), ticks (in as little as 1hour), mosquitoes, flea eggs, and lice: Acceptable only ifkills claims are revised to 'starts killing'. [Seven] [7] 

### Way Protection! Kills fleas (in as little as 1hour), ticks (in as little as I hour), mosquitoes, lice flea eggs, & 

### flea larvae: '7-way' is an unacceptable nebulous claim. Kills claims must be revised to 'starts killing' 6 [Six] Way Protection! Kills fleas (in as little as I hour), ticks (in as little as 1hour), mosquitoes, lice, flea eggs & 

### flea larvae: '6-way' is an unacceptable nebulous claim. Kills claims must be revised to 'starts killing' [4 Week] [Flea and Tick & 

### Treatment]: Acceptable Four (4) Week Flea, Tick, Mosquitoe and Lice Control: Acceptable With (s)-methoprene Insect Growth Regulator which Breaks the Flea Life Cycle: Acceptable With (s)-methoprene to Break Flea Life Cycle: Acceptable With Insect GrowthRegulator to Break FleaLife Cycle: Acceptable Triple Action [I]: 

### Fipronil and Cyphenothrinwith (s)-methoprene IGREffectively Breaks the Flea Life Cycle: Acceptable Triple Action [!]: 

### Effectively Breaks the Flea Life Cycle [I]: 

### Acceptable Best ifused year round!: Acceptable Kills & 

### Repels Fleas (in as little as I hour) Up to [4 weeks]!: Kills must be revised to 'starts killing' and 'repels' claim must be deleted. (ICON showing 4 week protection): Acceptable 4 Week Dose!: Acceptable 1Month Dose!: Acceptable Specially Formulated for Dogs and Puppies: Acceptable

### Kills FleaEggs & 

### Flea Larvae for [(4 months)]!: Unacceptable unless revised to '2 months' or 'up to 4 months'. Prevents Flea Eggs From Developing Into Biting Adults: Acceptable Kills Ticks (in as little as I hour) for Up to [4 weeks]!: Acceptable only ifrevised to 'starts killing'

. Kills [all stages of! Deer Ticks (vector ofLyme Disease) for up to 4 weeks: Acceptable Kills Ticks (in as little as I hour): Acceptable only ifrevised to 'starts killing' Kills Ticks including Deer Ticks for up to 4 weeks: Acceptable Kills BrownDogTicks (in as little as I hour): Acceptable only ifrevised to 'starts killing' Kills [Brown], [American.] [and Lone Stare] Dog Ticks for up to 4 weeks: Acceptable Kills Rhipicephalus sanguineus 

### for up to 4 weeks: Acceptable When used monthly [brand name] completely breaks the flea life cycle and controls tick and chewing lice infestations: Acceptable Kills American Dog Ticks [(Dermacentor variabilis)]

### for up to 4 weeks!: Acceptable Apply once every [4 weeks]!: Acceptable 4 weeks Flea and Tick Treatment: Acceptable Once A Month Flea and Tick Treatment: Acceptable Kills & 

### Repels Fleas (in as little as I hour) and Ticks (in as little as I hour) for up to 4 weeks!: Only acceptable ifrevised to starts killing, and also the repels claim must be deleted. Kills all stages ofthe flea life cycle: Acceptable Kills fleas (in as little as I hour). Ticks (in as little as I hour), FleaEggs & 

### Flea Larvae for up to 16 Weeks: Acceptable only ifrevised to 'starts killing' Kills mosquitoes: Acceptable Dogs can be bathed 24 hours after squeeze-on is applied: Unacceptable Prevents and controls reinfestations: Unacceptable unless a pest and duration ofcontrol is associated (e.g., 'prevents and controls reinfestations oflistedpests for I month [4 weeks

# n. Kills FleaEggs & 

### Flea Larvae for [(4 months)]!: Unacceptable unless revised to '2 months' or 'up to 4 months'. Prevents Flea Eggs From Developing Into Biting Adults: Acceptable Kills Ticks (in as little as I hour) for Up to [4 weeks]!: Acceptable only ifrevised to 'starts killing'

. Kills [all stages of! Deer Ticks (vector ofLyme Disease) for up to 4 weeks: Acceptable Kills Ticks (in as little as I hour): Acceptable only ifrevised to 'starts killing' Kills Ticks including Deer Ticks for up to 4 weeks: Acceptable Kills BrownDogTicks (in as little as I hour): Acceptable only ifrevised to 'starts killing' Kills [Brown], [American.] [and Lone Stare] Dog Ticks for up to 4 weeks: Acceptable Kills Rhipicephalus sanguineus 

### for up to 4 weeks: Acceptable When used monthly [brand name] completely breaks the flea life cycle and controls tick and chewing lice infestations: Acceptable Kills American Dog Ticks [(Dermacentor variabilis)]

### for up to 4 weeks!: Acceptable Apply once every [4 weeks]!: Acceptable 4 weeks Flea and Tick Treatment: Acceptable Once A Month Flea and Tick Treatment: Acceptable Kills & 

### Repels Fleas (in as little as I hour) and Ticks (in as little as I hour) for up to 4 weeks!: Only acceptable ifrevised to starts killing, and also the repels claim must be deleted. Kills all stages ofthe flea life cycle: Acceptable Kills fleas (in as little as I hour). Ticks (in as little as I hour), FleaEggs & 

### Flea Larvae for up to 16 Weeks: Acceptable only ifrevised to 'starts killing' Kills mosquitoes: Acceptable Dogs can be bathed 24 hours after squeeze-on is applied: Unacceptable Prevents and controls reinfestations: Unacceptable unless a pest and duration ofcontrol is associated (e.g., 'prevents and controls reinfestations oflistedpests for I month [4 weeks

# n.

### BACK/SIDE CARTON LABEL-MASTER LABEL [brand name] containes Fiproni!, cyphenothrin, and the insect growth regulator (IGR) (s)- methoprene to effectively kill [and repelJ Fleas [(in as little as 1hour)), Ticks [(in as little as I 

### hour)], and kills mosquitoes and (chewing) lice. The active ingredients in [brand name] work by collecting in the hair follicles and skin oils. This product features a sustained-release formula that discharges from the animal's hairfollicles using the natural skin oils, resulting in fast acting [and long lasting] control ofFleas and Ticks [(in as little as one hour)), [and kills mosquitoes] and chewing lice [for 30 days: All repels claims must be removed from the label. All references to action in as little as 1hour must be revised to 'starts acting' or 'starts killing' or alternatively, the claims of'inlittle as I hour' can be removed. 'Fast acting' claim must be removed. The claims about movement in hair follicles is deferred to the RM Reviewer and PM. BACK/SIDE CARTON LABEL-MASTER LABEL [brand name] containes Fiproni!, cyphenothrin, and the insect growth regulator (IGR) (s)- methoprene to effectively kill [and repelJ Fleas [(in as little as 1hour)), Ticks [(in as little as I 

### hour)], and kills mosquitoes and (chewing) lice. The active ingredients in [brand name] work by collecting in the hair follicles and skin oils. This product features a sustained-release formula that discharges from the animal's hairfollicles using the natural skin oils, resulting in fast acting [and long lasting] control ofFleas and Ticks [(in as little as one hour)), [and kills mosquitoes] and chewing lice [for 30 days: All repels claims must be removed from the label. All references to action in as little as 1hour must be revised to 'starts acting' or 'starts killing' or alternatively, the claims of'inlittle as I hour' can be removed. 'Fast acting' claim must be removed. The claims about movement in hair follicles is deferred to the RM Reviewer and PM.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### October 4,2010

OPP DecisionNumber: D-438361 EPA File Symbol or Registration Number: 2517-RUE OFFICE OF PREVENTION. PESTICIDES AND TOXIC SUBSTANCES



### Product Name: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### +METHOPRENE SQUEEZEON FORDOGS EPA Receipt Date: ll-Aug-2010 EPA CompanyNumber: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC. KELLY 

### R. HOSKINS SERGEANT'S PETCARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subjectto Registration Service Fee Dear Registrant: The Office ofPesticide Programs has received your application and certification of payment. Ifyou submitted data withthis application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has determined that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide Registration ImprovementAct. The Actionpreviously identified as R320 has been reclassified as Action Code: R310 NEWPRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); The fee associated with this aciton is $ 2,289 (50% of$ 4,578). Payment ifthe amount of $ 5,712 has beenreceived. A refund in the amount of$ 3,423 will be issued as soon as the action is completed. Ifyou have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerel , Fro**Procecc~'''''''''',ff'**



### fo gy & 

### Resources Management Division

# Memorandum Date: 

# U j 

## 9 / I 

### 0 

# To: 

# p IkJ 10 , 

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

# We expect that it

# will be approximately 5 days from the above date before the study-level data is available in OPPIN. Ifyouhave any questions aboutthis process, please contact Teresa Downs (305-5363).
This is a: S--fully accepted submission D 

# partially accepted submission D 

# rejected submission 

# Memorandum Date: 

# f / j 

## 9 / I 

### 0 

# To: ___ -'-P--'-/..::.J.·l1_.L.-'1 0",,-· ___ , 

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

# We expect that it

# will be approximately 5 days from the above date before the study-level data is available in OPPIN. Ifyouhave any questions aboutthis process, please contact Teresa Downs (305-5363).
This is a: S--fully accepted submission D 

# partially accepted submission D 

# rejected submission

# Completion of

# 21-Day Content Screen 

# PM- 

# /0 EPA Reg. #(File Symbol)

# as11-**kL1~** 

# Decision # 

# D

Thank you, 

# ------ Data package delivered to you on 0/19/ j() • (date) 

# Jacket/Mini-jacket will be transferred to you today. (Pick up from Document Center)



# Registration Division's 21-Day Content Team

# To the Document Center (ITRMD) *Please transferjacket/mini-jacketto the Product Manager Team circled below: 

# MinorUse Section: PM-5
Insecticide Branch: PM-lO PM-l3
Herbicide Branch: PM-23 PM-25 Fungicide Branch: PM-20 PM-2l PM-22
InsectIRodent Branch: PM-l PM-7

*Reminderto PM

- Ifapplicable, pick-up data from the Screening Room. Processed by RD's Completeness Check Team

(Team Member Signature) (Date)

# 21-Day 

# Screen Completedby 

# Contractor 

# 21-DayExpires on**~9~- /~-~/O~~_**  

# Jacket# ;?!3 

# /7-f(r.)G 

# MRID# t/ej/

# g9 :J

# Content Screen: Recommendedto 

# IPasSYFaH 86=5

# ReView:JPasse~/Faned/NA 

# Transfer This Jacketto:

;OJI;I-IO

## PRIA 2 - 21 Day Content Screen Review Worksheet (EPA/OPP Use Only) 3/23/09 21 Day Screen StartDate: /(

- 

### If
- 10 Experts In-Processing Signature: yv}1:: t-lA-tn./ICToN 

### Date 

## 8--/2-/0 Fee Paid: Yes

## ~ Division management contacted on issues No Yes Date

______ _ EPA Reg. Number: 

# "LStl
- 

# R.uE. EPA Receipt Date: 

# 2(- 1/- 10 Items for Review Yes No N/A* 1 

### Application Form (EPA Form 8570-1)(linkto form) signed & 

### complete 

# )( includingpackage type Confidential Statement ofFormula all boxes completed, form signed, and 

# X dated (EPA Form 8570-4) (Linkto form) 2 

### a) All inerts (link to http://www.epa.gov/opprdOOllinerts/), yes no including fragrances, approved for the proposed uses (see 

