REGISTRATION 

2517-143 
ISB'S Front-end PRlA Completeness Screen

Drall 3; 10/25107

-

'cipl Date: AUG 1 1 2010 EPA Reg. Number: ;2:)/7- PUG

Cheek List Item . ..... Ves No N/A ..

s the PRIA Fcc been Paid; is a copy ofthe check or j;> X

.gov receipt included in the Submission Package? J.Y

In Application Form (EPA Fom18570-1) included in the

'I hmissloll Package, is it completely 11 lied out and signed

-!tIding package lype?

...

Confidential Statement of Formula (EPA Fonn 8570-

.lncluJcd in the Submission Package, is it completely i

cd out and signed (boxes 1-21)?

- .._"

I Fnrmulator's E.xcmption Statement (EPA Form 8570- '/ ) Included in the Submission Package? ~--~---- .

I eel"lineation with Respect to Citation oCData (EPA

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

I Dalll Matrix (EPA Fonn 8570-35) Included in the ;< bmission Package? ...

Lnhcl Included in the Submission Package? l..-

e f)at.a Included in lhe Submission Package?

the Submission un Amendment? -

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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 of your Application 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 a review ofthis request for its applicability under

PRN 98-10 and [rods that the action(s) requested fall within the scope ofPfu'l 98-10. The Confidential

Statement of FOlTImla (CSF) and/or label submitted with the application has (have) been stamped

''Notification'' and will be placed in our records.

If you 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

2

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

April 6,2011 

KeUy 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: 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

The Agency is in receipt of your Application for Pesticide Notification under Pesticide 

Registration Notice (PRN) 98~1 0 dated March 24, 2011 for the following product(s). 

Sergeant's Fipronil + Cyphenothrin + NyIar Squeeze-On for Dogs 

(EPA Reg. No. 2517-143) 

The Registration Division (RD) has conducted a review of this request for its applicability under 

PRN 98-10 and fmds that the action(s) requested faU within the scope ofPfu'l 98-10. The Confidential 

Statement of FOlTImla (CSF) and/or label submitted with the application has (have) been stamped 

''Notification'' and will be placed in our records. 

If you have any questions, please contact Regina Foushee' -Smith at 703-605-0780. 

,Jj)1ce,!Yly, II /1. 1: 

!:1QA0-<-(.L L~x:P~ Richard Gebken 

Product Manager 

Insecticide Branch 

Registration Division 
J.~"tFj

3

Tracking 

Create Resubmission 

FFS Letters 

Action Code History 

J.~"tFj 

* Claimed confidential by submitter*
Sergeant's Pet Care Products, Inc.

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

March 24,2011

Richard Gebken, PMIO

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Document Processing Desk (NOTlF)

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Notification Submission per PR Notice 98-10 to Add an Alternate #2 CSF for

Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs (EPA

Registration Number 2517-143)

Dear Mr. Gebken:

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

1770, EPA Company Number 2517) is submitting a notification pursuant to PR Notice 98-10

to add an alternate formulation #2 and new Formulator's Exemption Statement to support the

registration of Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze~On for Dogs (EPA

Registration Number 2517-143). Please find enclosed the following documentation in

support ofthis registration:

• Cover letter (this docwnent);

• Application for Registration (EPA Form 8570-1);

• Copy ofCurrent EPA Approved Confidential Statement of Formulas (Basic and

Alternate # I);

• Copy ofthe new proposed Alternate #2 CSF Formulation (tv,ro copies); and

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

does not change the toxicological category or chemical properties ofthe

product. Further, this notification does not require any change to the current EPA approved

label language.

This notification is consistent with the provisions ofthe PR Notice 98-10 and EPA

regulations at 40 CFR 152.46, and no other changes have been made to the labeling or the

confidential statement of formula ofthis product. Iunderstand that it is a violation of 18

U.S.C. Sec. 1001 to willfully make any false statement to EPA. I futther understand that if

this notification is not consistent with the terms ofPR Notice 98-10 and 40 CFR 152.46, this

4

* Claimed confidential by submitter*
sergeant's Pet Care Products, Inc.

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

product may be in violation ofFIFRA and I may be subject to enforcement action and

penalties under sections 12 and 14 ofFIFRA.

Please note information found in this letter and enclosures is considered CONFIDENTIAL

BUSINESS INFORMATIONand must not be released to any party outside ofEPA.

Ifyou have any questions regarding this submission, please contact me at 402-938-7079.

Sincerely,

Manager

K~YofRegulatory Affalrs

Sergeant's Pet Care Products, Inc.

Enclosures

cc: Rosanna Louie-Juzwiak, EPA

5
Plem,e 'read mstrucffons on reverse before compteffng form Form Approved OMS No 20700060 - Approval expires 05-31 -98

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 Pet Care Products, Inc. I Sergeant's Fipronil + Cyphenothrin + Nvlar Squeeze-On For Doqs

5. Name and Address of Applicant (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 Check if this 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 letter dated 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 of Alternate #2 Confidential Statement of Formula and a Formulator's Exemptlon

as a Notification Pursuant to PR Notice 98-10.

Section III

1. Material This Product Will Be Packaoed In:

Chlld·Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container

[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 of Label 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! below for identiticatton of individual to be contacted, if necessalV, 10 process this applicafion.)

Name Title Telephone No. (Include Area Code)

Kelly R. Hoskins Manager of Regulatory Affairs 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 by fine or imprisonment or both (3tamped)

under applicable law.

-- :~~ignu~ jJl Jia 3. Title

Manager of Regulatory Affairs

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

-----

6 * Claimed confidential by submitter*
7

*Confidential Statement of Formula may be entitled to confidential treatment*
8

*Confidential Statement of Formula may be entitled to confidential treatment*
9

*Confidential Statement of Formula may be entitled to confidential treatment*
10

*Confidential Statement of Formula may be entitled to confidential treatment*
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 of Confidential Statement of Fonnula (EPA Fonn 8570-4)

03/24/2011

As an autholized representative of the applicant for registration of the 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) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that 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 of 40 CFR section 158.50(e)(2) or (3).

(3) Indicate by checking (A) or (B) below which 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 of the 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 ILlh Name and Title Date

Kelly R. Hoskins, Manager "

03/24/2011

EPA For~570 2J (Revfl6-'200"4) Copy 1 - EPA

11 *Product ingredient source information may be entitled to confidential treatment*
U.S. ENVIRONMENTAL PROTECTION

AGENCY

Office ofPesticide Programs

Regislralion Division (7504P)

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460

EPA Registralion No.

2517-143

Date of Issuance:

MAR 22 2011

NOTICE OF PESTICIDE,

0" Registration

o Reregistration

(under the Federal Insecticide, Fungicide,

and Rodenticide Act, as amended)

Name and Address of Registrant (include ZIP Code):

Sergeant's Pet Care Products, Inc.

c/o Exponent, Inc.

2625 South 1581h Plaza

Omaba, NE 68130

Term of Issuance:

Conditional Registration

Time-limited: see conditions below

Name of Pesticide Product:

Sergeant's Fipronil + Cyphenothrin +

Nylar Squeeze-on for Dogs

On the basis ofinfonnation furnished by the registrant, the above named pesticide is hereby registered under the

Federal Insecticide, Fungicide and Rodenticide Act.

Registration is in no way to be construed as an endorsement or recommendation ofthis product by the Agency. In

order to protect health and the environment, the Administrator, on his motion, may at any time suspend or cancel the

registration ofa pesticide in accordance with the Act. The acceptance of any name in connection with the

registration ofa product under this Act is not to be construed as giving the registrant a right to exclusive use of the

name or to its use ifit has been covered by others.

This product is conditionally registered 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 limiting the formulations of each 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 of Storage 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 of 5

12
4. Within one year ofthe date on this Notice ofRegistration, and prior to formulating this product,

you must provide the Agency the following:

a. The registration number and establishment number ofthe manufacturing or technical

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 of all offers to pay compensation and evidence oftheir

delivery, used to support the data required for this product.

