# REGISTRATION 2517-143

## ISB'S Front-end PRlA Completeness Screen Drall 3; 10/25107



# - 'cipl Date: 

## AUG 

## 1 1 

## 2010 EPA Reg. Number: 

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# J.Y In Application Form (EPA Fom18570-1) included in the 

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### Confidential Statement ofFormula (EPA Fonn 8570- 

# i .lncluJcd in the Submission Package, is 

### it completely cd out and signed (boxes 1-21)?

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### Fnrmulator's E.xcmption Statement (EPA Form 8570- 

# '/ ) Included in the Submission Package?**~--~----** . 

### Ieel"lineation with Respect to Citation oCData 

### (EPA 

# V rnl K570-34) Included in the Submission Package?**_._._~-"** ..- 

### IDalll Matrix 

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

# ;< bmission Package?

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

OFFiCE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 6, 20ll Kelly 

### R. Hoskins 

### Sergeant's Pet Care Products, Inc. 2625 South 158" Plaza Omaha, NE 68130 Subject: CSF Notification(s) for Pesticide Registration Notice 98-10

Dear: Kelly Hoskins: The Agency is in receipt ofyourApplication for Pesticide Notification under Pesticide 

### Registration Notice (PRN) 98-10 

### dated March 24, 2011 for the following product(s). Sergeant's Fipronil 

### + Cyphenothrin 

### + Nylar Squeeze-On for Dogs (EPA Reg. No. 2517-143) The Registration Division (RD) has conducted areview ofthis request for its applicability under PRN 98-10 and [rods thatthe action(s) requested fall within the scope ofPfu'l 98-10. The Confidential Statement ofFOlTImla (CSF) and/or label submittedwith the application has (have) been stamped ''Notification'' and will be placed in ourrecords. Ifyou have any questions, please contact Regina Foushee'-Smith at 703-605-0780. ,}j)1ceI!'ly, 

### II /1. 

# 1: NQA0-<-1..L**L~0'~** Richard Gebken Product Manager Insecticide Branch Registration Division 

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

April 6,2011 KeUy 

### R. Hoskins Sergeant's PetCareProducts, Inc. 2625 South 158" Plaza Omaha,NE 68130 Subject: CSFNotification(s) for PesticideRegistration Notice 98-10

Dear: Kelly Hoskins: OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

The Agency isinreceipt ofyourApplicationfor PesticideNotificationunder Pesticide RegistrationNotice (PRN)**98~1**0 dated March 24, 2011 for the followingproduct(s). 

### Sergeant'sFipronil

### +Cyphenothrin 

### +NyIarSqueeze-Onfor Dogs (EPAReg. No. 2517-143) The Registration Division (RD) has conducted areview ofthis request for its applicability under PRN 98-10 and fmds thatthe action(s) requested faU within the scope ofPfu'l 98-10. The Confidential StatementofFOlTImla (CSF) and/or label submittedwiththe application has (have) been stamped ''Notification''and will beplaced in ourrecords. Ifyouhave anyquestions, please contactReginaFoushee'-Smith at 703-605-0780. ,Jj)1ce,!Yly, 

### II /1. 

# 1: !:1QA0-<-(.L**L~x:P~** Richard Gebken ProductManager Insecticide Branch Registration Division

# J.~"tFj Tracking Create Resubmission FFS Letters

Action Code History

# J.~"tFjSergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeants.com


### March 24,2011 Richard Gebken, PMIO Office ofPesticide Programs (7504P) 

### U.S. Environmental Protection Agency DocumentProcessing Desk (NOTlF) Room S-4900, OnePotomac Yard 2777 South Crystal Drive Arlington, VA 22202 

### Subject: Notification Submissionper PRNotice 98-10 to Add an Alternate #2 CSF for Sergeant's Fipronil 

### + Cyphenothrin

### +Nylar Squeeze-On for Dogs (EPA RegistrationNumber2517-143) 

### Dear Mr. Gebken: Sergeant's Pet CareProducts, Inc. (Sergeant's, 2625 South 158'" Plaza, Omaha, NE 68130- 1770, EPA CompanyNumber2517) is submitting a notificationpursuantto PRNotice 98-10 

### to add an alternate formulation #2 and newFormulator's Exemption Statementto supportthe registration ofSergeant's 

### Fipronil 

### + Cyphenothrin +Nylar**Squeeze~On** 

### for Dogs (EPA Registration Number2517-143). Please find enclosedthe following documentation in support ofthis 

### registration:

• Cover letter (this docwnent);
• Application for Registration (EPA Form 8570-1);
• Copy ofCurrent 

### EPA Approved Confidential Statement ofFormulas 

### (Basic and Alternate 

### #I);


### • Copyofthe 

### newproposed Alternate #2 CSF Formulation (tv,ro copies); and

• Updated Formulator's Exemption Statement (EPA Form 8570-27).



### does not change the toxicological category or chemicalproperties ofthe product. Further, this notification does notrequire any change to the currentEPA approved label language. 

### This notification is consistent with the provisions ofthe PRNotice 98-10 and EPA regulations at 40 CFR 152.46, and no other changes have been made to the labeling orthe confidential statementofformula ofthis 

### product. Iunderstandthat it is aviolation of18 U.S.C. Sec. 1001 to willfully make any false statementto EPA. I futther understandthat if 

### this notification is not consistent with the terms ofPRNotice 98-10 and 40 CFR 152.46, thissergeant's PetCare Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeants.com product may be in violation ofFIFRA and Imay be subjectto enforcement action and penalties under sections 12 and 14 ofFIFRA. Please note information found in this letter and enclosures is considered 

### CONFIDENTIAL BUSINESSINFORMATIONand must notbe released to any party outside ofEPA. 

### Ifyou have any questions regarding this submission, please contact me at402-938-7079. Sincerely,

# K~Y Manager ofRegulatory Affalrs Sergeant's Pet Care Products, Inc. Enclosures

cc: Rosanna Louie-Juzwiak, EPAForm Approved OMS No 20700060 Approval expires 05 31 98 Plem,e 'read mstrucffons on reverse before compteffng form


### - - - United States 

# D Registration OPP Identifier Number 

# EPA Environmental Protection Agency 

# D Amendment Washington, DC 20460 

## r;g] Other Application for Pesticide
- Section I 1. CompanytProduct Number 2. EPA Product Manager 

# , Proposed Classification 2517-143 Richard Gebken 

# ,. CompanytProduct (Name) PM#10 [SjNone DRestricted Sergeant's PetCare Products, Inc. I Sergeant's Fipronil + Cyphenothrin + Nvlar Squeeze-On For Doqs 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 

## NOTIFICATION Omaha, NE 68130-1770 EPA Reg. No. 

## , Product Name n, " v 

# D Checkifthis is a new address Section II 

# D Amendment
- Explain below. 

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

# o Resubmission in response to Agency letterdated XX-XX·XX 

# D "Me Too" Application Notification

_Elq)lain below. 

# o Other- Explain below, Explanation: Use additional page(s) it necessary. (For section I and Section 11.) Submission ofAlternate #2 Confidential Statement of Formula and a Formulator's Exemptlon as a Notification Pursuantto PR Notice 98-10. Section III 1. Material This ProductWill Be Packaoed In: Chlld·Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type ofContainer [Zl**Yes~** [Zl Yes 

# DYe> 

# o Metal 

## ON' ON' 

## I:2J N, [Zl Plastic If "Yes" No. per If "Yes" No. per DGlass *Certification must Unit Packaging wgt. Container Package wgl. Container DPaper be submitted 0.023 fl oz (0.67 ml) 0.045 11 oz (1.34 mj) 3 vials 

## I DOther (Specify) Plastic Bag 0.09 t fl oz (2.68 ml) 0.13611 oz (4.02 ml) 

# ,. Location of Net Contents Information 4. Size(s) Retail Container 

# ,. Location ofLabel Directions [ZlLabel 

# o Container 0.017 fl oz (O.SOml) Dan label lZIOn labeling accompanying product 

# ,. Manner In Which label is Affixed to Product DLithograPh [ZlOther DPaper glued DStenciled Section IV 1. Contact Point (Complete ftems direct! belowfor identiticatton ofindividual to be contacted, ifnecessalV, 10 process this applicafion.) Name Title Telephone No. (Include Area Code) Kelly R. Hoskins Manager of RegulatoryAffairs 402938-7079 Certification 

# ,. Date Application I certify that the statements I have made on this form and all attachments thereto are true, accurate and compleh-. I**~eceived** acknowledge that any knowingly false or misleading statement may be punishable byfine or imprisonment or both (3tamped) under applicable law. 

# --**:~~ignu~**

# jJ 

# l 

# Jia 3. Title Manager of Regulatory Affairs 

# ,. Typed Name: / Kelly R. I·btkins 5. Date: 03/2412011



# -----Form approved. OMB No. 2070-0060, 2070-0057, 2070-0107, 2070-0t22, 2070-0164.

Copy 2 - Apptlcarrl copy 

# &EPA United States Environmental Protection Agency Washington, DC 20460 Formulator's Exemption Statement (40 CFR 152.85)
Applicant's Name and Address EPA File Symbol/Registration Number Sergeant's Pet Care Products, Inc. 2517-143 2625 South 158th Plaza Product Name Omaha, NE 68130 Sergeant's Fipronil 

### +Cyphenothrin 

### +Nylar 

# " Date ofConfidential Statement of Fonnula (EPA Fonn 8570-4) 03/24/2011 As an autholized representative ofthe applicant for registration ofthe product identified above, I certify that: (1) This product contains the following active ingredient(s): Fipronil (9.8%) Cyphenothrin (5.2%) Pyriproxyfen (4.0%) 

# " (2) Ofthese, each active ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat active ingredient in the manufacturing, fonnulation 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 158.50(e)(2) or (3). (3) Indicate by checking (A) or (B) belowwhich paragraph applies:
71 (A) An accurate Confidentiat Statement of Fonnula (EPA FORM 8570-4) for the above identified product is allached to this statement. That fonnula statement indicates, by company name, registration number, and product name, the source ofthe active ingredient(s) listed in paragraph (1), OR 

# , (B) The Confidential Statement of Fonnula (CSF)(EPA Form 8570-4) referenced above and on file with the EPA is complete, current, 

# '" accurate and contains the infonnation required on the current CSF. (4) The following active ingredients in this product qualify for the fonnulator's exemption.
Source Active Ingredient Product Name Registration Number Fipronil Fipronil Fipronil Cyphenothrin Pyriproxyfen 

# Sui ILl

# h Name and Title Date Kelly R. Hoskins, Manager 

# " 03/24/2011 EPA**For~570** 2J (Revfl6-'200"4) Copy 1 - EPAU.S. ENVIRONMENTAL PROTECTION AGENCY Office ofPesticide Programs Regislralion Division (7504P) 1200 PennsylvaniaAve., N.W.

Washington, D.C. 20460 EPARegistralion No.
2517-143 Date ofIssuance: 

## MAR 22 2011

NOTICE OF PESTICIDE, 0" Registration 

## o Reregistration (underthe Federal Insecticide, Fungicide, and Rodenticide Act, as amended)
Name and Address ofRegistrant (include ZIP Code): Sergeant's Pet Care Products, Inc. c/o Exponent, Inc. 2625 South 1581h Plaza Omaba, NE 68130 Term ofIssuance: Conditional Registration Time-limited: see conditions below Name ofPesticideProduct: Sergeant's Fipronil 

### + Cyphenothrin 

### + Nylar Squeeze-on for Dogs

Onthe basis ofinfonnation furnished bythe 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 orderto protect health andthe environment, the Administrator, on his motion, may at any time suspend orcancel the registration ofapesticide in accordance with the Act. The acceptance ofany name in connection with the registration ofa product underthis Act is notto be construed as giving the registrant aright to exclusive use ofthe name orto its use ifit has been covered by others. This product is conditionallyregistered in accordance with FIFRA §3(c)(7)(a) provided that: I. This registration is time-limited and expires two years from the date this product is first released for shipment. You must 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 limitingthe formulations ofeach product to one basic confidential statement offormula. The Agency may require this in the future. It is possible that no additional alternate formulations or minor formulation amendments will be approved for this product in the future. 3. As a condition ofregistration for this product, within one year from the date ofthis registration, you must submit the results ofStorage Stability and Corrosion Characteristics studies, corresponding to OCSPP Guidelines 830.6317 and 830.6320, respectively, including interim re orts made at 0, 3, 6, 9, and 12 month intervals. Page I of54. Within one year ofthe date on this Notice ofRegistration, and priorto formulating this product, you must provide the Agency the following:

a. The registration number and establishmentnumber 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). 5. Within 30 days from the date ofthis registration, in accordance with FIFRA §3(c)(I)(F) and 3(c)(2)(B), you must submit a copy ofall offers to pay compensation and evidence oftheir delivery, used to supportthe data required forthis product. 6. You must submit quarterly enhanced incidentreports and quarterly sales information in doses sold forthis productforthe quarterthat begins on April 1, 2011. The quarterly reports are due two months after each quarter ends. Please flag any Confidential Business Infonnation as such. Enhanced incidentreporting should be submitted to the Product Manager. Quarterly sales information should be submitted to the Registration Division (7504P), to the ProductManager's attention. The following is a list ofinformation that must be included in 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. (mmJdd/yyyy) State in which the incident occurred. (standard 2 letter abbreviation) Registrant case # Species: dog, cat, other (specify) Breed: (as reported by pet owner) Age: months oryears Sex: M, F, orneutered Weight pounds Primary Route ofExposure: dermal, oral, other animal, inhalation, other Body System: neurological, dennatological, GI, respiratory, ocular, other Major signs noted with separate column foreach sign, using standard tenninology Time to Onset (hours, days) Treated by veterinarian: yes or no Firsttime productused: yes or no Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) Any kno\'m precondition EPA Severity Code: death, major, moderate, minor Outcome: died, recovered, still treated, unknown Page 2 of57. Along with the enhanced incidentreporting, you must submit an analysis ofthe incidents seen, to include the following details: All incidents should be reported including all minor dennal and ocular initation reports. Summary table 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> dennal. In other words, an incident with both oral and dennal 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 showing number 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, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr, 6 yr, 7 yr, 8 yr, 9 yr, 10 yr, 11 yr, 12 yr, 13 yr, 14 yr, 15 yr, >15 yr. A summary table showing the number ofdog incidents for each severity code for each pet weight range on the product 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. 8. You must submit and/or cite all data required for registration ofyour productunder FIFRA §3(c)(5) when the Agency requires all registrants ofsimilarproducts to submit such data, and submit acceptable responses required for reregistration ofyour productunder FIFRA §4. All labeling comments below are in reference to the proposed master label, dated March 10.2011. 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: 9. Throughoutthe entire label, add "killing" so that the claim reads "starts killing in as little as 1 hour." 10. Throughout the entire label, any flea efficacy duration greater than nine weeks or 63 days must be deleted because this claim is not sunnorted by the submitted data. Page30f511. On page 1 under the header Fleas, revise the following claims to add the underlined words, or delete struck-out words, as follows: "[Controls flea reinfestation for up to [12 \yeeks]]" "[Research demonstrates that [brand name] kills adult fleas (starts killing in as little as I hour), flea eggs, and flea larvae ana prevents pupae for more than [63 days] [9 weeks].]" "[Prevents all flea stages (adult fleas (in as little as 1 hour), flea eggs, flea pU!9ae, and flea larYae.]" "[Kills flea eggs, and [larvae] [and] prevents [j3u!9ae] for more than [63 days] [9 weeks]]" "[Kills & Repels Fleas (starts killing in as little as 1 hour) Up to [4 weeks]!] [2 months] f; months]]" "[Kills Flea Eggs & Flea Larvae for [more than 2 months] [Uj3 to 1 months]]" "[Kills all stages ofthe flea life cycle]" 12. On page 2 under Multiple Infestations, revisethe following claims to add the underlined words, or delete**struck~out** words, as follows: "[Kills fleas (starts killing in as little as 1 hour), ticks (starts killing in as little as I hour), mosquitoes, chewing lice, flea eggs, and larvae ana pre't'eHts !9u]3ae]" "[Prevents and controls reintestations oflisted pests for up to [1 month] [4 weeks]]" 13. Throughout the entire label, perthe Acute Toxicity and Companion Animal Safety review, change "Up to 22 Ibs" to "4 to 22 Ibs" to include a minimum dog weight. 14. On page 2 under Multiple Infestations, revisethe following claims to add the underlined words, or delete struck-out words, as follows: "[Kills fleas (starts killing in as little as 1 hour), ticks (starts killing in as little as 1 hour), mosquitoes, chewing lice, flea eggs, and larvae ana prevents pU]3ae]" "[Kills fleas (starts in as little as I hour), ticks (starts in as little as 1 hour), flea eggs, and flea larvae for up to 16 weeks]" "[Prevents and controls reinfestations oflisted pests for up to [1 month] [4 weeks]" 15. On page 3 under All Others, delete all "brochure," "clip," and "card" references because these were not submitted to the Agency for review. 16. On page 3 under All Others, delete the following claims: "[Effective after bathing and exposure to water and sunlight]" because this is a duplicate. "[Prevents and controls reinfestations oflisted pests]" because no efficacy duration was included. 17. On page 3, delete the optional statement "[Ingredient Statement may be on front or back label]" because the ingredient statement must be placed on the Front Panel. 18. On page 3 in the Ingredients Statement, all Inert ingredients must be identified when electing to list the inert ingredients. 19. On page 6 in the Howto Apply section, correctthe reapplication interval from "4 weeks" to "30 days" to be consistent with the interval stated under Frequency ofApplication.

Page 4 of520. On page 6 in the Frequency ofApplication, delete "[Studies show that] [brand name] kills fleas (in as little 1 hour) fur up to three months]" because the efficacy data do not supportthis claim. 21. On page 6 underthe Frequency ofApplication, add the underlined words and delete the struck-out text in the following statement: "[Brand name] kills mosquitoes within 24 hours for upto the first 7 days after treatment, then within 48 hours for up to 28 days]." 22. On page 7 under the Storage and Disposal statement, replace "ContainerHandling" with "Container Disposal." 23. On page 7 inthe Warranty statement, remove the brackets within the paragraph so that ifused, the Warranty statement is present in its entirety. 24. On page 9 underthe End-back/side Panel section, delete the "Optional Insert or Package Copy" statementbecause the Agency has not reviewed the optional insert as part ofthe labeling for approval. 25. Revise the EPA Registration Numberto read: "EPA Registration No. 2517-143." Ifthe Agency detennines that future mitigation measures are necessary for all pet spot-on products, you will be infonned, and be expected to comply. Ifmitigation measures are necessary, the Agency maytake appropriate regulatory actions. Two copies ofthe fmished labeling must be submitted priorto releasing the productfor shipment. Ifthese conditions are not complied with, the registration will be subjectto cancellation in accordance with FIFRA sec. 6(e). Your release for shipment ofthe product constitutes acceptance ofthese conditions. A copy ofyour label stamped "Accepted with Comments" is enclosed for your records. Please contact Rosanna Louie-Juzwiak at (703) 308-0037 with any questions. Enclosure: Sergeant's Fipronil 

### + Cyphenothrin 

### +Nylar**Squeeze~on** for Dogs Label, StampedAccepted with Comments Signature ofApproving Official:

# /~J~L Richard Gebken, ProductManager(10) Registration Division, Insecticide Branch EPA Fonn 8570·6

Page 5 of5 Date: 

## MAR 22 201,10 March 2011 Infonnation 

### in [ ] is optional. 

# Sergeant's® MasterLabel Version 10.1 EPA Reg. No. 2517-RUG Page 1 of9 

### EON FIPR CYPHENCAR [Option text appears 

### in brackets-the [mal product label may include some or all ofthe optional text on front, back or side panels. The CRP required text 

### will not change.]**FRONTr~~E.**



### ACCEPTED with 

### COMMENTS In EPALetterDated: 

### MAR 2 2 2011**Und~r** .theFederafInsecticide, Fungicide, and RodenticideAct, as**~mended,** tortbe pesticide reglstered underEPARegl. N, 

### 6.5'1'7

- 19-3

. 

## Sergeant's Fipronil 

# + Cyphenothrin 

# + Nylar Squeeze-On for Dogs

[Apply to puppies over 12 weeks old] [Apply to puppies 12 weeks orolder] [ABNs] [(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) fo!" dogs] [(Sergeant's®) (Sent!"y®) EctoadvanceTM (Spot On) for dogs]

[Mosquitoes] ['Kills mosquitoes] [within 24 hours for up to 7 days] [and within 48 hours for up to 28 days] [·Kills mosquitoes] [Fleas] 

### [·CoB:trols flea reil'lfestatiofl for up to [12 weeks]] [-Research demonstrates that [brand name] kills adult fleas (starts killing in as little as 1 hour), flea eggs, and flea larvae aad preveffis pupae for more than [63 days] [9 weeks].] [-[brand name] prevents development ofall flea stages for more than [63 days][9 weeks].] [-Prevents all flea stages (adait fleas (starts killing in as little as I hour), flea eggs, flea pupae and flea larYae)] [·Kills flea eggs, and [larvae] [and] preYents [pupae] for more than [63 days][9 weeks]] [·With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle] [.WithNylar® to Break Flea Life Cycle] [.With Insect Growth Regulatorto Break FleaLife Cycle] [·Dual Action [!]:Fipronil with Nylar® IGR Effectively Breaks the Flea Life Cycle] ['Triple Action 

### [I]: Effectively Breaks the FleaLife Cycler!]] [·Kills & Repels Fleas (starts killing in as little as I hour) Up to [4 weeks]!] [2 months] 

### [3 months]] [.Kills FleaEggs & Flea Larvaefor [more than 2 months] [up te 4menths]] [-Prevents Flea Eggs From Developing Into Biting Adults] [-Kills all stages ofthe flea 

### life e)'cle] [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 killing in as little as 1 hour), chewing lice & mosquitoes]

# Sergeant's@ Master Label 10 March2011 Version 10.1 EPA Reg. No. 2517-RUG Information in [ [is optionaL Page 2 of9 [-Kills Fleas, Ticks and Mosquitoes] [-Kills fleas (starts killing in as little as 1 hour), ticks (starts killing in as little as 1 hour), mosquitoes, chewing lice, flea eggs, and larvae and prevents pupae] [-Monthly flea, tick, mosquito, chewing lice, and flea egg protection] [-Monthly flea, tick, mosquito, and chewing lice protection] [-Kills fleas (starts killing in as little as 1 hour), ticks (starts killing in as little as 1 hour), mosquitoes, flea eggs, and chewing lice] [. [Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] chewing lice, flea eggs, flea larvae [&] 

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

### [and] flea larvae] [. [4 Week] [Flea and Tick & 

### Treatruent]] [. [Four (4) Week] [Flea, Tick, Mosquito and Chewing Lice Control]] [-Whenused monthly [brand name] completelybreaks the flea life cycle and controls tick and chewing lice infestations.] [- 4 week Fleaand Tick Treatment!] ['Once A Month Flea and TickTreatment] [- Kills Fleas (starts killing in as little as I hour) and Ticks (starts killing in as little asl hour) for up to 4 weeks!] [- Kills Fleas (starts killing in as little as 1 hour), Ticks (starts killing in as little as 1 hour), Flea Eggs & 

### Flea Larvae for more than [63 days] [9 weeks]] [-Prevents and controls reinfestations oflistedpests for up to [1 month] [4 weeks]] [Ticks[[·Kills Ticks (starts in 

### as little as I hour)] [-Kills Ticks including those that may transmit Lyme disease] [·Kills Ticks (starts in as little as I hour) for Up to [4 weeks]!] ['Kills [all stages of] Deer Ticks (vector ofLyme Disease) for up to 4 weeks] [·Kills [Brown], [American,] [and Lone Star] Dog Ticks] [-Kills Rhipicephalus sanguineus 

### for up to 4 weeks] [-Kills AmericanDog Ticks [(Dermacentor variabilis)] 

### for up to 4 weeks!] [All Others] [-For Dogs and Puppies 12 weeks ofage or older] ['For Dogs 

### ["1'1 to 22Ibs], [23-44 Ibs], [45-88Ibs], [89-132Ibs] [·Fast Acting] ['Waterproof] [.Long Lasting] [-Ifdog is at high risk for flea reinfestation a once month application may be needed] [-Oflee a mOflth trea-tment is recommended} [-A 

### once monthly application is recommended for chewing lice.] [·Apply Monthly] [-Rapid elimination ofchewing lice infestations] [-Controls mites that may cause sarcoptic mange] ['Three Applications] andlor [3 Month Supply] or [12 Week Supply] [-Best ifused yearround!] ['(ICON Showing 4 Week Protection)]Version 10.1 Page 3 of9 

# Sergeant's® MasterLabel EPA Reg. No. 2517-RUG 10 March 20II Information in [ ] is optional. [04 Week Dose!] [01 Month Dose!] [oEasy to Use Application] [-Specially Formulated for Dogs and Puppies Over 12 Weeks] [o[Free] Calendar Stickers Inside!] [o[FreeJ Bra"aure IBside'J [-[Free] Brochure and Calendar Stickers Inside] [opatented Technology] [oApply once every [4 weeks]!] [o[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] 

### [eIijl] 

### [€af<I]] [-Effective afterbathing and exposure to water and sunlight] [-Prevents and controls reinfesta-tions oflisted pests] [0[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] 

### [eIijl] 

### [€af<I]] [03 applications] [oFiponil (9.8%) 

### + cyphenothrin (5.2%) 

### + [pyrproxyfen][Nylar®] (2.0%)] [oUS and Foreign patents pending] [-Lift [here] for more information] [oFor year round protection, apply (brand name) monthly] [3 Applications] [For use ONLY on dogs] 

## [1Jr

# ± to 22 lbs] [23-44 lbs] [45-88Ibs] [89-132 lbs] [over 

### 12 weeks ofage] [For Dogs & Puppies (12 weeks or older aud) lJj>

# ± to 22Ibs.] [For Dogs 23-44Ibs.] [For Dogs 45-88 Ibs.] [For Dogs 89-132 lbs.] 

### [ ]

- Denotes Optional Statements and/or Images that May be Used on Front, Back or Side Label Panels [IBgredient Statement may be on from orback label] ACTIVE INGREDIENTS: FiproniL ., 9.8% Cyphenothin 5.2% Pyriproxyfen 

### 2.0% OTHER INGREDIENTS*: 83.0% TOTAL: 100.0% [*diethylene glycol monoethyl ether]

# Sergeant's® MasterLabel 10 March2011 Version 10.1 EPA Reg. No. 2517-RUG Infonnation in [ ] is optionaL Page 4 of9 [Nylar® is a registered trademark ofMcLaughlin Gonnley King Company. U.S. PatentNo. 5,942,525] 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

[BACK/SIDE CARTON LABEL

- MASTERLABEL] [brand name] contains Fipronil, Cyphenothin and the insect growth regulator (lOR) Nylar® to effectively kill Fleas [(starts killing in as little as 1 hour)], Ticks [(starts killing in as little as 1 hour)], andkills flea eggs, flea larvae, mosquitoes and chewing lice. The active ingredients in [brand name] feature a sustained release fonnula developed for fast acting [and long lasting] control offleas, ticks, [mosquitoes] and chewing lice for up to [1 month] [[4] [four] weeks] on dogs. READ ENTIRE LABEL BEFORE EACH USE. USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS. WARNING. Causes substantial but temporary eye injury. Do not getin 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, or using the toilet. Remove and wash contaminated clothing before reuse. HAZARDS TO DOMESTIC ANIMALS. Forexternal use only. Do not use onpuppies under 12 weeks ofage. Individual sensitivities, while rare, may occur afterusing 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 with pesticides. Consult a veterinarianbefore using on medicated, pregnant, nursing, debilitated or aged dogs. Call 1-800-781-4738 for**24~hour** assistance.