# y Footnote A) 

### 3 Certificationwith Respect to Citation ofData (EPA Form 8570-34) (Link to 

# X form) completed and signed (N/ A if 100% repack) Certificate and data matrix consistent 

# -XIfapplicantis relying on datathat are compensable, is the offer yes no to pay statement included. (see Footnote B) ]f**~nnlir~hl"** 

### is there a letterofAuthorization for exclusive use only. Formulator's Exemption Statement (EPA Form 8570-27) (Link to form) 

# X 4 completed and signed (N/A ifsource is unregistered or applicant owns the tprhnira\) 

### DataMatrix (EPAForm 8570-35) (Link to form) both internal and external

# ~ copies (PR 98-5) (Link to PR98-5) completed and signed (N/A if 100% .!epack) yes no

# !~~'&l~lt~ 5 _a) Selective Method (Fee i 

### use) 

## Xb) Cite-All (Fee category experts use)

### /;'~?f1 i;, 

### c) Applicant owns all data (Fee category experts use) "iV' £/\ ,\.v;),: .'t'c"?;':,;;.-;;:.:, .,',: 

### 5 Copies ofLabel (linkto httI!://www.eI!a.gov/oI!I!feadlllabelill!vlrmD 6 

### (Electronic labels on CD are encouraged and guidance is available)( linkto 

# X htlpJlwww.epa.gov/peslicides/regulaling/regislering/submissions/index.hlm#labels )
17 Is the data package consistentwith PRNotice 86-5 (linkto PRN 86-5) 

# X
Notice ofFiling (linkto 

### 8 htt[!://www.e[!a.gov/[!esticides/regulating£tolerance [!etitions.htm) included

# ~ with petitions (linkto http://www.epa.gov/pesticides/regulating/tolerances.htm) 9 Ifapplicable for conventional applications, reduced risk rationale (link to 

# X http://www.epa.gov/opprdOOl/workplan/reducedrisk.html) Required Data (linkto htt[!://www.e[!a.gov/[!esticides/regulatinVdata reguirements.htm) and/or data waivers. See Footnote C.

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

10



### 2

### Comments:

I 

### «\ tOe u 

## -JD**o~**j\f-



## *N/A
- 

### Not Applicable

Footnotes A. 

### During the 21 day initial content review, all CSFs will be reviewed to determine whether all inerts listed, including fragrances, are approved for the proposed uses. 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, correcting mistakes on the CSF, etc. or2) provide the datato support 

### OPP approval ofthe inert or 3) withdrawthe application. Removing or substituting 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 beenreceived bythe Agency orthe 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 have been approved for the application's uses even ifa product is currently registered 

### by consulting the inert Web 3site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and ifthe inert is not approved, to obtain the necessary inert approval priorto submitting an applicatiou to registera pesticide product containingthatinert ingredient. Some inert ingredients are no longer approved for food uses or certaintypes ofuses. The name and/or CAS number ona CSF mustmatchthe name and CAS number onthis web site. Simpletypographical errors in the name or CAS number have resulted in processing delays. Ifan inertis not listed onthe inert ingredient web site andthe applicantbelieves that the inerthas been approved, the applicant should contactthe Inert Ingredient Assessment Branch (nAB) 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 reviewedby IIAB. The nAB should also be contacted for any questions on what supporting dataneeds to be submitted for and the Agency's inertreviewprocess. Questions onPIP inerts should be directed to the Chiefof Microbial Pesticides Branch [Linkto http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm ]. When a brand, trade, orproprietary name ofan inert ingredient is listed on a CSF, additional information such as an alternate name ofthe inert, CAS number or other information [linkto http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included to enable the Agency to determine ifit has been approved. Each component ofan inert mixture (including a fragrance) mustbe identified. In some cases, the supplier ofthe mixture or fragrance may needto provide this informationto the Agency. Priorto the Agency's receipt ofan application, applicants must arrange with a proprietary mixture or fragrance supplier to provide the component information to the Agency or promptlyupon EPA's request. Ifthe inert ingredients in a proprietary blend (including fragrances) cannot or are not identified orprovidedwithin the 21-day content reviewperiod, the Agency will rejectthe application. During the 21 day contentreview, applicants should submit informationto the individual identified bythe Agency whenthe applicant is informed ofan unapproved inert. Unapproved Inerts Identified on CSFs All applications except conventional newproducts and PIPs Once anunapproved inert is identified on a CSF, the Agency will contactthe applicant withthe following options: 1. Correctthe application by, for instance, correcting the inert's identity or CAS number, providing documentationthatthe inert has been approved, or removing the unapproved inert from the CSF or replacing itwith one that is approved for the application's uses; or 2. Submitthe information and data needed for the Agencyto approve the unapproved inert. Ifthis option is selected and implemented, the Agency may request an extension in the PRlA decision reviewtimeframe to accommodate the inertreview/approval process; 4 site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and ifthe inert is not approved, to obtain the necessary inert approval priorto submitting an applicatiou to registera pesticide product containingthatinert ingredient. Some inert ingredients are no longer approved for food uses or certaintypes ofuses. The name and/or CAS number ona CSF mustmatchthe name and CAS number onthis web site. Simpletypographical errors in the name or CAS number have resulted in processing delays. Ifan inertis not listed onthe inert ingredient web site andthe applicantbelieves that the inerthas been approved, the applicant should contactthe Inert Ingredient Assessment Branch (nAB) 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 reviewedby IIAB. The nAB should also be contacted for any questions on what supporting dataneeds to be submitted for and the Agency's inertreviewprocess. Questions onPIP inerts should be directed to the Chiefof Microbial Pesticides Branch [Linkto http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm ]. When a brand, trade, orproprietary name ofan inert ingredient is listed on a CSF, additional information such as an alternate name ofthe inert, CAS number or other information [linkto http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included to enable the Agency to determine ifit has been approved. Each component ofan inert mixture (including a fragrance) mustbe identified. In some cases, the supplier ofthe mixture or fragrance may needto provide this informationto the Agency. Priorto the Agency's receipt ofan application, applicants must arrange with a proprietary mixture or fragrance supplier to provide the component information to the Agency or promptlyupon EPA's request. Ifthe inert ingredients in a proprietary blend (including fragrances) cannot or are not identified orprovidedwithin the 21-day content reviewperiod, the Agency will rejectthe application. During the 21 day contentreview, applicants should submit informationto the individual identified bythe Agency whenthe applicant is informed ofan unapproved inert. Unapproved Inerts Identified on CSFs All applications except conventional newproducts and PIPs Once anunapproved inert is identified on a CSF, the Agency will contactthe applicant withthe following options: 1. Correctthe application by, for instance, correcting the inert's identity or CAS number, providing documentationthatthe inert has been approved, or removing the unapproved inert from the CSF or replacing itwith one that is approved for the application's uses; or 2. Submitthe information and data needed for the Agencyto approve the unapproved inert. Ifthis option is selected and implemented, the Agency may request an extension in the PRlA decision reviewtimeframe to accommodate the inertreview/approval process; 4

### 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implementedbythe applicant within the 21 day content reviewperiod, the Agency will reject the application and retain 25% ofthe full fee ofthe category identified. Conventional NewProduct Applications When the Registration Division identifies an unapproved inert on a CSF with an application for a newproductthat the applicanthas not identified as requiring an inert approval (R311, R312 or R313), it will contactthe applicant with the following options: I. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removingthe unapproved inert from the CSF or replacing it with one thatis approved for the application's uses; or 2. Submitthe information and data needed for the Agencyto approve the unapproved inert, including any required petitionto establish or amend a tolerance or exemption from a tolerance. (This option may change the PRIA category for the application, which could require a longer decisionreview time and a larger fee. Ifadditional fees are due, they must be received by the Agency withinthe 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 newproduct-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 inert does not accompany the application, it will contact the applicant withthe following options: 

### I. Correct the application by, for instance, correctingthe spelling or name ofthe inert to that in40 CFR 174, orproviding documentationthat the inert has been approved; or 2. Submit the information and dataneeded for the Agency to approve the unapproved inert. Ifan inert ingredient tolerance exemptionpetition is required, the petition must be received bythe Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizingthe timeframe for both actions. 

### 5 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implementedbythe applicant within the 21 day content reviewperiod, the Agency will reject the application and retain 25% ofthe full fee ofthe category identified. Conventional NewProduct Applications When the Registration Division identifies an unapproved inert on a CSF with an application for a newproductthat the applicanthas not identified as requiring an inert approval (R311, R312 or R313), it will contactthe applicant with the following options: I. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removingthe unapproved inert from the CSF or replacing it with one thatis approved for the application's uses; or 2. Submitthe information and data needed for the Agencyto approve the unapproved inert, including any required petitionto establish or amend a tolerance or exemption from a tolerance. (This option may change the PRIA category for the application, which could require a longer decisionreview time and a larger fee. Ifadditional fees are due, they must be received by the Agency withinthe 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 newproduct-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 inert does not accompany the application, it will contact the applicant withthe following options: 

### I. Correct the application by, for instance, correctingthe spelling or name ofthe inert to that in40 CFR 174, orproviding documentationthat the inert has been approved; or 2. Submit the information and dataneeded for the Agency to approve the unapproved inert. Ifan inert ingredient tolerance exemptionpetition is required, the petition must be received bythe Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizingthe timeframe for both actions. 

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

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

### A530, an application withoutthe necessary authorizations ofoffers to pay will beplaced into either R301 or A531. The Agency recommends that authorizations ofoffers to pay be submitted with other PRIA applications to avoid delays inthe Agency's decision. C. Biopesticide applicants are advisedto contact the Agency and discuss study waivers prior to submitting their application to the Agency. Documentation ofsuch discussions should be submitted withthe studywaiver.

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

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

### A530, an application withoutthe necessary authorizations ofoffers to pay will beplaced into either R301 or A531. The Agency recommends that authorizations ofoffers to pay be submitted with other PRIA applications to avoid delays inthe Agency's decision. C. Biopesticide applicants are advisedto contact the Agency and discuss study waivers prior to submitting their application to the Agency. Documentation ofsuch discussions should be submitted withthe studywaiver.

6**~~''''i~O sr",**  

## ,,; ft"'''' 

## "

.