6. You must submit quarterly enhanced incident reports and quarterly sales information in doses

sold for this product for the quarter that 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 incident reporting should

be submitted to the Product Manager. Quarterly sales information should be submitted to the

Registration Division (7504P), to the Product Manager'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 or years

Sex: M, F, orneutered

Weight pounds

Primary Route of Exposure: dermal, oral, other animal, inhalation, other

Body System: neurological, dennatological, GI, respiratory, ocular, other

Major signs noted with separate column for each sign, using standard tenninology

Time to Onset (hours, days)

Treated by veterinarian: yes or no

First time product used: 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 of5

13
7. Along with the enhanced incident reporting, you must submit an analysis ofthe incidents seen, to

include the following details:

All incidents should be reported including all minor dennal and ocular initation reports.

Summary table for dogs showing number of incidents of each severity code for each route

ofexposure. Each incident should only be reported once. If one incident has several

routes of exposure, 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 of each severity code for each route of exposure.

Summary table for dogs and table for cats showing number of incidents that are believed

due to secondary exposure (e.g., multi-pet households).

A summary table for dogs showing number of incidents 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 of dog incidents for each severity code for each pet

weight range on the product label.

A summary table for dog weight showing number of incidents 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 half of weight range, number

of incidents in dogs in upper half of weight 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 of incidents 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 product under FIFRA

§3(c)(5) when the Agency requires all registrants ofsimilar products to submit such data, and

submit acceptable responses required for reregistration ofyour product under 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. Throughout the 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.

Page30f5

14
11. 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, revise the 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 of listed pests for up to [1 month] [4 weeks]]"

13. Throughout the entire label, per the 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, revise the 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 of listed 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 of listed 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 How to Apply section, correct the reapplication interval from "4 weeks" to "30

days" to be consistent with the interval stated under Frequency of Application.

Page 4 of 5

15
20. On page 6 in the Frequency of Application, delete "[Studies show that] [brand name] kills fleas

(in as little 1 hour) fur up to three months]" because the efficacy data do not support this claim.

21. On page 6 under the Frequency ofApplication, add the underlined words and delete the struck-out

text in the following statement:

"[Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, then

within 48 hours for up to 28 days]."

22. On page 7 under the Storage and Disposal statement, replace "Container Handling" with

"Container Disposal."

23. On page 7 in the Warranty statement, remove the brackets within the paragraph so that if used, the

Warranty statement is present in its entirety.

24. On page 9 under the End-back/side Panel section, delete the "Optional Insert or Package Copy"

statement because the Agency has not reviewed the optional insert as part ofthe labeling for

approval.

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. If mitigation measures are necessary, the

Agency may take appropriate regulatory actions. Two copies ofthe fmished labeling must be submitted

prior to releasing the product for shipment. Ifthese conditions are not complied with, the registration will

be subject to cancellation in accordance with FIFRA sec. 6(e). Your release for shipment ofthe product

constitutes acceptance ofthese conditions. A copy of your 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, Stamped Accepted

with Comments

Signature of Approving Official:

/~J~L Richard Gebken, Product Manager (10)

Registration Division, Insecticide Branch

EPA Fonn 8570·6

Page 5 of5

Date:

MAR 22 201,

16
10 March 2011

Infonnation in [ ] is optional.

Sergeant's® Master Label

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 EPA Letter Dated:

MAR 2 2 2011 Und~r .the Federaf Insecticide,

Fungicide, and Rodenticide Act,

as ~mended, tor tbe pesticide reglstered under EPA Regl. 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 or older]

[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 of all 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]

[.With Nylar® to Break Flea Life Cycle]

[.With Insect Growth Regulator to Break Flea Life Cycle]

[·Dual Action [!]:Fipronil with Nylar® IGR Effectively Breaks the Flea Life

Cycle]

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

[·Kills & Repels Fleas (starts killing in as little as I hour) Up to [4 weeks]!] [2 months]

[3 months]]

[.Kills Flea Eggs & Flea Larvaefor [more than 2 months] [up te 4 menths]]

[-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]

17
Sergeant's@ Master Label

10 March2011 Version 10.1 EPA Reg. No. 2517-RUG

Information in [ [is optionaL Page 2 of 9

[-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]]

[-When used monthly [brand name] completely breaks the flea life cycle and controls tick

and chewing lice infestations.]

[- 4 week Flea and Tick Treatment!]

['Once A Month Flea and Tick Treatment]

[- Kills Fleas (starts killing in as little as 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 oflisted pests 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 American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!]

[All Others]

[-For Dogs and Puppies 12 weeks of age or older]

['For Dogs ["1'1 to 22Ibs], [23-44 Ibs], [45-88Ibs], [89-132Ibs]

[·Fast Acting]

['Waterproof]

[.Long Lasting]

[-If dog 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 of chewing lice infestations]

[-Controls mites that may cause sarcoptic mange]

['Three Applications] andlor [3 Month Supply] or [12 Week Supply]

[-Best if used year round!]

['(ICON Showing 4 Week Protection)]

18
Version 10.1

Page 3 of9

Sergeant's® Master Label

10 March 20 II EPA Reg. No. 2517-RUG

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 after bathing and exposure to water and sunlight]

[-Prevents and controls reinfesta-tions of listed 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 of age]

[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 or back label]

ACTIVE INGREDIENTS:

FiproniL ., 9.8%

Cyphenothin 5.2%

Pyriproxyfen 2.0%

OTHER INGREDIENTS*: 83.0%

TOTAL: 100.0%

[*diethylene glycol monoethyl ether]

19
Sergeant's® Master Label

10 March2011 Version 10.1 EPA Reg. No. 2517-RUG

Infonnation in [ ] is optionaL Page 4 of 9

[Nylar® is a registered trademark ofMcLaughlin Gonnley King Company.

U.S. Patent No. 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 - MASTER LABEL]

[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)], and kills 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

get in eyes or on clothing. Harmful ifswallowed. Harmful if absorbed through skin. Prolonged or

frequently repeated skin contact may cause allergic reactions in some individuals. Wash hands

thoroughly with soap and water after handling and before eating, drinking, chewing gum, using

tobacco, or using the toilet. Remove and wash contaminated clothing before reuse.

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

12 weeks of age. Individual sensitivities, while rare, may occur after using any pesticide product.

[Some dogs may experience temporary startle effects when any product is applied.] Dogs may

experience some temporary irritation at the site of product application. Ifsigns persist, or become

more severe within a few days of application, consult a veterinarian immediately. If your dog has

an unusual reaction to the initial application, consult a veterinarian before repeating treatment.

Certain medications can interact with pesticides. Consult a veterinarian before using on

medicated, pregnant, nursing, debilitated or aged dogs. Call 1-800-781-4738 for 24~hour

assistance.

20
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, if present, after the first 5 minutes, then continue rinsing

eye.

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

IfOn Skin Or • Take off contaminated clothing.

Clothing • Rinse skin immediately with plenty of water 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 OR VETERINARIAN

Treat patient symptomatically

DIRECTIONS FOR USE

It is a violation ofFederal law to use this product in a manner inconsistent with its labeling.

DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU

AND YOUR DOG, READ ENTIRE LABEL 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 if applied to or ingested hy cats.

FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks of age.

Weigh your dog to be sure you are applying the right dose fannulated for the weight ofyauT dog.

Do not treat your dog with more than one pesticide product at a time. Over dosing your dog can

result in serious illness and even death. Best if used year round. Certain medications can

interact with pesticides. Consult a veterinarian before using this product on debilitated, aged,

medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known

organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated

dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that

actively groom or engage in close physical contact with treated dog may be at risk ofserious

harmful effects. The most common signs of ingestion 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 talk to a veterinarian. Cats

exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately.

If your dog is exhibiting signs of and/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 product on dogs. Dogs may experience

some temporary irritation at the site of product application. Ifsigns ofsensitivity occur

21
10 March 2011 Version 10.1

Infonnation in [ Jis optional. Page 6 of9

Sergeant's® Master Label

EPA Reg. No. 2517-RUG

bathe your dog with a mild soap and rinse with large amounts of water.

consult a veterinarian immediately by calling 1-800-781-4738.