# Sergeant's® Master Label 10 March 2011 Version 10.1 EPA Reg. No. 2517-RUG 

### Information in [ 

## l is optional. Page 5 of9 FIRST AID 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 Or 

# • Take offcontaminated clothing. 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 e:ive anvthillf!: bv mouth to an unconscious oerson. 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 ORVETERINARIAN Treat patient symptomatically

DIRECTIONS FOR USE It 

### is a violation ofFederal law to use this product in amanner inconsistent with 

### its labeling. DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU AND YOUR DOG, READ ENTIRE LABEL BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS. DO NOT USE ON CATS. May he toxic and potentially fatal ifapplied to oringested hy 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 fannulated for the weight ofyauTdog. Do not treat your dog with more than one pesticide product at atime. Over dosing your dog can 

### result in 

### serious illness and even death. Best if

### usedyear round. Certainmedications can interact with pesticides. Consult a veterinarian before using this product on debilitated, aged, medicated, pregnant, or nursing dogs. Consult a veterinarianbefore using on dogs with known organ dysfunction. DO NOT USE ON CATS or animals otherthan 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 orengage in close physical contactwith treated dog may be atrisk 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 dog for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talkto a veterinarian. Cats exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately. Ifyour dog is exhibiting signs ofand/or are being treated for skin dermatitis, talk to your vet before applying any topical flea and tickcontrol product. Sensitivities may occur after using ANY pesticide product on dogs. Dogs may experience some temporary irritation at the site ofproduct application. Ifsigns ofsensitivity occur10 March 2011 Version 10.1 

### Infonnation in [ 

### Jis optional. Page 6 of9 

# Sergeant's® MasterLabel EPA Reg. No. 2517-RUG 

### batheyour dog with a mild soap and rinse with large amounts ofwater. consult a veterinarian immediately by calling 1-800-781-4738. Ifsigns continue,
[{OuterPackaging}] How to open: Remove producttubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cutoff the narrow end at the notches with scissors. How to apply: Inverttube over dog and use open end to part dog's hair. Squeeze tube frrmly 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 30 days 4 weeks.

# f~:e\\onal drawings that mayormay not appearon finished 

# Jg**I~.** FREQUENCY OF APPLICATION Use [brandname] monthly for complete control offlea, tick [and] chewing lice [and to kill mosquitoes] [infestations]. [Studies show that] [brand name] kills fleas (il'l as little as 1 ho1:H') for Ufl to three months. Ifyourpet is athigh 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 ftrst 7 days aftertreatment, 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 notreapply for 30 days.

# Sergeant's® MasterLabel EPA Reg. No. 2517-RUG Version 10,1 

## I is

# optiona~l.,-_**---:_c:.p"ag,,-e:...7-::.of:...9,--:-;~_~ ~~~~~~~~~**  10 March 201 I Information in [



### For Dogs Weighing up to 221bs. [including small dogs and puppies, 12 weeks or older] {For cartous containing .67 ml (0.023 fl. 

### oz.) applicator tubes} Apply one tube (.67 ml)(0.023 

### fl. oz.) [as a spotto the dog's back between the shoulder blades] [from the back ofthe neckto a pointmidway between the neck and tail]. 

### For Dogs Weighing Between 23

- 441bs. {For cartons containing 

### 1.34 ml (0.045 fl. 

### oz.) applicator tube} [Apply one tube (1.34 ml) (0.045 

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

### For Dogs Weighing Between 45

- 881bs. {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 backbetweentbe shoulder blades] [from the back ofthe neckto a point midway betweenthe neck and tail]. For Dogs Weighing 89 -1321hs. {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 backbetweenthe shoulder blades] [from the back ofthe neck to a point midway between the neck and tail]. STORAGE AND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the packuntil ready to use. Store in a cool [below 77°F (25°C)] dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight. CONTAINER DISPOSAL HANDLING: 

### Ifempty: Non-refillable container. Do not reuse or refill this container. Offerfor 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, HThe 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 orbuyer.H Sergeant's is committedto providing high quality products. To the extent consistent with applicable law, Sergeant's makes no warranties, express orimplied, of merchantability or offitness for a particularpurpose or otherwise, that extend beyond statements on this label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not be liable for indirect, special, incidental or consequential damages. To the extent consistent with applicable law, the exclusive remedy ofthe user orbuyer shall not exceed the purchase price paid.] [Ifyou have questions or comments about this 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 call1-800-224-PETS (7387) [Made in USA]Version 10.1 Page 8 of9 

# Sergeant's® Master Label EPA Reg. No. 2517-RUG 10 March 2011 Information in [ ] is optional. Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-RUG EPA Est. No. XXXXX-XX-XXX [BAR CODE AREA]



### [How to Apply

- May contain graphics illustrating product use, e.g., dog with a drop falling onto its neck from a vial on front, side, or backcarton label and/or applicator labeling.] [{Outer Packaging}] 

### [Application Instructions[ [Directions for Use] How to open 

### 1. Remove producttubes 

### [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 solutionto the dog's skin [as a spot to the dog's back between the shoulderblades.] [or] [from the back ofthe neckto a pointmidway between the neck and tail.]

[Flea life cycle diagrarn[ [Flea Life Cycle] [Sample coloring and layout rna)' be different on fmallabel]

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

• Weighyourpet
• Do NOT use Dog products on Cats
• Do NOT treat with more than one pesticide product at a time • Separate animals aftertreatmentto avoid chance ofingestion

• Do NOT splittubes between pets]

### 10 March 2011 Information in [ ] is optional. 

# Sergeant's® Master Label Version 10.1 EPA Reg. No. 2517-RUG Page 9 of9 [Brand Name] [3] [Month [Treatment] [Application] Tracker] [Foryear-roundprotection, apply [Brand name] monthly.] [pet's Name (Empty blank for ownerto fill 

### in name)] [First] [1st] [Second] [2nd] [Third] [3rd] [Dose] [Treatment] [Application] (Empty blankfor 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 Application Reminder Magnet (image ofreminder magnet)] [Enclosed for your convenience is an application remindermagnet. Push the (reset) button, and the reminder light will blinktwice. The reminder tag is now set for 30 days. Atthe end of30 days the reminder light will blink, reminding you to reapply [Brand name]. Press the button once and the blinking light will stop. Press the button again and this will resetthe timer for another 30 days.]

BackLabel KEEP OUT OF REACH OF CHILDREN WARNING: Read directions and precautions 

### before using. Use scissors to open. EPA REG. No. 2517-RUG (label code} 

## flea pupae flea larvae ... fleaeggs 

# lJlI AduHlea



# ..., 

# .. @ AdukFlea fleaeggs flea larvae fleapupae

• ticks 

# @ ticks Brown DogTick 

# @ Brown DogTick 

# + DeerTick 

# @ DeerTick American DogTick 

# @ American DogTick

" chewing lice 

# @ chewing lice LoneStarTick 

# @ LoneStarTick

mosquitoes 

# @ mosquitoes [Optional graphics above mayor may not appear on finished label] {END OPTIONAL INSERT OR PACKAGE COPY] iili\fDB'**yJJ;~1jjjWl'!z?i'iYA:~E/ i:':J:fE)£,:.d!;;?ffJ:'±~:!lf:!!if,P'!!?"";,**  

### FrontLabel {Brand Name}

# !(j)"~;F] Fipronil 9.8% 

### w!w, Cyphenothrin 5.2% w!w, 

### Pyriproxyfen 2.0% 

### w/w 0.023 

### fl oz (or) 0.045 fl oz (or) 0.091 fl oz (or) 0.136 

### fl oz {label code}

# - 0> o "0


### , §**N~>­** "'Crf....l <::"0 Z eel 

### 0 0**~-** 

# . III o 

# s60p J0

# :l- 

# ",Z pue.J8**'U'''~** ,oOlllno '0JOopu' litre UilIOPlonpoJd po.nun**«)~Id** JanoN "''''''l'lruj,u, 1",od<IP 10,1**~~uo6. OIS~il\** **PIIO~** 1"""'1 ,no,(**1~:pIIj/IJ** U'Olq"l!'''" ROUil"""'" JOjJeJlO ","",!HjUO' S!41WI"""' eSn"J IOU OQ**'JOU!n:uo~ olq~II~OJ-UON**  :.llduJoII**'lWOclSI<lIl3NlYmo~** "146'IUno lOO"!>lUOJllO"lOJd 'al"Ja6Jll'" IOU 00 "Sjad pUO U0'l'I!<t:' OJ 0l'1i'lS=eU!**~Id** J,;p**I:MV~,ll** ilIOjOq) 1000 U! oJ<lIS .",," OJ ,\po

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') .\f7.-/\.i?' 

## 2E 

# tl**I!~** E • 

## • • E 

# "

2ACTIVE INGREDIENTS: Fipronil ,•.......9.80% Cypha"oth,;n 5.20% Py,iproxytan 2,00% OTHER INGREDIENTS': 93.00% TOTAL: 100.00% 'Olethyle"" Glycol Monoelhyl Ether, Vitamin E Nlcollnate Controlsmites thatmay causesarcopticmange

• Waterproof 

### chewing lice m.;imnc:nuitoes I I·· '---1 \! 

# I For use ONLY on dogs I 

### ,.J 

# "-<

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### NetContents: Three0.045fl oz (1.34 mL) applicators

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ACTIVE INGREDIENTS: Fipronll 6.60% Cyphcnolhrjn ,..5.20% Pyriproxyfen 2.00% OTHER INGREDIENTS': 63.00% TOTAL' 100.00% 'Dlelh)'lena Glycol Monoelhyl Elhll., Vitamin E N1collnate ':;. Controls mites thatmay causesarcopticmange
• Waterproof

TOF REACH OF CHILDREN 

### RNING I.M>eIPoneiforAdditior>olPrecautiOO>rfstalMlenlS '-,**~~. ~~**  

### NetContents: Three0.091 floz (2.68 mL) applicators ---l 

# .Brand 

# Z'M**Ifordo~~** KILLS l)ll

## fleas 'lea eggs

icks chewing lice "",.mosquitoes



## '" -------·1 1--·--------- 

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ACTIVE INGREDIENTS: Flpronil 9.80% Cyphenolhrin 5,20% Pyriproxyten , 2.00% OTHER INGREDIENTS": 83.00% TQTAL: 100.01:1% "Diethylene Glycel Monoetllyl ElM', VItamIn E Nlcotlna!<l ';" Controls mites thatmay causesarcopticmange

• Waterproof 

# Brand 

# Z'M**~ordfi;J~** KILLS**~fleas** 'A 

## flea eggs +ticks fr chewing lice ",mosquitoes

• 

# - 1;: \;J 

## N V)

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### NetContents: Three0.136fl oz (4.02 mL)applicators 

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# •**}J31NI~d** 3Hl**}JO~** NOlonnsNI HV



## 2ART INSTRUCTION FORTHE PRINTER 

# ••

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### I#R 

## 22

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### ~I?(A-**d~**
7 Tracking Create Resubmission FFS Letters

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### DATA PACKAGE BEAN SHEET Date:**05~Oct~2010** Page 1 of3



### * * * Registration Information 

### * * *

Company: 2517
- SERGEANT'S PET CARE PRODUCTS, INC. Risk Manager:**~~_~~Q_::_J329!!~~~_~_~~~~n_~j!Q_~t?_g~~~!g_!_~_~~_I12~** __**'=~_~**

# __**~:!~~!:** 

### _ Risk Manager Reviewer: Rosanna Louie RLOUIE Decision 

### #: 438363 DP 

### #: (382783) 

### PRIA Parent DP 

### #: Submission #: 880188 ; 

# 1:)5(0 

# LQot

# \~CL

Sent Date: Calculated Due Dale: 23-Mar-2011 Edited Due Date:


### Action Desc:**~~3_!2t~~\t('=~Qg_~~:r:;_~9~_~E~_~:r:_"!"_~S~~JI_~_~_~~_l:l_~_~_~_§~~~!?_Q~_,=~ODU_CT _t?k!£::_~~~J**  Ingredients:**~ee 2ag~_~_______**  __ __ _ _



### * * 

### * Data Package Information 

### * * * Expedite: 

### 0 Yes. No DP Ingredient: See page 3 Date Sent: 05-0ct-2010 Due Back:

DP Title:**~~~~~~~_~_,=~q~_~_t?_~~~~~~~':Y~~__________________** 

### _ . _ CSF Included: • Yes 

### 0 No Label Included: • Yes 

## 0 No Paren1 DP #:

Organizalion: RD {TRB Date In Da1eOu1

................................ Last Possible Science Due Date: 2t-Feb-2011 Team Name: CHEM

--------- ---------------- ------------- -- ---------- Reviewer Name:

## H_tl&L~J~l

# __LtKf:t_9_1';:

_ Contractor Name: Science Due Date: Sub Data Package Due Date:



### * * * Studies Sent for Review 

### * * * Printed on Page 2


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

### * ** No Additional Data Packages 

### * * * Data Package Instructions 

### ** * Attn TRBfCHEM: Please conduct a product chemistry review ofthe attached package in support of1he proposed product. Contact Rosanna Louie-Juzwiak a1 308.0037 wi1h any ques1ions. Attachments:

- cover letter

- basic CSF

- drafllabel

- MRIDs 48188901, -02 

### DATA PACKAGE BEAN SHEET Date:**05~Oct~2010** Page 1 of3 

### * * * Registration Information 

### * * *

Company: 2517
- SERGEANT'S PET CARE PRODUCTS, INC. Risk Manager:**~~_~~Q_::_I329!!~~~_~_~~~~n_~j!Q_~t?_g~~~!g_!_I3_~~_Il2~**

### __**'=~_~**

# __**~:!~~!:**

### ______________ Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Dale: 23-Mar-2011 Decision 

### #: 438363 DP 

### #: (382783) 

### PRIA Parent DP 

### #: Submission #: 880188 ; 

# 1:)5(0 

# L(ol**\~CL**

Edited Due Date:

Action Desc:**~~3_!2t~~\t('=~Qg_~~:r:;_~9~_~E~_~:r:_"!"_~S:~JI_~_~_~~_I:l_~_~_~_§~~~!?_Q~_,=~ODU_CT _t?k!f::_~~~J**  Ingredients:**~ee 2ag~_~_______**  __ _ ____ _____________________ _ 

### * * 

### * Data Package Information 

### * * * Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient: See page 3

DP Title:**~~~~~~~_~_,=~q~_~_t?_~~~~~~~':Y~~__________________** 

### _ ______________________________.____ CSF Included: • Yes 

### 0 No Label Included: • Yes 

## 0 No Paren1 DP #:

Date In Da1eOu1 Organizalion: RD {TRB Last Possible Science Due Date: 2t-Feb-2011 Team Name: CHEM

--------- ---------------- ------------- -- ---------- Science Due Date: Reviewer Name:

## H_tl&L~J~l_.L)_Kf:t_9_1';:

# ___ Sub Data Package Due Date: Contractor Name: 

### * * * Studies Sentfor Review 

### * * * Printed on Page 2 

### * * *Additional Data Package forthis Decision 

### * * * NoAdditional Data Packages 

### * * * Data Package Instructions 

### ** * Attn TRBfCHEM: Please conduct a product chemistry review ofthe attached package in support of1he proposed product. Contact Rosanna Louie-Juzwiak a1 308.0037 wi1h any ques1ions. Attachments:

- cover letter

- basic CSF

- draft label

- MRIDs48188901, -02'uP#: (382783) Page 2
* * * Studies Sentfor Review * * * Decision#: (438363)
48188902

48188901

48188901

48188901

48188902

48188902

48188902

48188901

48t88901

48188901

48188902 Hoskins, K. (20 to) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs, Project Number: SERGEANTS/07/10104. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10103. UnpUblished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/03. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) Group A Product Chemistryfor Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number; SERGEANTs/07/tO/03. Unpublished study prepared by Sergeant's Pet Care Products, Inc, 64 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number; SERGEANTS/07/tO/04. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (20 to) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/04. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10104, Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10103. UnpUblished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) Group A Product Chemistryfor Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10103. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number; SERGEANTS/07l1 0103. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10104. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. 830.6304/0dor

830, 16201Description of production process
830.t670IDiscussion offormation of impurities 830.1550/Productldentity and composition 830.7tOONiscosity
830.6303/Physical state
830.7300IDensity/relatlve density
830.1600/Description of materials used to produce the product
830.1750/Certified limits
830.1650/Description offormulation process
830.6302lColor 'uP#: (382783)

48188901

48188901

48188901

48188902

48188902

48188902

48188901

48t88901

48188901

48188902 Page 2 * * * Studies Sentfor Review * * *
Fipronil

# ~ Cyphenothrin + Nylar

# ~~:~~;1:mi~~~9J Number:**SERGEANTS/07/1010~.** '''';,,,' Sergeant's Pet Care Products, Inc. p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10103. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10103. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 64p. Hoskins, K. (2010) GroupA Product Chemistryfor Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number; SERGEANTSl07/to/03. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/to/04. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (20to) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10/04. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10104. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Hoskins, K. (2010) Group A Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10103. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) Group A Product Chemistryfor Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10103. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 64 p. Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number; SERGEANTS/07/10103. Unpublished study prepared by Sergeant's Pet Care Products, lne. 64 p. Hoskins, K. (2010) Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs. Project Number: SERGEANTS/07/10104. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. Decision#: (438363)

830.16201Description of production process
830. t670IDiscussion offormation of impurities
830.1550/Product Identity and composition 830.7tOONiscosity
830.63031Physical state
830.7300IDensity/relative density
830.1600/Description of materials used to produce the product
830.1750/Certified limits
830.1650/Description offormulation process
830.6302/Color()P#: (382783) Page 3 * ** Product and Data Package Ingredients * * * Decision#: (438363)

1129032 195737-68-1 IPyriproxyfen /129121 It20068-37-3 IFipronil 1129121 1120068-37-3 JFipronil(9.8%) 1129013**~9515-40-7** !Cyphenothrin(5%) 1129032 195737-68-1 JPyriproxyfen(2%)DP BAR CODE NO.: 382783 PC Code(s): 129121, 129013, 129032 FOOD Use: No
DATE OUT: February 18, 2011 FILE SYMBOL NO.: 2517-RUG DECISION NO.: 438363 ACTION CODE: R310 NON-FOOD Use: Yes

SUBJECT: End Use Product Chemistry Review Product Name: Sergeant's Fipronil + Cyphenothrin + Ny!ar**Squeze~On** for Dogs FROM:
TO: Hari Mukhoty, Product Chemistry Team Technical Review Branch I Registration Division (7505P) Rosanna Louie I Richard Gebken PM
- 10 Insecticide Branch I Registration Division (7505P) Company Name: Formulation Type: INTRODUCTION: Sergeant's Pet Care Products, Inc. Liquid

The Registrant has submitted one basic CSF (dated: 08/11/2010) and a proposed product specific label for registration ofthe aforesaid products under EPA File Symbol No. 2517-RUG. The registrant submitted product chemistry data under MR!Ds: 481889-01 and -02 to support the registration ofthe proposed product. The primary review of the product chemistry data was performed by a contractor (attached as the last page of this review) and TRB is conducting the secondary review. TRB has been requested to evaluate the product chemistry data required forthe registration ofthe proposed basic product. SUMMARY OF FINDINGS: 1. Name ofActive Ingredient(s): Fiproni! (9.8%), Cyphenothrin (5.2%), and Pyriproxyfen (2.0%). 2. The source materials of the active ingredients are registered with the Agency. 3. All inert ingredients have been screened by IIAB on 08/13/2010 and have found to be approved for nonfood uses only. DP BAR CODE NO.: 382783 PC Code(s): 129121, 129013, 129032 FOOD Use: No
DATE OUT: February 18, 2011 FILE SYMBOL NO.: 2517-RUG DECISION NO.: 438363 ACTION CODE: R310 NON-FOOD Use: Yes

SUBJECT: End Use Product Chemistry Review
FROM:
TO: Product Name: Sergeant's Fipronil + Cyphenothrin + Nylar**Squeze~On** for Dogs Hari Mukhoty, Product Chemistry Team Technical Review Branch I Registration Division (7505P) Rosanna Louie I Richard Gebken PM
- 10 Insecticide Branch I Registration Division (7505P) Company Name: Sergeant's Pet Care Products, Inc. Liquid Formulation Type: INTRODUCTION: The Registrant has submitted one basic CSF (dated: 08/11/2010) and a proposed product specific label for registration ofthe aforesaid products under EPA File Symbol No. 2517-RUG. The registrant submitted product chemistry data under MRIDs: 481889-01 and -02 to support the registration ofthe proposed product. The primary review ofthe product chemistry data was performed by a contractor (attached as the last page ofthis review) and TRB is conducting the secondary review. TRB has been requested to evaluate the product chemistry data required forthe registration ofthe proposed basic product. SUMMARY OF FINDINGS: 1. Name ofActive Ingredient(s): Fiproni! (9.8%), Cyphenothrin (5.2%), and Pyriproxyfen (2.0%). 2. The source materials ofthe active ingredients are registered with the Agency. 3. All inert ingredients have been screened by IIAB on 08/13/2010 and have found to be approved for nonfood uses only.DP BAR CODE NO.: 382783 PC Cade(s): 129121, 129013, 129032 FOOD Use: No 4. Confidential Statement of Formula(s): FILE SYMBOL NO.: 2517-RUG DECISION NO.: 438363 ACTION CODE: R310**NON~FOOD** Use: Yes



### IXI Basic- Dated: 08/11/2011 resubmitted
- Dated: 02/28/2011 [X] Alternate #

- Dated: 02/28/2011 Alternate CSF(s) complies with 40CFR §152.43: IX 

### I Yes [J No. 5. Product label
a. Ingredient statement Nominal concentration of Al listed on CSF(s) concur with product label (PR Notice 91-2) [X ] Yes Metallic equivalent: 

### I I Yes 

### I X INA; Soluble arsenic: [[Yes 

### I X 

### JNA Isomeric ratios: 

### I I Yes [X] NA b. Health related sub statements: Petroleum distillate at> 10%: 

### I IYes I INa [X [NA 

### Methanol at > 

### 4%: 

### I IYes I INo I X INA
c. Physical chemical hazard statement Product label requires a statement per40 CFR §156.78 for: flammability, explosive potential or electric insulator breakdown? ]XjYes []Na

Is the sub statement in compliance with PR Notice 97-6? 

### I X 

### I YES
- Uses the term "Other Ingredients"

, if not, explain below: d. Label' requires an additional Storage and Disposal statement: [ [Yes 

### I X 

### I No
- from product chemistry point ofview; ifyes explain below: Final decision of overall label acceptance will be made by the PM.



### 2 DP BAR CODE NO.: 382783 PC Cade(s): 129121, 129013, 129032 FOOD Use: No FILE SYMBOL NO.: 2517-RUG DECISION NO.: 438363 ACTION CODE: R310**NON~FOOD** Use: Yes 4. Confidential Statement of Formula(s): 

### IXI Basic- Daled: 08/11/2011 resubmitted
- Dated: 02/28/2011 [X]Altemale# - Dated: 02/28/2011 Alternate CSF(s) complies with 40CFR §152.43: IX 

### I Yes [J No. 5. Product label
a. Ingredient statement Nominal concentration of AI listed on CSF(s) concur with product label (PR Notice 91-2) [X ] Yes Metallic equivalent: 

### I IYes 

### I X INA; Soluble arsenic: [[Yes 

### I X 

### JNA Isomeric ratios: 

### I I Yes [X] NA b. Health related sub statements: Petroleumdistiliateat> 10%: 

### I IYes I INa [X [NA 

### Methanol at > 

### 4%: 

### I IYes I INo I X INA
c. Physical chemical hazard statement Product label requires a statement per40 CFR §156.78 for: flammability, explosive potential or electric insulator breakdown? ]XjYes []Na

!sthe sub statement in compliance with PR Notice 97-6? 

### I X 

### I YES
- Usestheterm "Other Ingredients"

, if not, explain below: d. Label' requires an additional Storage and Disposal statement: [ [Yes 

### I X 

### I No
- from product chemistry point ofview; ifyes explain below: Final decision ofoverall label acceptance will be made by the PM.



### 2DP BAR CODE NO.: 382783 PC Code(s): 129121, 129013, 129032 FOOD Use: No 6. Group A: Product Chemistry Data FILE SYMBOL NO.: 2517-RUG DECISION NO.: 438363 ACTION CODE: R310 NON-FOOD Use: Yes

TRB's determination ofthe acceptability ofthe data for the proposed product is listed in the tables below. Data submitted Guideline TRB's No. Study Title Assessment MRID Nos. Yes No of Data 481889-01 Product Identity & Composition A 

### .. 830.1550 X Description of materials used to A " 830.1600 

### ' oroducetheoroduct X Description offormulation X A " 830.1650 orocess Discussion on the formation of X " 830.1670 impurities A 830.1700 Preliminarv analvsis NA Standard certified Limits X A " Certified limits Proposed Limits (158.350) Justification for 830.1750 wider limits Enforcement analytical method Cited MRID: 481226-01 from A- GC using EPA Reg. No. 830.1800 X FID 2517-140

A = Acceptance, NA = Not Acceptable, G = Data Gap, W = Waiver Request, I 

## =In Progress, NA

## =Not Applicable

3DP BAR CODE NO.: 382783 PC Code(s): 129121, 129013, 129032 FOOD Use: No 7. Group B: FILE SYMBOL NO.: 2517-RUG DECISION NO.: 438363 ACTION CODE: R310**NON~FOOD** Use: Yes

Guideline Study Title Value or Qualitative TRB's MRID Nos. No. Description Assessment 483503-03 & - of Data 04
830.6303 Phvsical State Liauid A " 830.6315 Flammabifit\t Flash Point is > 194 0 F A " EXDlodabilitv No explosive material in the 830.6316 formulation NA " nH Not soluble/dispersible in 830.7000 water A "**Denr~i~~** (Specific 1.02-1.06 nrlcc 830.7300 nravit A "

A = Acceptance, N 

## =Not Acceptable, G 

## =Data Gap, W = Waiver request, NA

## =Not applicable, I

## =In progress
CONCLUSIONS:
1. TRS has reviewed the CSFs (dated: 02/28/2011) for the proposed basic and alternate (Alt. # 1) products and has found them to be acceptable. The CSFs are attached with this review in OPPIN CHEM DOCS. 2. Product chemistry Group A and Group B data, with the exception ofone year storage stability (830.6317) and corrosion characteristics (830.6320) are satisfied and acceptable. 3. The registrant must generate one year storage stability (830.6317) and corrosion characteristics (830.6320) data on the proposed product. It is required that the observations be made at 0,3,6,9, and 12 month intervals. The results must be submitted to the Agency in electronic and hard copy format. 4. The proposed label was screened as it pertains to the product chemistry reqUirements. The final review ofthe proposed label and uses are the purview ofthe PM team.



### 4DATA EVALUATION RECORD FIPRONIL CYPHENOTHRIN PYRIPROXIFEN (Sergeant's Fipronil 

### + Cypbenothrin 

### + Nylar Squeeze-On for Dogs) STUDY TYPES: ProductIdentity and Composition (OPPTS 830.1550) Description ofMaterials Used to Produce the Product (OPPTS 830.1600) Description ofProduction Process (830.1620) Discussion ofFormation ofImpurities (OPPTS 830.1670) Preliminary Analysis (OPPTS 830.1700) Certified Limits (OPPTS 830.1750) EnforcementAnalytical Method (OPPTS 830.1800) Physical and Chemical Characteristics (OPPTS 830.6302-830.7950) MRIDs 481889-01 and 481889-02 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 Oak Ridge, TN 37831

Task OrderNo. 1-44
Primary Reviewer: Eric B. Lewis, M.S. Secondary Reviewers: Sylvia Milanez, Ph.D., D.A.B.T.