## ~ 

# "**$~ ~**  

# \IU.**~ \"",~** **~ ~L** **PRd'i~v~** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

# lY~ (,1)/1 August 30, 2010

PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT Or Pay On-Line at www.Pay.Gov (See Below for Details) OPP DecisionNumber: D-438361 EPA File Symbol or Registration Number: 2517-RUE OFFICE OF PREVENTION. PESTICIDES AND TOXIC SUBSTANCES



### ProductName: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### +METHOPRENE SQUEEZEON FORDOGS EPA Receipt Date: II-Aug-20I0 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CARE PRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee DearRegistrant: The Office ofPesticide Programs has received your application for registration. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has determined that this Action is subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration ImprovementAct. The Actionpreviously identified as R310 has been reclassified as Action Code: R320 NEWPRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE CITATIONS); The fee associated with this action is $ 5,712 (50% of$ 11,424). Payment in the amount of $ 2,289 has beenreceived. Please remit additional payment in the amount of$ 3,423. By USPS:

USEPA Washington Finance Center Pesticide Registration Service Fee PO Box 979074 St. Louis, MO 63197-9000 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### August 30, 2010

PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT Or Pay On-Line at www.Pay.Gov (See Below for Details) OPP DecisionNumber: D-438361 EPA File Symbol or Registration Number: 2517-RUE OFFICE OF PREVENTION. PESTICIDES AND TOXIC SUBSTANCES



### ProductName: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### +METHOPRENE SQUEEZEON FORDOGS EPA Receipt Date: II-Aug-20I 0 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CARE PRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee DearRegistrant: The Office ofPesticide Programs has received your application for registration. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has determined that this Action is subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration ImprovementAct. The Actionpreviously identified as R310 has been reclassified as Action Code: R320 NEWPRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE CITATIONS); The fee associated with this action is $ 5,712 (50% of$ 11,424). Payment in the amount of $ 2,289 has beenreceived. Please remit additional payment in the amount of$ 3,423. By USPS:

USEPA Washington Finance Center Pesticide Registration Service Fee PO Box 979074 St. Louis, MO 63197-9000

### By Courier: U.S. Bank Government Lockbox 979074 1005 Convention Plaza SL-MO-C2-GL St. Louis, MO 63197 Telephone: (412) 236-2294 All payments must be inUnited States currency by check, bank draft, or money order drawn to the order ofthe Environmental Protection Agency. To ensure proper credit, please write the OPP DECISIONNUMBER on your check, and enclose a copy ofthis letter withyour payment. Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select "searchby form name." From the nextpage, select "P," then click on "Pesticide Registration Improvement Act. Fee Payment" and complete the form, making certain to use the decision number and registration numberonthe invoice you receive from the Pesticide Program inthe space provided. You may be eligible for a partial waiver ofthe registration service fee if, for example, you qualifY as a small business or are applying for a minor use, or ifyour application is solely associated with an IR-4 tolerance petition. Please be advised that ifyou intend to request a waiver, you must do so inwriting within 15 days ofreceipt ofthis invoice instead ofremitting the amount indicated above. OPP will not considerwaiver requests after the registration service fee has beenpaid. Information regarding eligibility and how th request and document a fee waiver is available onthe OPP Fee for Service web site at www.epa.gov/pesticides/fees. Please send Registration Service Fee Waiver requests to: By USPS: Document Processing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency 1200 Pennsylvania Ave NW Washington, DC 20460 By Courier: Document Processing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room S4900 Potomac Yard 1 2777 S. Crystal Dr. Arlington, VA 22202 By Courier:

U.S. Bank Government Lockbox 979074 1005 Convention Plaza SL-MO-C2-GL St. Louis, MO 63197 Telephone: (412) 236-2294 All payments must be inUnited States currency by check, bank draft, or money order drawn to the order ofthe Environmental Protection Agency. To ensure proper credit, please write the OPP DECISIONNUMBER on your check, and enclose a copy ofthis letter withyour payment. Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select "searchby form name." From the nextpage, select "P," then click on "Pesticide Registration Improvement Act. Fee Payment" and complete the form, making certain to use the decision number and registration numberonthe invoice you receive from the Pesticide Program inthe space provided. You may be eligible for a partial waiver ofthe registration service fee if, for example, you qualifY as a small business or are applying for a minor use, or ifyour application is solely associated with an IR-4 tolerance petition. Please be advised that ifyou intend to request a waiver, you must do so inwriting within 15 days ofreceipt ofthis invoice instead ofremitting the amount indicated above. OPP will not considerwaiver requests after the registration service fee has beenpaid. Information regarding eligibility and how th request and document a fee waiver is available onthe OPP Fee for Service web site at www.epa.gov/pesticides/fees. Please send Registration Service Fee Waiver requests to: By USPS: Document Processing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency 1200 Pennsylvania Ave NW Washington, DC 20460 By Courier: Document Processing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room S4900 Potomac Yard 1 2777 S. Crystal Dr. Arlington, VA 22202

### A PRIA decisiontime review period will not start until a fee waiver is granted and/or the Agency receives certificationthat the outstanding fee has beenpaid. Ifthe Agency does not receive certification ofpayment for this action or a fee waiverrequest within the next 30 days, the Agency will presume that you no longer want to pursue this action. The Agency will then reject your application and issue an invoice for any applicable outstanding fees. Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerely,

& 

### Resources Management Division 

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



### August 12, 2010
OPP DecisionNumber: D-438361 EPA File Symbol or Registration Number: 2517-RUE OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES


### ProductName: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### +METHOPRENE SQUEEZEON FOR DOGS EPA Receipt Date: II-Aug-2010 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CARE PRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703 SUBJECT: Receipt ofApplication and 50% Small Business Waiver Request Dear Registrant: The Office ofPesticide Programs has received your application, 50% small business waiverrequest, and cerification ofpayment. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has determined that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Action has been identified as Action Code: R310 NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLlC HEALTH PEST EFFICACY); Your request for waiver has been forwarded for review. You will be notified in writing when a determination is made regarding your request. Ifyour waiver request is approved, the decision review time period will start on the date ofapproval. Ifyour waiver request is denied, you will receive an invoice for the outstanding balance. Ifyouhave any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerely, 

## C2,**J~u?ru~** Front End Processing Staff Information Technology & 

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



### August 12, 2010
OPP DecisionNumber: D-438361 EPA File Symbol or Registration Number: 2517-RUE OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES


### ProductName: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### +METHOPRENE SQUEEZEON FOR DOGS EPA Receipt Date: II-Aug-2010 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CARE PRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703 SUBJECT: Receipt ofApplication and 50% Small Business Waiver Request Dear Registrant: The Office ofPesticide Programs has received your application, 50% small business waiverrequest, and cerification ofpayment. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has determined that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Action has been identified as Action Code: R310 NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLlC HEALTH PEST EFFICACY); Your request for waiver has been forwarded for review. You will be notified in writing when a determination is made regarding your request. Ifyour waiver request is approved, the decision review time period will start on the date ofapproval. Ifyour waiver request is denied, you will receive an invoice for the outstanding balance. Ifyouhave any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerely, 

## C2,**J~u?ru~** Front End Processing Staff Information Technology & 

### Resources Management Division**:\~o** S1"-'I''''''**~"""** 'c-;s., ,,;

# - "**f~-- ~**  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
o '<**~ ~** **~1-I'-i{ PR~t.O~**  

### August 16,2010
SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH l58TH PLAZA OMAHA, NE 68130-1703
Report ofAnalysis for Compliance with PRNotice 86-5 OFFICE OF PREVENTION. PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal ofll-AUG-lO. Our staffhas completed a preliminary analysis ofthe material. The results areprovided as follows: Your submittal was found to be in full compliance with the standards for submission of data contained in PRNotice 86-5. A copy ofyour bibliographyis enclosed, annotated with Master Record ID's (MRlDs) assigned to eachdocument submitted. Please use these numbers in all future references to these documents. Thankyou for your cooperation. Ifyou have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have beenreleased. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### August 16,2010
SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703
Report ofAnalysis for Compliance with PRNotice 86-5 OFFICE OF PREVENTION. PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal ofll-AUG-lO. Our staffhas completed a preliminary analysis ofthe material. The results areprovided as follows: Your submittal was found to be in full compliance with the standards for submission of data contained in PRNotice 86-5. A copy ofyour bibliographyis enclosed, annotated with Master Record ID's (MRIDs) assigned to eachdocument submitted. Please use these numbers in all future references to these documents. Thankyou for your cooperation. Ifyou have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have beenreleased.I 

# IFee for Servicel 

# (880182$-

This package includes the following for Division

(!J 

# New Registration
o 

# Amendment**~Studies? ~**  

# Fee Waiver? if 

# Dvolpay 

# 0/0 Reduction: 

# SO Risk Mgr. 

# [JQJ
Receipt No. 

# s-I 880182 EPA File Symbol/Reg. No. 1 

# 2517-RUE Pin-Punch Date: 1 

# 8/11/2010 

# D This item is NOT subject to FFS action. Action--eo""d-he

....



# :----,II Parent/Child Decisions: I 

## Requested: 

# I R310 Granted: 

# I R3\0 

## Amount Due: 

# $ If;578


## Inert Cleared for Intended Use Uncleared Inert in Product Reviewer:__

## ,,-01+-·-=-(M_~_· _____ _ 

## Date:

## 't/J~JID Remarks:Regulatory Type: 'iProduct**Registratio~** - 'Section

### 3 Application Type:

### jNew Registration company:pS17**~** Fee For Service: 

### r. 

## jie'sl r NO';] 

# 3 Billable: C." Yes **C** No

Risk Manager:**JRegistr~.tion** DivJsion',, Risk**Manag~ment** Team

### 10 

# 3 Producl #: 2517:RUE .!Producl Nome:**~ERGEANT'S** FIPRONIL + CYPHENOTHRIN +**~ ~.** **-'---'-'-~** : ' ", ,:

Me Too ""SecliOn3: Me Too Product Name:

fEWEND·USE PRODUCT REGISTRATION APPliCATION

# FEE FOR 

# SERVICEPay.goy

- Online Payment

Online Payment Step 3: Confirm Payment Thank you. Yourtransaction has been successfully completed. Pay.goy Tracking Information Application Name: PRIA Service Fees Pay.goy Tracking 10: 2510lM08 Agency Tracking 10: 74122352649 Transaction Date and Time: 06/18/201014:38 EDT Payment Summary Account HolderSergeant's Pet Care Products, Name: Inc Payment Date: 06/21/2010 Decision Number: PaymentAmount: $2,289.00 Registration Number: 2517-new Page I of!

1 

### 1213

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

https:llwww.pay.goy/paygoy/payments/authorizeACHPayment.html 6/1812010 Pay.goy

- Online Payment

Online Payment Step 3: Confirm Payment Thank you. Yourtransaction has been successfully completed. Pay.goy Tracking Information Application Name: PRIA Service Fees Pay.goy Tracking 10: 2510lM08 Agency Tracking 10: 74122352649 Transaction Date and Time: 06/18/201014:38 EDT Payment Summary Account HolderSergeant's Pet Care Products, Name: Inc Payment Date: 06/21/2010 Decision Number: PaymentAmount: $2,289.00 Registration Number: 2517-new Page I of!