Ifsigns continue,

[{Outer Packaging}]

How to open: Remove product tubes [vial] from the package. Separate one tube from the others.

Holding the tube [vial] with notched end pointing up and away from the face and body, cut off

the narrow end at the notches with scissors.

How to apply: Invert tube 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 mayor may not appear on finished Jg I~.

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 (il'l as little as 1 ho1:H') for

Ufl to three months. If your pet is at high risk for flea reinfestation [, or in a highly infested

environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing lice.

[Brand name] kills mosquitoes within 24 hours for up to the ftrst 7 days after treatment, then

within 48 hours for up to 28 days. [Brand name] remains effective, even after bathing, water

immersion, or exposure to sunlight. Allow treated area to dry thoroughly. Do not reapply for 30

days.

22
Sergeant's® Master Label

Version 10,1 EPA Reg. No. 2517-RUG

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 spot to the dog's back between the shoulder blades]

[from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 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.] [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 tbe shoulder blades]

[from the back ofthe neck to a point midway between the 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 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 (25°C)] dry place inaccessible to children and pets. Do not refrigerate. Protect

from direct sunlight.

CONTAINER DISPOSAL HANDLING: If empty: Non-refillable container. Do not reuse or

refill this container. Offer for recycling if available. If partly 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 of this product are believed to adequate

and must be followed carefully. It is impossible to eliminate all risks associated with the use of this

product. Unintended consequences may result because ofunknown factors. All such risks shall be

assumed by the user or buyer.H Sergeant's is committed to providing high quality products. To the

extent consistent with applicable law, Sergeant's makes no warranties, express or implied, of

merchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this

label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not

be liable for indirect, special, incidental or consequential damages. To the extent consistent with

applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.]

[Ifyou have questions or comments about this product, please write: Sergeant's Consumer Response,

P.O. Box 540399, Omaha, NE 68154-0399.]

In Case of Emergency, call: 1-800-781·4738 [For more information] [Visit us at:] [www.sergeants.com]

Non·Emergency call1-800-224-PETS (7387) [Made in USA]

23
Version 10.1

Page 8 of9

Sergeant's® Master Label

10 March 2011 EPA Reg. No. 2517-RUG

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 back carton label and/or applicator labeling.]

[{Outer Packaging}]

[Application Instructions[ [Directions for Use]

How to open

1. Remove product tubes [vial} from the package.

2. Separate one tube from the others. Holding the tube [vial} with notched end pointing up

and away from the face and body, cut offthe narrow end at the notches with scissors.

How to apply:

1. Invert tube over dog and use open end to part dog's hair.

2. Squeeze tube firmly to apply all ofthe solution to the dog's skin [as a spot to the dog's

back between the shoulder blades.] [or] [from the back ofthe neck to a point midway

between the neck and tail.]

[Flea life cycle 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

• Weigh your pet

• Do NOT use Dog products on Cats

• Do NOT treat with more than one pesticide product at a time

• Separate animals after treatment to avoid chance of ingestion

• Do NOT split tubes between pets]

24
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]

[For year-round protection, apply [Brand name] monthly.]

[pet's Name (Empty blank for owner to fill in name)]

[First] [1st] [Second] [2nd] [Third] [3rd]

[Dose] [Treatment] [Application](Empty blank for owner to fill in date)(Date: MM/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 reminder magnet. Push the (reset) button, and

the reminder light will blink twice. The reminder tag is now set for 30 days. At the end of30

days the reminder light will blink, reminding you to reapply [Brand name]. Press the button

once and the blinking light will stop. Press the button again and this will reset the timer for

another 30 days.]

Back Label

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 Dog Tick @ Brown Dog Tick

+ Deer Tick @ DeerTick

American Dog Tick @ American Dog Tick

" chewing lice @ chewing lice

Lone StarTick @ Lone Star Tick

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'!!?"";,

Front Label

{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}

25
III o

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E

tl I!~

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2
ACTIVE 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

Controls mites that may

cause sarcoptic mange

• Waterproof

chewing lice

m.;imnc:nuitoes

I I·· '---1 \! I

For use ONLY on dogs I

,.J "-<

SENTRY.

Bra

for

I 1,) l,l I ""__. _

~pplrcaljons

3n~~

OUTOF REACH OF CHILDREN

WARNING

5eolJi<kUbelP..,.lforMOiliMalPreuotiOl1aryStitement> '-I~"' -,

Net Contents: Three 0.045 fl oz

(1.34 mL) applicators ,-----,,---------- I ,I, ), I I l~

( \

r-z---------;>--- rz--- ~-71 L__ L 7-~_ ___~_.J

V~7777\ 28
E

tl I!~ E

• •

E

MA.R 2 2
,.J \..., \

SENTRY.

--+

I \

I--:z·----->-- LZ---Zl L.__L L_ .. . \ I \ I .. -I-- 'wia:ono r ~.,," -- "--- , ,

~pplk:aIT(}ns

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 that may

cause sarcoptic mange

• Waterproof

TOF REACH OF CHILDREN

RNING

I.M>eIPoneiforAdditior>olPrecautiOO>rfstalMlenlS '-,~~.~~

Net Contents: Three 0.091 floz

(2.68 mL) applicators

---l

.Brand Z'M Ifordo~~KILLS

l)ll fl eas

'lea eggs

icks

chewing lice

"",.mosq uitoes

'"

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SENTRY.

,....J '--., \

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 that may

cause sarcoptic mange

• Waterproof

Brand Z'M ~ordfi;J~KILLS

~fleas

'A flea eggs

+ticks

fr chewing lice

",mosquitoes

•

-

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Net Contents: Three 0.136 fl oz

(4.02 mL) applicators "-l-l I _..,_._,,_,.._ .. "U I I _ .."'__.. I ,I, ),! I I dill

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34
ART INSTRUCTION FOR THE PRINTER

••

,lACK PM; lnl

Printer/Vendar:

Additional Notes:

Dote lent:

I#R 22

35
36
Nl.W ~I?(A- d~

7

37

Tracking 

Create Resubmission 

FFS Letters 

Action Code History 

'30 ~: \2-SCOl>G<> .. 

t\ ~ LX Qcvvci. , 

V \ ',', ~ 

r::_ 

j OG-l T' '0 ;; 
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 of the 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

38

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: 2 t-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 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 of the attached package in support of1he proposed product. Contact Rosanna 

Louie-Juzwiak a1 308.0037 wi1h any ques1ions. 

Attachments: 

- cover letter 

- basic CSF 

- draft label 

- MRIDs 48188901, -02 
'uP#: (382783)

Page2

*** Studies Sent for 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) 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, Inc. 64 p.

Hoskins, K. (2010) GroupA 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) GroupA Product Chemistry for 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) GroupB 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) GroupB 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) GroupB 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) 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, 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, Inc. 64 p.

Hoskins, K. (2010) GroupA 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) GroupB 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 of formation 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 of formulation

process

830.6302lColor

39

'uP#: (382783) 

48188901 

48188901 

48188901 

48188902 

48188902 

48188902 

48188901 

48t88901 

48188901 

48188902 

Page 2 

* * * Studies Sent for 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. 64 p. 

Hoskins, K. (2010) Group A Product Chemistry for 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. (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 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/07/1 0103. 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 of formation 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 of formulation 

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%)

40
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 of the 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 of the 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 for the registration of the proposed

basic product.

SUMMARY OF FINDINGS:

1. Name of Active 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.

41

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. 

Formulation Type: Liquid 

INTRODUCTION: 

The Registrant has submitted one basic CSF (dated: 08/11/2010) and a proposed product specific label for 

registration of the 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 of the 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 for the registration of the proposed 

basic product. 

SUMMARY OF FINDINGS: 

1. Name of Active 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 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 I No I X INA

c. Physical chemical hazard statement Product label requires a statement per 40 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 of view; if yes explain below:

Final decision of overall label acceptance will be made by the PM.

2

42

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 I Yes I X INA; 

Soluble arsenic: [[Yes I X J NA 

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 I No I X INA 

c. Physical chemical hazard statement Product label requires a statement per 40 CFR §156.78 for: 

flammability, explosive potential or electric insulator breakdown? 