Robert H. Ross, M.S., Group Leader Quality Assurance: Kimberly G. Slusher, M.S.

Disclaimer Signature: Date: Signature: Date: Signature: Date: Signature: Date:

# ~~~$.X~**jAI~** 

### 1 1 

## 1011

JAN 1 11&'"
•.•J, j.

This review mayhave been altered SUbsequentto 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-AC05·000R22725.Decision 

### #: 438363 DP 

### #: (382785) 

### PRIA Parent DP 

### #: Submission 

### #: 880188

Edited Due Date: Calculated Due Date: 23-Mar-2011 

### DATA PACKAGE BEAN SHEET Date: 05 MQctM2010 Page t of3

Sent Date: 

### * * * Registration Information 

### * * * Registration:**g~-'t?-=-~t}~_::_§gJ~9J;~~I'~FIERONIL** +**gY~HEfI!QltLF~tr'~** 

### ____**NYb_~R_§q!Jg** Company: 2517
- SERGEANT'S PET CARE PRODUCTS, INC. Risk Manager: RM 1**~:B.~~ard _~eE~~~_:J?i?~L~g~:§!i?.~J~.90I1!_!-p.:t~.~::!~_~7**  

### _ Risk Manager Reviewer: Rosanna Louie RLOUIE

Ingredients:**~_7::._e?J!~~** _



### * * * Data Package Information 

### * ** Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient: See page 3

DP Title: #2517-RUG:**C0r:!Pan.~~ An~~~~~~'!!.!t_~E!.Yl~**  _ CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP #:

Organization: RO I**T~** _ Team Name: TOX Date In Date Out

--------------------------- L"t p",'b1, So,,,"' D" D,t, 21-F'b-2011 / Science Due Date: Reviewer Name: Sub Data Package Due Date:

_ Contractor Name:


### * * * Studies Sent for Review 

### * 

### * * Printed on Page 2


### * '!< 

### * Additional Data Package for this Decision 

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


### * * * Data Package Instructions 

### * * * Attn TRBfTOX: Please condvct a companion animal safety study 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

• data matrix 

### DATA PACKAGE BEAN SHEET Date: 05 MQctM2010 Page t of3 

### * * * Registration Information 

### * * * Decision 

### #: 438363 DP 

### #: (382785) 

### PRIA Parent DP 

### #: Submission

### #: 880188 Registration:**g~J?-=-~t}~_::_§gJ~9J;~~I'~FIERONIL** +**gY~HEfI!QltLF~lrot~** 

### __**NYb_~R_§q!J!=** Company: 2517
- SERGEANT'S PET CARE PRODUCTS, INC. Risk Manager: RM 1**~:B~~ard _~eE~~~_·J!.I?~L~g~:§!I?~J~.90Il!_~p.:t~** **.~::!~_~7** ______________________ Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Date: 23-Mar-2011 Edited Due Date:

Ingredients:**!?_7::._e?J!~~**_____________________________________________________________________________________________________________ 

### * * * Data Package Information 

### * * * Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient: See page 3

DP Title: #2517-RUG:**C0r:!Pan.~~ An~~~~~~'!!.!t_~E!.Yl~** ________________________,__" _______________________________________ CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP#:

Date In Date Out

--------------------------- Organization: RO I**T~**_____________ _ L"Ip",'b1, So'eore D" D,I, 21-F'b-2011 / Team Name: TOX 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 TRBfTOX: Please condvct a companion animal safety study review ofthe attached package in support ofthe proposed product. Contact Rosanna Louie·Juzwiak at 308.0037 with any questions. Attachments: • cover leiter

- basic CSF

- draft label

- data matrixDP#: (382785)

43863802

43t21t11

43121110

46166108

47849609

43577711

48129614

43121111

43863802

43444905

43121110 Page 2 ** * Studies Sent for Review * * * Decision#: (438363) SludyofRM1601C (Frontline Spray Treatment) Juvenile Dogs: Lab Project

## """b"" 94423: PS-232DAS. Unpublished study prepared by**Wh~e** Ea91e Toxicology labs. t71 p. Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by Topical Administration to D09S: Fipronll Spot Treatment (RM 1601 E): Lab Project Number: MRX 231950406. Unpublished study prepared by Huntin9don Research Centre, L1d. 219 p. Arnaud, J.; Consalvi, P. (1993) DomeSlicAnimal Safety: Assessment ofthe Tolerance of a 0.25% RM 1601 Spray in Nursin9 Puppies Administered Twice at a 28 Day Interval at a Dose Rate of 6 mllk9: Revised: lab Project Number Cli t80. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Arnaud, J.; Consalvi, P. (1993) Assessment ofTolerance of a 0.25% RM 1601 Spray Formulation in D09S at 3, 9, and 15 ml1k9 When Applied 6 times to the Haircoat at 28 Day Intervals: Revised: lab Project Number C1I138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. Kuhn, J. (2003) Companion Animal Safety StUdy in D09s: Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project Number: 7650/03. Unpublished study prepared by Slillmeadow, Inc. and Miller, Thomas A. 53 p. Delport, P. (2009) Companion Animal Safety Evaluation on Dogs ofSpo1-0n Products Containin9 Multiple Toxicants and Insect Growth Regulators: Final Report. Project Number: 2517FEGEN, CV/08/551. Unpublished study prepared by Clin Vet International. 129 p. Walker, K. (1995) Discussion in Support of Bridgin9 Domestic Animal Safety Data on Frontline Spray Treatment to Frontline Spo1 Trealment 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 + Cyphenothrin Squeeze-On for D09s. ProjeCl Number: SERGEANTSI06/1O/06. Unpublished study prepared by Sergeant's Pel 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 Nursin9 Puppies Administered Twice at a 28 Day Interval at a Dose Rale of6 m11k9: Revised: lab Project Number C1I180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Powell, L.; Paffell, R. (1995) Domestic Animal Safety Study by 870.7200/Companion animal safety Topical Adminis1ration to D09S: Fipronil Spo1 Treatment (RM 1601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Research Centre, Ltd. 219 p. Schwartz, E. (1994) Domestic Animal Safety Study of RM1601C 870.7200/Companion animal safety Topical Spray (Frontline Spray Treatment) in Juvenile D09S: Lab Project Number: 94423: PS-232DAS. Unpublished study prepared by White Ea91e Toxicology labs. 17t p. Arnaud, J.; Consalvi, P. (1993) Assessment ofTolerance of a 870.7200/Companion animal safety 0.25% RM 160t Spray Formulation in D09S at 3,9, and 15 ml/k9 When Applied 6 times to the Halrcoat at 28 Day Intervals: Revised: Lab Project Number C1I138. Unpublished study prepared by Rhone Merieux, Inc. 69 p. DP#: (382785)

43863802

43t21 t11

43121110

46166108

47849609

43577711

48129614

43121111

43863802

43444905

43121110 Page 2 * * *Studies Sentfor Review * * * Decision#: (438363)
Spray Treatment) il Dogs: Lab : PS-232DAS. Unpublished study I Toxicology Labs. t71 p. Domestic Animal Safety Study by Dogs: Fipronil Spot Treatment (RM Lab Project Number: MRX 231950406. Unpublished prepared by Huntingdon Research Centre, L1d. 219 p. Arnaud, J.; Consalvi, P. (1993) DomeSlicAnimal Safety: Assessment ofthe Tolerance ofa 0.25% RM 1601 Spray in Nursing Puppies Administered Twice at a28 Day Interval at a Dose Rate of 6 mllkg: Revised: Lab Project Number CLI t80. Unpublished study prepared by Rhone Merieux, !nc. 32 p. Arnaud, J.; Consalvi, P. (1993) Assessment ofTolerance ofa 0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg When Applied 6 times to the Haircoat at 28 Day !ntervals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, !nc. 69 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. Delport, P. (2009) Companion Animal Safety Evaluation on Dogs ofSpo1-0n Products Containing Multiple Toxicants and !nsect Growth Regulators: Final Report. Project Number: 2517FEGEN, CV/08/551. Unpublished study prepared by Clin Vet International. 129 p. Walker, K. (1995) Discussion in Support of Bridging Domestic Animal Safety Data on Frontline Spray Treatment to Frontline Spo1 Trealment 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 + Cyphenothrin Squeeze-On for Dogs. ProjeCl Number: SERGEANTS!OS/to/06. Unpublished study prepared by Sergeant's Pel Care Products, !nc. 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 a28 Day Interval at a Dose Rale of6 mllkg: Revised: Lab Project Number CLl180. Unpublished study prepared by Rhone Merieux, Inc. 32 p. Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by 870.7200/Companion animal safety Topical Adminislration to Dogs: Fipronil Spo1 Treatment (RM 1601 E): Lab Project Number: MRX 23/950406. Unpublished study prepared by Huntingdon Research Centre, Ltd. 219 p. Schwartz, E. (1994) Domestic Animal Safety Study of RM1601C 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. 17t p. Arnaud, J.; Consalvi, P. (1993) Assessment ofTolerance ofa 870.7200/Companion animal safety 0.25% RM 160t Spray Formulation in Dogs at 3,9, and 15 ml/kg When Applied 6 times to the Haircoat at 28 Day !ntervals: Revised: Lab Project Number CLl138. Unpublished study prepared by Rhone Merieux, Inc. 69 p.Decislon#: (438363) Page 3

* * * Product and Data Package Ingredients * * * DP#: (382785)

1129032**~5737-68-1** IPyriproxyfen 1129121 1120068-37-3 /Fipronfl 1129121 1 120068-37-3 IFipronil(9.8%) 1129013 1 3951 5-40.7 !Cyphenothrin(5%) 1129032 195737-68-1 IPyriproxyfen(2%)Decision 

### #: 438363


### /

\ DP 

### #: (382784) PRIA Parent DP 

### #: Submission 

### #: 880188 

### DATA PACKAGE BEAN SHEET Date:**05~Oct-2010** Page 1 of 3

Company: 2517
- SERGEANTS PET CARE PRODUCTS, INC. 

### * 

### ** Registration Information 

### * * * Registration:**~~tI~R!!@** 

### __**~_§!;R_@_I:;~_~!I:§J:I~J~9NI1~ CYPHEN~~HRIN** **~~YLAB~~lJ!;**

Risk Manager:**~~_!Q-=B!~~~-.':9_ Ge~~l:l~--=-J~~~L~~3::?2~~~;?_~~_~_~.Y_!** 

### __**1?_-?~~~** 

### _ Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Date: 23-Mar-20t1 Edited Due Date: 

### Action Desc:**(~~!gU~_~_~_~~S?!:>!:'_~!!_~2!':!:.I:'~1?_"!"_!~~~~~'=!:JPE~~EVI** 

### EWS**_2!':!'_~92~~"I_~!:I_~~~1?_!**

Ingredients: See page 3



### * * 

### * Data Package Information 

### * * *

Expedite: 

### 0 Yes. No Dale Sent: OS-Qct-2010 Due Back: DP Ingredient: See page 3

CSF Included: • Yes 

### 0 No Label Included: • Yes 

### 0 No Parent DP #:

Organization: RD ITRS Date In Da1e Out 21-F"-2011 // Last Possible Science Due Oate: Team Name: TOX Science Due Date: Reviewer Name: Sub Data Package Due Date'. Contractor Name:


### * * * Studies Sent for Review

### * * * Printed on Page 2


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

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

### ** * Data Package Instructions 

### * * * Attn TRSITOX: Please conduct an acute toxicity review ofthe attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 with any ques1ions. Attachments:

- cover letter

- basic CSF

- draft label

- data matrix 

### DATA PACKAGE BEAN SHEET Date:**05~Oct-2010** Decision 

### #: 438363 DP 

### #: (382784)
Page 1 of 3 PRIA Parent DP 

### #: 

### / 

### *

### ** Registration Information 

### ** * Submission

### #: 880188 Registration:**~~tI~R!!@** 

### __**~_§!;R_@_I;~_~!I:§J:I~J~9NI1~ CYPHEN~~HRIN** **~NYLAB~~IJ!;** Company: 2517
- SERGEANTS PET CARE PRODUCTS, INC. \ Risk Manager:**~~_!Q-=B!~~~~9_ Ge~~I:l~--=-J~~~L~~3::?2~~~.?_~~_~_~.Y_!** 

### __**l?_-?~~~**

### ______________ Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Date: 23-Mar-20t1 Edited Due Date: 

### Action Desc;**(~~!gU~_~_~_~~s?!:>!:'_~!!_~2!':!:.':'~l?_"!"_!~~~~~'=!:lPE~~EVI**

### EWS**_2!':!,_~92~~"I_~!:1_~~~l?_!**

Ingredients: See page 3

Expedite: 

### 0 Yes. No DP Ingredient: See page 3

CSF Included: • Yes 

### 0 No

Organization: RD ITRS Team Name: TOX Reviewer Name: Contractor Name: 

### * * 

### * Data Package Information 

### * * *
Dale Sent: 05-Oct-2010 Due Back:

Label Included: • Yes 

### 0 No Parent DP #:
Date In Da1e Out 21-F'b-2011 // Last Possible Science Due Oate: Science Due Date: Sub Data Package Due Date'. 

### * * * Studies Sentfor Review

### * * * Printed on Page 2 

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

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

### * * * Data Package Instructions

### * * * Attn TRSITOX: Please conduct an acute toxicity review ofthe attached package in support ofthe proposed product. Contact Rosanna Louie-Juzwiak at 308.0037 with any ques1ions. Attachments:

- cover letter

- basic CSF

- draft label

- data matrixDP#: (382784)

48129603

48129608

48129606

48129607

48129604

48129605 Page 2 Studies Sentfor Review**~.,** Decision#: (438363)
Rats): Final Report.**9~;';''';';o, U;::~;:::'~:**  study prepared by BSL L.**~i** Gmbh. 34 p. Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with 870.1100/Acute Oral Toxicity 009 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: t00141B. 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 (in Rabbits): Final Report. Project Number: 100140B. 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 Requirement for Further 870.1300/Acute inhalation toxicity Testing forAcute Inhalation Toxicity for Following Sergeant's Products: Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs, Sergeant's Fipronll + Cyphenothrin + Methoprene Squeeze-On for Dogs, Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs, Sergeant's Fipronil + NylarSqueeze-On for Dogs, Sergeant's Fipronil + Etofenprox Spot-On for Cats, 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: SERGEANTS/06/10/05. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p. DP#: (382784)

48129603

48129608

48129606

48129607

48129604

48129605 Page 2**~ ~ ~** Studies Sentfor Review**~ ~.,** Decision#: (438363)

p. Leoni, A, (2010) Acute Oral Toxicity Up and Down Procedure with 870.1100/Acute Oral Toxicity 009 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: t00141B. Unpublished study prepared by BSL Bioservice Scientific Laboratories Gmbh. 41 p. Ahuja, V. (2010) Acute Eye Irritation/Corrosionwith Dog Products 870.2400/Acute eye irritation (in Rabbits): Final Report. Project Number: 100140B. Unpublished study prepared by BSl Bioservice Scientific Laboratories Gmbh, 33 p. Ahuja, V, (2010) Acute Dermal Irritation/Corrosionwith Dog 870.2500/Acute dermal irritation Products (in Rabbits): Final Report. Project Number: 1001398. 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 Requirement for Further 870.1300/Acute inhalation toxicity Testing forAcute Inhalation Toxicity for Following Sergeant's Products: Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs, Sergeant's Fipronll + Cyphenothrin + Methoprene Squeeze-On for Dogs, Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs, Sergeant's Fipronil + NylarSqueeze-On for Dogs, Sergeant's Fipronil + Etofenprox Spot-On for Cats, 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: SERGEANTS/06/10/0S. Unpublished study prepared by Sergeant's Pet Care Products, Inc. 6 p.DP#: (382784) Page 3
* * * Product and Data Package Ingredients * * * Decision#: (438363)

1129032 195737-68-1 jPyriproxyfen 1129121 1120068-37-3 ]Fipronil 1129121 1120068-37-3 jFipronil(9.8%) 112g013 139515-40-7 ]Cyphenolhrin(5%) 1129032 

### 195737-68-1 jPyriproxyfen{2%)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
February 16, 2011 MEMORANDUM

Byron T. Backus, Ph.D., Toxicologist Technical Review Branch Registration Division (7505P) Rosanna**Louie~JuzwiaklRichard** Gebken RM 10 Insecticide Branch Registration Division (7505P) Subject:

From:

To: Name ofPesticide Product: EPA Reg. No./File Symbol: 

### DP Barcodes: Decision No.: Action Code: PC Codes: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### + NYLAR SQUEEZE-ON FOR DOGS 2517-RUG DP 382784, 382785 438363 R310 129121 (Fipronil: 9.8%) 129013 (Cyphenothrin: 5.0%) 129032 (Pyriproxyfen: 2.0%) 

# n C'I

# n~

# ~-'\I.- ,!-o,' t

# rf/~ ,

Registrant: SERGEANT'S PET CARE PRODUCTS, INC. FORMULATION FROM LABEL: Active Ingredient(s): 129121 Fipronil 129013 Cyphenothrin 129032 Pyriproxyfen Other Ingredient(s): TOTAL
ACTION REQUESTED: The Risk Manager requests: bywt. 9.8% 5.0% 2.0% 83.2% 100.0%

For DP 382784: "
...Please conduct an acute toxicity review ofthe attached package in support of the proposed product.
.. " Page 1 of4

### For DP 382785: "
...Please conduct a companion animal safety study review ofthe attached package in support ofthe proposed product
... " BACKGROUND: The material received for review includes a datamatrix, a CSF (dated 81ll/2010) and a proposed label for this product, indicating use on adult dogs and puppies 12 weeks ofage and older. COMMENTS AND RECOMMENDATIONS: 1. The five cited acute toxicity studies (48129603, 48129604, 48129606

- 48129608) were conducted on a fonnulation containing as active ingredients: Fipronil (9.8%), (S)wMethoprene (8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as acceptable (TRB memorandum dated November 23, 2010 for 25I7-RUN), and can be used to support the registration of2517-RUG. The signal word is WARNING, based on the eye irritation potential (MRlD 48129606). 2, The material in the inhalation waiver request in MRID 48129605 is applicable to 2517-RUG. Referto the TRB memorandum dated November 23, 2010 for 2517-RUN which states: "Based on the 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 applicationmethod (directly to the skin ofthe dog or cat) which does notresult in any respirable particles, TRB concludes that a waiver for the acute inhalation study requirementis appropriate, and that these products can be assigned to EPA Toxicity Category IV by this exposure route." 3. The proposed label dosage rates for 25I7-RUG are 0.67 mL for dogs up to nIbs; 1.34 mL for dogs 23-44 lbs; 2.68 mL for dogs 45-88 Ibs; and 4.02 mL for dogs 89-132Ibs. 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 mean total 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. Assuming that the test substances and proposed product have a specific gravity = 

### 1.0, the puppies were treated with means of151 mg cyphenothrinlkg, 180 mg fipronil/kg, and 159 mg pyriproxyfenlkg. Dividing these values by 5 would give 30.2 mg cyphenothrinlkg, 36 mg fipronil/kg and 31.8 mg pyriproxyfenlkg. Interms ofthe fonnulation for 25l7-RUG these values would be 0.604, 0.367, and 1.59 mLlkg, respectively, indicating that 0.67 mL would be acceptable for puppies weighing 1.83 (0.67 mL divided by 0.367 mLlkg) kg or more. 1.83 kg is 4.03 Ib, so (applying a 5X safety factor) we can accept the data for dogs weighing 4 pounds or more. The cited companion animal safety studies adequately supportthe use ofthis product on dogs and puppies 12 weeks old orolder. Labeling should indicate a minimum weight of4 1bs for dogs or puppies.

Page 2 of4 

### For DP 382785: "
...Please conduct a companion animal safety studyreviewofthe attached packagein support ofthe proposedproduct
..." 

### BACKGROUND: The materialreceived for reviewincludes a data matrix, a CSF (dated 811112010) and a proposed label for this product, indicating use onadult dogs and puppies 12 weeksofage and older. 

### COMMENTS AND RECOMMENDATIONS: 1. The five cited acute toxicity studies (48129603, 48129604, 48129606

- 48129608) were conducted on a fonnulation containing as active ingredients: Fipronil (9.8%), (S)wMethoprene (8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as acceptable (TRB memorandum datedNovember 23, 2010 for 2517-RUN), and canbe used to support the registration of2517w RUG. The signal word is WARNING, based on the eye irritation potential (MRID48129606). 2, Thematerial inthe inhalation waiverrequest inMRID 48129605 is applicable to 2517w RUG. Referto the TRB memorandum datedNovember 23, 2010 for 2517w RUN which states: "Based onthe amount offormulation applied (0.5w 4.5 mL), the packaging ofthese products (singlewuse containers or ampoules), the nonwvolatile nature ofthe formulations,'and the applicationmethod (directly to the skin ofthe dog orcat) which does notresult in any respirable particles, TRB concludesthat a waiver for the acute inhalation study requirementis appropriate, and that these products canbe assigned to EPA Toxicity Category IV by this exposure route." 3. Theproposed label dosage rates for 2517-RUG are 0.67 mLfor dogs up to 221bs; 1.34 mL for dogs 23-44 Ibs; 2.68 mL for dogs 45-88 Ibs; and 4.02 mL for dogs 89-1321bs. The cited companion animal safety studies includeMRID 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)mL/kg for test substance IA and 6,88 (range: 6,69w7.05) 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), Themean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance IA and 0.395 (range: O.352w 0.443) mLlkg for substance HI. Assuming that the test substances and proposed product have a specific gravity = 

### 1.0, the puppies were treated with means of151 mg cyphenothrinlkg, 180 mg fipronillkg, and 159 mg pyriproxyfenlkg. Dividing these valuesby 5 would give 30.2 mg cyphenothrinlkg, 36 mg fipronillkg and 31.8 mg pyriproxyfenlkg. Intermsofthe fonnulation for 25l7wRUG these values would be 0.604, 0.367, and 1.59 mLlkg, respectively, indicating that 0,67 mL would be acceptable for puppies weighing 1.83 (0,67 mL divided by 0.367 mLlkg) kg or more. 1.83 kg is 4.03 Ib, so (applying a 5X safety factor) we can accept the data for dogs weighing 4pounds or more. The cited companion animal safety studies adequately supportthe useofthis product on dogs and puppies 12 weeks old orolder. Labelingshould indicate a minimumweightof4 1bs for dogs orpuppies.

Page 2 of44. The following is the acute toxicity profile for Sergeant's Fipronil 

### + Cyphenothrin 

### +Nylar SqueezewOn for Dogs (EPA File Symbol 2517-RUG), based on the results ofthe acute toxicity studies:Acute oral toxicity Acute dennal toxicity Acute inhalation toxicity Primary eye irritation Primary dennal irritation Dermal sensitization III III (IV)

II IV Positive Cited Cited Waived Cited Cited Cited 

### MRID 48129603 

### MRID 48

### I29604 

### (MRID 48129605) 

### MRID 48129606 

### MRID 48129607 MRlD 48129608 5. Based on the acute toxicity profile above, and taking into consideration the proposed uses specified on the label and infonnation in the CSF, the following would be the precautionary and first aid labeling for EPA File Symbol 25 17-RUG [Sergeant's Fipronil 

### + Cyphenothrin 

### +Nylar Squeeze-On for Dogs] as obtained from the Label Review System: PRODUCT ID #: PRODUCT NAME: FOR DOGS 002517-00143 SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### + NYLAR SQUEEZE-ON
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 orfrequently repeated skin contact may cause allergic reactions in some individuals. First Aid: Ifin eyes: -Hold eye open and rinse slowly and gently with water for 15-20 minutes, wRemove contact lenses, if present, after the first 5 minutes, then continue rinsing. weall a fXlison control center or doctor for treatment advice. Ifon skin: -Take offcontaminated clothing. -Rinse skin immediately with plenty ofwater for 15w 20 minutes. -Call a poison control center or doctor for treatment advice. If swallowed: wCall a poison control center or doctor immediately for treatment advice, Page 3 of4 4. The following isthe acutetoxicityprofile for Sergeant's Fipronil 

### + Cyphenothrin 

### +Nylar SqueezewOn for Dogs (EPA File Symbol 2517-RUG), based on the results ofthe acutetoxicity studies: Acute oral toxicity III Cited MRID 48129603 Acute dennal toxicity III Cited MRID 48129604 Acuteinhalationtoxicity (IV) Waived (MRID 48129605) Primary eyeirritation II Cited MRID 48129606 Primarydennal irritation IV Cited MRID 48129607 Dermal sensitization Positive Cited MRlD 48129608 5. Basedonthe acute toxicityprofile above, and taking into considerationtheproposed uses specified on the label and infonnationin the CSF,the followingwouldbetheprecautionary and first aid labeling for EPAFile Symbol 2517-RUG [Sergeant's Fipronil 

### +Cyphenothrin 

### +Nylar Squeeze-On for Dogs] as obtainedfrom the Label Review System: PRODUCT ID #: 002517-00143 PRODUCT NAME: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### + NYLAR SQUEEZE-ON FOR DOG5 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 undertheir 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 notget 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 longw sleeved shirt and long pants, socks, shoes, and gloves. Prolonged orfrequently repeated skin contact may cause allergic reactions in some individuals. First Aid: Ifin eyes: -Hold eye open and rinse slowly and gently with water for 15-20 minutes. wRemove contact lenses, if present, afterthe first 5 minutes, then continue rinSing. weall a fXlison control center or doctor for treatment advice. Ifon skin: wTake offcontaminated clothing. wRinse skin immediately with plenty ofwaterfor 15w 20 minutes. weall a poison control center or doctor for treatment advice. If swallowed: wCall a poison control center or doctor immediately for treatment advice. Page 3of4-Have person sip a glass ofwater if able to swallow. -Do not induce vomiting unless told to by a poison control center or doctor. -Do not give anything to an unconscious person. NOTE TO PHYSICIAN: Note to PMfCRMfRegistrant: The proposed label should contain a "Note to Physidan". The following statements are suggested types ofinformation that may be included, if applicable:

- technical information on symptomatology; use ofsupportiVe treatments 

### to maintain life functions;

- medicine that will counteractthe 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 or cats), the risk ofeye exposure is adequately reduced, and a restricted use classification is not necessary. 6. The proposed label has the statement: "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
..." This should be 

### deleted. 7. The CSF (dated 8/1 112010) for 2517-RUG should also be reviewed and accepted by the TRE Chemistry Team.

Page 4 of4 -Have person sip a glass ofwater if able to swallow. -Do notinduce 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 ofinformation that may be included, if applicable:

- technical information on symptomatology;

- use ofsupportiVe treatments 

### to maintain life functions;

- medicine thatwill counteractthe 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, Accordingto the 

### LRS, this productis a candidate for restricted use because itis in Toxicity Category II for eye exposure. However, TRB concludesthat, based onthe packaging (in ampules) andproposed productuse (direct applicationto the skin ofdogs orcats), the risk ofeye exposure is adequately reduced, and a restricted use classification is not necessary. 6. Theproposed label has the statement: "The active ingredients in [brand name] workby collectinginthe hairfollicles and skin oils. This productfeatures a sustained-release formula that discharges from the animal'shairfollicles using the natural skin oils
..." This shouldbe deleted. 7. TheCSF (dated 811 112010) for 2517-RUG should also bereviewed and accepted by the TRE Chemistry Team.