1 

### 1213

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

httPs://www.pay.goy/paygoy/payments/authorizeACHPayment.html 6/18/2010Print Letter 

### I 

# I Enter More Information 

## I Tracking;...Ind,: S:Utl E"1Y,;o**t1t~. t.1'clr:tlo.~** **':"Olr,:~** QU!:4 01 P,lIJ(ICll**~;~~'l'nl** Ir,fOI(:,.lllor F.fIOUJ: .. 1 ,AC**~':"""~fl :::"~'ll'O"!**  Ir,(Cdrn.lllon**:";~Ii:t\** e.,jr,-=:-, 

# SEPA

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# No(s:),: ,



# Plv1: _I_o ____ -c:-- ____ --'--_

# C}IE~ATCAl 

# No.: ____**~_~** 

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# this action can be 

# requested through the J.ACKETS 

# S)'stem,UN. J STATES ENVIRONMENTAL PROTEClluNAGENCY WASHINGTON, D.C. 20460


### September 7,20I0
OPP DecisionNumber: D-438361 EPA File Symbol orRegistrationNumber: 2517-RUE OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES


### ProductName: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FORDOGS EPA Application Receipt Date: II-Aug-20I0 EPA Waiver Request Receipt Date: II-Aug-2010 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CAREPRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703 SUBJECT: Approval of50% SmaIl Business Waiver Request Dear Registrant: The Office ofPesticide Programs has approved your request for 50% waiver ofthe pesticide registration fee associated with the action referenced above. The decision review period for this action will begin on the date ofthis letter. The Actionhas been identified as Action Code: R320 NEWPRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTNE CITATIONS); Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman, at (703) 308-9362. Sincerely, 

# JVl**!~lJ~ I~~\**  J .-;;n- 

### \) Oscar Morales, Director InformationTechnology & 

### Resources Management Division Office ofPesticidePrograms UN. J STATES ENVIRONMENTAL PROTEClluNAGENCY WASHINGTON, D.C. 20460


### September 7,20I 0
OPP DecisionNumber: D-438361 EPA File Symbol orRegistrationNumber: 2517-RUE OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES


### ProductName: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FORDOGS EPA Application Receipt Date: II-Aug-20I 0 EPA Waiver Request Receipt Date: II-Aug-2010 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PET CAREPRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703 SUBJECT: Approval of50% SmaIl Business Waiver Request Dear Registrant: The Office ofPesticide Programs has approved your request for 50% waiver ofthe pesticide registration fee associated with the action referenced above. The decision review period for this action will begin on the date ofthis letter. The Actionhas been identified as Action Code: R320 NEWPRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTNE CITATIONS); Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman, at (703) 308-9362. Sincerely, 

# JVl**!~lJ~ I~~\**  J .-;;n- 

### \) Oscar Morales, Director InformationTechnology & 

### Resources Management Division Office ofPesticideProgramsSergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com


### August 11,2010 Richard Gebken, PMlO Office ofPesticide Programs (7504P) 

# u.s. Environmental Protection Agency Document ProcessingDesk Room S-4900, One PotomacYard 2777 South Crystal Drive Arlington, VA22202 Subject: Child Resistant Packaging Certification Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs EPA File Symbol 2517

## -NEW(Zv.(C; Dear Mr. Gebken: I certify that thepackagingused for the following product meets the standards of40 CFR 157.32, includingthe revised standards in 16 CFR 1700.15(b), whentestedbytherevised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995):

• Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs (EPA File Symbol 2517-NEW) Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th 

### Plaza, Omaha, NE 68130-1770, EPA CompanyNumber 2517) is submittingthis child resistant packaging certificationto support for the new end-use product for Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs (EPA File Symbol 2517-NEW). All productlabels have language specifYing the use of scissors to opentheproduct container and label language stating the product is not to be applied bychildren. Ifyouhave anyquestions, please contactme at 402-938-7079. Sincerely,

# ~ 

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

# / t-Iti Kelly

## R~oskins ManagerofTechnical Affairs

cc: LarryNouvelSergeant's PetCare Products, Inc. 2625 South 1581h Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com August 11,2010
Rosalind Gross clo Richard Gebken Registration Division Office ofPesticide Programs (7504P) 

# u.s. Environmental ProtectionAgency DocumentProcessingDesk Room S-4900, One PotomacYard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child Resistant Packaging Support Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs (EPA File Symbol: 2517-NfoW) 

### (ZIJ}"" Dear Ms. Gross: Sergeant's Pet Care Products, Inc. (EPA CompanyNumber2517) is submitting a request to rely onpreviously submitted Child Resistant Packaging (CRP) studies to support this new registration. The CRP data were submitted to EPA on April 12, 20lOin support ofthe pending registration applications under EPAFile Symbols: 25I7-RGT, 2517-RGA, 25I7-RGL, and 25 1 7-RGU (all ofwhich contain Fipronil at 9.7-9.8%). Sergeant's generated CRP dataon a standard white applicatorin sizes 0.5, 0.67, 1.34,2.68, and 4.02 mL. The following is a summarytable ofthe applicators that were tested and submitted to EPAinthe CRP data: Use ApplicatorBase Color Fill Weight (mL) Color Dog Up to 22 lbs White 0.67 Orange Dog 23-44 lbs White 1.34 Green Dog 45-88 lbs White 2.68 Red Dog 89-132Ibs White 4.02 Blue Cats All Weights White 0.50 Purple CRP datais required for this newproductbecause ofthe inclusion ofthe active ingredient fipronil (9.8%) inthepet squeeze-onproduct. The CRP testing was conducted on a standard package size and colorconfiguration for a product containing fipronil (9.8%). The Sergeant's Fipronil 

### +Cyphenothrin 

### +Methoprene Squeeze-On for Dogsproductbeing submitted today also contains fipronil at 9.8%. Additionally, Sergeant's alreadyhas dog squeeze-onproducts approved byEPA containing 20-30% cyphenothrin (EPARegistration Numbers 2517-127 through 2517-132) that are not subject to CRP. This newproduct contains 5% cyphenothrin and
ISergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com 8.8 

### % methoprene. Additionally, there are EPAregistered products containing s-methoprene, none ofwhich are subjectto CRP. Furthermore, Sergeant's does not anticipate any additional toxicitythrough the combination of fipronil, cyphenothrin andmethoprene. When Sergeant'sFipronil 

### + Cyphenothrin 

### + Methoprene Squeeze-On for Dogsis marketed, it will have the same applicator color (white) and fill weight colors permL fill weight as was used inthe submitted andreferenced CRP testing. Based on available information, the densityrange ofthe pendingproducts onwhich the CRP data were generated is the same as the newproduct (1.0-1.5 gr/cc). Therefore, Sergeant'sis relying on MRID's: 48059803, 48059804, 48059805, and 48059806 to fulfill the CRP datarequirements for Sergeant's Fipronil 

### + Cyphenothrin 

### + Methoprene Squeeze-On for Dogs. Ifyou have any questions,please contactme at 402-938-7079. Sincerely,

# ~ 

# B· t\obluy !7::f.--1 Kelly R. Hoskins ManagerofTechnical Affairs

cc: LarryNouvel

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

### August 11,2010 Richard Gebken, PMlO Office ofpesticidePrograms (7504P) (REGFEE) U.S. Environmental ProtectionAgency Document ProcessingDesk Room S-4900, One PotomacYard 2777 South Crystal Drive Arlington, VA 22202 Subject: Sergeant's Fipronil 

### + Cyphenothrin 

### + Methoprene Squeeze-On for Dogs EPA File**Symb(j125l7-:r~EWn,-<G** 

### DearMr. Gebken: Sergeant'sPet Care Products, Inc. (Sergeant's, 2625 South l58th 

### Plaza, Omaha, NE 68130-1770, EPA CompanyNumber2517) is submitting an EPAregistration application for thenewproduct Sergeant's Fipronil 

### + Cyphenothrin

### +Methoprene Squeeze-On for Dogs [containing the EPA registered active ingredients Fipronji (9.8%), Cyphenothrin (5.0%), and s-Methoprene (8.8%)]. Please find enclosed the following documentation in support ofthis registration: (1) Transmittal Document; (2) Application for Registration (EPAForm 8570-1); (3) Confidential Statement ofFormula (EPAForm 8570-4) (two copies); (4) Certification with Respectto Citation ofData (EPAForm 8570-34); (5) Formulator'sExemption Statement (EPAForm 8570-27); (6) DataMatrix (EPA Form 8570-35)

- EPA and Public Versions; (7) Product Label (five copies); (8) LetterofAuthorization; 

### '"(9) Child Resistant Package (CRP) Certification Statement;

(10) BridgingArgumentto Cite CRP Data; (11) Submission ofEPA Pesticide Registration ImprovementAct InformatioJl; (12) Voluntary Small Business CertificationForm; (13) PRlAFeeWaiver Certification Statement; (14) PRlAFeeWaiver Support Letter; (15) Recent EPAApproval of50% Small Business WaiverRequest (D-425455); (16) PRlACategoryR3l0, Payment Confirmation Receipt; and (17) Three Copies ofSupporting Studies. Theregistration ofSergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-Onfor Dogs is a selective citation registration for a new end-use product. Sergeant'sis submittingnewproduct chemistry studies in support ofthis end-useproductregistration, and onenew efficacy study. Additionally, Sergeant's is citing acute toxicity studies, companion animal safety data and efficacy studies submitted to EPA on June 18,2010 with the registration application forSergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### Sergeant's Fipronil 

### + Cyphenothrin Squeeze-On for Dogs. The acute toxicity studies were conducted on a "soup"that contains multiple active ingredients that canbebridged across multiple formulated end-useproducts. This registration applicationis considered a PRIA Category R310 (new end-useproduct) with a PRIAreviewtime of6 months. Sergeant's submitted a PRIA Small Business Waiver Request under separate cover on April 14, 2010, and itwas approved byEPA on May4, 2010. A copy of this approval letteris enclosed. We lookforward to working with the Agencyto register Sergeant's Fipronil 

### + Cyphenothrin 

### + Methoprene Squeeze-Onfor Dogs. Ifyouhave any questions orneed additional information regarding this registration application, please contactme at 402-938-7079. Sincerely,
KellyR. Hoskins Manager ofTechnical Affairs EnclosuresPlease read instructions on reverse bero ',mplelinf(form. Form Appro" ,. OMB No 20700060 Approval expires 05-31 98

- - United States**~_Registration** OPP Identifier Number 

# EPA Environmental Protection Agency D_Amendment Washington, DC 20460 D Other Application for Pesticide
- Section I 1. CompanylProduct**NUR~r** ..- 2. EPA Product Manager 3. Proposed Classification 2517-NEW 

### I 

### u. t::: Richard Gebken 4. Company/Product (Name) 5.PM# 10

### ~None DRestricted Sergeant's Pet Care Products, Inc.! Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On For Dogs 5. Name and Address ofApplicant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(I), my Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling to: 2625 South 158th Plaza Omaha, NE 68130-1770 EPA Reg. No. Product Name 

# o Check ifthis is a new address 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 Notitication

### ~ Explain below.

### ~ Other
- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section II.) Submission of a new end-use product registration application. Section III 1. Material This Product Will Be Packaqed In:**Child~Resistant** Packaging Unit Packaging Water Soluble Packaging 2. Type of Container**~Yes' ~Yes**  DYes 

# o Metal DNo 

# o No**~** No r:g] Plastic If"Yes" No. per If"Yes" No. per DGlass 'Certification must Unit Packaging wgt. Container Package wgt. Container DPaper be submitted 0.023 fl oz (0.67 ml) 0.045 fl oz (1.34 ml) 

## I 3 vials 

## I DOther (Specify) pla,tic Bag 0.091 fl oz (2.68 ml) 0.136 fl oz (4.02 ml) • 3. Location of Net Contents Information 4. Size(s) Retail Container 5. Location of Label Direct!'Jns r:g]Label 

# o Container 0.067 ml, 1.34 ml, 2.68 ml, 4.02 ml DOn**c~;.·** [8]On Label:.l,'} accomr!'nyin:J product 6. Manner in Which Label is Affixed to Product Duthograph**~Other** DPaper glued DStenciled

. Section IV . . 