]XjYes []Na 

!s 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 of view; if yes explain below: 

Final decision of overall label acceptance will be made by the PM. 

2 
DP 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 of the acceptability of the 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 of formulation 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

3

43
DP 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

830.7300 nravit 1.02-1.06 nrlcc 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 of one 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

of the proposed label and uses are the purview of the PM team.

4

44
DATA EVALUATION RECORD

FIPRONIL

CYPHENOTHRIN

PYRIPROXIFEN

(Sergeant's Fipronil + Cypbenothrin + Nylar Squeeze-On for Dogs)

STUDY TYPES: Product Identity and Composition (OPPTS 830.1550)

Description of Materials Used to Produce the Product (OPPTS 830.1600)

Description of Production Process (830.1620)

Discussion of Formation ofImpurities (OPPTS 830.1670)

Preliminary Analysis (OPPTS 830.1700)

Certified Limits (OPPTS 830.1750)

Enforcement Analytical Method (OPPTS 830.1800)

Physical and Chemical Characteristics (OPPTS 830.6302-830.7950)

MRIDs 481889-01 and 481889-02

Prepared for

Registration Division

Office of Pesticide 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 Order No. 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 may have been altered SUbsequent to the contractor's signatures above.

Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC, for the U.S. Department of Energy under

Contract No. DE-AC05·000R22725.

45
Decision #: 438363

DP #: (382785)

PRIA

Parent DP #:

Submission #: 880188

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

DATA PACKAGE BEAN SHEET

Date: 05 M Qct M 2010

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 of the attached package in support of the proposed product. Contact

Rosanna Louie-Juzwiak at 308.0037 with any questions.

Attachments:

• cover letter

- basic CSF

- draft label

• data matrix

46

DATA PACKAGE BEAN SHEET 

Date: 05 M Qct M 2010 

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"I p",'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 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 of the attached package in support of the proposed product. Contact 

Rosanna Louie·Juzwiak at 308.0037 with any questions. 

Attachments: 

• cover leiter 

- basic CSF 

- draft label 

- data matrix 
DP#: (382785)

43863802

43t21t11

43121110

46166108

47849609

43577711

48129614

43121111

43863802

43444905

43121110

Page2

*** 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 of the Tolerance of

a 0.25% RM 1601 Spray in

Nursin9 Puppies Administered Twice ata 28 Day Interval ata

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 of Tolerance of

a

0.25% RM 1601 Spray Formulation in D09S at 3, 9, and 15 ml1k9

When Applied6 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

of Spo1-0n 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) Domestic Animal Safety: 870.7200/Companion animal safety

Assessment of the Tolerance of

a 0.25% RM 1601 Spray in

Nursin9 Puppies Administered Twice ata 28 Day Interval ata

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 of Tolerance of

a 870.7200/Companion animal safety

0.25% RM 160t Spray Formulation in D09S at 3,9, and 15 ml/k9

When Applied6 times to the Halrcoat at 28 Day Intervals:

Revised: Lab Project Number C1I138. Unpublished study

prepared by Rhone Merieux, Inc. 69 p.

47

DP#: (382785) 

43863802 

43t21 t11 

43121110 

46166108 

47849609 

43577711 

48129614 

43121111 

43863802 

43444905 

43121110 

Page 2 

* * * Studies Sent for 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 of the Tolerance of a 0.25% RM 1601 Spray in 

Nursing Puppies Administered Twice at a 28 Day Interval at a 

Dose Rate of 6 mllkg: Revised: Lab Project Number CLI t80. 

Unpublished study prepared by Rhone Merieux, !nc. 32 p. 

Arnaud, J.; Consalvi, P. (1993) Assessment of Tolerance of a 

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 

of Spo1-0n 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) Domestic Animal Safety: 870.7200/Companion animal safety 

Assessment of the Tolerance of a 0.25% RM 1601 Spray in 

Nursing Puppies Administered Twice at a 28 Day Interval at a 

Dose 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 of Tolerance of a 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

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

1129032 ~5737-68-1 IPyriproxyfen

1129121 1120068-37-3 /Fipronfl

1129121 1120068-37-3 IFipronil(9.8%)

1129013 13951 5-40.7 !Cyphenothrin(5%)

1129032 195737-68-1 IPyriproxyfen(2%)

48
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 I TRS

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 of the attached package in support of the proposed product. Contact Rosanna

Louie-Juzwiak at 308.0037 with any ques1ions.

Attachments:

- cover letter

- basic CSF

- draft label

- data matrix

49

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 I TRS 

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 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 of the attached package in support of the proposed product. Contact Rosanna 

Louie-Juzwiak at 308.0037 with any ques1ions. 

Attachments: 

- cover letter 

- basic CSF 

- draft label 

- data matrix 
DP#: (382784)

48129603

48129608

48129606

48129607

48129604

48129605

Page 2

Studies Sent for 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 for Acute 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 + Nylar Squeeze-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.

50

DP#: (382784) 

48129603 

48129608 

48129606 

48129607 

48129604 

48129605 

Page 2 

~ ~ ~ Studies Sent for 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/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: 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 for Acute 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 + Nylar Squeeze-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%)

51
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~JuzwiaklRichardGebken RM 10

Insecticide Branch

Registration Division (7505P)

Subject:

From:

To:

Name of Pesticide 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

52
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 data matrix, a CSF (dated 81ll/2010) and a proposed

label for this product, indicating use on adult dogs and puppies 12 weeks of age 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.

Refer to the TRB memorandum dated November 23, 2010 for 2517-RUN which states: "Based

on the amount of formulation applied (0.5-4.5 mL), the packaging ofthese products (single-use

containers or ampoules), the non-volatile nature ofthe formulations,' and the application method

(directly to the skin ofthe dog or cat) which does not result in any respirable particles, TRB

concludes that a waiver for the acute inhalation study requirement is appropriate, and that these

products can be assigned to EPA Toxicity Category IV by this exposure route."

3. The proposed label dosage rates for 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 of 151 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. In terms of the

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

support the use ofthis product on dogs and puppies 12 weeks old or older. Labeling should

indicate a minimum weight of 4 1bs for dogs or puppies.

Page 2 of 4

53

For DP 382785: " ... Please conduct a companion animal safety study review of the attached 

package in support of the proposed product ... " 

BACKGROUND: 

The material received for review includes a data matrix, a CSF (dated 811112010) and a proposed 

label for this product, indicating use on adult dogs and puppies 12 weeks of age 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 2517-RUN), and can be used to 

support the registration of2517wRUG. The signal word is WARNING, based on the eye 

irritation potential (MRID 48129606). 

2, The material in the inhalation waiver request in MRID 48129605 is applicable to 2517wRUG. 

Refer to the TRB memorandum dated November 23, 2010 for 2517wRUN which states: "Based 

on the amount of formulation applied (0.5w4.5 mL), the packaging of these products (singlewuse 

containers or ampoules), the nonwvolatile nature of the formulations,' and the application method 

(directly to the skin of the dog or cat) which does not result in any respirable particles, TRB 

concludes that a waiver for the acute inhalation study requirement is appropriate, and that these 

products can be assigned to EPA Toxicity Category IV by this exposure route." 

3. The proposed label dosage rates for 2517-RUG are 0.67 mL for 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 include MRID 47849609, in which six Group A2 puppies were 

treated with 5 applications of substance IA (containing 8.2% cyphenothrin and 9.8% fipronil) 

and 5 applications of substance II (55.16% etofenprox, 8.78% methoprene and 2.31 % 

pyriproxyfen). The mean total dose was 1.84 (range: 1.79-1.88) mL/kg for test substance IA and 

6,88 (range: 6,69w 7 .05) mLlkg for substance II. Group B2 adults were treated with 5 applications 

of substance IA and 5 applications of substance 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: 

O.352w0.443) mLlkg for substance HI. Assuming that the test substances and proposed product 

have a specific gravity = 1.0, the puppies were treated with means of 151 mg cyphenothrinlkg, 

180 mg fipronillkg, and 159 mg pyriproxyfenlkg. Dividing these values by 5 would give 30.2 

mg cyphenothrinlkg, 36 mg fipronillkg and 31.8 mg pyriproxyfenlkg. In terms of the 

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 4 pounds or more. The cited companion animal safety studies adequately 

support the use of this product on dogs and puppies 12 weeks old or older. Labeling should 

indicate a minimum weight of 4 1bs for dogs or puppies. 