Page 4 of4

### DATA PACKAGE BEAN SHEET Date:**05~Oct~2010** Page 1 of3 Decision #: 438363 DP 

### #: (382786) PRIA Parent DP#: Submission 

### #: 880188 

### ** * Registration Information 

### * * 

### * 

## 1 4

) Registration: 2517-RUG

- SERGEANT'S**FIPRONIL+_.C),I'IiEl'lJlTI:IJ~jl't+-'\IY_LAFt~QUE** Company: 2517
- SERGEANT'S PET CARE PROOUCTS, INC. Risk Manager: RM 10
- RIchard GebkenRisk Manager Reviewer: Rosanna Louie RLOUIE 305-6701 Room# PYI 5-7237
Sent Date: Calculated Due Oate: 23-Mar-201 t Edited Due Date:

Ingredients: S"**p,,~e.33_._.** _.._ _ _._........ .. ._._.__ _.. . _ _._.... ._ ..



### * * * Data Package Information 

### * * 

### * Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 Due Back: DP Ingredient:**~~~_E'~~_~_~** __
DP Title: #2517-RUG: CRP Review CSF Included: • Yes 

## 0 No Label Included: • Yes 

### 0 No Parent DP #:

Organizalion: RD I**TR~** _ Team Name: Chlld**Res~~~r:'.!J:~~~JI~ng** Reviewer Name: Date In 

# ---17 La/.f'Li7 Date Out



# ____**\._~t~.:~_h~** Last Possible Science Due Date:

### 21-F.~b.~~_~~~ _ Science Due Date: Sub Data Package Due Date: Contractor Name:



### * * * Studies Sent for Review * * * Printed on Page 2


### * * Additional Data Package for this Decision 

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


### * 1< 

### * 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 quesllons. 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 pyriproxyfen or cyphenothrin exposure (i.e., does not trigger need for CRP) that would exceed that offiproniL 

### DATA PACKAGE BEAN SHEET Date:**05~Oct~2010** Page 1 of3

1< 1< 1< 

### Registration Information 1< 1< 1< Decision #: 438363 DP 

### #: (382786) PRIA Parent DP#: Submission

### #: 880188 Registration: 2517-RUG

- SERGEANT'S FIPRONIL+

__**C)'I'IiEl'lJlTI:IJ~jl't+-'\IY_LAFt~QUE** Company: 2517
- SERGEANT'S PET CARE PROOUCTS, INC. Risk Manager: RM 10
- Richard GebkenRisk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: 305-6701 Room# PYt S-7237

Calculated Due Oate: 23-Mar-201 t



### * * * Data Package Information 

### * 1< 

### * Expedite: 

### 0 Yes. No Date Sent: 05-0ct-2010 DP Ingredient:**~~~_E'~~_~_~**__
DP Title: #2517-RUG: CRP Review CSF Included: • Yes 

## 0 No Label Included: • Yes 

### 0 No Parent DP #:

Organizalion: RD I**TR~** ___________________ Date In 

# ---17 La/.f'Li7 Date Out Edited Due Date:

Due Back:

Science Due Date: Team Name: Child**Res~~~r:'.!.':~~~JI~ng** Reviewer Name: Sub Data Package Due Date: Contractor Name: 

### * * * Studies Sentfor Review 1< 

### * * Printed on Page 2 

### ***~** 

### * Additional Data Package for this Decision 

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

### * 1< 

### * Data Package Instructions

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

- cover letter

- letter for CRP certification (including cited studies)

- letter for CRP information·

- basic CSF

- draft label

- data matrix NOTE: with regards to CRP review, there is no greater toxicity from pyriproxyfen or cyphenothrin exposure (i.e., does not trigger need for CRP) that would exceed that offipronil.48059804

48059806

48059805 Page 2

Ward, R. Applicatorwith Label Indicator F=1 as a Polson Prevention Package Pet Care Products, Inc.: Final Report. Project Number: 1746/002. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation ofthe Dog Squeeze on 1.34ml White Applicatorwith Green Label Indicator (3x), Scissors to Open
- F=1 as a Poison Prevention Package for Sergeant's Pet Care Products, Inc.: Final Report. Project Number: 1746/003. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation ofthe Dog Squeeze on 4.02ml White Applicatorwith Blue Label Indicator (3x), Scissors to Open
- F=1 as a Poison Prevention Package for Sergeant's Pet Care PrOducts, Inc.: Final Report. Project Number: 1746f005. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation of the Dog Squeeze on 2.68ml White Applicatorwith Red Label Jndicator (3x), Scissors to Open· F=1 as a Poison Prevention Package for Sergeant's Pet Care Products. Inc.: Final Report. Project Number: 1746/004. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. DP#: (382786)

48059804

48059806

48059805 Page 2 ••• Studies Sentfor Review' ••

as a Poison Prevention Package Products, Inc.: Final Report. Project Number: 1746/002. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation ofthe Dog Squeeze on 1.34ml White Applicatorwith Green Label Indicator (3x), Scissors to Open
- F=1 as a Poison Prevention Package for Sergeant's Pat Care Products, Inc.: Final Report. Project Number: 1746/003. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation ofthe Dog Squeeze on 4.02ml White Applicatorwith Blue Label Indicator (3x), Scissors to Open
- F=1 as a Poison Prevention Package for Sergeant's Pet Care PrOducts, Inc.: Final Report. Project Number: 1746f005. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Ward, R. (2010) Evaluation ofthe Dog Squeeze on 2.68ml White Applicatorwith Red Label Jndicator (3x), Scissors to Open
- F=1 as a Poison Prevention Package for Sergeant's Pet Care Products. Inc.: Final Report. Project Number: 1746/004. Unpublished study prepared by Perritt Laboratories, Inc. 28 p. Decision#: (438363)DP#: (382786) Page 3 ** * Product and Data Package Ingredients * * * Decision#: (438363)

1129032**~5737-6a..1** !Pyriproxyfen J129121**1120068-37~** !Fipronil 

### 1 1 ,29121**1120068~37-3** 

### W ipronil(9.8%) 1 129013 )39515-40-7 JCyphenolhrin(5%) 1129032**~5737-68-1** !Pyriproxyfen{2%)UNITED STATES ENVIRONMENTALPROTECTION AGENCY WASHINGTON, D.C. 2fW6U

OH'JCE OJ, CHDJJC.\L S,\FETY ,\ND POLLl'TJON PREVENTION 

### December 23,2010 NOTE TO RM 10 Rosanna Louie-Juzwiak SUBJECT: Certification to Compliance with Child-Resistant Packaging Regulations EPA FILE NO: 2517-RUG, DP 382786, Decision 

### # 438363 The August 11, 2010 CRP certification and bridging letter (indicating the same size and color package as package tested) for EPA Registration No. 2517-RUG are acceptable. The August 11, 2010 label for EPA Registration No. 2517-RUG has the same 

### CRP directions as were used in the 

### CRP testing, All the requirements for CRP have been mettor EPA Registration No. 2517- RUG. 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.

Rosali nd L. Gross UNITED STATES ENVIRONMENTALPROTECTION AGENCY WASHINGTON, D.C. 2fW6{)



### NOTE TO RM 10 Rosanna Louie-Juzwiak On"leEOJ,CHDllC.\L**.~,"FETY** ,\:-;-n**POLLI'TJO~** I'REYENTlO;>;" 

### December 23,2010

SUBJECT: Certification to Compliancewith Child-Resistant Packaging Regulations EPA FILE NO: 2517-RUG, DP 382786, Decision

### # 438363 TheAugust 11. 2010 CRP certification and bridging letter (indicating the same size and color package as package tested) for EPA Registration No. 2517-RUG are acceptable. The August 11, 2010 label for EPA Registration No. 2517-RUG has the same CRP directions as were used in the CRP testing. All the requirementsfor CRP have been melfor EPA Registration No. 2517- RUG. 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 rightto reexamine this data comprehensively and to question the child resistance ofthe package involved. Thankyou for your cooperation in this matter. Ifyou have any questions please contact me at (703)-308-7368.

Rosalind L. GrossSergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha,NE68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com August 11,2010 Richard Gebken, PM10 Office ofPesticide Programs (7504P) 

### U.S. Environmental Prote'Si0n Agency Document**Processir~** Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: 

### Child Resistant Packaging Certification Sergeant's Fipronil + 

### Cyphenothrin +

### Nylar Squeeze-On for Dogs

### EPAFileSymbol251~**\l\}.~** DearMr. Gebken: I certify thatthe packagingused for the following productmeets the standards of40 CFR 157.32, including the revised standards 

### in 16 CFR 1700.15(b), when tested by the revised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July21, 1995):

• Sergeant's Fipronil 

### + Cyphenothrin

### + Nylar Squeeze-On for Dogs (EPA File Symbol 2517-NBW)

# "vG Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th Plaza, Omaha, NE 68130-1770, 

### EPACompanyNumber 2517) 

### is submittingthis child resistantpackaging certificationto support for the new end-use product Sergeant's Fipronil 

### + Cyphenothrin

### + Nylar Squeeze-Qn for Dogs (EPAFile Symbol 2517-NEW). All product labels have language specifyingthe use ofscissors 

### to openthe product container and label language 

### statingthe product is notto be appliedby children. 

### Ifyou 

### have anyquestions, please contactme at 402-938-7079. 

### Sincerely, 

# £-.**~\9,~~** 

# I
Kelly R. Hoskins ManagerofTechnical Affairs



### cc: Larry

### Nouvel

### Sergeant's PetCareProducts, Inc. 2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax402.938.7091 • www,sergeants.com 

### August 11, 2010 Rosalind Gross 

### cJo Richard Gebken Registration Division Office ofPesticide Programs (7504P) U.S, Environmental ProtectionAgency DocumentProcessing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 6 !LeJ-"



### Subject: ChildResistant Packaging Infonnation Sergeant's Fipronil 

### + Cyphenothrin

### +Nylar Squeeze-On for Dogs (EPAFiIf: ' Symbol: 2517-lIrnW) 

# !\-(,( GDearMs. Gross: Sergeant's Pet Care Products, lnc. (Sergeants, 2625 South 158'" Plaza, Omaha, NE 68130-1770, EPA CompanyNumber2517) is submitting arequestto rely onpreviously submitted Child ResistantPackaging (CRP) studies to supportthis new registration. The CRP data were submitted to EPA on April 12,2010in 

### support ofthe pending registration applications under EPAFile Symbols: 2517-RGT, 2517-RGA, 25l7-RGL, and 2517-RGU (all ofwhich contain Fipronil at 9.7-9.8%). Sergeant's generated CRP data on a standard white applicatorin sizes 0.67, 1.34,2.68, and 4.02 mL. The following is a summary table ofthe applicators thatwere tested and submittedto EPA inthe CRP data: Use ApplicatorBase Color FiU 

### Wei.ht (mLl Color Do. Up to 22 lbs White 0.67 Orange ,// Dog 23-441bs White 1.34 Green v / 

### Doe45-88 lbs White 2.68 Red 

## v. Dog 89-1321bs White 4.02 Blue 

### v CRP datais required for this new productbecause ofthe inclusion ofthe active ingredient fipronil (9.8%) in the pet squeeze-onproduct. The CRP testing was conducted on a standard package size and color configurationthat is identical for this product. The Sergeant's Fipronil 

### + Cyphenothrin

### +Nylar Squeeze-On for Dogs productbeing submitted today also contains fipronil at 9.8%. Additionally, Sergeant's already has dog squeeze-onproducts approvedby EPA containing**20~30%** 

### cyphenothrin (EPA Registration Numbers 2517-127 through 2517-132) that are not subject to CRP. This new product contains 5% cyphenothrin and 2% nylar. Furthermore, Sergeant's does not anticipate any additional toxicity through the combination offipronil,
1Sergeant's PetCare Productsl Inc.



# 12-
, 2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### cyphenothrin and pyriproxyfen. When Sergeant's Fipronil 

### + Cyphenothrln 

### +Nylar Squeeze-On for Dogs is marketed, it will utilize the same applicator: color (white) and fill weightcolors per mL fill weight as was used in the submitted and referenced CRP testing. Based on available infonnation, the densityrange ofthe

### pendingproqucts onwhich the CRP datawere generatedis the sam, as the ne\fproduct Q/0-L5 gr/cc).**The~fore,** 

### Sergeant's is relying on MRID's: 48059&03, 48059804, 480598a5, and4805980610 fulfill the CRP datarequirements for 

### Sergeant's Fipronil 

### + Cyphenothrln + 

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

### Sincerely,

Kelly R. Hoskins 

### Manager ofTechnical 

### Affairs

cc: Larry

### Nouvel

2Decision 

### #: 438363 DP 

### #: (382787) PRIA Parent DP 

### #: Submission 

### #: 880188 

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



### * * * Registration Information 

### * * * Registration: 2517-RUG
- SERGEANT'S FIPRONIL "-**CYPHENOI~Bl~+_r-I'(LAR ~qUE** 

-- ---------- Company: 2517· SERGEANT'S PET CARE**P!3_Q!?!:::!C;:_!!5_,_!~~ ~~**  _ Risk Manager: RM 10 Richard Gebken.:_C!.93) 305-670 I**Roo~l!£,:Yt_~~237** _ Risk Manager Reviewer: Rosanna Louie RLOUIE Sent Date: Calculated Due Dale: 23-Mar-2011 Edited Due Dale: Type of Registrallon: Product Registration •**S~ctio~_1_** Ingredlenls:**~Et.Pa~** . __



### * 

### ** Data Package Information 

### * * * Expedite: 

### 0 Yes. No Dale Sent: 05-OcI-2010 Due Back: DP Ingredient:**~!~_pa"g''O''3** __
DP Tille;**~2517-RUG: Effic~~~~~_v!.~** **~__** _ _ _ CSF Included: 

### 0 Yes. No Label Included: 

## 0 Yes. No Parent DP#:

Assigned To Date In Date Out Organization: RD I TRB Last Possible Science Due Date: 2t-Feb-2011 Team Name:**~_ffic~5=Xl!~)** _ Science Due Date: Reviewer Name: Sub Data Package Due Date:

_ Conlractor Name:



### * * * Studies Sent for Review

### * * * Printed on Page 2


### * 

### ** Additional Data Package for this Decision 

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

### * * * Data Package Instructions 

### * * 

### * Attn EFFICACY REVIEWER: Please conduct a product efficacy review ofthe attached package in support ofIhe proposed product. Conlact Rosanna Louie-Juzwiak at 308.0037 with any questions. Attachments:

- cover letler

- draft label

• data matrix 

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

### * * * Registration Information 

### * * * Decision 

### #: 438363 DP 

### #: (382787) PRIA Parent DP 

### #: Submission

### #: 880188 Registration: 2517-RUG
- SERGEANT'S FIPRONIL

### +.**CYPHENO.l~Bl~+_foI'(LAR ~qUE**  Company: 2517·SERGEANT'S PET CARE**P!3_Q!?'!:!C;:_!!5_,_!~~**__________**~~**___________________ Risk Manager: RM 10**~** Richard Gebken.:_C?S!3) 305-670t**Roo~l!£,:Yt_~~237**_______ _ Risk Manager Reviewer: Rosanna Louie RLOUIE

-- ---------- Sent Date: Calculated Due Date: 23-Mar-20t1 Edited Due Date: Type of Registratfon: Product Registration •**S~ctio~_1_** Ingredienls:**~Et.Pa~**_____________________________________________ 

### * 

### ** Data Package Information 

### * * * Expedite: 

### 0 Yes. No Date Sent: 05-Oct-201Q Due Back: DP Ingredient:**~!~_pa"g''O''3** __
DP Title:**~25**t7-RUG:**Effic~~~~~_v!.~**_____________________**~__** __________ _ _ ___**~**________ CSF Included: 

### 0 Yes. No Label Included: 

## 0 Yes. No Parent DP#:

Assigned To Date In Date Out Organization: RD I TRB Last Possible Science Due Date: 2t-Feb-2011 Team Name:**~_ffic~5=Xl!~)** _________________ Science Due Date: Reviewer Name: Sub Data Package Due Date: __________ Conlractor 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 a product efficacy review ofthe attached package in support ofIhe proposed product. Conlact Rosanna Louie·Juzwiak at 308.0037 with any questions. Attachments:

- cover let1er

- draft label

- data matrixDP#: (382787) Page 2 * * * Studies Sent for Review * *" Decision#: (438363)

810.3300fTreatments to control pests of humans and pets 810.3300fTreatments to control pests of humans and pets 45620501

43121 t14

45612701 46298501

43121115

43121116

4634660t

48t29610

43121 t17

45620505

48129611

43121118

43121122

45620504 Pengo, G.; Pollmeier, M.; Barrick, R. (2000) An Efficacy Study of Frontline Spray, Frontline Top Spot, and ML-2,095,988 509T, for the Treatment and Control ofTrichodectes canis in the Dog: Final Report: lab Project Number: PR&D 0022101, PR&D 00221. Unpublished study prepared by Centro Veterinario Oriolo. 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 ofthe 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 Meria!. 40 p. Miller, T. (2003) Effect of Shampoo AfterTreatment with Cyphenothrin Squeeze-on on Efficacy againstAdult Cat Flease (Ctenocephalides felis), Adult Brown Ticks (Rhipicephalus saguineus) on Dogs: Analysis of Data and Conclusions. Project Number; MS/20D. Unpublished study prepared by Sharp Veterinary Hospital and Vetoquinol NA, Inc. 15 p. Cruthers, L. (t993) Product Performance: A Dose Confirmation Study to Verify the Optimal Spray Concentration of RM 1601 for Long Residual Control ofthe 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. (1 993) A Comparative Evaluation of Two Treatment Regimes Using RM t60 t Spray for 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. Cruthers, L. (2003) Dose Titration of a Pyriproxyfen Spot-On Formulation For Flea Ova Sterilization. Project Number: PLRS/0242. Unpublished Study Prepared By Professional Laboratory & Research Services, Inc. 53 p. Sharp, M. (2009) Immediate Efficacy ofa Combined Application of 810.3300lTreatments 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 Conclusions. Project Number; MS/164/D. Unpublished study prepared by Sharp Veterinary Research. 24 p. McCall, J.; McTier, T. (1993) Laboratory Evaluation of RM 1601 Spray for Control Dermacentorvariabllis and Rhipecephalus sanguineus on the Dog: Lab Project Number: RMfTKS/931tl: PSI229LT. Unpublished study prepared by TRS Labs, Inc. 18 p. Gaxiola, S.; Alva, R.; Irwin, J. (2001) PR& 0 0052301: Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509T/DogsiSolutionlTopical: Final Report; Lab Project Number: PR&D 0052301, PR&D 00523. Unpublished study prepared by University of Sinaloa. 40 p. {OPPTS 810.3300} Sharp, M. (2010) Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze-On Against Fleas (Ctenocephalides felis) 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 ofBathing of laboratory Dogs on the Efficacy of RMt60t Spray: Revised: Lab Project Number: RMD 592: P/220LT. Unpublished study prepared byAgresearch Consultants, Inc. 43 p. Cruthers, L. (1993) Efficacy of RM1601C at 3 mllkg and 6 mllkg Against Ixodes scapularis/dammini Nymphs, Dermacentor variabilis Nymphs, Amblyomma americanum Nymphs, Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair as the Testing Substrate: Revised: Lab Project Number: 9320: P1225LT. Unpublished study prepared by Professional lab and Research Services, Inc. 28 p. Marchiondo, A. (2001) PR & 0 0024 t01: Frontline Spray/Frontline**Spot~Dn/ML-2,** 095, 988 509T/DogsiSolutionfTopical: Final Report: lab Project Number: PR&D 0024t01: PR&D 00241. Unpublished study prepared by Stillmeadow, Inc. 29 p. (OPPTS 810.3300} DP#: (382787)

43121t14

45612701 46298501

43121115

43121116

4634660t

48t29610

43121t17

45620505

48129611

43121118

43121122

45620504 Page 2 "" " Studies Sentfor Review"""

Everett, R.; Cunningham, J. (1993) A Dose Titration Study to Determine the Optimal Spray Concentration of RM 1601 for Long Term Control ofthe Cat Flea Ctenocephalides felis and the Brown Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab Project Number: RMD 292: Pf214L T. 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 Shampoo AfterTreatment with Cyphenothrin Squeeze-on on Efficacy againstAdult Cat Flease (Ctenocephalides felis), Adult Brown Ticks (Rhipicephalus saguineus) on Dogs: Analysis of Data and Conclusions. Project Number: MSf20D. Unpublished study prepared by Sharp Veterinary Hospital and Vetoquinol NA, Inc. 15 p. Cruthers, L. (t993) Product Performance: A Dose Confirmation Study to Verify the Optimal Spray Concentration of RM 1601 for Long Residual Control ofthe 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 t60t Spray for 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. Crulhers, L. (2003) Dose Titration of a Pyriproxyfen Spot-On Formulation For Flea Ova Sterilization. Project Number: PLRS/0242. Unpublished Study Prepared By Professional Laboratory & Research Services, Inc. 53 p. Decision#: (438363)

810.3300fTreatments to control pests of humans and pets

Sharp, M. (2009) Immediate Efficacy ofa Combined Application of 810.3300lTreatments to control Fronlline Plus with Cyphenothrin as a Squeeze-On Against Fleas pests of humans and pets (Ctenocephalides felis) and Ticks (Rhipicephalus san9uineus) on Dogs: Analyses of Data Conclusions. Project Number: MS/164/D. Unpublished study prepared by Sharp Veterinary Research. 24 p. McCall, J.; McTier, T. (1993) Laboratory Evaluation of RM 1601 Spray for Control Dermacentorvariabilis and Rhipecephalus sanguineus on the Dog: Lab Project Number: RMfTKS/93!tl: PSI229LT. Unpublished study prepared by TRS Labs, Inc. 18 p. Gaxiola, S.; Alva, R.; Irwin, J. (2001) PR& 0 0052301: Frontline Spray/Frontline Spot-On/ML-2, 095, 988 509T/DogsJSolutionlTopical: Final Report: Lab Project Number: PR&D 0052301, PR&D 00523. Unpublished study prepared by University of Sinaloa. 40 p. {OPPTS 810.3300} Sharp, M. (20tO) Immediate Efficacy Following Application of Fronlline with Cyphenothrin Squeeze-On Against Fleas (Ctenocephalides felis) 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 ofBathing of laboratory Dogs on the Efficacy of RMt60t Spray: Revised: Lab Project Number: RMD 592: P/220LT. Unpublished study prepared byAgresearch Consultants, Inc. 43 p. Cruthers, L. (1993) Efficacy of RM1601C at3 mllkg and 6 mllkg Against Ixodes scapularis/dammini Nymphs, Dermacentor variabilis Nymphs, Amblyomma americanum Nymphs, RhipicephalUS sanguineus Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair as the Testing Substrate: Revised: Lab Project Number: 9320: P1225LT. Unpublished study prepared by Professional lab and Research Services, Inc. 28 p. Marchiondo, A. (2001) PR & 0 0024t01: Frontline Spray/Frontline**Spot~Dn/ML-2,** 095, 988 509T/DogsiSolutionfTopical: Final Report: Lab Project Number: PR&D 0024tOl: PR&D 00241. Unpublished study prepared by Stillmeadow, Inc. 29 p. (OPPTS 810.3300} 810.3300fTreatments to control pests of humans and petsDP#: (382787) Page 3

••• Product and Data Package Ingredients··· Decision#: (438363)

1129032 1129121 1129121 1129013 1129032 195737-68-1 It20068-37-3**~5737-68-1** lPyriproxyfen IFipronil IFipronil(9.8%) lCyphenothrin(5%) !Pyriproxyfen(2%)

### Efficacy Review Date: December 6, 20I0 Efficacy Reviewer: Clayton Myers, Ph.D., Entomologist, 

### RD-IB lJA0 mvcrs.clavtol1(ZL';epa.gov 

## \0/ 703-347-8874 

# L}L/
RiskManager Rev.: Rosanna Louie

2517-RUG Products: 

### EPA Reg. #: A.I.'s: Decision #s: 

### DP#s: Submission: MRIDs: Sergeant's Fipronil + Cyphenothrin**+-Metlrop're"nt~~SqueezeRon** 

### for Dogs**Y:4';p''O'''~1** < > 

### Fipronil (9.8%), Cyphenothrin (5.0%), Pyriproxyfen (2.0%) 438363 382787 R310, New Products, RD Science Review Submitted: 48129609,48129610,48129611,48129612,48129613,



### GLP:

MRID 48129609 Cited:



### No 43121114,43121115,43121116,43121117,43121118, 43121122,43577712,45612701,45620501,45620504, 45620505,45620506,45628201,46298501,46346601, 47849608

Title: Overview and Summary ofFipronil/Cyphenothrin Dog Efficacy for Sergeant's Fipronil 

### + Cyphenothrin SqueezeROn for Dogs (Overview ofother submissions). Guideline: OPPTS 8103300 Study Summary ofthe Results: This submission is an overall summary and clarification ofthe other submitted MRIDs associated withthis application Entomologist's ObservationslDiscussion: Supplementary lnfonnation 

### EfficacyReview Date: December 6, 2010 EfficacyReviewer: Clayton Myers, Ph.D., Entomologist, 

### RD-IB lJA0 mvcrs.clavtol1(ZL';epa.gov

### ~**~** 

### \1:' 703-347-8874 

# L}L/
RiskManagerRev.: Rosanna Louie Products: EPA Reg. #: A.I.'s: Decision #s: 

### DP#s: Submission: MRIDs:



### GLP:

MRID 48129609 

### Sergeant'sFipronil + Cyphenothrin**+-Met~n~~Squeeze-on** 

### for Dogs 2517-RUG 

## \>4"p n**~** , 

### Fipronil (9.8%), Cyphenothrin (5.0%), Pyriproxyfen (2.0%) 438363 382787 R310, NewProducts, RD Science Review Submitted: 48129609.48129610.48129611,48129612.48129613, Cited:



### No 43121114,43121115.43121116,43121117,43121118, 43121122,43577712,45612701,45620501,45620504. 45620505,45620506,45628201.46298501,46346601, 47849608

Title: Overviewand Summary ofFipronil/CyphenothrinDog Efficacy for Sergeant's Fipronil 

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

### OPPTS 8103300 StudySummary oftheResults: This submission is an overall summary and clarification ofthe other submitted MRIDs associated withthis application Entomologist's ObservationslDiscussion: Supplementary InfonnationMRID 48129810 Title: Immediate Efficacy ofa Combined Application ofFrontline Plus with Cyphenothrin as a Squeeze-on against Fleas 

### (Ctenocephalisfelis) 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 nottaken into account for the existing fipronil, therefore fipronil dosage was slightly lowerthan that ofFrontline alone. 18 dogs were allocated to 6 groups of3 dogs each. 