# . 1. Contact Point (Complete items directly below foridentification ofindividual to be contacted, ifnecessary, to process this**appJicati~n'.)** Name Title Telephone No. (Include Area Code) Kelly R. Hoskins Manager ofTechnical Affairs 402-938-7079 Certification 6. Date Application I certify that the statements I have made on this form and all attachments thereto are true. accurate and complete. I Received acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both (Stamped) under applicable law. 2.**Signatur~**

# ~lM"'5/MT 3. Title BY: .,**c~**

## ~ Manager ofTechnical Affairs 4. Typed Name: 5. Date: 08/11/2010 Kelly R. Hoskins

### TRANSMITTAL DOCUMENT NAMEAND ADDRESS OF SUBMITTER: Sergeant'sPet Care Products, Inc. 2625 South 158th Plaza Omaha,NE 68130-1770 

### CONTACT PERSON (Return to) KellyR. Hoskins Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza Omaha, NE 68130-1770 

### REGULATORY ACTION SUPPORTED BY THIS PACKAGE: This submission is prepared to support an EPAregistration application for the new end-use product Sergeant's Fipronil 

### +Cyphenothrin 

### +Methoprene Squeeze-On for Dogs. 

### SUBMITTAL DATE: August 11,2010

Volume StudyTitle MRIDNo. 1 Administrative Materials 2 Group A Product Chemistry for Sergeant's Fipronil 

### + Cyphenothrin 

### + Methoprene Squeeze-Onfor Dogs 3 GroupB Product Chemistryfor Sergeant'sFipronil 

### + Cyphenothrin

### + Methoprene Squeeze--On for Dogs 

### 4 Dose Titration with S-Methoprene Squeeze-Ons onDogs Measuring FleaEgg Sterilization.**~**Form approved. OMS No. 2070-0060, 2070-0057, L'J/0-0107, 2070-0t22, 2070-0t64. 

# &EPA United States Environmental Protection Agency Washington, DC 20460 Formulator's Exemption Statement (40 CFR 152.85)
Applicant's Name and Address EPA**FiI~/Registration** Number Sergeant's Pet Care Products, Inc. 2517- 

### R\ft..& 2625 South 158th Plaza Product Name Omaha, NE 68130-1770 Sergeant's Fipronil +Cyphenothrin + Methoprene Squeeze-On for 0 Date ofConfidential Statement of Formula (EPA Form 8570-4) 0811112010 As an authorized representative of the applicant for registration of the product identified above, I certify that: (1) This product contains the following active ingredient(s): Fipronil S-methoprene Cyphenothrin (2) Ofthese, each active ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat active ingredient in the manufacturing, formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another person and meets the requirements of40 CFR section t58.50{e){2) or (3). (3) Indicate by checking (A) or (8) below which paragraph applies: 71 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and product name, the source of the active ingredient{s) listed in paragraph ttl. OR I (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) referenced above and 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 qualify for the formulator's exemption.
Source Active Ingredient Product Name Registration Number Fipronil
S-methoprene S-methoprene Cyphenothrin

# ~~.**'tlP~~s.J**

# W+

# r Name and Title Date Kelly R. Hoskins, Manager of G 0811112010 EPA**For~570'27** (Rev. 06·2004)' Copy 1 EPA ·A Copy 2 ppllcant copyForm Approved OMS Nos. 2070-0060; 2070-0057; 2070-0107; 2070-0122; 2070-0164

",,"'''',<, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### (

## "" 

# , S:Z' 1200 Pennsylvania Avenue, N.W

. ...,,,,,,,,,,# WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The P-Jblic reporting burden for this collection ofinformation isestimated to avernge 1.25 hours per response for registration and 0.25 hours per response forreregistration and special reviewactivities, including time forreading the instructions and completing the necessary forms. Send comments regarding burden estimate or any other aspectofthis collection ofinformation, including suggestions for reducing the blU'den to: Director, Collection Strategies Division (2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the completed form to this address, Certification with Respect to Citation ofData Applicanfs/ReQistranfs Name, Address, and Telephone Number EPA ReQistration Number/File Symbol Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha, NE 68130-t770 2517-NEW Adive InQredient(s) and/or representative test compound(s) Date Fipronil , Cyphenothrin , and S-methoprene 08/111/2010 General Use Patem(s) (list aU those claimed for this product usinQ 40 CFR Part 158) Product Name Domestic indoor non-food Sergeant's Fipronil + Cyphenothrin + Methoprenefi NOTE: Ifyour produd is a 100% repackaging ofanother purchased EPA-registered produd labeled for aD the same uses on your label, you do not need to submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27). 

# D I am responding 10 a Data-Call-In Notice, and have induded with this form a list ofcompanies sent offers of compensation (the Data Matrix form should be used for this purpose).
SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

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

## [2] I am using the seledive method ofsupport (or cite-all option a list ofcompanies sent offers ofcompensation (the Data Matrix form under the seledive method), and have induded with this form a should be used for this purpose). completed list ofdata requirements (the Data Matrix form must be used). SECTION II: GENERAL OFFERTO PAY [Required if using the cite-all method orwhen using the cite-all option under the seledive method to satisfy one or more data requirements) 

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

SECTION Ill: 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, orthe Data-Call-In response. In addition, ifthe cite-all option or cite-all option underthe selective method is indicated in Sedion I, this application is supported by all data in the Agency's files that (1) concem the properties or effects ofthis product or an identical or substantially similar produd, or one or more ofthe ingredients in this produd; and (2) is a lype ofdata that would be required 10 be submitted under the data requirements in effed on the date of approval ofthis application ifthe application sought the initial registration ofa product of identical or similar composition and uses. I certify that for ead! exdusive use study cited in support ofthis registration or reregistration, that I am the original data submitter orthat Ihave obtained the written permission ofthe original data submitterto cite that study. I certify that for each study cited in support ofthis registration or reregistration that is not an exdusive use study, either: (a) I am the original data submitter; (b) I have obtained the permission ofthe original data submitter to use the study in support ofthis application; (c) all periods ofeligibility for compensation have expired for the study; (d) the study is in the public literature; or(e) I have notified in writing the company that submitted the study and have offered (I) to pay compensation to the extent required by sedions 3(c)(1)(F) and/or 3(c)(2)(8) of FIFRA; and Qi) to commence negotiations to determine the amount and terms ofcompensation, if any, to be paid for the use ofthe study. I certify that in all instances where an offer ofcompensation is required, copies ofall offers to pay compensation and evidence oftheirdelivery in accordance with sedions 3(c)(1)(F) andlor 3(c)(2)(8) of FIFRA are available and will be submitted to the .t\gency upon request. Shoud Ifail to produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with FIFRA. I certify thatthe statemenls I haw made onthis form and all attachments to it are true, accurae, and complete. I acknovJedge that any knowingly false or misleadirg statement may be punishable I¥ fine or imprisonment or both under applicable law. Signature

# ~~ 'L- fu,'i,

# lAA 1\:& 

# }2dt-T Date Typed or Printed Name and TItle 08/11/2010 Kelly R Hoskins, Manager ofTechnical Affairs EPA Fonn 8570-34**(12~2003)** EledronlC and Paper versIOns available. Submit only Paper version.

### R310
Must submit Group A and Bproduct chemistry data for each proposed product. End Use (EP) or Manufacturing Use (MP) product or Technical Grade of the Active Ingredient (TGAI)

EP Data MP Data Guideline Group A: Product Chemistry Data Submitted Submitted TGAI No. Study Title Yes No Yes No Yes No 830.1550 Product Identity & Composition 

### / Description of materials used to 

### / 830.1600 produce the product 830.1650 Description of formulation process 

## V 830.1670 Discussion on the formation of impurities 

## / 830.1700 Preliminary.analysis**~** ,/ 830.1750 Certified limits (158.345) 

### V 830.1800 Enforcement analytical method ( lis L:c! Cl (' ; ::., 

### j/ J EP Data MP Data Guideline No. Group B: Product Chemistry Data Study**~~!1)!~~J-j!~!1)!~~~~~-~** Title

II

Grayed out = data not required

1

## R310

New products must either: 1) supply the product specific acute toxicity 6 pack data (listed below), or 2) provide a bridging rationale document. The bridging document directs OPP to use a currently registered set of 6 acute toxicity data and label; instead of submitting product specific data.
Data Guideline Acute toxicity (6 pack) submitted Cited No. Study Title Yes No Yes No 870.1100 Acute Oral (LD50) ,/ 870.1200 Acute Dermal (LD50) 

### ,/ 870.1300 Acute Inhalation (LC50) ./ 870.2400 Acute Eye Irritation 

## / 870.2500 Acute Derrnallrritation ./ 870.2600 Dermal Sensitization 

## /

Efficacy
- which guideline is used depends on the proposed label use Data Guideline submitted Cited No, Study Title Yes No Yes No Comments 810.3100 Soil Treatments for Imported Fire Ants Livestock, Poultry, Fur and Wool-Bearing 810.3200 Animal Treatments Treatments to Control Pests of Humans and 

### ,/ 810.3300 Pets Mosquito, Black Fly, and Biting Midge 810.3400 (Sand Fly) Treatments 810.3500 Premises Treatments 810.3600 Structural Treatments Methods for Efficacy Testing ofTermite 810.3800 Baits

2Form Appro\'ed OMB 1\'0.2070·0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0,25 hours per response for reregistration and special review activities, including time for reading the instruction and completingthe necessary forms. Send commel1s regarding the burden estimate or any other aspectofthis collection ofinformation, including suggestions for redu::ing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protectioo Agency, 401 MStreet, S.W., Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Date: August II, 2010 EPA Reg No.lFile Symbol 25 I7-l:JF;W 

### J2v.

## e Page I of4 Applicant's/Registrant's Name & Address Product: Sergeant's Fipronil + Cyphenothrin + Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Methoprene Squeeze-On for Dogs Ingredients: Fipronil, Cyphenothrin and (s)-Methoprene Guideline Reference Number Guideline Study Name MRIDNumber Submitter I Status Note 830.1550,830.1600,830.1620, Group A Product Chemistr), for Sergeant's Fipronil + Cyphenothrin + New submission Sergeant's Pet Care Products, Inc. OWN 830.1650,830.1670, 830.1750 Methoprene Squeeze-On for Dogs 830.1800 Enforcement analytical method 48122601 Sergeant's Pet Care Products, Inc. OWN 830.6302,830.6303, 830.6304, Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + New submission Sergeant's Pet Care Products, Inc. OWN 830.6313, 830.6314, 830.6315, Methoprene Squeeze-On for Dogs 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 Submitted Sergeant's Pet Care Products, Inc. OWN Upon Completion 870.1100 Acute Oral Toxicity Up and Down Procedure with Dog Products 48129603 Sergeant's Pet Care Products, Inc. OWN 870.1200 Acute Dermal Toxicity (Limit Test) with Dog Products 48129604 Sergeant's Pet Care Products, Inc. OWN 870.1300 WaiverRequest ofRequirement for Further Testing for Acute 48129605 Sergeant's Pet Care Products, Inc. OWN Inhalation Toxicity 870.2400 Acute Eye Irritation/Corrosion with DogProducts 48129606 Sergeant's Pet Care Products, Inc. OWN 870.2500 Acute Dermal Irritation/Corrosion with Dog Products 48129607 Sergeant's Pet Care Products, Inc. OWN 870.2600 Test for Sensitization (GuineaPig Maximisation Test) with Dog 48129608 Sergeant's Pet Care Products, Inc. OWN Products 870.7200 Companion Animal Safety for Sergeant's Fipronil + Cyphenothrin 48129614 Sergeant's Pet Care Products, Inc. OWN Squeeze-On for Dogs 870.7200 Companion Animal Safety Study in Dogs