Page 2 of 4 
4. 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 if absorbed through skin. Harmful if swallowed. Do

not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses), Wash

thoroughly with soap and water after handling and before eating, drinking, cheWing gum, or using

tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin, Wear longsleeved shirt and long pants, socks, shoes, and gloves.

Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.

First Aid:

If in eyes:

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

wRemove contact lenses, if present, after the first 5 minutes, then continue rinsing.

weall a fXlison control center or doctor for treatment advice.

If on skin:

-Take off contaminated clothing.

-Rinse skin immediately with plenty of water for 15w20 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 of 4

54

4. 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 of the acute toxicity 

studies: 

Acute oral toxicity III Cited MRID 48129603 

Acute dennal toxicity III Cited MRID 48129604 

Acute inhalation toxicity (IV) Waived (MRID 48129605) 

Primary eye irritation II Cited MRID 48129606 

Primary dennal irritation IV Cited MRID 48129607 

Dermal sensitization Positive Cited 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 2517-RUG [Sergeant's Fipronil + Cyphenothrin + Nylar 

Squeeze-On for Dogs] as obtained from 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 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 if absorbed 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 longw 

sleeved shirt and long pants, socks, shoes, and gloves. 

Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. 

First Aid: 

If in eyes: 

-Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

wRemove contact lenses, if present, after the first 5 minutes, then continue rinSing. 

weall a fXlison control center or doctor for treatment advice. 

If on skin: 

wTake off contaminated clothing. 

wRinse skin immediately with plenty of water for 15w20 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 3 of 4 
-Have person sip a glass of water 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 of information that may be included, if

applicable: - technical information on symptomatology; use of supportiVe treatments to maintain life

functions; - medicine that will counteract the specific physiological effects of the 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 of dogs or cats), the risk of eye

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 hair follicles 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 of 4

55

-Have person sip a glass of water 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 PM/CRM/Registrant: The proposed label should contain a "Note to 

Physician", The following statements are suggested types of information that may be included, if 

applicable: - technical information on symptomatology; - use of supportiVe treatments to maintain life 

functions; - medicine that will counteract the specific physiological effects of the 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 of dogs or cats), the risk of eye 

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 hair follicles using the natural skin oils ... " This should be 

deleted. 

7. The CSF (dated 811 112010) for 2517-RUG should also be reviewed and accepted by the TRE 

Chemistry Team. 

Page 4 of 4 
DATA PACKAGE BEAN SHEET

Date: 05~Oct~2010

Page 1 of3

Decision #: 438363

DP #: (382786)

PRIA

Parent DP#:

Submission #: 880188

1 ** * Registration Information * * * 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 of the attached package in support of the proposed product. Contact Rosanna

Louie-Juzwiak at 308.0037 with any quesllons.

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 of fiproniL

56

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: 

Team Name: Child Res~~~r:'.!.':~~~JI~ng Science Due Date: 

Reviewer Name: Sub Data Package Due Date: 

Contractor Name: 

* * * Studies Sent for 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 of the attached package in support of the 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 of fipronil. 
48059804

48059806

48059805

Page2

Ward, R.

Applicator with Label Indicator

F=1 asa 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 of the Dog Squeeze on 1.34ml White

Applicator with Green Label Indicator (3x), Scissors to Open

- F=1

asa 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 of the Dog Squeeze on 4.02ml White

Applicator with Blue Label Indicator (3x), Scissors to Open

- F=1

asa 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

Applicator with Red Label Jndicator (3x), Scissors to Open· F=1

asa 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.

57

DP#: (382786) 

48059804 

48059806 

48059805 

Page 2 

••• Studies Sent for 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 of the Dog Squeeze on 1.34ml White 

Applicator with 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 of the Dog Squeeze on 4.02ml White 

Applicator with 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 

Applicator with 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

11,29121 1120068~37-3 Wipronil(9.8%)

1

129013 )39515-40-7 JCyphenolhrin(5%)

1129032 ~5737-68-1 !Pyriproxyfen{2%)

58
UNITED STATES ENVIRONMENTAL PROTECTION 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 of the package involved.

Thank you for your cooperation in this matter. If you have any questions please

contact me at (703)-308-7368.

Rosali nd L. Gross

59

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 2fW6{) 

NOTE TO RM 10 Rosanna Louie-Juzwiak 

On"leE OJ, CHDllC.\L .~,"FETY 

,\:-;-n POLLI'TJO~ I'REYENTlO;>;" 

December 23,2010 

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 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 right to reexamine this data 

comprehensively and to question the child resistance of the package involved. 

Thank you for your cooperation in this matter. If you have any questions please 

contact me at (703)-308-7368. 

Rosali nd L. Gross 
Sergeant's Pet Care Products, Inc.

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

August 11,2010

Richard Gebken, 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\}.~

Dear Mr. Gebken:

I certify that the packaging used for the following product meets the standards of 40 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 (July 21, 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,

EPA Company Number 2517) is submitting this child resistant packaging certification to support

for the new end-use product Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-Qn for Dogs

(EPA File Symbol 2517-NEW). All product labels have language specifying the use ofscissors

to open the product container and label language stating the product is not to be applied by

children.

If you have any questions, please contact me at 402-938-7079.

Sincerely,

£-. ~\9,~~ I

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

60
Sergeant's Pet Care Products, Inc.

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

August 11, 2010

Rosalind Gross

cJo Richard Gebken

Registration Division

Office of Pesticide Programs (7504P)

U.S, Environmental Protection Agency

Document Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

6 !LeJ-"

Subject: Child Resistant Packaging Infonnation

Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs (EPA FiIf: '

Symbol: 2517-lIrnW) !\-(,( GDear Ms. Gross:

Sergeant's Pet Care Products, lnc. (Sergeants, 2625 South 158'" Plaza, Omaha, NE 68130-1770,

EPA Company Number 2517) is submitting a request to rely on previously 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

EPA File 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 applicator in sizes 0.67, 1.34,2.68, and 4.02

mL. The following is a summary table ofthe applicators that were tested and submitted to EPA

in the CRP data:

Use Applicator Base Color FiU Wei.ht (mLl Color

Do. Up to 22 lbs White 0.67 Orange ,//

Dog 23-441bs White 1.34 Green v /

Doe 45-88 lbs White 2.68 Red v.

Dog 89-1321bs White 4.02 Blue v

CRP data is required for this new product because 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 configuration that is identical for this product. The Sergeant's Fipronil +

Cyphenothrin + Nylar Squeeze-On for Dogs product being submitted today also contains fipronil

at 9.8%. Additionally, Sergeant's already has dog squeeze-on products approved by 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,

1

61
Sergeant's Pet Care 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 weight colors per

mL fill weight as was used in the submitted and referenced CRP testing. Based on available

infonnation, the density range ofthe pending proqucts on which the CRP data were generated is

the sam, as the ne\fproduct Q/0-L5 gr/cc). The~fore, Sergeant's is relying on MRID's:

48059&03, 48059804, 480598a5, and 4805980610 fulfill the CRP data requirements for

Sergeant's Fipronil + Cyphenothrln + Nylar Squeeze-On for Dogs.

If you have any questions, please contact me at 402-938-7079.

Sincerely,

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

2

62
Decision #: 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 of the attached package in support of Ihe proposed product. Conlact

Rosanna Louie-Juzwiak at 308.0037 with any questions.

Attachments:

- cover letler

- draft label

• data matrix

63

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) 305-670 t 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 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 of the attached package in support of Ihe proposed product. Conlact 

Rosanna Louie·Juzwiak at 308.0037 with any questions. 