### Group 1, 

### untreated control; Group 2, Frontline alone, Groups 3-5 Frontlineplus cyphenothrin at described rates. Dogs were infested with 100 fleas and 50 ticks one day 

### before treatment, and again at 7 and 14 days after treatment. Counts were made at 1 and 4 hours post treatment and also on day 14 at 1 and 4 hours post placement-this was to measure speed ofkill 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 calculatedusing Abbott's formula. For speed ofkill/repellence, the number ofkilled/repelled fleas on the liner below each 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 orreinfestation with parasites, through 14 days after treatment. 2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-74% for 1-4 hours immediately after treatment. With reinfestations after 14 days from treatment, efficacy exceeded 99% within 4 hours for all treatments that included cyphenothrin. 3. Immediate efficacy on ticks ranged from 2-64% for 1-2 hours immediately after treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95% within 1 hour, for the lowestpercentage ofcyphenothrin treatment, and exceeded 84% for all treatments. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls claims through 14 days aftertreatment. 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 by this data, but not immediately after treatment of the animals. MRID 48129810 Title: ImmediateEfficacy ofa CombinedApplication ofFrontline Plus with Cyphenothrin as a Squeeze-on against Fleas 

### (Ctenocephalisfelis) and Ticks 

### (Rhipicephalus sanguineus) onDogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrin was addedto Frontline plus at 3 rates (5%, 10%, and 15%)

### for efficacy evaluations. Dosevolumes applied were based on theFrontlinelabel, but dilution was nottaken into account for the existingfipronil, therefore fipronil dosage was slightlylowerthanthat ofFrontline alone. 18 dogs were allocated to 6 groups of3 dogs each. Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontlineplus cyphenothrin at described rates. Dogs were infested with 100 fleas and 50 ticks oneday 

### before treatment, and again at 7 and 14 days after treatment. Counts were made at 1and4 hours post treatmentand also onday 14 at 1 and4 hours postplacement-this was to measure speed ofkill 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 calculatedusing Abbott's formula. For speed ofkill/repellence,the number ofkilled/repelled fleas on the liner beloweachtreated dog was dividedbythetotal number offleas placedonthe dog (all x 100), adjusted for 'normal' attrition oncontrol dogs. Study Summary oftheResults: 

### 1. Meanefficacy againstfleas andticks exceeded90% when assessed at 1-2 days after treatment orreinfestation withparasites, through 14 days after treatment. 2. Immediate efficacy onfleas (i.e. kill/repellence within4 hours oftreatment) ranged from 9-74%for 1-4 hours immediately after treatment. Withreinfestations after 14 days from treatment, efficacyexceeded99% within 4 hours for all treatments that includedcyphenothrin. 3. Immediate efficacyonticks ranged from 2-64% for 1-2 hours immediately after treatment. Withreinfestations after 14days from treatment, efficacy exceeded 95% within 1hour, for the lowestpercentage ofcyphenothrintreatment, and exceeded 84% for all treatments. Entomologist's ObservationslDicussion: 1. Efficacyagainstfleas andticks was adequateto support controls claims through 14 days aftertreatment. 2. 'While immediateefficacy against fleas and ticks was enhancedwhen assessed at 1 and 4 hours aftertreatment (or reinfestation), the immediate efficacy did notexceed 90%with anyconsistencyfor thetreatments evaluated immediately after treatment. However, after 14 days, this immediate efficacy was observed for reinfestations of bothfleas andticks. This islikely due to the more complete spread ofthe spot-on material throughout the animal coat at 14days. Claimsfor killing (or 'startskilling') withinhours wouldbe supported bythis data, butnot immediately after treatment of the animals.

### MRID 48129811 Title: Immediate Efficacy Following Application ofFrontline with Cyphenothrin Squeeze-on against Fleas 

### (Ctenocephalisfelis) and Ticks 

### (Rhipicephalus sanguineus) on Dogs. 

### Guideline: OPPTS 810.3300 

### Materials and Methods: Cyphenothrin was added to Frontline plus atthe rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dose volmnes 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 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, 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/orrepellency. Counts were also made at 24 and48 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 kilVrepellence, the number ofkilled/repelled fleas on the liner below each treated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'nonnal' 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 28 days aftertreatment. 2. Immediate efficacy onfleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-68% for 1-4 hours immediately aftertreatment. Withreinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all treatments that included cyphenothrin, but did not exceed 90% within 1 hour after reinfestation. 3. Immediate efficacy on ticks ranged from 5-75% for 1-2 hours immediately after treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all dates. For21 and 28 days from treatment, adequate efficacy was observed within 1 hour ofreinfestation. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls claims through 28 days (one month) aftertreatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at 1 and 4 hours after treatment (orreinfestation), 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 ofbothfleas and ticks. This is likely due to the more complete spread ofthe spot-onmaterial throughoutthe animal coat at 7+ days. Claims for killing (or MRID48129811 Title: ImmediateEfficacy FollowingApplication ofFrontlinewith Cyphenothrin Squeeze-on against Fleas 

### (Ctenocephalisfelis) and Ticks 

### (Rhipicephalussanguineus) onDogs. 

### Guideline: OPPTS 810.3300 

### Materials andMethods: Cyphenothrinwas added to Frontline plus atthe rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dosevolmnes applied were based on the Frontlinelabel, butdilution was not taken into account for the existingfipronil, therefore fipronil dosage was slightly lower than that 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 beforetreatment, and again at 7, 14,21, and 28 days aftertreatment. Counts were made at 1and 4 hoursposttreatment and also after everyreinfestation-thiswas to measure speed ofkill and/orrepellency. Counts were also made at24 and48 hours after initial infestation and all re-infestations. Parasites were not removed until the final count. Mortality was calculatedusing Abbott'sformula. For speed of kilVrepellence, the number ofkilled/repelled fleas on the liner below each treated dog was divided bythetotal number offleas placed on the dog (all x 100), adjusted for 'nonnal' attrition on control dogs. StudySummaryofthe Results: 1. 

### Meanefficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after treatment orreinfestation with parasites, through 28 days aftertreatment. 2. Immediate efficacy onfleas (i.e. kill/repellence within 4 hours oftreatment) ranged from 9-68% for 1-4hours immediately aftertreatment. Withreinfestations after 7, 14,21, and 28 days from treatment, efficacy exceeded 90% within 4hours for all treatments that included cyphenothrin, but did not exceed 90% within 1hour after reinfestation. 3. Immediate efficacy on ticks ranged from 5-75% for 1-2 hours immediately after treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all dates. For21 and 28 days from treatment, adequate efficacy was observed within 1hour ofreinfestation. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controlsclaims through28 days (one month) aftertreatment. 2. While immediate efficacy against fleas and ticks was marginally enhanced when assessed at 1 and 4 hours after treatment (orreinfestation), the immediate efficacy did notexceed 90% with any consistencyfor the treatments evaluated immediately after treatment. However, after 7 days, this immediate efficacy was observed for reinfestations ofbothfleas and ticks. This is likely due to the more complete spread ofthe spot-onmaterial throughoutthe animal coat at 7+days. Claims for killing (or

### 'starts killing') within hours would be supported by this data, but not immediately aftertreatment ofthe animals.

MRID 48129812 Title: Immediate Efficacy Following Application ofFrontline Plus with Cyphenothrin**Squeeze~** 

### on against Fleas (Ctenocephalisfelis) 

### and Ticks (Rhipicephalus sanguineus) 

### on Dogs. 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 taken into 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 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline alone
.. Dogs were infestedwith 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 I and 4 hours posttreatment and also after every reinfestation-this was to measure speed ofkill and/orrepellency. 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 liner below eachtreated 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 orreinfestation with parasites, through 35 days aftertreatment. 2. Immediate efficacy on fleas (i.e. kill/repellence within4 hours oftreatment) ranged from 0-75% for**1~4** 

### hours immediately aftertreatment. Withreinfestations 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. Withreinfestations after 7, 14, 21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for reinfestations on days 14,21,28, or 35 days after treatment. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls claims through 35 days (one month) aftertreatment. 2. While immediate efficacy againstfleas andticks was marginally enhanced when assessed at 1 and 4 hours after treatment (or reinfestation) compared to fipronil alone, 'startskilling') within hours would be supportedby this data, but not immediately aftertreatment ofthe animals.

MRID 48129812 Title: Immediate Efficacy Following Application ofFrontlinePlus with Cyphenothrin**Squeeze~** 

### on against Fleas 

### (Ctenocephalisfelis) and Ticks 

### (Rhipicephalussanguineus) on Dogs. 

### Guideline: OPPTS 810.3300 Materials and Methods: Cyphenothrinwas added to Frontlineplus at the rate ofapproximately 5% (4.76% cyphenothrin) for efficacy evaluations. Dosevolumes applied were based on the Frontlinelabel, butdilutionwas not taken into account for the existingfipronil, 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 infestedwith 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-thiswas to measure speed ofkill and/orrepellency. 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'sformula. For speed of kill/repellence, the number ofkilled/repelled fleas onthe linerbelow eachtreated dog was divided by the total number offleas placed on the dog (all x 100), adjusted for 'nonnal' attrition oncontrol dogs. Study Summary oftheResults: 1. Meanefficacy against fleas and ticks exceeded 90%when assessed at 1-2 days after treatment orreinfestation with parasites, through 35 days aftertreatment. 2. Immediateefficacy onfleas (i.e. killlrepellence within4 hours oftreatment) ranged from 0-75% for**1~4** 

### hours immediately aftertreatment. Withreinfestations after 7, 14,21,28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all onlythe 7 dayreinfestation. Efficacy didnot exceed 90% within 4 hours for reinfestations on days 14,21,28,or 35 days after treatment. 3. Immediateefficacy onticks ranged from 11-71% for 1-4hours immediately after treatment. Withreinfestations 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 ondays 14,21,28, or 35 days after treatment. Entomologist's ObservationslDicussion: 1. Efficacy against fleas and ticks was adequate to support controls claimsthrough 35 days (one month) aftertreatment. 2. While immediate efficacy againstfleas andticks was marginally enhanced when assessed at 1 and 4 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 datadoes not support any claims for faster kill or repellence due to the addition ofcyphenothrin.


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

### andtick (Haemaphysalis elliptica, Rhipicephalus sanguineus, 

### andDermacentor variabilis) 

### infestations on dogs. Guideline: 

### OPPIS 810.3300 Materials and Methods: Cyphenothrin was addedto Seargeant's Fipronil-Methroprene formulationFrontline plus at the rate ofapproximately 5% for efficacy evaluations. This treatment was comparedto fipronil-methoprene alone, and apositive 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 atthe high end ofeach respective weight class. Dogs were subgrouped by weight class with 6 dogs in each subclass (split overtime to 3 dogs ofeach class in 2 consecutive studies). Group I, untreated control; Group 2, Fipronil+Methoprene, Group 3, Fipronil+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs were infested with 100 fleas and 50ticks one day before treatment, and again at 7, 14,21, and 28 days after treatment. Counts were made at I 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 calculatedusing Abbott's formula. For speed ofkillirepellence, the number of killed/repelled fleas on the linerbelow each 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 exceeded 90% when assessed at 2 days after treatment or reinfestation with parasites, 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 inunediate efficacy claims (i.e., within IA hours ofapplication or reinfestation by parasites) are supportedby this 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 7days after treatment. This datadoes not support any claims for faster kill or repellence 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) 

### andtick (Haemaphysalis elliptica, Rhipicephalussanguineus, 

### andDermacentor variabilis) 

### infestations on dogs. Guideline: OPPTS 810.3300 

### Materials and Methods: Cyphenothrin was addedto Seargeant'sFipronil-Methroprene formulationFrontlineplus at the rate ofapproximately 5% for efficacy evaluations. This treatment was comparedto fipronil-methoprene alone, and apositive control, Merial'sFrontline Plus. Dose volumes appliedwere based on a titration by whichdogs received 0.067 mLlkg body weight, to simulate the dosing atthe high end ofeachrespective weight class. Dogs were subgrouped by weight class with 6 dogs in each subclass (split overtime to 3dogs ofeach class in 2 consecutive studies). Group I, untreated control; Group 2, Fipronil+Methoprene, Group 3, Fipronil+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs were infested with 100 fleas and 50ticks one day before treatment, and again at 7, 14,21, and 28 days after treatment. Counts were made at I and 4 hours posttreatment andalso 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 calculatedusing Abbott's formula. For speed ofkillirepellence,the number of killed/repelled fleas on the linerbeloweach treated dog was divided bythe total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition oncontrol dogs. StudySummary ofthe Results: 1. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment or reinfestation with parasites, 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. Noinunediate efficacy claims (i.e., within I A hours ofapplication or reinfestation by parasites) are supportedbythis data.Overall Review 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 except to state "starts killing within hours" or "starts killing in as little as one holli'''. No data was cited or submitted in this application to support any claims against mosquitoes, therefore, any such claims mustbe deleted from the label. Repellence claims for fleas and ticks are not supported and must 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 9 weeks after treatment.
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 and mosquitoes claim must be deleted. Controls flea reinfestation for up to (12 weeks]: Fast Acting: Unacceptable Kills ticks (in as little as I hour): Acceptable only ifrevised to say 'starts killing' Kills ticks including those thatmay transmit Lyme disease: Acceptable Dogs can be bathed 24 hours aftertreatment: Unacceptable Waterproof: Acceptable Long Lasting: Acceptable Research demonstrates that [brandname] kills adult fleas (in as little as 1 hour). flea eggs, larvae and pupae for more than [63 days] [9 weeks]: Acceptable only ifrevised to 'starts' killing. Claim against 'pupae' must be deleted, as no data was submitted indicating the productkills flea pupae exposed to residue. [brand name] prevents development ofall flea stages for more than [63 days] [9 weeks]: Acceptable Kills fleas (in as little as I hour), ticks (in as little as I holli'). mosquitoes, (chewing) lice. flea eggs, larvae. and pupae: Acceptable only ifkills claims are revised to 'starts killing' and mosquitoes claim must be deleted 

### 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 "startskilling in as little as one hOtrr". No data was cited or submitted in this application to support any claims against mosquitoes, therefore, any such claims mustbe deleted from the label. Repellence claims for fleas and ticks are not supported and must beremoved from the label. Kill claims against flea eggs or larvae, are supported. Control claims against flea eggs or larvae, or claims against breakingthe flea life cycle are supported for up to 9 weeks after treatment.
LinebyLineReview 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 andticks. Kills (and Repels) Fleas. Ticks. and Mosquitoes: Repels claim and mosquitoes claim must be deleted.
. A

## c.cn~\k(' OVllA.) Acceptable 

### ,A\\v' 

## '1,.,. ..1**~c** 

## iI-\(**~** OJ

### V~U'-"-' 

### Controls flea reinfestation for up to (12 weeks]: Fast Acting: Unacceptable Killsticks (in as little as I hour): Acceptable onlyifrevised to say 'startskilling' Kills ticks including those thatmaytransmit Lyme disease: Acceptable Dogs can be bathed 24 hours aftertreatment: Unacceptable Waterproof: Acceptable LongLasting: Acceptable Research demonstrates that [brandname] kills adult fleas (in as little as 1hour). flea eggs, larvae andpupae for more than [63 days] 

### [9 weeks1: Acceptable only ifrevised to 'starts' killing. Claim against 'pupae' mustbe deleted, as no datawas submitted indicating the productkills flea pupae exposed to residue. [brand name] prevents development ofall flea stages for more than [63 days] [9 weeks]: Acceptable Kills fleas (in as little as I hour), ticks (in as little as I hotrr)' mosquitoes, (chewing) lice. flea eggs, larvae. and pupae: Acceptable only ifkills claims are revised to 'startskilling' and mosquitoes claim must be deleted

### Prevents all flea stages (adult fleas (in as little as I hour), flea eggs. flea pupae, and flea larvae): Acceptable except claim against 'pupae' must be deleted, as nO datawas submitted indicating the product kills flea pupae exposed to residue. Ifdog is ahighrisk for flea re-infestation once a month application may be needed: Acceptable. Once a monthtreatment is recommended: Acceptable. A once monthly applicationis 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' mu.stbe deleted, as no datawas submitted**indic~ti?-g ~e**  

### product**kill~** 

### flea pupae exposedto reSIdue.**L\V\O~CL~'>';W'O\r.l·,** Dr,l,,11**V~\:** i"O 

# qwe.e.k$ Aids incontrol ofsarcoptic mange: Acceptable. Kills fleas (in as little as I hour), ticks (in as little as I hour). mosquitoes. flea eggs. and lice: Acceptable only ifkills claims are revised to 'starts killing', and mosquitoes claims must be deleted. [Seven] [71 Way Protection! Kills fleas (in as little as I hour). ticks (in as little as I hour). mosquitoes. lice flea eggs. & 

### flea larvae: '7-way' is anunacceptable nebulous claim. Kills claims mustbe revisedto 'starts killing' and mosquitoes claim mustbe deleted 6 [Six] Way Protection! Kills fleas (in as little as I hour). ticks (in as little as I hour), mosquitoes. lice. flea eggs & 

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

### Treatment]: Acceptable Four (4) WeekFlea. Tick. Mosquitoe and Lice Control: Acceptable WithNylar® Insect Orowth Regulator which Breaks the Flea Life Cycle: Acceptable WithNylar® to Break Flea Life Cycle: Acceptable With Insect Growth Regulator to BreakFlea Life Cycle: Acceptable Dual Action [!]: Fipronil with Nylar® lOR Effectively Breaks the FleaLife Cycle: Acceptable. Prevents all flea stages (adult fleas (in as little as I hour), flea eggs, flea pupae, and flea larvae): Acceptable exceptclaim against 'pupae' mustbe deleted, as nO datawas submittedindicating the product kills flea pupae exposed to residue. Ifdog is ahighrisk for flea re-infestation once a month application may be needed: Acceptable. Once a monthtreatment is recommended: Acceptable. A once monthly applicationis 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 [larvae1 [pupae] for up to 4 months: Acceptable except claim against 'pupae' mu.stbe deleted, as no datawas submitted**indic~ti?-g ~e**  

### product**kill~** 

### flea pupae exposedto reSIdue.**l'\v\O~CL~'>';W~\r.l·, Df',l~11** **V~\:** '{"O 

# qwe.e.k£ Aids incontrol ofsarcoptic mange: Acceptable. Kills fleas (in as little as I hour), ticks (in as little as I hour), mosquitoes, flea eggs, and lice: Acceptable only ifkills claims are revised to 'startskilling', and mosquitoes claims must be deleted. [Seven] [71 Way Protection! Kills fleas (in as little as I hour), ticks (in as little as I hour), mosquitoes, lice flea eggs. & 

### flea larvae: '7-way' is anunacceptable nebulous claim. Kills claims mustbe revisedto 'startskilling' and mosquitoes claim mustbe deleted 6 [Six] Way Protection! Kills fleas (inas little as I hour), ticks (in as little as I hour), mosquitoes, lice, flea eggs & 

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

### Treatment]: Acceptable Four (4) WeekFlea. Tick, Mosquitoe and Lice Control: Acceptable WithNylar® Insect OrowthRegulator which Breaksthe Flea Life Cycle: Acceptable WithNylar® to BreakFlea Life Cycle: Acceptable With Insect Growth Regulator to BreakFleaLife Cycle: Acceptable Dual Action [!]: Fipronil with Nylar® lOREffectively Breaksthe FleaLife Cycle: Acceptable.

### Triple Action [!J: 

### Effectively Breaks the FleaLife Cycle [!J: Acceptable Bestifused year round!: Acceptable Kills & 

### Repels Fleas (in as little as 1 hour) Up to [4 weeksJ![2 monthsJ [3 months): Kills must be revised to 'starts killing' and 'repels' claim must 

### be deleted. Ow'\\Aj

## Wf<

## -..k Cj (ICON showing 4 week protection): Acceptable 4 Week Dose!: Acceptable I Month Dose!: Acceptable Specially Fonnulated for Dogs and Puppies: Acceptable Kills Flea Eggs & 

### Flea Larvae for more than [63 days]. [9 weeksJ!: Unacceptable unless revised to '2 months' or 'up to 4 months'. Prevents FleaEggs From Developing Into Biting Adults: Acceptable Kills Ticks (in as little as 1 hour) for Up to [4 weeksJ!: Acceptable only ifrevisedto 'starts killing'
. Kills [all stages of! Deer Ticks (vector ofLyme Disease) for up to 4 weeks: Acceptable Kills [Brown). [American.] [and Lone StareJ Dog Ticks: Acceptable Kills Rhipicephalussangu;neus 

### for up to 4 weeks: Acceptable When used monthly [brandnameJ completely breaks the flea life cycle and controls tick and chewing lice infestations: Acceptable Kills American Dog Ticks 

### [(Dermacentor variabilis)Jfor up to 4 weeks!: Acceptable Apply once every [4 weeksJ!: Acceptable 4 weeks Flea and Tick Treatment: Acceptable Once A Month Fleaand Tick Treatment: Acceptable Kills & 

### Repels Fleas (in as little as 1 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 Triple Action [!J: 

### Effectively Breaksthe FleaLife Cycle [!J: Acceptable Bestifused year round!: Acceptable Kills & 

### Repels Fleas (in as little as 1hour) Up to [4 weeks]![2 months1 [3 months): Kills must berevised to 'starts killing' and 'repels' claim must 

### be deleted.**Ow'\~**

## Wf<**~** 

### Cj**~** 

### (ICON showing4 week protection): Acceptable 4 Week Dose!: Acceptable I MonthDose!: Acceptable SpeciallyFonnulatedfor Dogs and Puppies: Acceptable Kills FleaEggs & 

### Flea Larvae for morethan [63 days). [9 weeksJ!: Unacceptable unless revised to '2 months' or 'upto4 months'. PreventsFleaEggsFromDeveloping Into Biting Adults: Acceptable Kills Ticks (in as little as 1hour) for Up to [4 weeks]!: Acceptable onlyifrevisedto 'starts killing'
. Kills fall stages of! DeerTicks (vector ofLyme Disease) for upto 4 weeks: Acceptable Kills [Brown1- [American.] [and Lone Stare] Dog Ticks: Acceptable KillsRhipicephalussanguineus for up to4 weeks: Acceptable When used monthly [brandname] completely breaks the flea life cycle and controls tick and chewing lice infestations: Acceptable Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to4 weeks!: Acceptable Apply once every [4 weeks]!: Acceptable 4 weeks Flea and Tick Treatment: Acceptable Once A MonthFleaand Tick Treatment: Acceptable Kills & 

### Repels Fleas (in as little as 1hour) and Ticks (in as little as I hour) for up to 4 weeks!: Only acceptable ifrevised to startskilling, and also the repels claim must be deleted. Kills all stages ofthe flea life cycle: Acceptable

### Kills fleas (in as little as 1 hour). Ticks (in as little as I hour), FleaEggs & 

### Flea Larvae for more than [63 days] [9 weeks]: Acceptable only ifrevisedto 'starts killing' Kills mosquitoes: Unacceptable Dogs can be bathed 24 hours after squeeze-onis applied: Unacceptable Prevents and controls reinfestations: Unacceptable unless apest and duration ofcontrol is associated (e.g., 'prevents and controls reinfestations oflisted pests for I month [4 weeks]'). 

### BACK/SIDE CARTON LABEL-MASTERLABEL fbrand name] containes Fiproni!. cyphenothrin. and the insect growth regulator OGR) nylarto effectively kill [and repel] Fleas [(in as little as I hour)]. Ticks [(in as little as 1 hour)]. and kills mosquitoes and (chewing) lice. The active ingredients in [brand name] work by collecting in the hair follicles and skin oils. Tills product features a sustained-release fonnula 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 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 I hourmust be revisedto 'starts acting' or 'starts killing' or alternatively, the claims of'in little as I hour' can be removed. 'Fast acting' claim mustbe removed. The claims about movementin hair follicles is deferred to the RM Reviewer and PM. Kills fleas (in as little as 1hour). Ticks (inas little as I hour), FleaEggs & 

### FleaLarvae for more than [63 days] [9 weeks]: Acceptable only ifrevisedto 'startskilling' Kills mosquitoes: Unacceptable Dogs canbe bathed 24 hours after squeeze-onis applied: Unacceptable Prevents and controlsreinfestations: Unacceptable unless apest and duration ofcontrol is associated (e.g., 'prevents and controls reinfestations oflistedpests for I month [4 weeks]'). 

### BACK/SIDE CARTONLABEL-MASTERLABEL fbrand name] containes Fiproni!. cyphenothrin. and the insect growth regulator OGR) nylarto effectivelykill [and repel] Fleas [(in as little as I hour)]. Ticks [(in as little as 1hour)]. and kills mosquitoes and (chewing) lice. The active ingredients in [brand name] work by collectingin the hair follicles and skin oils. Tills product features a sustained-release fonnulathat 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 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 I hourmustbe revisedto 'starts acting' or 'starts killing' or alternatively, the claims of'in little as I hour' canbe removed. 'Fastacting' claim mustbe removed. The claims about movementin hair follicles is deferred to the RM Reviewer and PM.**-------------~- -~-** **-~~~~~--------------~------------------** 

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# Completion of

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--- EPA Reg. # (File Symbol) 

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# Herbicide Branch: PM-23 PM-25 

# Fungicide Branch: PM-20 PM-21 PM-22


# Insect/RodentBranch: PM-l PM-7

*Reminderto PM

- Ifapplicable, pick-up data from the Screening Room. ProcessedbyRD's Completeness CheckTeam
(TeamMember Signature) (Date)

# 21-Day Screen Completed by Contractor 

# 21-Day Expires on**~l_-/_-_!_O** 

# _ Jacket 

# # c?!5/7- f(Ub

# MRID# Lf<g f

# 8'i51 

# Content Screen: Recommended to

# lPas~/Fan 86-5 Review:

# l!asse~Failed/NA 

# Transfer This Jacketto:

# Memorandum Date: 

# 8" / It / I 0 

# To:

__**--'-P--'M~---'-I...J...O'-----,'**

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

# We expect that it will be approximately 5 days from the above date before the study-level data is available in OPPIN. If

# you have any questions about this process, please contact TeresaDowns (305-5363).
This is a: I1-fully accepted submission 

# o partially accepted submission 

# o rejected submission 

# Memorandum Date: 

# 8" / It / / 0 

# To: __**--'-P--'M~---'-/..J...O'-----,'** 

# RegulatoryManager From: Information Services Branch, ITRMD Yourreceipt ofthis data submissionis notan indicationthatMRIDs for the enclosed studies have beenpostedto OPPIN. 