- Cyphenothrin-IGR Spot- 46166108 Sergeant's Pet Care Products, Inc. OWN On for Dogs, 870,7200 Companion Animal Safety Evaluation on Drop ofSpot-On Products 47849609 Sergeant's Pet Care Products, Inc. OWN Containing Multiple Toxicants and Insect Growth Regulators. 870.7200 Assessment ofTolerance ofaO.25% RM 1601 Spray Formulation in 43121110 Merial Limited OLD Dogs at 3,9, and 15 mllkg When Applied 6 times to the Haircoat at 28 Dl].)' Intervals Signature:

# ~ tlo:)i.u'-'{ 

# /2-i}r Name and Title Date 

# (12- Kelly R. Hoskins, Manager ofTechnical Affairs 08111/2010

JOP.!. "" EPA Fo**~~7n...1**5 (9.97) Elee . _ ..**~n** .. " .' ..•..."
.....**~** ..L .'. _ ... " 

### " Iy**P~P'** •____.. '_0

____•,,__ r"__•• gency pyForm Approvcd OMB No. 2070-0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

# " 401 M Street, S.W. 

# " WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and speciaJ review activiies, including time for reading the in2eregistrationcompleting the necessary forms. Send comments regarding the burden estimate or any other**~ect**ofthis collection ofinformation, including suggestions for redu::ing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protectioo Agency, 401 MStreet, S.W., Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Date: August II, 2010 EPA Reg No.!File Symbo12517-NEW Page 2 of4 Applicant'sfRegistrant'sName & Address Product: Sergeant's Fipronil + Cyphenothrin + Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Methoprene Squeeze-On for Dogs Ingredients: Fipronil, Cyphenothrin and (s)-Methoprene Guideline Reference Number Guideline Study Name MRlDNumber Submitter Status Note 870.7200 Domestic Anima! Safety: Assessment ofthe Tolerance ofa 0.25% RM 43121111 Merial Limited OLD 160I Spray in NursingPuppies Administered Twice at a 28 Day Interval at a Dose Rate of6 mllkg: 870.7200 Domestic Animal Safety Study ofRM1601C Topical Spray (Frontline 43444905 Merial Limited OLD Spray Treatment) in Juvenile Dogs: 870.7200 Discussion in Support ofBridging Domestic Animal Safety Data on 43577711 Merial Limited OLD Frontline Spray Treatment to Frontline Spot Treatment Data Package. 870.7200 Domestic Animal Safety Study by Topical Administration to Dogs: 43863802 Merial Limited OLD Fipronil Spot Treatment (RM 1601E) 810.3300 Dose Titration with (S)-Methoprene Squeeze-Ons on Dogs Measuring New submission Sergeant's Pet Care Products, Inc. OWN Flea Egg Sterilization. " SI'B,\2.0;' 810.3300 Overview and Summary ofFipronillCyphenothrin Dog Efficacy for 48129609 Sergeant's Pet Care Products, Inc. OWN Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs 810.3300 Immediate Efficacy ofa Combined Application ofFrontline Plus with 48129610 Sergeant's Pet Care Products, Inc. OWN Cyphenothrin as a Squeeze-on againstFleas (Ctenocephalides felis) and Ticks (Rhipicephalus sanf!.Uineus) on Dogs MS 164 D 810.3300 Immediate Efficacy FollowingApplication ofFrontline Plus with 48129611 Sergeant's Pet Care Products, Inc. OWN Cyphenothrin Squeeze-on against Fleas (Ctenocephalides felis) and Ticks (Rhipicephalus sanf!.Uineus) on Dogs MS 183 D 810.3300 Immediate Efficacy FollowingApplication ofFrontline with 48129612 Sergeant's Pet Care Products, Inc. OWN Cyphenothrin Squeeze-on against Fleas (Ctenocephalidesfelis) and Ticks (Rhipicephalus sanguineus) on Dogs MS 175 D 810.3300 Comparative efficacy evaluation ofSergeant's Squeeze-on and Frontline 48129613 Sergeant's Pet Care Products, Inc. OWN Plus for thetreatment ofadult cat flea (Ctenocephalidesfelis) and tick (Haemaphysalis elliptica, Rhipicephalussanguineus and Dermacentor variabilis) infestations on dogs 810.3300 A Dose Titration Study to Detenninethe Optimal Spray Concentration of 43121114 Merial Limited OLD RM 1601 for Long Tenn Control ofthe CatFlea Ctenocephalides felis and tile Brown Dog Tick Rhipicephalus sanguineus in the Dog Signature:

# ~**\\oS~~5** 

# I:'2;-11- 

## T Name and Title Date 

# 12- Kelly R. Hoskins, Manager ofTechnical Affairs 0811 1/2010

EPA Fonn 8570.35 (9-97) Electronic and Paper Versions Available <:"h.,.", nnl- ,,- y Papel -

### ._._--_. ,,-- ....- gCIICY pyForm Approved OMB No. 2070-0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

## " 401 M Street, S.W. 

# '" WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activiies, including time for reading the in3eregistrationcompleting the necessary forms. Send comments regarding the burden estimate or any other**a~ect** ofthis collection ofinfonnation, including suggestions for redl£ing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 MStreet, S.W., Washington, DC 20460. Do not send the form to this address. 

### DATAMATRlX Date: August II, 20 IO EPA RegNo./File Symbol 25I7-NEW Page 3 of4 Applicant'siRegistrant'sName & Address Product: Sergeant's FipronU + Cyphenothrin + Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Methoprene Squeeze-On for Dogs Ingredients: Fipronil, Cyphenothrin and (s)-Methoprene Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note 810.3300 ProductPerformance: A Dose Confirmation Study to Verify the 43121115 Merial Limited OLD Optimal Spray Concentration ofRM 1601 for Long Residual Control ofthe Cat Flea (Ctenocephalides felis) and the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog 810.3300 A Comparative Evaluation ofTwo Treatment Regimes Using RM 1601 43121116 Merial Limited OLD Spray for Control ofthe Cat FleaCtenocephalides felis on the Dog: 810.3300 Laboratory Evaluation ofRM 160ISpray for Control Dermacentor 43121117 Merial Limited OLD variabilis and Rhipecephalus sanguineus on the Dog 810.3300 An Investigation Study to Evaluate the Effect ofBathing of 43121118 Merial Limited OLD Laboratory Dogs on the Efficacy ofRMI601 Spray 810.3300 Efficacy ofRMI60lC at 3 ml/kg and 6 mllkg Against Ixodes 43121122 Merial Limited OLD scapularis/dammini Nymphs, Dermacentor variabilis Nymphs, Amblyomma americanum Nymphs, Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair as the Testing Substrate 810.3300 Positive Referenced and Untreated Controlled, Confirmatory 43577712 Medal Limited OLD Laboratory Trial ofRMI60lE SPOT-ON Formulation Applied to Dogs as 3 WeightClass Defined Volumes for the Control ofthe Cat Flea Ctenocephalides felis, the Brown Dog Tick Rhipicephalus sanguineus, and the American DogTick Dermacentor variabilis 810.3300 Study Summaries: Frontline Plus For Dogs. 45612701 Medal Limited PAY 810.3300 An Efficacy Study ofFrontline Spray, Frontline Top Spot, and ML- 45620501 Merial Limited PAY 2,095,988 509T, for the Treatment and Control ofTrichodectes canis in the Dog 810.3300 PR & D 0024101: Frontline Spray/ Frontline Spot-OnIML-2, 095, 988 45620504 Medal Limited PAY 509TIDogs /Solutionrropical 810.3300 PR& D 0052301 :Frontline Spray/Frontline Spot-OnIML-2, 095, 988 45620505 Medal Limited PAY 509T/Dogs/ Solution!Topical 810.3300 Frontline Spray & Top Spot!Dogs/Solutionffopical CliniallDose 45620506 Medal Limited PAY Confirmationl Ectoparasites, Mites, Sarcoptes Scabiei var canis Signature:**\L-~**

### y~. 

# I?--A-r Name and Title Date 

## t\.oe;!.L\V-S Kelly R. Hoskins, Manager ofTechnical Affairs 0811 I120IO

EPA Form 8S7()")S (9-97) Electronic and PJpcr Vcrsions AVJilable. Submit only Paper version Agency**rnurn~1** Usc CopyForm Approved OMB No. 2070·0060 

### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY 

## " 401 M Street, S.W. 

# " WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinfonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activiies, including time for reading the in4eregistrationcompleting the necessary forms. Send comments regarding the burden estimate or any other aspectofthis collection ofinfonnation, including suggestions for redu::ing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protectioo Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the fonn to this address. 

### DATA MATRIX Date: August 11,2010 EPA Reg No.lFile Symbol 2517-NEW Page 4 of4 Applicant'slRegistrant's Name & Address Product: Sergeant's Fipronil + Cyphenothrin + Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Methoprene Squeeze-On for Dogs Ingredients: Fipronil, Cyphenolhrin and (s)-Methoprene Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note 810.3300 Study to Confirm the Efficacy ofFipronii Against Lice in Dogs Under 45628201 Merial Limited PAY Field Conditions 810.3300 A Study to Evaluate the Efficacy ofFrontline Plus for Control of 45866902 Merial Limited PAY Mosquitoes, Aedes aegypti, on Dogs 810.3300 Effect ofShampoo Application after Treatment with a Cyphenothrin 46298501 Sergeant's Pet Care Products, Inc. OWN Squeeze-On on Efficacy Against Cat Fleas (Ctenocephalides felis), Adult Brown Dog Ticks (Rhipicephalus sanguineus) on Dogs 40 CFR Part 157.32 Evaluation ofthe Dog Squeeze On 0.67 ml White Applicator with 48059803 Sergeant's Pet Care Products, Inc. OWN Orange Label Indicator (3x), scissors to open - F=I as a Poison Prevention Package for Sergeant's Pet Care Products, Inc. 40 CPR Part 157.32 Evaluation ofthe Dog Squeeze On 1.34 ml White Applicator with 48059804 Sergeant's Pet Care Products, Inc. OWN Green Label Indicator (3x), scissors to open - F=l as a Poison Prevention Package for Sergeant's Pet Care Products, Inc. 40 CFRParl 157.32 Evaluation ofthe Dog Squeeze On 2.68 ml White Applicator with Red 48059805 Sergeant's Pet Care Products, Inc. OWN Label Indicator (3x), scissors to open - F=l as a Poison Prevention Package for Sergeant's Pet Care Products, Inc. 40 CFR Part 157.32 Evaluation ofthe Dog Squeeze On 4.02 ml White Applicator with Blue 48059806 Sergeant's Pet Care Products, Inc. OWN Label Indicator (3x), scissors to open - F=l as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.