Attachments: 

- cover let1er 

- draft label 

- data matrix 
DP#: (382787)

Page2

* * * 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 of Trichodectes 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 of the Cat Flea Ctenocephalides felis and the Brown

Dog Tick Rhipicephalus sanguineus in the Dog: Revised: lab

Project Number: RMD 292: P/214LT. Unpublished study prepared

by Agresearch Consultants. 53 p.

Ahmed, Z. (2002) Study Summaries: Frontline Plus For Dogs.

Unpublished study prepared by Meria!. 40 p.

Miller, T. (2003) Effect of Shampoo After Treatment with

Cyphenothrin Squeeze-on on Efficacy against Adult 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 of the Cat Flea (Ctenocephalides felis) and

the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog:

Revised: Lab Project Number: 9251: P/215LT. Unpublished study

prepared by Professional labs and Research Services, Inc. 51

p.

Everett, R.; Cunningham, J. (1 993)A Comparative Evaluation of

Two Treatment Regimes Using RM t60

t Spray for Control of the

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 ofa 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 asa 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 Dermacentor variabllis 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 of Bathing of laboratory Dogs on the Efficacy

of RMt60t Spray: Revised: Lab Project Number: RMD 592:

P/220LT. Unpublished study prepared by Agresearch

Consultants, Inc. 43 p.

Cruthers, L. (1993) Efficacy of RM1601C at3 mllkg and6 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}

64

DP#: (382787) 

43121t14 

45612701 

46298501 

43121115 

43121116 

4634660t 

48t29610 

43121t17 

45620505 

48129611 

43121118 

43121122 

45620504 

Page 2 

"" " Studies Sent for Review""" 

Everett, R.; Cunningham, J. (1993) A Dose Titration Study to 

Determine the Optimal Spray Concentration of RM 1601 for Long 

Term Control of the Cat Flea Ctenocephalides felis and the Brown 

Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab 

Project Number: RMD 292: 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 After Treatment with 

Cyphenothrin Squeeze-on on Efficacy against Adult 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 of the Cat Flea (Ctenocephalides felis) and 

the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog: 

Revised: Lab Project Number: 9251: P/215L T. 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 t60 t Spray for Control of the 

Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project 

Number: RMD 692: P/222l T. 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 of a 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 Dermacentor variabilis 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 of Bathing of laboratory Dogs on the Efficacy 

of RMt60t Spray: Revised: Lab Project Number: RMD 592: 

P/220L T. Unpublished study prepared by Agresearch 

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: P1225L T. 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 pets 
DP#: (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%)

65
Efficacy Review

Date: December 6, 20 I0

Efficacy Reviewer: Clayton Myers, Ph.D., Entomologist, RD-IB lJA 0

mvcrs.clavtol1(ZL';epa.gov \0/

703-347-8874 L}L/

Risk Manager 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 of Fipronil/Cyphenothrin Dog Efficacy for Sergeant's Fipronil +

Cyphenothrin SqueezeROn for Dogs (Overview of other submissions).

Guideline: OPPTS 8103300

Study Summary of the Results:

This submission is an overall summary and clarification ofthe other submitted MRIDs

associated with this application

Entomologist's ObservationslDiscussion:

Supplementary lnfonnation

66

Efficacy Review 

Date: December 6, 2010 

Efficacy Reviewer: Clayton Myers, Ph.D., Entomologist, RD-IB lJA 0 

mvcrs.clavtol1(ZL';epa.gov ~ ~ \1:' 

703-347-8874 L}L/ 

Risk Manager Rev.: Rosanna Louie 

Products: 

EPA Reg. #: 

A.I.'s: 

Decision #s: 

DP#s: 

Submission: 

MRIDs: 

GLP: 

MRID 48129609 

Sergeant's Fipronil + Cyphenothrin +-Met~n~~Squeeze-on for Dogs 

2517-RUG 

\>4"p n ~ , 

Fipronil (9.8%), Cyphenothrin (5.0%), Pyriproxyfen (2.0%) 

438363 

382787 

R310, New Products, 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: Overview and Summary of Fipronil/Cyphenothrin Dog Efficacy for Sergeant's Fipronil + 

Cyphenothrin Squeeze-On for Dogs (Overview of other submissions). 

Guideline: OPPTS 8103300 

Study Summary of the Results: 

This submission is an overall summary and clarification of the other submitted MRIDs 

associated with this application 

Entomologist's ObservationslDiscussion: 

Supplementary Infonnation 
MRID 48129810

Title: Immediate Efficacy ofa Combined Application of Frontline 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 not taken into account for the existing fipronil, therefore fipronil dosage was

slightly lower than that of Frontline alone. 18 dogs were allocated to 6 groups of 3 dogs each.

Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at

described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and

again at 7 and 14 days 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 of kill and/or

repellency. Counts were also made at 24 and 48 hours after initial infestation and all reinfestations. Parasites were not removed until the final count. Mortality was calculated using

Abbott's formula. For speed ofkill/repellence, the number ofkilled/repelled fleas on the liner

below each treated dog was divided by the total number of fleas placed on the dog (all x 100),

adjusted for 'normal' attrition on control dogs.

Study Summary of the Results:

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after

treatment or reinfestation with parasites, through 14 days after treatment.

2. Immediate efficacy 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 lowest percentage of cyphenothrin 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 after treatment.

2. 'While immediate efficacy against fleas and ticks was enhanced when assessed at 1

and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed

90% with any consistency for the treatments evaluated immediately after treatment.

However, after 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.

67

MRID 48129810 

Title: Immediate Efficacy ofa Combined Application of Frontline 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 not taken into account for the existing fipronil, therefore fipronil dosage was 

slightly lower than that of Frontline alone. 18 dogs were allocated to 6 groups of 3 dogs each. 

Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at 

described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and 

again at 7 and 14 days 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 of kill and/or 

repellency. Counts were also made at 24 and 48 hours after initial infestation and all reinfestations. Parasites were not removed until the final count. Mortality was calculated using 

Abbott's formula. For speed ofkill/repellence, the number ofkilled/repelled fleas on the liner 

below each treated dog was divided by the total number of fleas placed on the dog (all x 100), 

adjusted for 'normal' attrition on control dogs. 

Study Summary of the Results: 

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after 

treatment or reinfestation with parasites, through 14 days after treatment. 

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours of treatment) 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 lowest percentage of cyphenothrin 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 after treatment. 

2. 'While immediate efficacy against fleas and ticks was enhanced when assessed at 1 

and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 

90% with any consistency for the treatments evaluated immediately after treatment. 

However, after 14 days, this immediate efficacy was observed for reinfestations of 

both fleas and ticks. This is likely due to the more complete spread of the 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 48129811

Title: Immediate Efficacy Following Application of Frontline 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 at the rate of approximately

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 of Frontline 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 after treatment. Counts were made at 1 and 4 hours post treatment and also

after every reinfestation-this was to measure speed of kill and/or repellency. Counts were also

made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not

removed until the final count. Mortality was calculated using Abbott's formula. For speed of

kilVrepellence, the number of killed/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 of the 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 after treatment.

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged

from 9-68% for 1-4 hours immediately after treatment. With reinfestations after 7,

14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for 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. For 21 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) after treatment.

2. While immediate efficacy against fleas and ticks was marginally enhanced when

assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did

not exceed 90% with any consistency for the treatments evaluated immediately after

treatment. However, after 7 days, this immediate efficacy was observed for

reinfestations ofboth fleas and ticks. This is likely due to the more complete spread

ofthe spot-on material throughout the animal coat at 7+ days. Claims for killing (or

68

MRID 48129811 

Title: Immediate Efficacy Following Application of Frontline 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 at the rate of approximately 

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 of Frontline 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 after treatment. Counts were made at 1 and 4 hours post treatment and also 

after every reinfestation-this was to measure speed of kill and/or repellency. Counts were also 

made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not 

removed until the final count. Mortality was calculated using Abbott's formula. For speed of 

kilVrepellence, the number of killed/repelled fleas on the liner below each treated dog was 

divided by the total number of fleas placed on the dog (all x 100), adjusted for 'nonnal' attrition 

on control dogs. 

Study Summary of the 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 after treatment. 