# We expectthatit willbe approximately 5 days from the above date before the study-level data is available in OPPIN. If

# youhave any questions aboutthis process, please contact TeresaDowns (305-5363).
This is a: I1J'ully accepted submission 

# o partially accepted submission 

# orejected submissionUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

August 16,2010 OFFICEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158TH PLAZA OMAHA, NE 68130-1703
Report ofAnalysis for Compliance with PRNotice 86-5 Thank you for your submittal**of1I~AUG-10.** Our staffhas completed apreliminary analysis ofthe material. Theresults are provided as foUows: Your submittal was found to be in fuU compliance with the standards for submission of data contained 

### in PR Notice 86-5, A copy ofyour bibliography is enclosed, annotated with Master Record ID's (MRIDs) assigned to each document submitted. Pleaseuse these numbers in aU future references to these documents. Thank you 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 withPRNotice 86-5 OFFICEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal oflI-AUO-IO, Our staffhas completed apreliminary analysis ofthe material. Theresults areprovided as follows: Your submittal was found to be in

### full compliance withthe standards for submissionof data contained 

### in PR Notice 86-5. A copyofyour bibliographyis enclosed, annotated with Master Record ID's (MRIDs) assigned to eachdocument submitted. Pleaseuse thesenumbers in 

### all future references to these documents, Thank you for your cooperation. Ifyou have any questions concerning this data submission, please raise themwiththe cognizant Product Manager, to whom the datahavebeenreleased,Company:

## p""S"1""'- ;SERGEANT'S PET CARE PRODUCTS'."'N"C'.

### ~~ r--'_M

__ , S: 13'60168 Regulatory Type: Product RegistratIOn
- Section 3 Application Type: lNeiw Registration Fee For Service: Billable: r. Yes 

### r No Print Letter Enter More Irrlormmion Tracking

Risk Manager: jRegistration Division,**Ri~k** ManlllgetTlentT'earn 10 

# 'G:J ProductI:'**2511~RUG** ' 

# !Product Name:**IsERGEA~T'S** FIi>R0NIL +**CYPHENOTHR~N** + Ii**~-:-c--.--~---­**

# 'A**:::;;;-..:....-~·~·l.,-·~~-** 

### "'f::::":,::,,

I 

### I 

# =-.JI481889-00 Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE**68130~** 1770 • Telephone 402.938.7000 • Fax402.938.7091 • www.sergeants.com



### August 11,2010 Richard Gebken, PMI0 Office ofPesticide Programs (7504P) (REGFEE) 

### U.S. Environmental ProtectionAgency 

### Document Processing Desk Room 8-4900, One PotomacYard 2777 South Crystal Drive Arlington, VA 22202 Subject: 

### Sergeant's Fipronil 

### + Cyphenothrin

### + Nylar Squeeze-On forDogs EPAFile Symbol 2517-NEW DearMr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeants, 2625 South 158th 

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

### EPA CompanyNumber 2517) is submitting an EPAregistration application for the new end-use product Sergeant's Fipronil 

### + Cyphenothrin 

### + Nylar Squeeze-On for Dogs [containingthe EPA registered active ingredients Fipronil (9.8%), Cyphenothrin (5.0%), and Pyriproxyfen (Nylar) 

### (2.0%)]. Please find enclosed the following documentation in support 

### ofthis registration: (I) (2) 

### (3) 

### (4) (5) (6) 

### (7) (8) (9) 

### (10) (11) (12) (13) (14) (15) (16) (17) 

### Transmittal Document; Application for Registration (EPA Form 8570-1); Confidential Statement ofFormula (EPAForm 8570-4) (Two Copies); Formulator's Exemption Statement (EPAForm 8570-27); Certification With Respect to Citation ofData (EPAForm 8570-34): DataMatrix (EPA Form 8570-35)

- EPA and Public Versions; Product Label (Five Copies); 

### Letter ofAuthorization; ChildResistantPackaging (CRP) Certification Statement; Bridging Argument to Cite CRP Data; 

### Submission ofEPA Pesticide Registration Improvement Act Information; Voluntary Small Business Certification Form; PRIAFeeWaiver Certification Statement; PRIA FeeWaiver Support Letter; RecentEPA Approval of50% Small Business WaiverRequest (D-425455); PRIA Category R31 0, Payment Confirmation Receipt; and Three Copies ofSupporting Studies. 

### The registration ofSergeant's 

### Fipronil 

### + Cyphenothrin 

### +Nylar Squeeze-On for Dogs is a selective citation registration for anew end-use product. Sergeant's is submitting new product chemistry studies in support ofthis 

### end-useproduct registration. Additionally, Sergeant's is citing acute toxicity studies, companion animal safetydata, and efficacy studies submittedto ISergeant's Pet Care Products, Inc. 2625 South t58th Plaza • Omaha, NE**6a130~** 1770 • Telephone 402.938.7000 • Fax 402.938.709t • www.sergeants.com EPA onJune 18, 2010 with the registration application for 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 fonnulated end-use products. This registration application is considered aPRIA CategoryR310 (new end-use product) with a PRIAreview time of6 months. Sergeant's submitted a PRIA Small Business Waiver Request under separate cover on April 14, 2010, and it was approvedby EPA onMay 4,2010. A copy of this approval letteris enclosed. We look forward to working with the Agency to register Sergeant's Fipronil 

### + Cyphenothrin

### + Nylar Squeeze-Onfor Dogs. Ifyou have any questions orneed additional infonnationregarding this registration application, please contactme at**402-938~** 7079. Sincerely,

# ~d- 

# e-. Hoiuw.)btl KellyR. Hoskins Manager ofTechnical Affairs Enclosures

2

### TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Sergeant's Pet Care Products, Inc. 2625 South 158tl' 

### Plaza Omaha, NE 68130-1770 CONTACT PERSON (Returnto) Kelly R. Hoskins Sergeant's Pet CareProducts, Inc. 2625 South 158tl' 

### Plaza Omaha, NE68130-l770 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 +NylarSqueeze-On for Dogs. SUBMITTAL DATE: August 11,2010

Volume StudyTitle MRlDNo. 1 Administrative Materials

.. 

## - 2 Group A 

### Product ChemistryFor Sergeant's Fipronil 

### + Cyphenothrin

### +Nylar Squeeze-OnForDogs 48188901

.. 

### ---- 3 Group B Product ChemistryFor Sergeant's Fipronil 

### + 48188902 

### ICyphenothrin

### +Nylar Squeeze-OnForDogs

.. . 

### -

3'-"',d•.: S:llrl E."·,,,,; ."'11**~,,;,:I'O." :.,~.r'1:,** **Cift~1** C: PUI'C,(jl**~1C'V'~'nl Ir;IOtrr,~I,ur** **~~IOU':fl** Inc**Sr."~'~11** ::''''II,on**Ir,fo"n~ltOr, :'~~'~'I**  a.,H.C.". 

## • 

# BEPA

Plvf: 10**----------,-------~--** 

# C:f-<:E?vITCAl 

# No.: --'-

_

Thejacket for 

# this action can be 

# requested through the J"-',CKETS system.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

October 4, 2010 OFFlCEor PREVENTION, PESTICIDES AND TOXIC SUBSTANCES opp 

### DecisionNumber: D-438363 EPA File Symbol or Registration Number: 2517-RUG ProductName: SERGEANT'S F1PRONIL 

### + CYPHENOTHRIN 

### +NYLAR SQUEEZE-ON FOR DOGS EPA Receipt Date: 11-Aug-2010 EPA Company Number: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PET CARE PRODUCTS, INC. 2625 SOUTH 158THPLAZA OMAHA, NE 68130-1703


### SUBJECT: Receipt ofRegistration Application Subjectto Registration Service Fee DearRegistrant: 

### The Office ofPesticide Programs has received your application and certification of payment. Ifyou 

### submitted datawith 

### this application, the results ofthe 

### PRN-86-5 screen will be communicated separately. Duringthe administrative screen, the Office ofPesticide Programs has detennined that this Action is subjectto aPesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Action previously identified as R320 has been reclassified as Action Code: R310 NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLlC HEALTH PEST EFFICACY);



### The fee associated with this aciton is $ 2,289 (50% of$ 4,578). Payment

### ifthe amount of $ 5,712 has been received. 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. 

### Sincerely, Front End g Staf Inform trOn

### T~olo esources ManagementDivisionUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

August 30,2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT Or Pay On-Line at www.Pay.Gov (See Below for Details) OPP Decision Number: D-438363 EPA File Symbol or Registration Number: 2517-RUG ProductName: SERGEANT'S FIPRONIL 

### + CYPHENOTHRlN 

### + NYLAR SQUEEZE-ON FOR DOGS EPA Receipt Date: II-Aug-2010 EPA Company Number: 2517 Company Name: 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 Subjectto Registration Service Fee Dear Registrant: The Office ofPesticide Programs has received your application for registration. Ifyou submitted data with this application, the results ofthe PRN M 86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has detennined thatthis Action is subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Actionpreviously identified as R31 0 has been reclassified as Action Code: R320 NEW PRODUCT;NON-FAST TRACK;NEWPHYSICALFORM (EXCLUDES SELECTIVE CITATIONS); The fee associated with this action is $ 5,712 (50% of$ 11,424). Payment in the amount of $ 2,289 has been received. 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 COPYOF THIS LETTERWITH PAYMENT Or Pay On-Line atwww.Pay.Gov (See Belowfor Details) OPP DecisionNumber: D-438363 EPAFile Symbol orRegistrationNumber: 2517-RUG OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

ProductName: SERGEANT'S FIPRONIL 

### +CYPHENOTHRIN

### +NYLAR SQUEEZE-ON FORDOGS EPAReceipt Date: ll-Aug-2010 EPA CompanyNumber: 2517 CompanyName: SERGEANT'S PETCAREPRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PETCARE PRODUCTS, INC. 2625 SOUTH 158THPLAZA OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subjectto Registration ServiceFee DearRegistrant: The Office ofPesticideProgramshas receivedyour application for registration. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will becommunicated separately. Duringthe administrative screen, the Office ofPesticide Programshas detennined thatthis Action is subjectto a Pesticide Registration Service Fee as defined inthe Pesticide Registration ImprovementAct. TheActionpreviouslyidentified as R310 hasbeenreclassified as Action Code: R320 NEWPRODUCT;NON-FASTTRACK;NEWPHYSICALFORM (EXCLUDES SELECTIVE CITATIONS); The fee associated withthis action is $ 5,712 (50%of$ 11,424). Paymentinthe amount of $ 2,289 has beenreceived. Pleaseremit additional paymentinthe amountof$ 3,423. By USPS:

USEPAWashingtonFinance Center Pesticide Registration ServiceFee PO Box 979074 St. Louis, MO 63197-9000

### By Courier: U.S. Bank Government Lockbox 979074 1005 Convention Plaza SL-MO-C2-GL St. Louis, MO 63197 Telephone: (412) 236-2294 All payments must be in United States currency by check, bank draft, or money order drawn to the orderofthe Environmental Protection Agency. To ensure proper credit, please write the OPP DECISIONNUMBER on your check, and enclose a copy ofthis letter with your payment. Effective November 1,2006, fees may be paidon-line via credit card or electronic fund transfer. To submit a paymenton-line, visit www.pay.gov. From the pay.gov home page, select "search by fonn name." Fromthe next page, select "P," then clickon "Pesticide Registration Improvement Act. Fee Payment" and complete the form, making certain to use the decision number and registration number onthe invoice you receive from the Pesticide Program in the space provided. You may be eligible for a partial waiverofthe registration service fee if, for example, you qualify as a small business orare applying for a minor use, or ifyour application is solely associated with an IRA tolerance petition. Please be advised that ifyou intendto request a waiver, you must do so in writing within 15 days ofreceiptofthis invoice instead ofremitting the amount indicated above. OPP will not consider waiverrequests after the registration service fee has been paid. Infonnationregarding eligibility andhowthrequest and document a fee waiver is available on the 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 o[Pesticide Programs (7504C) U.S. Environmental Protection Agency 1200 PennsylvaniaAve NW Washington, DC 20460 By Courier: Document Processing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental ProtectionAgency 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, bankdraft, or moneyorder drawnto the orderofthe Environmental Protection Agency. To ensureproper credit, please write the OPPDECISIONNUMBERonyour check, and enclose a copy ofthis letter withyour payment. Effective November 1,2006,fees may be paidon-line via credit card orelectronic fund transfer. To submit a paymenton-line, visit www.pay.gov. From the pay.gov home page, select "searchby fonnname." Fromthe next page, select "P," then clickon "Pesticide Registration Improvement Act. Fee Payment" and completethe form, making certain to usethe decision number and registration number onthe invoice youreceive from the Pesticide Program in the space provided. Youmay be eligible for a partial waiverofthe registration service fee if, for example, you qualify as a smallbusiness orare applying for a minor use, or ifyour application is solely associated with an IRAtolerance petition. Please be advised that ifyou intendto request a waiver, you must do so in writing within 15 days ofreceiptofthis invoice instead ofremitting the amount indicated above. OPP will notconsider waiverrequests after the registration service fee has beenpaid. Infonnationregarding eligibility andhowthrequest and document a fee waiver is available on the OPP Fee for Service web site at www.epa.gov/pesticides/fees. Please send Registration Service Fee Waiver requests to: By USPS: DocumentProcessing Desk (WAIVER) Office o[Pesticide Programs (7504C) U.S. Environmental Protection Agency 1200PennsylvaniaAve NW Washington, DC 20460 By Courier: DocumentProcessing Desk (WAIVER) Office ofPesticide Programs (7504C) U.S. Environmental ProtectionAgency Room S4900 Potomac Yard 1 2777 S. Crystal Dr. Arlington, VA 22202

### A PRIA decision time review period will not start until a fee waiver is granted and/orthe Agency receives certification that the outstanding fee has beenpaid. Ifthe Agency does not receive certificationofpayment for this action or a fee waiver request within the next 30 days, the Agency will presume thatyou no longerwantto pursue this action. The Agency will then rejectyour 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,

Management Division

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

### 3/23109 21 Day Screen StartDate: 

# 6-
- 1/

- I 0 / Experts In-Processing Signature: 

### /??,c !/#9(M/'t:J.lO# Date**~-/** 2 -/0' Fee Paid: Yes**~V** 

### Division management contacted on issues No Yes Date
EPA Reg. Number: 

## z..S-

## t?

- 

# RuG EPA ReceiptDate: 

## [i- f/
- 

# I()
Items for Review Yes No N/A*


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

# K including package type 

### Confidential Statement ofFormula all boxes completed, form signed, and 

# :x dated (EPA Form 8570-4) (Linkto form) 

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

# )( Footnote A) 

## !f\f

## r~:i 

# n O"r'

## !rrd1r( 

# xi",:;;',)(:1-

## iL~L 3 Certification with Respect to 

### Cltation ofData (EPA Form 8570-34) (Linkto 

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

# XIfapplicant is relying on datathat are compensable, is the offer yes no to pay statement included. (see Footnote B)
Ifaoolicable, is there a letter ofAuthorization for exclusive use only. Formulator's Exemption Statement (EPA Form 8570-27) (Linkto fonn) 4 completed and signed (N/A ifsource is tmregistered or applicant O\Vl1S the 

# X technical) Data Matrix (EPA Form 8570-35) (Link to form) both internal and external 

# X copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% reDack)

, yes no 

### iX 5 a) Selective Method (Fee category experts use) 

# I >( b) Cite-All (Fee category experts use) c) Applicant owns all data (Fee category experts use)
5 Copies ofLabel (linkto http://www.epa.gov/oppfeadlllabelingllrmD 

# X 6 (Electronic labels on CD are encouraged and guidance is available)( link to http://www.epa.gov/pesticides/regulating/registering/submissionslindex.htm#labels )


### 1

### 7 Is the data nacka!!e consistent with PR Notice 86-5 (link to PRN 86-5) 

# X
Notice ofFiling (link to 8 http://www.epa.gov/pesticides/regulatingitolerance petitions.htm) included 

# \- with petitions (linkto http://www.epa.gov/pesticides/regulating/tolerances.htm) 

### 9 If

### applicable for conventional applications, reduced riskrationale (link to 

# >< http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) Required Data (link to http://www.epa.gov/pesticides/regulatingldata 

### requirements.htm) and/or data waivers. See Footnote C.

a) 

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

# i 10

2

### Comments: 

### 61\X'l\fS 

### tDS..>Ccl \1\'(\.,U

. 0 

### \rn 

## t:. C\{J

### yY\)'"'(cJ 

### C\"bt 'I**,~;** '\' ,""t U:LU



## *N/A NotApplicable

Footnotes A. 

### During the 21 day initial contentreview, all CSFs will be reviewed to detennine whether all inerts listed, including fragrances, are approved for the proposed uses. If

### an unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for example, removing the inert, substituting itwith an approved inert, submitting documentationthatEPA 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) withdraw the application. Removing or substituting an inert ingredient will require a new CSF and may require submission ofdata. All information, fonns, data and documentationresolving the inert issue musthave been received by the Agency or the application withdrawn ",rithin the 21 day period, otherwise, the Agency will rejectthe application as described below. To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouraged to verify that all inertingredients have been approved for the application's uses even if

### a product 

### is currently registered by consulting the inert Web 

### 3

### site [linkto http://www.epa.gov/opprdOO1!inerts/lists.html] and ifthe inert is not approved, to obtain the necessary inert approval priorto submitting an application to register a pesticide product containing that inert ingredient. Some inert ingredients are no longer approved for food uses or certain types ofuses. The name and/or CAS number on a CSF must match the name and CAS number on this web site. Simple typographical errors inthe name or CAS numberhave resulted in processing delays. Ifan inert is not listed on the inert ingredientweb site and the applicant believes that the inerthas been approved, the applicant should contactthe InertIngredient Assessment Branch (lIAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe correspondence withIIAB resolving the issue should accompany the application. All new inerts except PIP inerts are reviewedby lIAB. The IIAB should also be contacted for any questions on what supporting dataneeds to be submitted for and the Agency's inert review process. Questions on PIP inerts should be directed to the Chiefof Microbial Pesticides Branch [Link to http://v.'WW.epa.gov/oppbppdl/biopesticides/contactsbppd.htm]. When abrand, 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.pdfJ must also be included to enable the Agency to determine ifit has been approved. Each component ofan inert mixture (including a fragrance) must be identified. In some cases, the supplier ofthe mixture or fragrance may need to provide this information to the Agency. Priorto the Agency's receipt ofan application, applicants must arrange with aproprietary mixture or fragrance supplierto provide the component informationto the Agency or promptlyupon EPA's request. Ifthe inert ingredients in aproprietary blend (including fragrances) cannot or are not identified orprovided within the 21Mday content review period, the Agency will rejectthe application. During the 21 day content review, applicants should submit informationto the individual identified by the Agency whenthe applicant is informed ofanunapproved inert. Unapproved Inerts Identified on CSFs All applications except conventional new products and PIPs Once an unapproved inert is identified on a CSF, the Agency will contact the applicantwiththe following options: 1. Correctthe application by, for instance, correcting the inert's identity or CAS number, providing documentationthatthe inerthas been approved, or removing the unapproved inert from the CSF or replacing it with onethat is approved for the application's uses; or 2. Submit the information and dataneeded for the Agency to approve the unapproved inert Ifthis option is selected and implemented, the Agency may request an extension inthe PRIA decision review timeframe to accommodate the inert review/approval process; 4 

### site [linkto http://www.epa.gov/opprdOO1linerts/lists.html] and ifthe inertis not approved, to obtainthe necessary inertapprovalpriorto submitting an application to registera pesticide productcontainingthat inertingredient. Someinert ingredients are no longer approved for food uses orcertain types ofuses. The name and/or CAS number on a CSF must match the name and CAS number on this web site. Simpletypographical errorsinthe name or CAS numberhave resulted in processing delays. Ifan inert is not listed on the inert ingredientweb site and the applicant believes that the inerthas been approved, the applicant should contactthe InertIngredient Assessment Branch (lIAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe correspondence withIIAB resolving the issue should accompanythe application. All newinerts except PIP inerts are reviewedbylIAB. The IIAB should also be contacted for any questions onwhat supporting dataneeds to be submitted for and the Agency's inertreviewprocess. Questions on PIP inerts should be directed to the Chiefof Microbial Pesticides Branch [Link to http://v.rww.epa.gov/oppbppdl/biopesticides/contacts bppd.htm

### J. When abrand, trade, orproprietary name ofan inert ingredient is listed ona 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 ifithas been approved. Each component ofan inert mixture (including a fragrance) mustbe identified. In some cases, the supplier ofthe mixture or fragrance may need to provide this information to the Agency. Priorto the Agency'sreceipt ofan application, applicants must arrange with aproprietary mixture or fragrance supplierto provide the componentinformationto the Agency or promptlyupon EPA'srequest. Ifthe inertingredients in aproprietaryblend (including fragrances) cannot or are not identified orprovided within the 21Mday contentreviewperiod, the Agency will rejectthe application. During the 21 day contentreview, applicants should submitinformationto the individual identifiedby the Agency whenthe applicant is informed ofanunapproved inert. UnapprovedInertsIdentified on CSFs All applications except conventional newproducts and PIPs Once an unapproved inert is identified ona CSF, the Agency will contact the applicantwiththe following options: 1. Correctthe applicationby, for instance, correctingthe inert's identity or CAS number, providing documentationthatthe inerthas been approved, or removing the unapprovedinert from the CSF or replacing it with onethat is approved for the application'suses; or 2. Submit the informationand dataneeded for the Agency to approvethe unapproved inert Ifthis optionis selected and implemented, the Agency may requestan extensioninthePRIA decision reviewtimeframe to accommodate the inert review/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 implemented by the applicant within the 21 day content review period, the Agency will reject the application and retain 25% ofthe full fee ofthe category identified. Conventional New Product Applications Vlhenthe RegistrationDivision identifies an unapproved inert on a CSF with an application for a new productthatthe applicant has not identified as requiring an inert approval (R311, R312 or R313), itwill contactthe applicant with the following options: 1. 

### Correctthe application by, for instance, correcting the inert's identity or CAS number, providing documentation thatthe inert has been approved, or removing the unapproved inert from the CSF orreplacing it with one that is approved for the application's uses; or 2. Submitthe information and data needed for the Agency to approve the unapproved inert, including any requiredpetition to establish or amend a tolerance or exemption from atolerance. (This optionmay change the PRIA category for the application, which could require a longer decision review time and a larger fee. Ifadditional fees are due, they mustbe received by the Agency within the 21 day contentreview 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-reviewperiod, the Agency will reject the application and retain 25% of the appropriate fee for the new product-inert approval category. PIP Applications Vlhen the Biopesticide and PollutionPrevention Division identifies an unapproved inert on a PIP CSF and arequestto approve the inert does not accompany the application, it will contactthe applicant withthe following options: 1. Correct the application by, for instance, correcting the spelling or name ofthe inertto that in 

### 40 CFR 174, orproviding documentationthatthe inert has been approved; or 2. Submit the information and data needed for the Agency to approve the unapproved inert. Ifan inert ingredienttolerance exemption petitionis required, the petition mustbe received by the Agency and the B903 fee paid v,rithin the 21 day period. Ifthis option is selected and implemented, the Agency will discuss hannonizing the timeframe for both actions. 5 

### 3. Withdrawthe application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implementedby the applicant within the 21 day contentreview period, the Agency will reject the application and retain 25% ofthe full fee ofthe category identified. Conventional NewProductApplications Vlhenthe RegistrationDivision identifies an unapproved inert ona CSF with an application for a newproductthatthe applicant has not identified as requiring an inert approval (R311, R312 or R3l3), itwill contactthe applicant with the following options: 1. 

### Correctthe application by, for instance, correcting the inert's identity or CAS number, providing documentation thatthe inert has been approved, or removingthe unapproved inert from the CSF orreplacing it with one that is approved for the application's uses; or 2. Submitthe information and data needed for the Agency to approve the unapproved inert, including any requiredpetitionto establish oramend a tolerance or exemption from atolerance. (This optionmay change the PRIA category for the application, which could require a longer decision review time and a largerfee. Ifadditional fees are due, they mustbe received bythe Agency within the 21 day contentreview period.) 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee categoryestimated); or
Ifnone ofthe above options is selected and implemented during the 21-day content-reviewperiod,the Agency will reject the application and retain25% of the appropriate fee for the newproduct-inert approval category. PIP Applications Vlhen the Biopesticide and PollutionPreventionDivision identifies an unapproved inert on a PIP CSF and arequestto approve the inert does not accompany the application, it will contactthe applicant with

### the following options: 1. Correct the application by, for instance, correctingthe spelling or name ofthe inertto that in

### 40 CFR 174, orproviding documentationthatthe inert has been approved; or 2. Submitthe information and data needed for the Agencyto approve the unapproved inert. Ifan inert ingredienttolerance exemption petitionis required, the petitionmustbe received bythe Agency and the B903 fee paid v,rithin the 21 day period. Ifthis option is selected and implemented, the Agency will discuss hannonizingthe timefrarne for both actions. 5

### 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthe above options is selected and implemented during the 21 day contentreview period, the Agency will rejectthe application andretain 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) new product, R300 or A530, an application without the necessary authorizations ofoffers to pay will be placed into either R30 1 or A531. The Agency recommends that authorizations ofoffers to pay be submittedwith other PRIA applications to avoid delays in the Agency's decision. C. 

### Biopesticide applicants are advised to contact the Agency and discuss study waivers priorto submitting their application to the Agency. Documentation ofsuch discussions should be submitted withthe study waiver.

6 

### 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 contentreview period, the Agency willrejectthe application andretain25% 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) new product, R300 or A530, an application without the necessary authorizations ofoffers to pay will beplacedinto either R301or A531. TheAgency recommends thatauthorizations ofoffers to pay be submittedwith other PRIA applications to avoid delays in the Agency'sdecision. C. 

### Biopesticide applicants are advised to contactthe Agency and discuss studywaivers priorto submittingtheir application to the Agency. Documentation ofsuchdiscussions should be submitted withthe study waiver.

6UNITeD STATES ENVIRONMENTAL PROTECTIoN AGENCY WASHINGTON, D.C. 20460

August 12,2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES OPP Decision Number: D-438363 EPA File Symbol or Registration Number: 2517-RUG Product Name: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### + NYLAR SQUEEZE-ON FORDOGS EPA Receipt Date: II-Aug-20I0 EPA Company Number: 2517 Company Name: 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 waiver request, and cerification ofpayment. Ifyou submitted data with this application, the results ofthe PRN-86-5 screen will be conununicated separately. During the administrative screen, the Office ofPesticide Programs has determined thatthis 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: R31 0 NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PESTEFFICACY); Your request for waiver has been forwarded for review. You will be notified in writing when a detennination 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. 

### Ifyou have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerely,**~I** 

# 7'

J!.AQA-&- 

## uiTu/X<L Front End Processing Staff Information Technology & Resources Management Division**UNIT~O** STATES ENVIRONMENTAL PROTECTIoN AGENCY WASHINGTON, O.C. 20460

August 12,2010

OPP DecisionNumber: D-438363 EPAFile Symbol orRegistrationNumber: 2517-RUG OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
Product Name: SERGEANT'S FlPRONIL

### + CYPHENOTHRIN 

### +NYLAR SQUEEZE-ON FORDOGS EPAReceipt Date: II-Aug-20I 0 EPACompanyNumber: 2517 Company Name: SERGEANT'S PET CARE PRODUCTS, INC. KEllYR. HOSKINS SERGEANT'S PET CARE PRODUCTS,INC. 2625 SOUTH 158THPLAZA OMAHA,NE 68130-1703 SUBJECT: Receipt ofApplication and 50% Small Business Waiver Request Dear Registrant: The Office ofPesticide Programs has received your application, 50% small business waiver request, and cerification ofpayment. Ifyou submitted datawiththis application, the results ofthe PRN-86-5 screen will be conununicated separately. Duringthe administrative screen, the Office ofPesticideProgramshas determined thatthis Actionis subjectto a Pesticide Registration Service Fee as defined in the Pesticide Registration ImprovementAct. The Actionhas been identified as Action Code: R310 NEWPRODUCT;NON-FASTTRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTHPESTEFFICACY); Your request for waiver has beenforwarded for review. You will be notified inwriting when a detenninationis made regarding your request. Ifyour waiver request is approved, the decision reviewtime period will start on the date ofapproval. Ifyour waiver request is denied, you will receive an invoice for the outstandingbalance. 

### Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsmanat (703) 308-9362. Sincerely,**~I** 

# 7'.JUI.QA.&- Ua-u./Jv::L.. FrontEndProcessing Staff Information Technology & Resources Management Division

# IFee for Servicel .$

# {880188H
# l_ Risk Mgr. Studies? [i!] 

# Fee Waiver? v u 

# volpay % 

# Reduction: 50
'------

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

# ------------;::========- ---------------------------, Receipt No.

# S-I=8~8~0~18~8= EPA File Symbol/Reg. No. I 2517-RUG Pin-Punch Date: I 8/11/2010 

# --

n LJ 

# This item is NOT subject to FFS action.

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

# --A-ction Code:

. Parent/Child Decisions: ! Requested: 

# I R310

, Granted: 

# I r<,?> I

# 0 

# I 'moon! D"eo $

# ~,578

Reviewer:

__..J<tlC+lJ.:-'e·

# i7YJ:..:...:.::~~'=---- _ 

## Remarks: Inert Cleared for Intended Use Uncleared Inert in Product Date: 

## /?/I::2/IORegull!llory Type: fi[Oducl Registrl!llion
- Section 3 

# 2G Fee For Service: r. 

### ii;;:es! (" No**~''''-=--'** Application Type: !New Registration 

# iJ Billable: Ii' Yes 

### r No Cotnpany; PS17

### ~EANT'S PET CARE'PRODUCTS', INC. 

# :Y1 Print Letter Enter More Information Tracking
Manager: jRegistra1ion Division, Ri$k Manageineilt Team 10 Product #:**2511~RUG** ,

# IProduct Name:**~E~C'>EANT'S** F,IPRONIL + CYPHENOTHRIN f'i



# I**'<'C~** ,;/ve;kiGft: j

Me Too Section3: 

# I

,-", u,-,-ii 

### >,: View/Edit 

# F' v

# FEE 

# FOR SERVICE FEE 

# FOR SERVICESergeant's Pet Care Products, Inc. 2625 South 1581h Plaza • Omaha, NE 68130·1nO • Telephone 402.938.7000 • Fax402.938.7091 • www.sergoonts.com August 11, 2010 Richard Gebken, PM10 Office ofPesticide Programs (7504P) (REGFEE) 

### U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 

### Subject: Submission ofEPA 

### Pesticide Registration ImprovementActInformation Dear Mr. 

### Gebken: Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158"' Plaza, Omaha, NE 68130-1770, 

### EPA CompanyNumber 2517), is submitting Pesticide Registration Improvement Act Information for the following new registration application:

• Sergeant's Fipronil 

### + Cyphenothrin

### +Nylar Squeeze-On for Dogs R31 0, $4,578 (50% fee waiver $2,289), Pay.gov Tracking ID: 251 OlLPM, Agency Tracking ID: 74122352439. 

### This registration application is for anew end-use product with supporting data and is considered an R310, new end-use product, requires review ofdatapackage within RD, PRIA reviewtime frame 6 months, and afee of$4,578. Sergeant's qualifies for aPRIA fee waiver/reduction of50% (referto OPP Decision NumberD-425455). Ifyou 

### have any questions or need additional information regarding this registration application, please contact me at 402-938-7079. 

### Sincerely,

# ~H:nstk~~!UT Manager ofTechnical 

### AffairsPay.goy w Online Payment

Online Payment Step 3: Confirm Payment Thank you. Yourtransaction has been successfully completed. Pay.gov Tracking Information Application Name: PRIA Service Fees Pay.gov Tracking 10: 2510lLPM Agency Tracking 10: 74122352439 Transaction Date and Time: 06118/201014:35 EDT Payment Summary Page 1 of 1

11213

Account HolderSergean1's Pel Care Products, Name: Inc Payment Amount: $2,289.00 Account Type: Business Checking Routing Number: Account Number: " 5483 Payment Date: 0612112010 Decision Number: Registration Number. 2517-new Company Name: Sergeanl's Pet Care Produ Company Number: 2517 Action Code: R310

https://www.pav.gov/pavgoy/pavrnents/authorizeACHPavrnent.html 6118/2010 Pay.goy w OnlinePayment

Online Payment Step 3: Confirm Payment Thank you. Yourtransaction has been successfully completed. Pay.gov Tracking Information Application Name: PRIA Service Fees Pay.gov Tracking 10: 2510lLPM Agency Tracking 10: 74122352439 Transaction Date and Time; 06118/201014:35 EDT Payment Summary Account HolderSergeanfs Pel Care Products, Name: Inc Payment Date: 0612112010 Decision Number: Payment Amount: $2,289.00 Registration Number. 2517-new Page 1of 1

11213

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

https://www.pay.gov/paygoy/payrnents/authorizeACHPayment.html 6118/2010OMS No 20700060 Approval expires 05-31 98 Form**Appro~** Please read rnstructfons on reverse before npleting fonn "-, 

### - 

## - United States

### ~_Registration OPP Identifier Number 

# EPA Environmental Protection Agency D,Amendment Washington, DC 20460 D Other Application for Pesticide Section I 1.**company~ct** Number 

# 'f?u6; 2. EPA Product Manager 3. Proposed Classificalion 2517- \ Richard Gebken 

# •• Company/Product (Name) 5.PM# 10

### ~None DRestricted Sergeant's Pet Care Products, Inc. I Sergeants Fipronil + Cyphenothrin + Nvlar Squeeze-On For Doqs 5. Name and Address 01 Applicant (Inc/ude Zip Code) 6. Expedited Review. In accordance with FlFRA 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 D Checkifthis isa newaddress Section II 

# D Amendment
- Explain below. D Final printed labels in response to Agency letter dated

### XX~XX-XX 

# D Resubmission in response to Agency letter dated XX-XX-XX D "Me Too" Application 

# D Notification
- Explain below. Other
- Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section 11.) Submission of a new end-use registration application. Section III 1. Material This ProductWill Be Packaqed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type ofContainer 

### IS] Yes"**~ves** Dves DMetal DNo D No 

# Is:J No C2J Plastic 11 "Ves" No. per If"Ves" No. per DGlaSS *Certification must Unit Packaging wgt. Container Package wgl. Container DPaper be submitted 0.02311 02 (0.67 ml) 0.045 fl 02 (1.34 

### mOl 3 vials 

## I DOther (Specify) Plastic Bag 0.091 11 02 (2.68 ml) 0.136 fl 02 (4.02 

### m!) 3. Location of Nel Contents Information 4. Size(s) Retail Container 5. Location of Label Directions C2JLabel D Container 0.67 ml, 1.34 ml, 2.68 ml, 4.02 ml DOn Can [glOn Labeling accompanying product 6. Manner in Which Label is Affixed to Product DLithograph C2JOther DPaperglued 

### .'., DStenCJled



# - Section IV



# - 1- Contact Point (Complete items direclfybelow forfdentification ofindividualto be contacted, ifnecessary, to process,this**~pplicai'ot)"** " Name Title Telef-hone No. (Influde Area Code) Kelly R. Hoskins Manager ofTechnical Affairs 4Lr2.-b::>6-7079 Certification 1 6 -Date Application I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I F:eceived acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both 

# , (Stamped) under aoolicable law. 2. Signature**~C~V** 3. Title BY, 

# lL .,'"**~.-** 

# t\oZluV-.!**l:~T** Manager ofTechnical Affairs**'~(\** 

# • Typed Name: 5. Date: 08111f2010 Kelly R, Hoskins

### TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Sergeant's Pet Care Products, Inc. 2625 South 158'" Plaza Omaha, NE 68130-1770 CONTACT PERSON (Return to) Kelly R. Hoskins Sergeant's Pet Care Products, Inc. 2625 South 158'" 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 +Nylar Squeeze-On for Dogs. SUBMITTAL DATE: August 11, 2010



### Volume StudyTitle MRIDNo. 1 Administrative Materials

.. 

## - 2 Group A 

### Product ChemistryFor Sergeant's Fipronil 

### + Cyphenothrin

### +Nylar Squeeze-On ForDogs



### -- 

### ---- 3 Group B Product Chemistry For Sergeant's Fipronil 

### + Cvnhenothrin 

### +Nylar Saueeze-OnForDo"s

.. 

### --

3Sergeant's Pet Care Products, Inc. 2625 South t58th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938,7091 • www.sergeants,com August II, 2010 Richard Gebken, PMIO Office ofPesticide Programs (7504P) 

### U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One PotomacYard 2777 South Crystal Drive Arlington, VA 22202 Subject: 

### Child Resistant Packaging Certification Sergeant's Fipronil 

### + Cyphenothrin 

### +Nylar Squeeze--On for Dogs EPA File Symbol 25I7-Nffi¥ 

### 1'-\;1.<:' Dear Mr. Gebken: I certifY that the packaging used for the following productmeets the standards of40 CFR 157.32, 

### including the revised standards in 16 CFR 1700.15(b), when tested bythe revised testing procedures in 16 CFR 1700.20, as published in 60 FR 37710 

### (July 21, 1995):



### • Sergeant's Fipronil 

### + Cyphenothrin 

### + Nylar Squeeze-On for Dogs (EPAFile Symbol 25I7-NEW) Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158'" Plaza, Omaha, NE 68130-1770, 

### EPACompanyNumber2517) is submittingthis child resistantpackaging certification to support for the new end-use product Sergeant's Fipronil 

### + Cyphenothrin 

### +Nylar Squeeze-On for Dogs (EPA File Symbol 2517-NEW). All product labels have language specifying the use ofscissors 

### to open the productcontainer and label language 

### stating the product is not to be applied by children. Ifyou 

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

# ~t**~o~L<...~ I'~**  Kelly R. Hoskins 

### Manager ofTechnical 

### Affairs

cc: Larry

### NouvelSergeant'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 Rosalind Gross c/o Richard Gebken Registration Division Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Document Processing Desk Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202 Subject: Child Resistant Packaging Information Sergeant's Fipronil 

### + Cyphenothrin 

### + Nylar Squeeze-On for Dogs (EPAFEe Symbol:

### 2517-~) 

## !l-iAl>, DearMs. Gross: Sergeant's Pet Care Products, Inc. (Sergeants, 2625 South 158th 

### Plaza, Omaha, NE 68130-1770, EPA CompanyNumber 2517) is submitting a requestto rely onpreviously submitted Child Resistant Packaging (CRP) studies to support this new registration. The CRP data were submitted to EPA on April 12, 2010 in support ofthe pending registration applications under EPAFile Symbols: 2517-RGT, 2517-RGA, 2517-RGL, and 2517-RGU (an ofwhich contain Fipronil at 9.7-9.8%). Sergeant's generated CRP data on a standard white applicatorin sizes 0.67, 1.34, 2.68, and 4.02 mL. The following is a summary table ofthe applicators thatwere tested and submitted to EPA in the CRP data: Use AnnlicatorBase Color 

### FillWeioht (roLl Color 

### DO"

## Unto 22 Ibs 'White 

### 0.67 Oram!e Dog 23-44 Ibs 'White 

### 1.34 Green 

### Do" 45-881bs White 

### 2.68 Red 

### Doo 89-132 Ibs White 

### 4.02 Blue CRP datais required for this new productbecause ofthe inclusion ofthe active ingredient fipronil (9.8%) in the pet**squeeze~on** 

### product. The CRP testing was conducted on a standard package size and color configurationthat is identical for this product. The Sergeant's Fipronil 

### + Cyphenothrin

### + Nylar Squeeze-On for Dogs productbeing submittedtoday also contains fipronil at 9.8%. Additionally, Sergeant's already has dog squeeze-onproducts approvedby EPA containing 20-30% cyphenothrin (EPA Registration Numbers 2517-127 through 2517-132) that are not subject to CRP. This new product contains 5% cyphenothrin and 2% nylar. Furthermore, Sergeant's does not anticipate any additional toxicity through the combination offipronil,
I

### sergeant's PetCareProducts, Inc. 2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

### cyphenothrin andpyriproxyfen. When Sergeant's Fipronil 

### +Cyphenothrin 

### +Nylar Squeeze-On for Dogs is marketed, itwill utilize the same applicator color (white) and fill weight colors per mLfill weight as was usedin the submitted and referenced CRP testing. Based on available information, the density range ofthe pending products on whichthe CRP data were generated is the same as the new product (1.0-1.5 gr/cc). Therefore, Sergeant's is relying on MRID's: 48059803,48059804,48059805, and48059806 to fulfill the eRP 

### datarequirements for Sergeant's Fipronil 

### + Cyphenothrin

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

# ~. '\L

# ~~~ 

# /1:?r"l Kelly R. Hoskins ManagerofTechnical Affairs

cc: Larry Nouvel



### 2Sergeant's Pet Care Products, Inc.

Subject:

2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com

August 

### II, 2010 Richard Gebken, PMIO Office ofPesticide Programs (7504P) (REGFEE) 

### U.S. Environmental Protection Agency DocumentProcessingDesk Room S-4900, One PotomacYard 2777 South Crystal Drive Arlington, VA 22202 

### Sergeant's Fipronil + Cyphenothrin +Nylar Squeeze-On forDogs



### . EPA FIle Symbol 25 

### I 7)lEW**,<'".~** 

### Dear Mr. Gebken: Sergeant's Pet Care Products, Inc. (Sergeants, 2625 South 158'" Plaza, Omaha, NE 68130-1770, 

### EPACompanyNumber2517) is submitting an EPAregistration application for the new end-use product Sergeant's Fipronil 

### + Cyphenothrin 

### + Nylar Squeeze-On forDogs [containingthe EPA registered active ingredients Fipronil (9.8%), Cyphenothrin (5.0%), and Pyriproxyfen (Nylar) 

### (2.0%)]. Please find enclosed the following documentation in 

### support ofthis 

### registration: (I) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) (14) (15) (16) (17) 

### Transmittal Document; Application for Registration (EPA Form 8570-1); Confidential Statement ofFormula (EPA Form 8570-4) (Two Copies); Formulator's Exemption Statement (EPA Form 8570-27); CertificationWith Respectto Citation ofData (EPA Form 8570-34): DataMatrix (EPA Form 8570-35)

- EPA and Public Versions; Product Label (Five Copies); 

### Letter ofAuthorization; ChildResistantPackaging (CRP) Certification Statement; Bridging Argumentto Cite CRP Data; 

### Submission ofEPA 

### PesticideRegistration Improvement Act Infonnation; Voluntary Small Business CertificationFonn; PRIAFeeWaiver Certification Statement; PRIAFeeWaiver Support Letter; Recent EPA Approval of50% Small Business WaiverRequest (D-425455); PRIA Category R31 0, Payment Confirmation Receipt; and 

### Three Copies ofSupporting Studies. The registration ofSergeant's Fipronil 

### + Cyphenothrin 

### +Nylar**Squeez~n** 

### forDogs is a selective citation registration for anew end-use product. Sergeant's is submitting newproduct chemistry studies in support ofthis 

### end-use product registration. Additionally, Sergeant's is citing acute toxicity studies, companion animal safetydata, and efficacy studies submitted to ISergeant's Pet Care Products, Inc. 2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.936.7091 • www.sergeants.com 

### EPA onJune 18, 2010 withthe registration application for 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 fonnulated end-useproducts. This registration application is considered a PRIA Category R31 0 (new end-useproduct) with a PRIA review time of6 months. Sergeant's submitted a PRIA Small Business WaiverRequest under separate coveron April 14, 2010, and itwas approvedby EPA onMay 4, 2010. A copy of this approval letter is enclosed. We look forward to working withthe Agency to register Sergeant's Fipronil 

### + Cyphenothrin

### + Nylar Squeeze-On for Dogs. Ifyou have any questions orneed additional infonnationregarding this registration application, please contactme at 402·938-7079. Sincerely,

# ~~ (L. 

# HoiUk{):v+, KelIy R. Hoskins ManagerofTechnical Affairs Enclosures



### 2Form approved. OMB No. 2070-0060, 2070-0057,**~_(0·Oi07,** 2070-0t22, 2070-0t64. 

# aEPA United States Environmental Protection Agency Washington, DC 20460 

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



### --

# -- Applicant's Name trd I'.C!jress EPA File SymbotiRegistration Number**Se~geant's** Pet Can;.. Products, Inc. 2517-NEW 2625 '3011th 15Mh Piaza Product Name Omaha, NE 68' 30-1'170 Sergeant's Fipronil + Cypheno1hrin +Nylar Squeeze-On for Dogs Date ot Confidential Statement of Formula (EPA Form 8570-4) 08/11/2010 As an authorized representative ofthe applicantfor registration ofthe product identified above, I certify that: (1) This product contains the fotlowing active ingredient{s}: Fipronil Cyphenothrin Pyriproxyfen {2} Ofthese, each aclive ingredient listed in paragraph (4) is present solely as the result ofthe use ofthat active ingredient in the manufacturing, formulation or repackaging another productwhich 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 i58.50(e){2) or (3). (3) Indicate by checking (A) or (B) 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 ofthe active ingredienl(s) listed in paragraph (i). OR 

# , (B) 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 qualifyfor the formulator's exemption.

Source Active Ingredient Product Name Registration Number Fipronil Technical
Cyphenothrin Pyriproxyfen

## S~ 

# 'k'-**l~** 

# iLl r

# h-lf Name and Title Dale 

## -!:i Kelly R. Hoskins, Manager ofTechnical Affai'b 08/11/2010 EPA Form 85'10-27 (Rev. 06-2004) Copy t EPA Copy 2 • Applicant copyForm Annroved OMS Nos. 207Q.-0060; 2070-0057; 2070-{lt07; 2070-{lt22; 2070-{lf64**f'~"** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### (- lll!'Z' 1200 Pennsylvania Avenue, N.W. 

## <7 WASHINGTON, D.C. 20460



## --- Paperwork Redoctio:;Acl NOlice: The public reporting burden forthis collection ofinformation isestirnaled to avernge 1.25 hours per response for**registr~tion** and 0.25**rour~** Vefle'P0nSe forreregistration and special reviewaclivities, including lime for rcading lhe inslruclions and complcting the necessary forms. Send comments regarding buroen esriinati'- or'any otheraspectofthis cotlection ofinformalion, inctooing suggestions for reducing the burden to: Direclor, Collection Strategies DiviSIon (2822T), U.S.**El,~vironmental** Protection Agency, t200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do notsend the completed form to Ihis address,

. 

## - Certification with Respect to Citation ofData 

## .,.,-- ApplicanfslRe!listranfs Name, AddrE''.>S, and Telephone Number EPA Re!listration Number/File Symbol Sergeant's Pei Care Produc:s, ';nc

.. '2625 South t58th Plaza, Omaha, NE 68t3Q.-t770 2St7-NEW



# - Active**InQredrnt(~:** and/or representative test oompound(s) Date Fipronil, Cyphenothrin and Pyriproxyfen 08/11/2010 General Use PatEm(s) Oist al those claimed for this product using 40 CFR Part t58) Product Name Domestic indoor non-food Sergeant's Fipronil + Cyphenothlin +NylarSqueeze-On to NOTE: Ifyour product is a tOO% repackaging ofanother purchased EPA-registered product labeled for aU the same uses On your label, you do not need to submit this form. You must submit the Formulator's Exerrption Statement (EPA Form 8570-27). 

# D t am responding to a Data-Call-In Notice, and have induded with this form a list of oompanies sent offers ofcompensation (the Data Matrixform shout! be used forthis purpose).
SECTION I: METHOD OF OATA 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 selective method ofsupport (or cite--all option a list ofcompanies sent offers ofoompensation (the Data Matrix form under the selective method), and have inducled with this form a should be used for**th~** purpose). completed list ofdata requlremenls (the Data Ma1rix form must be used). SECTION It: GEtlERAL OFFER TO PAY IRequired ifusing the cKe-aU method or when using the cite-all option under the setedive method to satisfy one or more data requirementsl 

# D I hereby offer and agree to pay oompensation. to other persons, wKh regard to the approval ofthis application, to the extent required by FIFRA.
SECTtON lit: CERTIFICATION I certify that this application for registration, this form for reregistration, IX" this Data-Call-In response is supported by all data submitted or cited in the application for registration, the form for reregistration, or the Data-Call-In response. In actdKion, ifthe cite-all option IX" cite-all option under the selective mel hod is indicated in Section I, this applicatiOn is supported by all data i1 the Agef1cy's flies that (t) concem the properties oreffects ofthis product or an identical or substantially similar product, or one IX" more ofthe ingredients in this product: and (2) is a type ofdata thatWould be required to be submitted Ulderthe data requirements in effect On the date ofapproval ofthis application ifthe application soughtthe initial registration ofa product ofidentical or similar composKion and uses. I certify that for each eXdusive use study cited in support ofthis regislration or reregistration, that I am the original data submitter or that I have obtained the written pennission ofthe original data submitterto cite that study. I certify thatfor each study eKed in support ofthis registration or reregistralion that is not an exdusive use study, either: (a) I am the original data submitter: (b) I have obtained the poonission ofthe Ofiginal data submitterto use the study in support ofthis appUcation: (c) all periods ofeligibilnyfor compensation have expired for the study; (d) the study is in the publiC literature; or (e) I have notified n writing the company that submitted the study and have offered (I) to pay oompensation to the extent required by sections 3(c)(t)(F) andlor 3(c)(2)(B) ofFIFRA: and (ii) to commence negotiations to determine the amount and terms ofoompensation, ifany, to be paid forthe use ofthe study. I certify that in all instances where an offer ofoompensation is required, ooples ofaU offers to pay oompensation and evidence oftheirdeUvery in accordance with sections 3(c)(t)(F) and/or3(c)(2)(B) of FIFRA are available andwill be submitted to the Agency upon request. Shol.ld I fail to produce such evidence to the Agency upon request, I understand that the Agency may initiate actiOn to deny, cancet or suspend the registration ofmy product in conformrtywith FIFRA. t certify that the statements I have made on this form and all attachments to It are true, accurate, and complete. I acknov.ledge that any knowingly fatse or mlsleadirg statement may be punishabte by fine or Impt"isonmort or both underapplicabto taw. Signature 

# U

# olru**~.**

# ~luA\/niT 0.- Typed or Printed Name and nle A- 081t tl20tO Kelly R. HoskinS, Manager ofTechnicatAffairs

. E ; EPA Form 857Q.-34 (t2 2003) 1ectron c and Paper versions aVailable. Submrt only Paper versIon

.

### R310 Must submit Group A and B product chemistry data for each proposed product. End Use [EP) or Monufocturing Use (MP) product or Technicol 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 

## V Description of materials used to 

# v 830.1600 produce the product 830.1650 Descriotion offormulation orocess 

### ./ 830.1670 Discussion on the formation of impurities 

# v 830.1700 Preliminarv analvsis 

# v 830.1750 Certified limits 

### r158.3451 

## V 830.1800 Enforcement analytical method! 

### 1t5\r.rir 1. (y:! 

## l/

Guideline No. EP Data MP Data Group B: Product Chemistry Data Study f-S",u",b",m"-T'itt"e..-d

__p:su",b",m"-T'itt"e..-d

__t-T_G_A_I

### ,..-_-1 Title Yes No Yes No Yes No 830.6302 Color 830.6303 Ph sical state

830.6315 Flammabilit 830.6316 Ex lodabilit Oxidation/Reduction 830.6314 Chemical incom atibilit Odor 830.6304 Stability to normal and elevated 830.6313 tem eratures metal and metal ions

830.6317 Stora e stabilit 830.6319 Miscibilit 830.6320 Corrosion Characteristics 830.6321 Dielectric Breakdown Volta e 830.7000 H 830.7050 UV/ Visible Absor tion 830.7100 Viscosit 830.7200 Meltin Point 830.7220 Boilin Point 830.7300 Densit 830.7370 Dissociation Constant 830.7550 Partition Coefficient 830.7840 Water Solubilit 830.7950 Va or Pressure 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 OraIILD50) 

## / 870.1200 Acute Dermal [LD50) 

# / 870.1300 Acute Inhalation (Le50) 

# / 870.2400 Acute Eve Irritation 

# / 870.2500 Acute Dermal Irritation 

# / 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 ImDorted 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 Rv) Treatments 810.3500 Premises Treatments 810.3600 structural Treatments Methods for Efficacy Testing ofTermite 810.3800 Baits



### 2

# Sergeant's® MasterLabel**~\j\1.1** 11 August 2010 Version 10.1 EPA Reg. No. 2517p Information 

### in [ ] is optional. Page 1 of8 [CARTON LABEL

- DRAFT MASTERLABEL COpy] 

## Sergeant's Fipronil 

# + Cyphenothrin 

# + Nylar Sqneeze-On for Dogs [ABNs) [(Sergeant's") (Sentry®) VetSpotTM (Spot On) for dogs] [(Sergeant's") (Sentry") VetSpotTM (Spot On) for dogs] [(Sergeant's·) (Sentry") FRONTIER GOLD (Spot On) for dogs] [(Sergeant's®) (Sentry") EctoadvanccTM (Spot On) for dogs]

[Apply to puppies over 12 weeks old] [Apply to puppies 12 weeks or older] 

### [0 Flea & Tick Control for Dogs & Puppies 12 weeks old and older] [-For Dogs and Puppies 12 weeks ofage or older] [oFor Dogs [up to 221bs], [23-441bs], [45-881bs], [89-1321bs] [-Kills fleas (in as little as 1 hour), flea eggs, Ticks (in as little as 1 hour), chewing lice & mosquitoes] [oKilis (and Repels) Fieas, Ticks and Mosquitoes] [-Controls flea reinfestation for up to [12 weeks]] [oFastActing] [oKills Ticks (in as little as 1 hour)] [-Kills Ticks including those that may transmit Lyme disease] [-Dogs can be bathed 24 hours after treatment] [oWaterproof] [oLong Lasting] [-Research demonstrates that [brand name] kills adult fleas (in as little as' 1':lOur), flea eggs, flea larvae and pupae for more than [63 days] [9 weeks].]
.. [. [brand name] prevents development ofall flea stages for more than 63 'Jays/9**w~~k-;,]** [-Kills fleas (in as little as I hour), Ticks (in as little as 1 hour), mosquitoesi (chewing) lice, flea eggs, larvae and pupae] [-Prevents all flea stages (adult fleas (in as little as I hour), flea eggs, flea pupae <:!1cfflea larvae)] [- Ifdog is a high risk for flea reinfestation 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] [oKills flea eggs [larvae] [pupae] for more than 63 days/9 weeks] [-Aids in Control ofSarcoptic Mange] [-Kills fleas (in as little as I hour), Ticks (in as little as I hour), mosquitoes, flea eggs, and iice]

# Sergeant's® Master Label 11 August 2010 Version 10.1 EPA Reg. No. 25l7-XX Information in 

## I ] is optional. Page 2 of8 

### [0 [Seven] [7] Way Protection [Kills fleas (in as little as 1 hour), 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 1 hour), Ticks (in as little as 1 hour), mosquitoes, lice, flea eggs & flea larvae] 

### [0 [4 Week] [Flea and Tick & Treatment] 

### [0 [Four (4) Week] [Flea Tick, Mosquito and Lice Control] 

### [0 With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle] 

### [0 With Nylar® to Break Flea Life Cycle] 

### [- With Insect Growth Regulator to Break Flea Life Cycle] 

### [0 Dual Action [!]:Fipronil with Nylar® IGREffectively Breaks the Flea Life Cycle] 

### [0 Triple Action [I]: Effectively Breaks the Flea Life Cycler!]] 

### [0 Three Applications {for cartons with 3 applicators}] and/or [3 Month Supply] or [12 Week Supply] 

### [. Best ifused 

### year round!] 

### [0 Kills & Repels Fleas (in as little as 1 hour) Up to [4 weeks]!] [2 months] [3 months]] 

### [0 (ICON Showing 4 Week Protection)] 

### [04 Week Dose!] 

### [0 1 Month Dose!] 

### [0 Easy to Use Application] 

### [0 Specially Formulated for Dogs and Puppies] 

### [0 [Free] Calendar Stickers Inside!] 

### [0 [Free] Brochure Inside!] 

### [0 [Free] Brochure and Calendar Stickers Inside] 

### [0 Patented Technology] 

### [0 Kills FleaEggs & Flea Larvae for more than [63days], [9 weeks]!] 

### [- Prevents Flea Eggs From Developing Into Biting Adults] 

### [0 Kills Ticks (in as little as 1 hour) for Up to [4 weeks]!] [- Kills [all stages of] Deer Ticks (vector ofLyme Disease) for up to 4 weeks] 

### [0 Kills [Brown], [American,] [and Lone Star] Dog Ticks] 

### [. Kills Rhipicephalus sanguineus 

### for up to 4 weeks] 

### [-When used monthly [brand name] completely breaks the flea life cyrJe :l.'1'i 

### comr'Jls:tEck and chewing lice infestations.] [- Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weel::d] 

### [0 Apply once every [4 weeks]!] [- 4 week 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 asl hour) for 

### up-to 

### 4 weeks!] 

### [0 Kills all stages ofthe flea life cycle] [- Kills Fleas (in as little as I hour), Ticks (in as little as I hour), Flea Eggs & Flea Larvae for more than [63 days] [9 weeksll 

### [0 [Kills mosquitoes] [- Dogs can be bathed 24 hours after squeeze-on is applied] [-Prevents and controls reinfestations] 

### [0 [Free with purchase] [Free inside] MontWy Application Reminder [Magnet] [clip] [cardll

### 11 August 2010 Infonnation in [ ] is optional. 

# Sergeant's® MasterLabel Version 10.1 EPA Reg. No. 2517-XX Page 3 of8 [ForDogs & 

### Puppies (12 weeks or olderaud) up to 22 Ibs.] [For Dogs 23-44 Ibs.] [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% 

### Cyphenothin 5.00/0 Pyriproxyfen (CAS# 95737-68-1) 

### 2.0% OTHER INGREDIENTS: 83.2% TOTAL: .................................................................•. 100.0% [Nylar® is a registeredtrademark ofMcLaughlin Gonnley King Company. U.S. PatentNo. 5.942.525] 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] applicatorsVersion 10.1 Page 4 of8 

# Sergeant's® Master Label EPA Reg. No. 2517-XX 

## I is optional. 11 August 2010 Information in [

(BACK/SIDE CARTON LABEL

- MASTER LABELl [brand name] contains Fipronil, Cyphenothin and the insect growthregulator (JGR) Nylar® to effectively kill (and repel] Fleas ((in as little as 1 hour)], Ticks ((in as little as I hour)], and kills flea eggs, flea larvae, 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 I hour)], [and kills mosquitoes] and chewing lice [for 30 days]. 