Signature:

# ~ t\-ostuy (

# ~t:t+1 Name and Title Date

# ~ Kelly R. Hoskins, Manager ofTechnical Affairs 0811 112010

EPA Form 857{)..35 (9-97) Electronic and Paper Versions Available. Submit only I'aper versio**"a~n~**.. r
..**,~~**..**~l** l1u C"nn
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# ",ergeant's® Master**LaL.~1** II August 2010 Version 10.1 EPA Reg. No. 2517-XX Information in [ ] is optional. Page 1of8 [CARTON LABEL

- DRAFT MASTER LABEL COPY] 

## Sergeant's Fipronil 

# + Cyphenothrin 

# +Methoprene Squeeze-On for Dogs [ABNs] [(Sergeant's®) (Sentry®) VetSpofl'M (Spot On) for dogs] [(Sergeant's®) (Sentry®) VetSpotTM (Spot On) for dogs]**[(Sergeant's~ (Sentry~**  

### FRONTIER GOLD (Spot On) for dogs] [(Sergeant's®) (Sentry®) EctoadvanceTM 

### (Spot On) for dogs]

. . ...../

... i' .•,

### ....·hqG.~riu~~iE'·PN

## FIPR()NILt.CYPREN()tHB.fN';'·MEIDiJq.~B.EN~ [Apply to puppies over 12 weeks old] [Apply to puppies 12 weeks or older] [. Plea & Tick Control for Dogs & Puppies 12 weeks old and older] [·Por Dogs and Puppies 12 weeks ofage or older] [·Por Dogs [up to 22Ibs], [23-44Ibs], [45-88Ibs], [89-132Ibs] [·Kills fleas (in as little as I hour), flea eggs, ticks (in as little as 1hour), ckewing I';ct-'& mosquitoes] [·Kills (and Repels) Pleas, Ticks and Mosquitoes] [·Controls flea reinfestation for up to [16 weeks

## II [·Past Acting] [·Kills ticks (in as little as 1hour)] [.Kills ticks including those that may transmit Lyme disease] [·Dogs can be bathed 24 hours after treatment] [.Waterproof] [•Long Lasting] [·Research demonstrates that [brand name] kills adult fleas (in as little as 1hour), flea eggs, flea larvae and pupae for up to four months.] [.[brand name] prevents development ofall flea stages for up to four months.] [·Kills fleas (in as little as I hour), ticks (in as little as 1hour), mosquitoes, (chewing) lice, flea eggs, larvae and pupae] [·Prevents all flea stages (adult fleas (in as little as I hour), flea eggs, flea pupae and flea larvae)] [.Ifdog is a high risk for flea re-infestation a once month application may be needed] [·Once a month treatment is recommended] [·A once monthly application is recommended for chewing lice,] [.Rapidly eliminates infestations with chewing lice] [·Monthly flea, tick, mosquito, lice, and flea egg protection] [·Monthly flea, tick, mosquito and lice protection] [·Kills flea eggs [larvae] [pupae] for up to 4 months] [·Aids in Control ofSarcoptic Mange]

# ~ergeant's® 

# Master Lak..d II August 2010 Version 10.1 EPA Reg. No. 2517-XX Information in [ ] is optional. Page 2 of8 [·Kills fleas (in as little as I hour), ticks (in as little as I hour), mosquitoes, flea eggs, and lice] [·[Seven] [7] Way Protection [Kills fleas (in as little as 1hour), ticks (in as little as 1 hour), mosquitoes, lice, flea eggs, flea larvae and flea 

### pupae]] 

### [·6 [Six] Way Protection! Kills fleas (in as little as 1hour), ticks (in as little as I hour), mosquitoes, lice, flea eggs & flea larvae] [. [4 Week] [Flea and Tick & Treatment] [. [Four (4) Week] [Flea, Tick, Mosquito and Lice Control] [. With (S)-methoprene Insect Growth Regulator which Breaks the Flea Life Cycle] [. With (S)-methoprene to Break Flea Life Cycle] [. With Insect Growth Regulator to Break Flea Life Cycle] [. Triple Action [!]:Fipronil and Cyphenothrin with (S)-methoprene IGR Effectively Breaks the Flea Life Cycle] [. Triple Action [I]: Effectively Breaks the Flea Life Cycle[!]] [. Three Applications {for cartons with 3 applicators}] and/or [3 Month Supply] or [12 Week Supply] [. Best ifused year round!] [. Kills & Repels Fleas (in as little as I hour) Up to [ 4 weeks]!] [. (ICON Showing 4 Week Protection)] 

### [·4 Week Dose!] [. I Month Dose!] [. Easy to Use Application] [. Specially Formulated for Dogs and Puppies] [. [Free] Calendar Stickers Inside!] [. [Free] Brochure Inside!] [. [Free] Brochure and Calendar Stickers Inside] [. Patented Technology] [. Kills Flea Eggs & Flea Larvae for [(4 months)]!] [. Prevents Flea Eggs From Developing Into Biting Adults] [. Kills Ticks (in as little as 1hour) for Up to [4 weeks]!] [. Kills [all stages of] Deer Ticks (vector ofLyme Disease) for up to 4 weeks] [. Kills Ticks (in as little as 1hour)] [. Kills Ticks including Deer Ticks for up to 4 weeks] [. Kills Brown Dog Ticks (in as little as 1hour)] [. Kills [Brown], [American,] [and Lone Star] Dog Ticks for up to 4 weeks] [. Kills Rhipicephalus sanguineus for up to 4 weeks] [·When used monthly [brand name] completely breaks the flea life cycle and controls tick and chewing lice infestations.] [. Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!] [. Apply once every [4 weeks]!] 

### [·4 weeks Flea and Tick Treatment!] [·Once A Month Flea and Tick Treatment] [. Kills & Repels Fleas (in as little as I hour) and Ticks (in as little as I hour) for up to 4 weeks!] [. Kills all stages ofthe flea life cycle] [. Kills Fleas (in as little as 1 hour), Ticks (in as little as I hour), Flea Eggs & Flea Larvae for up to 16 Weeks]

# Jergeant's@ Master La....d II August 2010 Version 10.1 Information in [ ] is optional. Page 3 of8 [. [Kills mosquitoes

## II [. Dogs can be bathed 24 hours after squeeze-on is applied] [.Prevents and controls reinfestations] EPA Reg. No. 2517-XX

[. [Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [clip] [cardll [For Dogs & Puppies (12 weeks or older and) up to 22 Ibs.] [For Dogs 23-44 lbs.] [For Dogs 45-88 Ibs.] [For Dogs 89-132 Ibs.] [ ] - Denotes Optional Statements and/or Images that May be Used on Front, Back or Side Label Panels [Ingredient Statement may be on front or back label] ACTIVE INGREDIENTS: Fipronil.

......................................................................... 9.8% Cyphenothrin

................................................................. 5.0% (S)-methoprene

............................................................. 8.8% OTHER INGREDIENTS:........................................ 76.4% TOTAL: 100.0%

KEEP OUT OF REACH OF CHILDREN 

### WARNING See [Back][or][Side] [Label Panel[s] [ or] [insert] for Additional Precautionary Statements
NET CONTENTS: Contains (3) [0.023 fl oz] [0.67 ml] applicators Contains (3) [0.045 fl oz] [1.34 ml] applicators Contains (3) [0.091 fl oz] [2.68 ml] applicators Contains (3) [0.136 fl oz] [4.02 ml] applicators

# ...,ergeant's® Master Laud II August 2010 EPA Reg, No, 25]7-XX Information in [ ] is optional. Version 10,] Page 4 of8



## , ,,' ", ,",:,fjOGSQUEEZifON**FIJ>lWNIL+CYPHENOTII~+METHOP@'.N1t** [BACK/SIDE CARTON LABEL

- MASTER LABEL] [brand name] contains Fipronil, cyphenothrin, and the insect growth regulator (lOR) (S)- methoprene,to effectively kill [and repel] Fleas [(in as little as I hour)], Ticks [(in as little as I hour)], and kills mosquitoes and (chewing) lice, The active ingredients in [brand name] work by collecting in the hair follicles and skin oils, This product features a sustained-release formula that discharges from the animal's hair follicles using the natural skin oils, resulting in fast acting [and long lasting] control ofFleas and Ticks [(in as little as] hour)], [and kills mosquitoes] and chewing lice [for 30 days], [diagram with visual offipronil collecting and being released from hair follicle] READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS. WARNING. Causes substantial but temporary eye injury, Do not get in eyes or on clothing, Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco, Remove and wash contaminated clothing before reuse, Harmful ifswallowed, Harmful ifabsorbed through skin, Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals,
FIRSTAID IfIn Eyes 

## • Hold eye open and rinse slowly and gently with water for 15-20 minutes, 

## • Remove contact lenses, ifpresent, afterthe first 5 minutes, then continue rinsing eye, 

## • Call a poison control center or doctor for further treatment advice, IfOn Skin 

## • Take offcontaminated clothing, Or Clothing 

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

## • Call a poison control center or doctor for treatment advice, IfSwallowed 

## • Immediately call a poison control center or doctor. 

## • Do not induce vomiting unless told to do so by a poison control center or doctor. 

## • Have person sip a glass ofwater ifable to do so. 

## • Do not give anything by mouth to an unconscious person, HOT LINE NUMBER Have the product container or label with you when calling a poison control center or doctor, or going for treatment. For more information on this pesticide product (including health concerns, medical emergencies or pesticide incidents), you may call 1-800-781-4738, NOTE TO PHYSICIAN OR VETERINARIAN Treat patient symptomatically

# ..;ergeant's@ Master Laud 11 August 2010 Information in [ ] is optional. Version 10.1 Page 5 of8 EPA Reg. No. 2517-XX



### ...•... . . . ......**DQ~SQJJE,E:ZE** 

### QN

### .Fi~RONIL+CYPHENOTHRIN+ME'J.'HQPRENE DIRECTIONS FOR USE It is a violation ofFederal law to use this product in a manner inconsistent with its labeling. READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE. DO NOT USE ON CATS. May be toxic and potentially fatal ifapplied to or ingested by cats. FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks ofage. Weigh your dog to be sure you are applying the right dose formulated for the weight ofyour pet. Do not treat your pet with more than one pesticide product at a time. Over dosing your animal can result in serious illness and even death. Best ifused year round. Certain medications can interact with pesticides. Consult a veterinarian before using this product on debilitated, aged, medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that actively groom or engage in close physical contact with treated dog may be at risk ofserious harmful effects. The most common signs ofingestion are excessive salivation and foaming at the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your pet for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately. Ifyour dog is exhibiting signs ofandlor are being treated for skin dermatitis, talk to your vet before applying any topical flea and tick control product. Sensitivities may occur after using ANY pesticide product on pets. Ifsigns ofsensitivity occur batheyour dogwith a mild soap and rinse with large amounts ofwater. Ifsigns continue, consult a veterinarian immediately by calling 1-800-781-4738. [{Outer Packaging or Insert Copy}] 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 off the narrow end at the notches with scissors. How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to apply all ofthe solution to the dog's skin, as directed below. Repeat application may be made if necessary, but do not apply more often than once every 4 weeks. FREQUENCY OFAPPLICATION Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill mosquitoes] [infestations]. [Studies show that] [brand name] kills fleas (in as little as 1hour) for up to three months. Ifyour pet is at high risk for flea reinfestation [, or in a highly infested environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills mosquitoes within 24 hours for the first 7 days after treatment, then within 48 hours for up to 28 days. [Brand name] remains effective, even after bathing, water immersion, or exposure to sunlight. Allow treated area to dry thoroughly. Do not reapply for 30 days.