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours of treatment) ranged 

from 9-68% for 1-4 hours immediately after treatment. With reinfestations after 7, 

14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for 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. For 21 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) after treatment. 

2. While immediate efficacy against fleas and ticks was marginally enhanced when 

assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did 

not exceed 90% with any consistency for the treatments evaluated immediately after 

treatment. However, after 7 days, this immediate efficacy was observed for 

reinfestations of both fleas and ticks. This is likely due to the more complete spread 

of the spot-on material throughout the animal coat at 7+ days. Claims for killing (or 
'starts killing') within hours would be supported by this data, but not immediately

after treatment 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: Cyphenothrin was added to Frontline plus at the rate of approximately

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 of Frontline alone. 18 dogs were allocated to 3 groups of6

dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline

alone.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7,

14,21,28, and 35 days after treatment. Counts were made at I and 4 hours post treatment and

also after every reinfestation-this was to measure speed of kill and/or repellency. Counts were

also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not

removed until the final count. Mortality was calculated using Abbott's formula. For speed of

kill/repellence, the number of killed/repelled fleas on the liner below each treated dog was

divided by the total number of fleas placed on the dog (all x 100), adjusted for 'normal' attrition

on control dogs.

Study Summary of the Results:

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after

treatment or reinfestation with parasites, through 35 days after treatment.

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged

from 0-75% for 1~4 hours immediately after treatment. With reinfestations after 7,

14,21,28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all

only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for

reinfestations on days 14,21,28, or 35 days after treatment.

3. Immediate efficacy on ticks ranged from 11-71% for 1-4 hours immediately after

treatment. With reinfestations after 7, 14, 21, and 28 days from treatment, efficacy

exceeded 90% 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) after treatment.

2. While immediate efficacy against fleas and ticks was marginally enhanced when

assessed at 1 and 4 hours after treatment (or reinfestation) compared to fipronil alone,

69

'starts killing') within hours would be supported by this data, but not immediately 

after treatment of the animals. 

MRID 48129812 

Title: Immediate Efficacy Following Application of Frontline Plus 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 at the rate of approximately 

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 of Frontline alone. 18 dogs were allocated to 3 groups of6 

dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline 

alone .. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 

14,21,28, and 35 days after treatment. Counts were made at 1 and 4 hours post treatment and 

also after every reinfestation-this was to measure speed of kill and/or repellency. Counts were 

also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not 

removed until the final count. Mortality was calculated using Abbott's formula. For speed of 

kill/repellence, the number of killed/repelled fleas on the liner below each treated dog was 

divided by the total number of fleas placed on the dog (all x 100), adjusted for 'nonnal' attrition 

on control dogs. 

Study Summary of the Results: 

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after 

treatment or reinfestation with parasites, through 35 days after treatment. 

2. Immediate efficacy on fleas (i.e. killlrepellence within 4 hours of treatment) ranged 

from 0-75% for 1~4 hours immediately after treatment. With reinfestations after 7, 

14,21,28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all 

only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for 

reinfestations on days 14,21,28, or 35 days after treatment. 

3. Immediate efficacy on ticks ranged from 11-71 % for 1-4 hours immediately after 

treatment. With reinfestations after 7, 14, 21, and 28 days from treatment, efficacy 

exceeded 90% 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) after treatment. 

2. While immediate efficacy against fleas and ticks 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 data does not support any claims for faster kill or repellence due

to the addition of cyphenothrin.

MRID 48129813

Title: Comparative efficacy evaluation of Sergeant's Squeeze-on and Frontline Plus for the

treatment of adult cat flea (Ctenocephalidesfelis) and tick (Haemaphysalis elliptica,

Rhipicephalus sanguineus, and Dermacentor variabilis) infestations on dogs.

Guideline: OPPIS 810.3300

Materials and Methods: Cyphenothrin was added to Seargeant's Fipronil-Methroprene

formulation Frontline plus at the rate of approximately 5% for efficacy evaluations. This

treatment was compared to fipronil-methoprene alone, and a positive control, Merial's Frontline

Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mLlkg body

weight, to simulate the dosing at the high end ofeach respective weight class. Dogs were

subgrouped by weight class with 6 dogs in each subclass (split over time to 3 dogs of each 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 50 ticks one day before treatment, and again at 7, 14,21, and 28 days after treatment.

Counts were made at I and 4 hours post treatment and also after every reinfestation--this was to

measure speed of kill and/or repellency. Counts were also made at 24 and 48 hours after initial

infestation and all re-infestations. Parasites were not removed until the final count. Mortality

was calculated using Abbott's formula. For speed ofkillirepellence, the number of

killed/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 of the 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 on ticks (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 of application or reinfestation by

parasites) are supported by this data.

70

the immediate efficacy did not exceed 90% with any consistency for the treatments 

evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days 

after treatment. This data does not support any claims for faster kill or repellence due 

to the addition of cyphenothrin. 

MRID 48129813 

Title: Comparative efficacy evaluation of Sergeant's Squeeze-on and Frontline Plus for the 

treatment of adult cat flea (Ctenocephalides felis) and tick (Haemaphysalis elliptica, 

Rhipicephalus sanguineus, and Dermacentor variabilis) infestations on dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Seargeant's Fipronil-Methroprene 

formulation Frontline plus at the rate of approximately 5% for efficacy evaluations. This 

treatment was compared to fipronil-methoprene alone, and a positive control, Merial's Frontline 

Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mLlkg body 

weight, to simulate the dosing at the high end of each respective weight class. Dogs were 

subgrouped by weight class with 6 dogs in each subclass (split over time to 3 dogs of each 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 50 ticks one day before treatment, and again at 7, 14,21, and 28 days after treatment. 

Counts were made at I and 4 hours post treatment and also after every reinfestation--this was to 

measure speed of kill and/or repellency. Counts were also made at 24 and 48 hours after initial 

infestation and all re-infestations. Parasites were not removed until the final count. Mortality 

was calculated using Abbott's formula. For speed ofkillirepellence, the number of 

killed/repelled fleas on the liner below each treated dog was divided by the total number of fleas 

placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. 

Study Summary of the 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 on ticks (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 I A hours of application or reinfestation by 

parasites) are supported by this data. 
Overall Review of Label 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 must be 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 of Label 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 that may transmit Lyme disease: Acceptable

Dogs can be bathed 24 hours after treatment: Unacceptable

Waterproof: Acceptable

Long Lasting: Acceptable

Research demonstrates that [brand name] 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 product kills flea

pupae exposed to residue.

[brand name] prevents development of all 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

71

Overall Review of Label 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 hOtrr". No data was cited or submitted in this application to 

support any claims against mosquitoes, therefore, any such claims must be 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 of Label 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. 

. 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 

Kills ticks (in as little as I hour): Acceptable only if revised to say 'starts killing' 

Kills ticks including those that may transmit Lyme disease: Acceptable 

Dogs can be bathed 24 hours after treatment: Unacceptable 

Waterproof: Acceptable 

Long Lasting: Acceptable 

Research demonstrates that [brand name] kills adult fleas (in as little as 1 hour). flea eggs, larvae 

and pupae for more than [63 days] [9 weeks1: Acceptable only if revised to 'starts' killing. 

Claim against 'pupae' must be deleted, as no data was submitted indicating the product kills flea 

pupae exposed to residue. 

[brand name] prevents development of all 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 'starts killing' 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 data was submitted indicating the

product kills flea pupae exposed to residue.

If dog is a high risk for flea re-infestation once a month application may be needed: Acceptable.

Once a month treatment is recommended: Acceptable.

A once monthly application is recommended for chewing lice: Acceptable.

Rapidly eliminates infestations with chewing lice: Acceptable.

Monthly flea, tick. mosquito. lice. and flea egg protection: Acceptable.

Monthly flea. tick. mosquito. and lice protection: Acceptable.