### (diagram with visual ofFipronillcyphenothrin 

### INylar 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 buttemporary 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. Hannful ifabsorbed through skin. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. FIRST AID 

### 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 ordoctor for further treatment advice. 

### IfOn Skin Or 

# • Take offcontaminated clothing. Clothing 

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

# • Call a noison 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 oesticide incidents), you may**call1~800-781-4738.** NOTE TO PHYSICIAN ORVETERINARIAN Treat patient symptomaticallyVersion 10.1 

### Page 5 of8 

# Sergeant's@ Master Label EPA Reg. No. 2517-XX ] is optional. II August 2010 Information in [ DIRECTIONS FOR USE It is a violation ofFederal law to use this product in amanner 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 ofyourpet. Do nottreat yourpet with more than one pesticide product at atime. 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, ornursing 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 conunon signs ofingestion are excessive salivation and foaming at the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitoryour 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 ofand/or 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 producton pets. Ifsigns ofsensitivity occur bathe your dog with 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 producttubes [vial] from the package. Separate one tube from the others. Holding the tube [vial] with notched end pointing up and away from the face and body, cut off the narrow end at the notches with scissors. How to apply: Invert tube over dog and use open endto part dog's hair. Squeezetube 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 OF APPLICATION 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 I hour) 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 notreapply for 30 days.Version 10.1 Page 6 of8 

# Sergeant's@ Master Label EPA Reg. No. 2517-XX ] is optionaL II August 2010 Information in [



### ForDogs Weighing up to 221bs. {For cartons containing .67 ml (0.023 fl. 

### oz.) applicator tubes} Apply one tube (.67 ml)(0.023 

### fl. oz.) [as a spotto 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 23-44 Ibs. {For cartons containing 1.34 ml (0.045 fl. 

### oz.) applicatortube} [Apply two tubes (.67ml)(0.023 

### fl. oz.) as a spot on the dog's back between the shoulderblades] [or] [Apply one tube (1.34 ml)(0.045 

### fl. oz.)] [as a spotto 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 45-881bs. 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 apoint midway between the neck and tail]. For Dogs Weighing 89-132Ibs 

### 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 point midway between the neck and tail]. STORAGE AND DISPOSAL PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool (below 77°F (2S"C)] dry place inaccessible to children and pets. Do notrefrigerate. Protectfrom direct sunlight. PESTICIDE DISPOSAL AND CONTAINERHANDLING:**Non~refiJlable** container. Do notreuse or refill this container. Ifempty: Place in trash or offerfor recycling ifavailable. Ifpartly filled: Call your local solid waste agency for disposal instructions. Neverplace unused product down any indooror outdoor drain. [WARRANTY Read the entire Directions for Use and Warranty before using this Product. By using this product, user or buyer accepts the following warranty. [[The directions for use ofthis productare believed to adequate and must be followed carefully. It is impossible to eliminate all risks associated with the use ofthis product. Unintended consequences may resultbecause ofunknown factors. All such risks shall be assumed by the user orbuyer.] [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 consistentwith applicable law, the exclusive remedy ofthe user orbuyer shall not exceed the purchase price paid.] (Ifyou have questions or comments about this 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] [Visitus at] [www.sergeants.com] Non-Emergency call l-800-224-PETS (7387) [Made in USA]Version 10.1 Page70f8 

# Sergeant's® Master Label EPA Reg. No. 2517-XX 

## l is optionaL II August 2010 Information in [ Distributed by: Sergeant's Pet Care Products, Inc. P.O. Box 540399 Omaha, NE 68154-0399 EPA Reg. No. 2517-XX EPA Est. No. XXXXX-XX-XXX [BAR CODE AREA]

[Optional Insert orpackage copy] 

### [How to Apply

- May contain graphics illustrating product use, e.g., dog with a drop falling onto its neckfrom a vial on front, side, or backcarton label and/or applicator labeIlng_1 [{OuterPackaging orInsert 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 endpointing up and away from the face and body, cut offthe narrow end at the notches with scissors. 

### How to apply: 1. inverttube overdog 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) 6 Step [Easy] [Spot On] [Squeeze-Onl [Topical] Checklist
• Read the label completely and follow directions

• Weigh yourpet
• Do NOT use Dog products on Cats
• Do NOT treat with more than one pesticide product at atime
• Separate animals aftertreatmentto avoid chance ofingestion
• Do NOT splittubes between pets] [Brand Namel [Monthly reminder card] [Apply [Brand Name] monthly for continuous protection againstFleas (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 ownerto fill in date)] [Second [dose] [Treatment] (Empty blank for ownerto fill in date)] [Third [dose] [Treatmeut] (Empty blank for owner to fill in date)] [calendar stickers with brand name] [place stickers on your calendar as a reminderto reapply [brand name] [in 30 days.]

### 11 August 2010 Infonnation in [ 

# Sergeant's® Master Label Version 10.1 EPA Reg. No. 2517-XX 

### [is optional. Page 8 of8 [Monthly Application Reminder Magnet (image ofreminder magnet) 

### Enclosed for your convenience is an application reminder magnet. Push the (reset) buttonto 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 magnetwill flash (and beep) reminding you to reapply.] {END

- OPTIONAL INSERT OR PACKAGE COPY}


### Front Label {Brand Name} Fipronil 9.8%, Cyphenothrin, 5.0\% Pyriproxyfen 2.0% 

### 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. 25l7-XX {label code} [Optional: Example pictograms that mayormay not be found on the printed label]UN, J STATES ENVIRONMENTAL PROTECl ,uN AGENCY WASHINGTON, D.C. 20460
September 7, 2010 OFFICE OF PREVENTION, PESTICIDES AL'JD TOXIC SUBSTANCES opp Decision Number: D-438363 EPA File Symbol orRegistrationNumber: 2517-RUG ProductName: SERGEANT'S FIPRONIL 

### + CYPHENOTHRIN 

### + NYLAR SQUEEZE-ON FORDOGS EPA Application Receipt Date: II-Aug-20I0 EPA Waiver Request ReceiptDate: ll-Aug-2010 EPA Company Nmnber: 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: Approval of50% Small Business Waiver Request DearRegistrant: The Office ofPesticide Programs has approved your requestfor 50% waiver ofthe pesticideregistration fee associated with the action referenced above. The decision review period for this action will begin on the date ofthis letter. The Action has been identified as Action Code: R320 NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE CITATIONS); 

### Ifyou have any questions, please contactthe Pesticide Registration Service Fee Ombudsman, at (703) 308-9362.

OscarMorales, Director InfonnationTechnology & Resources Management Division Office ofPesticide Programs UN, J STATES ENVIRONMENTAL PROTECl ,uNAGENCY WASHINGTON, D.C. 20460
September7, 2010

opp Decision Number: D-438363 EPAFile SymbolorRegistrationNumber: 2517-RUG OFFICE OF PREVENTION, PESTICIDES AL'JD TOXIC SUBSTANCES
ProductName: SERGEANT'S F1PRONIL 

### +CYPHENOTHRIN

### +NYLARSQUEEZE-ON FORDOGS EPAApplication Receipt Date: 11-Aug-201 0 EPAWaiverRequest ReceiptDate: ll-Aug-2010 EPACompanyNmnber: 2517 CompanyName: SERGEANT'S PET CAREPRODUCTS, INC. KELLY R. HOSKINS SERGEANT'S PET CAREPRODUCTS, INC. 2625 SOUTH 158TI-I PLAZA OMAHA, NE 68130-1703 SUBJECT: Approval of50% Small BusinessWaiver Request DearRegistrant: The Office ofPesticide Programs has approvedyour requestfor 50% waiverofthe pesticideregistrationfee associated withthe actionreferenced above. The decision review periodfor this action will begin onthe date ofthis letter. TheActionhasbeenidentified as ActionCode: R320 NEWPRODUCT;NON-FAST TRACK;NEWPHYSICAL FORM(EXCLUDES SELECTIVE CITATIONS); 

### Ifyouhave any questions, please contactthe PesticideRegistration Service Fee Ombudsman, at (703) 308-9362.

OscarMorales, Director InfonnationTechnology & Resources Management Division Office ofPesticideProgramsh**~-** Form App",nd OMD No. 2010:iio6"0 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 40I M Street, S.W. WASHINGTON, D.C. 20460 Pllpcnvork Reduction Act Nolice: The public reporting burdell for this collection ofinlollnalion is estimated to avemge 0.25 hours per response for regiSI:alio:J

### ll~tivilics**~nd** 0.2) hons

### p-;;~**res~on;e** for f rercgistmlion and special revielV activities, includillg time for readllg tllC illSlruclioll and completing the necessary fOfms. Send cammenlS regarding the**bU<den~sl:mate** or::my otller aspect "fill'S cdlcction of infornmlion, including suggc,tions for reducing the b.mlcn 10 Director: OPPE Informmion Management Division (2137) U.S. Environmental Protection Agency, .10'1 M**Sl·c~:;** S:V.'" Wash,ngion, DC 20460. Do Ilol send the form to Ihis address. 

### DATA MATRIX Date: August 11, 2010 Applicant'sJRegistrmlt's Name & Address Sergeant's Pct Care Products, Inc, 2625 South 158th Plaza, Omaha, NE 68130-1770 Ingredients: Fipronil, Cyphenothrin and Pyriproxyfcn EPA Reg

## No.7FiicSYffibOi')~i7-1fE~'. 

# I Page I of4 

### I Product: Sergeant's Fipron:1 +**Cy~hejjothiln** +. Nylar Squeezc-On for**Dog~** Guideline Reference Numbcr Guideline Study Name 830.1550, 830.1600, 830.1620, Group A Product Chemistry For Sergeant's Fipronil + 830.1650,830.1670, 830.1750 C henothrin +N lar S ueeze-On for Do.e.s 830.1800 Enforccmcnt Analytical Method 830.6302,830,6303,830.6304, 

# I Group B Product Chcmistry For Sergeant's Fipronil + 830.63 13, 830.6314, 830.63 I5, Cyphenothrin +Nylar Squeeze-On for Dogs 830.63 16, 830.6317, 830.6319, 830.6320,830.6321,830.7000, 830.7100,830.7300,830.7520 830.6317,830.6320 870.1100 Storage stability and corrosion characteristics Acute Oral Toxicity Up and Down Procedurc with Dog Products MRIDNumbcr New submission 48122601 NclV submission

To Be Submitted Upon Completion 48129603 Submitter Sergeant's Pet Care Products, Inc. Scrgcant's Pet Care Products, Inc. Sergeant's Pet Carc Products, Inc.

Scrgeant's Pet Care Products, Inc. Scrgcant's Pet Care Products, Inc. Status OWN OWN OWN

OWN OWN Note

870.1200 870.1300 870.2400 870.2500 870.2600 870.7200
870.7200 870.7200 Acute Dermal Toxicity (Limit Test) with Dog Products Waiver Requcst ofRcquirement for Further Testing for Acutc Inhalation Toxicitv Acute Eye Irritation/Corrosion with Dog Products Acute Demml Irritation/Corrosion with Dog Products Test for Scnsitization (Guinea Pig Maximisation Test) with Dog Products Companion Animal Safcty for Scrgeant's Fipronil + Cyphenothrin Squeeze-On for Dogs Companion Animal Safety Study in Dogs: Cyphenothrin -IGR Soot-on for Dogs Companion Animal Safety Evaluation on Dogs ofSpot-On Products Containing Multiple Toxicants and Insect Growth Regulators 48129604 48129605 48129606 48129607 48129608 48129614
46166108 47849609 sergeant's Pct Care ProductS", Inc. I OWN Sergeant's Pet Carc Products, Inc. 

### I OWN Sergeant's Pet Carc Products, Inc. 

### I OWN Sergeant's Pet Care Products, Inc. OWN Sergeant's Pct Care Products, Inc. OWN Scrgeant's Pet Care Products, Inc. OWN Sergcant's Pet Care Products, Inc. OWN Scrgcant's Pct Care Products, Inc. OWN

870.7200 Assessment ofTolerance ofa 0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mlJkg When Applicd 6timcs to the l-Iaircoat at 28 Day Intervals 43121110 Merial Limitcd OLD
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EPA form gi'ii):)lt9.97) £Ieo"oo,o andPa"er Ve,,;o", A"a,I,bl,**-S',-;~m,'** oolyr.per ""ioo Namc and Title Kelly R. Hoskins, Manager ofTechnical Affairs Ageo'l' '0""0" U,. Copy Datc 08/11/2010 

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## (2l~CT'",**,~,n.y** Iy Paper per**Ver~o",** Av,il.bl. EPA Foom'S:'fiii:Bt9.97)flee'",' Foro" App...,
...d OMB No. 1010·0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY n :

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

### .""./. 

### WASHINGTON, D.C. 20460 Papern'Ofk Rcduction ActNotice: Tile public reportingburden for Olis collcction ofinfomlation is estimated to avclage 0.25 hours pel respollsc for lcgi'\h'tion =ctiv:;ies hnd 0.23 hours pee**resron~c** furlcrcgistratiOll alld spceial review activities, including time for reading the instruction and cOinpletiligthe lIeccssary fonns. Send commcrts regarding the burden eSlimale or any o;ller**asPf~t** o(tl;is collection 01 i'ltomJation, including suggeslions for redlCillg!he burdcli to Dilcetor: OPPE Information Managemcnt Division (2137) U.S. EnvironlUental ProlectiOll Agency, 401 MSheet, S.W., Wa,hingl011, lJC 20460. Do not send the form to this address. 

### DATA MATRIX Date: Au ust II, 2010 EPA Reg No.lFi1e**Svmb~** 251:-NEW Pa e20f4 Applicant'sJRegistrant's Name & Address Product: Sergeant's Fipronil + Cyphencilhril: + Serpeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Nvlar Saueeze-On for OMS In redients: Fi ronil, Cynhenothnn and P ri roxyfen Guideline Reference Number Guideline Study Name MRlDNumber Submitter Status Note 870,7200 Domcstic Animal Safety: Assessment ofthe Tolerance ofa 025% RM 43121111 Merial Limited OLD 1601 Spray in Nursing Puppies Administered Twice at a 28 Day Interval at a Dose Rate of6 ml/kg 870.7200 Domestic Animal Safety Study ofRMI60lC Topical Spray (Frontline 43444905 Merial Limited OLD SDrav Treatment) in Juvenile Do.!!:s 870.7200 Discussion in Support ofBridging Domestic Animal Safety Data on 43577711 Merial Limited OLD Frontline Smav Treatment to Frontline Soot Treatment Data Package 870.7200 Domestic Animal Safety Study by Topical Administmtion to Dogs: 43863802 Merial Limited aLa Fipronil Snot Treatment (RM 160IE)' 810.3300 Overview and Summary ofFipronil/Cyphenotltrin Dog Efficacy 48129609 Sergeant's Pet Care Products, Inc. OWN for Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dol'S 810.3300 Immediate Efficacy ofa Combined Application ofFrontline Plus with 48129610 Sergeant's Pet Care Products, Inc. OWN Cyphenothrin as a Squeeze-on against Fleas (Cteuacephalidesfelis) and Ticks (Rln"nicenhalus saneuinens) on Do!':s MS 164 0 810.3300 Immediate Efficacy Following Application ofFrontline Plus with 48129611 Sergeant's Pet Care Products, Inc. OWN Cyphenotluin Squeel--c-on against Fleas (CtenocephalidesfeUs) and Ticks**(Rhivice~halus** saneuinells) on Do!':s MS 183 0 810.3300 Immediate Efficacy FollowingApplication ofFrontline with 48129612 Sergeant's Pct Care Products, Inc. OWN Cyphenothrin Squeeze-on against Fleas (Ctellocephalidesfe/is) and Ticks (Rhiv'-cephalns SOlI.l;ninells) on Dogs MS 175 0 810.3300 Comparative efficacy evaluation ofSergeant's Squeeze-on and 48129613 Sergeant's Pet Care Products, Inc. OWN Frontline Plus for thl.: treatment ofadult cat l1ea (Ctenocephalidesfelis) and tick (Haemaphysalis elliptica, Rhipicephalns sanguillells and Dennacentol· variabilis) infestations on dOES 810.3300 A Dose Titration Study to Determine the Optimal Spray Concentration 43121114 Merial Limited aLa ofRM 1601 for Long TemI Control ofthe Cat Flea Ctenocephalides Felis and the Brown Dol' Tick Rhinicenhalus salll!Uineus in the DOl!: 810.3300 Product PerfomJanee: 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) mId the Brown Dog Tick (Rhinicenhalus san!':uineus) in the DOl!: Signature: 

## lO'ti Name and Title DatI.:

## \~o-;,L..."" Kelly R. Hoskins, Manager ofTeclmieal Affairs 08111/20I0
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## '" Form Appro,'ed OMB No. 1070_0060 

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

### 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden forthis eOlieCliOl1 ofillformlltion is estilllated 10average 0.25 hOnrs per response for**rcg;~t<rtion:;ctiv:lies-;;,nd** 0.23 hours pe' res;10n:e for reregistration and special review activities, includingtime for reading the instruction and completingthe ncecssary fonns. Sendcomments regarding the**bU:rden'~st'rnale** or:my (It!;er aspect tJfthlS ,,:olleetion of infonnalion, including suggeslions forreducing the burden to Director: OPPE InformationManagement Division (2137) U.s, Environmental ProtectionAgency, "Ot MStreet, S.W., Washingion, OC 20460. Do not sendthe fonn tothis address. 

### DATA MATRIX

. Datc: Au ust II, 2010 EPA Re NO.fFile S 'mbol**~:17-1m_W** Pac30f4 Applicant'sJRegislrant's Namc & Address Product: Sergcant's Fipron:1 +C:YI;henoth;in-t, Serp-eant's Pet Carc Pmducts, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Nylar Snueezc-On for Dogs In redients: Fi roniL C henothrin and P ri rox en Guideline Reference Number Guideline Stud Name MRIDNumber Submitter Status Note 8103300 A Comparative Evaluation ofTwo Treatment Rcgimes Using RM 1601 43121116 Merial Limited OLD Sora for Control ofthe Cat Flea Ctenoccohalides felis on the DO!' 810.3300 Laboratory Evaluation ofRM 1601 Spray for Control Dermacentor 43121117 Merial Limited OLD variabilis and RJlipecephaius sanl'uincus on the Dol' 810.3300 An Investigation Study to Evaluate the Eftect ofBathing ofLaboratory 43121118 Merial Limited OLD Dogs on thc Efficacy ofRMI601 SpraY 810.3300 Efficacy ofRMI601C at 3 mllkg and 6 mllkg Against Ixodes 43121122 Merial Limitcd OLD scapularisfdammini Nymphs, Dermacentor variabilis Nymphs, Amblyomma americanum Nymphs, Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides Adults Using Treatcd Dog Hair as thc Testinl1 Substrate 810.3300 Positive Refercnccd and Untreated Controlled, Confirmatory 43577712 Melial Limited OLD Laboratory Trial ofRM160lE SPOT-ON Formulation Applicd to Dogs as 3 Weight Class Defined Volumes for thc Control ofthe Cat Flea Ctenocephalides felis, the Brown Dog Tick RJlipicephalus sanguineus, and thc American Dol!. Tick Dermacentor variabilis 810.3300 Study Summaries: Frontline Plus For Dogs 45612701 Merial Limitcd PAY 810.3300 An Efficacy Study ofFrontline Spray, Frontline Top Spot, and ML- 45620501 Medal Limitcd PAY 2,095,988 509T, for the Treatment and Control ofTlichodcctcs canis in the DOl! 8103300 PR & 0 0024101: Frontline Spray/Frontline Spot-OnIML-2, 095, 988 45620504 Medal Limited PAY 509T/DoJ!,s /Solutionn'opical 810.3300 PR & 0 0052301: Frontline SprayfFrontline Spot-On/ML-2, 095, 988 45620505 Medal Limited PAY 509TlDogs/Solution/ Topical 810.3300 Study to Confirm the Efficacy ofFipronil Against Lice in Dogs Under 45628201 Medal Limited PAY Field Conditions 810.3300 Frontline Spray & Top SpotlDogs/SolutionfTopical CliniallDose 45620506 Melial Limited PAY Confirmation/Ectonarasites, Mites, Sarcontes Scabici var canis 810.3300 Effect ofShampoo Application aftcr Treatment with a Cyphenothrin 46298501 Sergeant's Pet Carc Products, Inc. OWN Squeeze-On on Efficacy Against Cat Fleas (Ctenocephalides felis), Adult Brown Dog Ticks (Rhipicephalus san.e;uineus)'on Doos Signature: 

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# ('b!-r Name and Title Datc Kelly R. Hoskins, Manager ofTcchnical Affairs 0811112010 EPA Form8170-35 19·9))Fled",n\< ",od P'D" W,,;o", '\yailabl< S
..hmilonlvP,,,,,r**Yer~o"** A.e.", In,.en>1 U.eCom"Fo,m App,o".d**O~lB** l'io.1070-0060 

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

### 401 M Street, S.W. WASHINGTON, D.C. 20460 Pllpern'ork ReduClion Act Norlce: The public reporting burden fortlris collcction ofinfonnation is estimated to average 0,25 hours per response for registration**~ctivitie~a;rd O.~"**  Irours r::;**rCSLon~e** for reregistration and special review activities, including time for reading the instruction mrd completingthe necessary fonns. Send comments regarding the**l"I'!!~n e~'ima~~**  or ,;.ny ollrer aspect "ftlric crlIection of information, induding suggestions for reducing the burden to Director: OPPE In('omlalion Management Division (2l37) U.S. Environmentill Protection**Ag~ncy.** 40'- M**Str_c~t,** 5.\1:., Washini,ton, IX 20460. Do not send the form to this address. 

### DATA MATRIX Date: Au ustll,2010 EPA Ref!, No.lFile Symbol**2j:~'-NcW** Page 4 of4 Applieant'sJRegislrant's Namc & Address Product: Sergeant's Fiproni: "':::yp;rrno;hflP'" Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha., NE 68130-1770 Nylar Squeezc-On for OMS lngredients: Fipronil, Cyphenothrin and Pyriproxvfen Guideline Reference Number Guideline Sludy Name MRIDNumber StrbmiUer Status Note 810.3300 Dose Titration ofa Pyriproxyfen Spot-On Formulation For Flea Ova 46346601 Sergeanl's Pel Care Products, Inc. OWN Sterilization. 8103300 Analyses ofefficacy and safely data to support label claims for 47849608 Sergeant's Pel Care Products, Inc. OWN Sergeant's squeeze-on for small dogs containing etofellprox and nvrinroxvfen 40 CFR Part 15732 Evaluation oftlJe Dog Squeeze On 0.67 ml While Applicator wilh 48059803 Sergeanl's Pet Care Products, Inc. OWN Orange Label Indicator (3x), scissors to open - F=I as a Poison Prevention Package for**Sefl:~eant's** Pet Care Products, Inc, 40 CFR Part 157.32 Evaluation ofthc Dog Squeeze all 1.34 ml White Applicator with 48059804 Sergeant's Pet Care Products, Inc, OWN Grecn Label Indicator (3x), scissors 10 open - F=I as a Poison Prevention Package for Sergeant's Pet Care Producls, Inc. 40 CPR Part 157.32 Evaluation ofthe Dog Squeeze On 2.68 ml WIJileAppl1cator with 48059805 Sergeanl's Pet Care Products, Inc. OWN Red Labellndicalor (3x), scissors to open - F=l as a Poison Prevention Packa.e,e for Sen'eant's Pet Care Products, Inc, 40 CFR Part 15732 Evaluation ofthc Dog Squeeze On 4.02 ml White Applicator with 48059806 Sergeant's Pct Care Products, Ille. OWN Blue Label Indicator (3x), scissors 10 open- F=I as a Poison Prevention Package for Sere.eant's Pet Care Products, Inc.

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# !?/l--/ Name and Title Date Kelly R. Hoskins, Manager ofTechllical Affairs 08/11/2010 r.PA**,,~'"'** .,J()..\\ !9.97ll'I""" ;0 ,"n P,n",**v,,~"",** A,',I!.>"I,**~"h,";t ~"I"**  P'n"**"",~o"** A••ll." l"l,m,1 fJ

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# i_517- (CV(:iSergeant's Pet Care Products, 1m:. 2()25 SOllii1 158th Pi2Zi] Olnnln, \iE GanO- '1770 $ Teiephone ,:02.935 7000 Fax 402,938.7099
1 December 200t) Richanl (Jc!lkcn Prod11d :\/1;mager 22 J)uclllllcnl Proeessm.g**DL~sk** Oftlce ;:d' Pesticide Programs U,S, Environmental Protection ABcn;.:y Ruom S-4000. On,,-' Potlllnae Yard 2717 South CrysUll Drin:, AriingtlHL VA 221(12-4501 Dcar Mr. Ciebkcn: SCl"l!:Cill1(S Pet Care ProduCls. Inc. (Senl.CHnt·s. 2(125 South 158 11. PI;17:a. Onwl1a. Nebraska
, , 

### 6S 130-1 770. EPA Company Number 

### 25 I

### Tl. authorizes Expollel1t. Inc. (! 

### 150 Connecticut i\venlle. NW. Suite I 100. \Vashingtoll DC 1003(1) to act on our behalL as our Authorizcd Represelltalive, fIr all necessary interadions regarding nil ofour produet rcgistmtiolt applications and registrations. Please note ihis docs not L'hangc the current lilcd Authorized Agent for Sergeant's. The Exponent Inc. contact is as f()!!ows: James ivlcssina :mdior Rick Tinsworth Exponent. Inc. I 150 Connecticut Avc.. NVv' Suite 1 100 \Vnshington, DC 200:)6 (]O]) 

### 772-4932 (201) 771-4979 h'i Jine5SIn**a({j~** expunCIli

.Cllm'"rtinsworth(fCexponen1.c(\11') lfyoll have any questions. pknsc**eOll\~lct** 11'\C at 402-93x-7079. Sinccrd;.'. 

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## /~/~ / Kelly R, Hoskins ManaJ;cr ofTcdlllica!**An:'lir~**
cc: James Messina**_l**