# 0ergeant's® Master**La~d** II August 2010 Information in [ ) is optional. Version 10.1 Page 6 of8 EPA Reg. No. 2517-XX

.•....•.•. ... .. ..... .. .... .. ·.DOG 

### SQUEEZE ON FIPRONIL+CYPHEN01;'HRIN+METH(JPRENE For Dogs Weighing up to 22 Ibs. {For cartons containing .67 ml (0.023 fl. oz.) applicator tubes} Apply one tube (.67ml)(0.023 fl. oz.) [as a spot to the dog's back between the shoulder blades) [from the back ofthe neck to a point midway between the neck and tail1. For Dogs Weighing Between 23-44 Ibs. {For cartons containing 1.34 ml (0.045 fl. oz.) applicator tube} [Apply two tubes (.67 ml)(0.023 fl. oz.) as a spot on the dog's back between the shoulder blades) [or] [Apply one tube (1.34 ml)(0.045 fl. oz.) as a spot to the dog's back between the shoulder blades.) [from the back ofthe neck to a point midway between the neck and tail]. For Dogs Weighing Between 45-88Ibs. For cartons containing 2.68 ml (0.091 fl. oz.) applicator tube} Apply one tube (2.68 ml)(0.091 fl. oz.) [as a spot on the dog's back between the shoulder blades) [from the back ofthe neck to a point midway between the neck and tail). For Dogs Weighing 89-132 Ibs. For cartons containing 4.02 ml (0.136 fl. oz.) applicator tube} Apply one tube (4.02 ml)(0.136 fl. oz.) [as a spot on the dog's back between the shoulder blades) [from the back ofthe neck to a pointmidway between the neck and tail]. STORAGE AND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool [below nOF (25"C)] dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight. PESTICIDE DISPOSAL AND CONTAINERHANDLING: Non-refillable container. Do not reuse or refill this container. Ifempty: Place in trash or 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. By using this product, user or buyer accepts the following warranty. [[111e directions for use ofthis product are believed to adequate and must be followed carefully. It is impossible to eliminate all risks associated with the use ofthis product. Unintended consequences may result because ofunknown factors. All such risks shall be assumed by the user or buyer.]] Sergeant's is committed to providing high quality products. To the extent consistent with applicable law, Sergeant's makes no warranties, express or implied, of merchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not be liable for indirect, special, incidental or consequential damages. To the extent consistent with applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.] [Ifyou have questions or comments aboutthis product, please write: Sergeant's Consumer Response, p.o. Box 540399, Omaha, NE 68154-0399.]
In Case ofEmergency, call: 1-800-781-4738 [For more information] [Visit us at] [www.sergeants.com] Non-Emergency call 1-800-224-PETS (7387) [Made in USA]

# .Jergeant's® Master La",,d II August 2010 Information in [ ) is optional. Distributed by: Version 10.1 Page 7of8 EPA Reg. No. 2517-XX

Sergeant's Pet Care Products, Inc. P.O. Box 540399 [BAR CODE AREA] Omaha, NE 68154-0399 EPA Reg. No. 2517-XX EPA Est. No. XXXXX-XX-XXX [Optional Insert orpackage copy] [How to Apply

- May contain graphics illustrating product use, e.g., dogwith a drop falliug onto its neck from a vial on front, side, or back carton label and/or applicator labeling.) [{Outer Packaging or Insert Copy}] 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: 

### 1. Invert tube over dog and use open end to part dog's hair. 2. Squeeze tube firmly to apply all ofthe solution to the dog's skin [as a spot to the dog's back between the shoulder blades.] [or] [from the back ofthe neck to a point midway between the neck and tail.] [Flea life cycle diagram) [Look at the Label (Look at the Label icon) [Easy] 6 Step [Spot On] [Squeeze-On] [Topical] Checklist • Read the label completely and follow directions • Weigh your pet • Do NOT use Dog products on Cats • Do NOT treat with more than one pesticide product at a time • Separate animals after treatment to avoid chance ofingestion • Do NOT split tubes between pets] [Brand Name) [Monthly reminder card] [Apply [Brand Name] monthly for continuous protection against Fleas (in as little as I hour), Ticks (in as little as I hour), [and] chewing lice [and mosquitoes].] [Pet's Name (Empty blank for owner to fill in name)] [First [dose] [Treatment] (Empty blank for owner to fill in date)] [Second [dose] [Treatment] (Empty blank for owner to fill in date)] [Third [dose] [Treatment] (Empty blank for owner to fill in date)]

# Jergeant's® Master 

# La",d 11 August 2010 Version 10.1 EPA Reg. No. 2517-XX Information in [ ] is optional. Page 8 of8 [calendar stickers with brand name] [Place stickers on your calendar as a reminder (0 reapply [brand name] [in 30 days.] [Monthly Application Reminder Magnet (image ofreminder magnet) Enclosed for your convenience is an application reminder magnet. Push the (reset) button to start the clock. After 30 days the magnet will flash (and beep) reminding you to reapply [Brand Name]. This application reminder can be used for future treatments. Just press the reset button and in another 30 days the reminder magnet will flash (and beep) reminding you (0 reapply.] 

### {END - OPTIONAL INSERT OR PACKAGE COPY} 

## TlJ.I3E 

## /WALLABEL Front Label 

### {Brand Name) Fipronil 9.8%, Cyphenothrin 5.0%, (S)- methoprene 8.8% 0.67 mL 

### (or) 1.34 mL 

### (or) 2.68 mL 

### (or) 4.02 mL {label code) Back Label KEEP OUT OF REACH OF CHILDREN WARNING: Read directions and precautions before using. Use scissors to open. EPA REG. No. 2517-XX {label code) [Optional: Example pictograms that mayor may not be found on the printed label]Pet CarB 2G25 South 158th Piaza * Omaha. tJE**68130~**'1770 a Tenon"""p 402,938,7000 9 Fax 402.938,7099 G www.sergeants,corn

!5. December 200tJ Richard Gcbkcn Product lVlanager 22 Document Processing Desk Officc ofPesticide Programs U.S. Environmental Protection Room S-4900. One Potomac Yanl 2777 South Crystal Drive Arlington. VA 22:?02-450 I Dear Mr. Gcbken: Sergeum's Pet Cnre Products. Inc. (Sergeant's. 2625 South lSg'h Plaza. Omaha. Nehraska log 130·1770. EPA Company Number 2SI7). authorizes Exponent. Inc. (1150 Connecticut Avenue, NW. Suite 1100. Washington DC.**2()O~6)** to act on our behalf as our Authorized Representative. tClr all necessary interactions regarding all ofour product registration applications and registrations. Please note this does not change the CU1Tcnt IilccI Authorized Agclll!t)l' Sergeant's. The 

### Exponen!. Inc. e<1I1tact is as (,lIows: James Messina and/or Rick Tinsworth Exponent. Inc. 1150 Connecticut Ave" NW Suite I JOO \Vashington, DC 20036 (lOl) 772·4932 (lOll 77]A979 til, jmessi II

### (1(//exponent.comlrtinsWorth((lJeXponent.com If you hayc any questions,

Kelly R. fvlanager ofTechnicid Affllirs

cc: James MessinaSergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com August 11, 2010 Richard Gebken, PMI0 Office ofPesticide Programs (7504P) (REGFEE) U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA22202 Subject: Submission ofEPAPesticide Registration Improvement Act Information DearMr. Gebken: Sergeant's Pet CareProducts, Inc. (Sergeant's, 2625 South 158th Plaza, Omaha, NE 68130-1770, EPA CompanyNumber 2517), is submitting Pesticide Registration Improvement Act Information for the following newregistration application:

• Sergeant'sFipronil 

### + Cyphenothrin 

### +Methoprene Squeeze-On for Dogs R31O, $4,578 (50% fee waiver $2,289), Pay.govTracking ID: 251OIM08, AgencyTracking ID: 74122352649. Thisregistration application is for a new end-use product with supporting data and is considered an R310, new end-use product, requires review ofdatapackage within RD, PRIAreview time frame 6 months, and a fee of$4,578. Sergeant's qualifies for a PRIA fee waiver/reduction of50% (refer to OPP DecisionNumberD-425455). Ifyouhave any questions or need additional information regardingthis registration application, please contactme at 402-938-7079. Sincerely, 

# 0A**~.** 

# tk'biu wS )

# tA-l Kelly QHoskins Manager ofTechnical Affairs

### Voluntary SmallBusiness Certification Formfor Pesticide Registration FeeWaiverlReduction Section 1: Business Identification CompanyName: Sergeant's Pet Care Products, Inc. Address: 2625 South 158m 

### Plaza Omaha, NE 68130-1770 EPA CompanyNumber: 2517 ContactName: Kelly R. Hoskins Manager ofTeclmical Affairs PhoneNumber: 402-938-7079 Fax Number: 402-938-7091 Email: KHoskins@SERGEANTS.com Section 2: EPA PendingAction Identification Product Name: Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs Description ofAction Submitted to EPA: New end-useproduct with efficacydata EPA Identification 25I7-NEW EPAFee Category and Fee EPA PRIA fee category R31 0, 6month review, $4,578 (50% fee waiver $2,289) Section 3: SmallBusiness Information/Documentation FeeWaiver Support as a Small Business (as Yes, 50%. applicable): Is the Applicant a business entitywith one or No. Refer to previouslyfiled request ofDmore affiliates? 425455 (May4, 2010) Business structure: include a chart or statement Refer to previouslyfiled request ofDdescribing the applicant'sbusiness 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: Inelude revenue statements for Refer to previously filed request ofDthe Applicant showing annual global gross 425455 (May4, 20I0) revenue from pesticides for each ofthe three mostrecent completed fiscal ortax years. Applicant's ( ) fiscal year (x) tax year ends on: September30 Applicant's Audited Financial Statements are January 31 available on/about: Does the Applicantnow employ 500 orfewer Yes employees? Documentation: includethe most recent IRS 941 Refer to previously filed request ofDorW3 orotherofficial documentation 425455 (May4, 20I0)

### Section 4: Certification Statement I, Joe Connealy, the Vice President ofFinance (title), ofthe above-named Applicant, am authorized andhavepersonal knowledge sufficient to makethis certification onbehalfofthis Applicant. I herebycertifyunderpenaltyofpeIjurythat the information in Sections 1-3 above and the documentation submitted and/orrelied on in connection with this Applicant's Fee Waiver/Reduction request are true, complete, and correct in all material respects, and accurately represent the currentbusiness status ofthis Applicant.

# ~-s;;; 

# Cvllttu1lUt1 Joe Connealy 

# I**~** 

# 11- 2010 Date 

### Section 4: Certification Statement I, Joe Connealy, the Vice President ofFinance (title), ofthe above-named Applicant, am authorized andhavepersonal knowledge sufficient to makethis certification onbehalfofthis Applicant. I herebycertifyunderpenaltyofpeIjurythat the information in Sections 1-3 above and the documentation submitted and/orrelied on in connection with this Applicant's Fee Waiver/Reduction request are true, complete, and correct in all material respects, and accurately represent the currentbusiness status ofthis Applicant.

# ~-s;;; 

# Cvll1t4 /Ut1 Joe Connealy 

# I 

# 08-11- 2010 Date