Kills flea eggs [larvae] [pupae] for up to 4 months: Acceptable except claim against 'pupae'

mu.st be deleted, as no data was submitted indic~ti?-g ~e product kill~ flea pupae exposed to

reSIdue. L\V\O~CL~'>';W'O\r.l·, Dr,l,,11 V~\: i"O qwe.e.k$

Aids in control 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 if kills 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 an unacceptable nebulous claim. Kills

claims must be revised to 'starts killing' and mosquitoes claim must be 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) Week Flea. Tick. Mosquitoe and Lice Control: Acceptable

With Nylar® Insect Orowth Regulator which Breaks the Flea Life Cycle: Acceptable

With Nylar® to Break Flea Life Cycle: Acceptable

With Insect Growth Regulator to Break Flea Life Cycle: Acceptable

Dual Action [!]: Fipronil with Nylar® lOR Effectively Breaks the Flea Life Cycle: Acceptable.

72

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 data was submitted indicating the 

product kills flea pupae exposed to residue. 

If dog is a high risk for flea re-infestation once a month application may be needed: Acceptable. 

Once a month treatment is recommended: Acceptable. 

A once monthly application is recommended for chewing lice: Acceptable. 

Rapidly eliminates infestations with chewing lice: Acceptable. 

Monthly flea, tick. mosquito, lice, and flea egg protection: Acceptable. 

Monthly flea, tick. mosquito, and lice protection: Acceptable. 

Kills flea eggs [larvae1 [pupae] for up to 4 months: Acceptable except claim against 'pupae' 

mu.st be deleted, as no data was submitted indic~ti?-g ~e product kill~ flea pupae exposed to 

reSIdue. l'\v\O~CL~'>';W~\r.l·, Df',l~11 V~\: '{"O q we.e.k£ 

Aids in control of sarcoptic mange: Acceptable. 

Kills fleas (in as little as I hour), ticks (in as little as I hour), mosquitoes, flea eggs, and lice: 

Acceptable only if kills 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 an unacceptable nebulous claim. Kills 

claims must be revised to 'starts killing' and mosquitoes claim must be 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) Week Flea. Tick, Mosquitoe and Lice Control: Acceptable 

With Nylar® Insect Orowth Regulator which Breaks the Flea Life Cycle: Acceptable 

With Nylar® to Break Flea Life Cycle: Acceptable 

With Insect Growth Regulator to Break Flea Life Cycle: Acceptable 

Dual Action [!]: Fipronil with Nylar® lOR Effectively Breaks the Flea Life Cycle: Acceptable. 
Triple Action [!J: Effectively Breaks the Flea Life Cycle [!J: Acceptable

Best if used 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 Flea Eggs From Developing Into Biting Adults: Acceptable

Kills Ticks (in as little as 1 hour) for Up to [4 weeksJ!: Acceptable only ifrevised to '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 Rhipicephalus sangu;neus for up to 4 weeks: Acceptable

When used monthly [brand nameJ completely breaks the flea life cycle and controls tick and

chewing lice infestations: Acceptable

Kills American Dog Ticks [(Dermacentor variabilis)J for up to 4 weeks!: Acceptable

Apply once every [4 weeksJ!: Acceptable

4 weeks Flea and Tick Treatment: Acceptable

Once A Month Flea and 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 if revised to starts killing, and also the repels claim must be deleted.

Kills all stages ofthe flea life cycle: Acceptable

73

Triple Action [!J: Effectively Breaks the Flea Life Cycle [!J: Acceptable 

Best if used year round!: Acceptable 

Kills & Repels Fleas (in as little as 1 hour) Up to [4 weeks]![2 months1 [3 months): Kills must 

be revised to 'starts killing' and 'repels' claim must be deleted. Ow'\~ Wf< ~ 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 Flea Eggs From Developing Into Biting Adults: Acceptable 

Kills Ticks (in as little as 1 hour) for Up to [4 weeks]!: Acceptable only ifrevised to 'starts 

killing' . 

Kills fall stages of! Deer Ticks (vector of Lyme Disease) for up to 4 weeks: Acceptable 

Kills [Brown1- [American.] [and Lone Stare] Dog Ticks: Acceptable 

Kills Rhipicephalus sanguineus for up to 4 weeks: Acceptable 

When used monthly [brand name] completely breaks the flea life cycle and controls tick and 

chewing lice infestations: Acceptable 

Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!: Acceptable 

Apply once every [4 weeks]!: Acceptable 

4 weeks Flea and Tick Treatment: Acceptable 

Once A Month Flea and Tick Treatment: Acceptable 

Kills & Repels Fleas (in as little as 1 hour) and Ticks (in as little as I hour) for up to 4 weeks!: 

Only acceptable if revised to starts killing, and also the repels claim must be deleted. 

Kills all stages of the flea life cycle: Acceptable 
Kills fleas (in as little as 1 hour). Ticks (in as little as I hour), Flea Eggs & Flea Larvae for more

than [63 days] [9 weeks]: Acceptable only ifrevised to 'starts killing'

Kills mosquitoes: Unacceptable

Dogs can be bathed 24 hours after squeeze-on is applied: Unacceptable

Prevents and controls reinfestations: Unacceptable unless a pest and duration of control is

associated (e.g., 'prevents and controls reinfestations oflisted pests for I month [4 weeks]').

BACK/SIDE CARTON LABEL-MASTER LABEL

fbrand name] containes Fiproni!. cyphenothrin. and the insect growth regulator OGR) nylar to

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 of Fleas 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 hour must be revised to 'starts acting' or 'starts killing' or alternatively, the claims

of 'in little as I hour' can be removed. 'Fast acting' claim must be removed. The claims about

movement in hair follicles is deferred to the RM Reviewer and PM.

74

Kills fleas (in as little as 1 hour). Ticks (in as little as I hour), Flea Eggs & Flea Larvae for more 

than [63 days] [9 weeks]: Acceptable only ifrevised to 'starts killing' 

Kills mosquitoes: Unacceptable 

Dogs can be bathed 24 hours after squeeze-on is applied: Unacceptable 

Prevents and controls reinfestations: Unacceptable unless a pest and duration of control is 

associated (e.g., 'prevents and controls reinfestations oflisted pests for I month [4 weeks]'). 

BACK/SIDE CARTON LABEL-MASTER LABEL 

fbrand name] containes Fiproni!. cyphenothrin. and the insect growth regulator OGR) nylar to 

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 of Fleas 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 hour must be revised to 'starts acting' or 'starts killing' or alternatively, the claims 

of 'in little as I hour' can be removed. 'Fast acting' claim must be removed. The claims about 

movement in hair follicles is deferred to the RM Reviewer and PM. 
-------------~- -~- -~~~~~--------------~------------------

Completion of 21-Day Content Screen

PM- 10 ---

EPA Reg. # (File Symbol) 8"611- jZ.LAC;-

Decision # D _

Data package delivered to

you on &/1'1/10 . (date)

Jacket/Mini-jacket will be

transferred to you today.

(Pick up from Document Center)

Thank you,

Registration Division's 21-Day Content Team

75

--------------- -~- -~~~~----------------------------------

Completion of 21-Day Content Screen 

PM- /0 ---

EPA Reg. # (File Symbol) 8"6/1- f-LAC~ 

Decision # D ____ _ 

Data package delivered to 

you on &//'1/10 . (date) 

Jacket/Mini-jacket will be 

transferred to you today. 

(Pick up from Document Center) 

Thank you, ~ 

Registration Division's 21-Day Content Team 
To the Document Center (ITRMD)

*Please transferjacket/mini-jacket to the Product Manager

Team circled below:

Minor Use Section: PM-5

Insecticide Branch: (!M-1~ PM-13

Herbicide Branch: PM-23 PM-25

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

Insect/Rodent Branch: PM-l PM-7

*Reminder to PM - If applicable, pick-up data from the

Screening Room.

Processed by RD's Completeness Check Team

(Team Member Signature) (Date)

76
21-Day Screen Completed by

Contractor

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

Jacket # c?!5/7- f(UbMRID# Lf<g f 8'i51

Content Screen: Recommended to

lPas~/Fan

86-5 Review:l!asse~Failed/NA

Transfer This Jacket to:

77
Memorandum

Date: 8" / It / I 0

To: __--'-P--'M~---'-I...J...O'-----,'Regulatory Manager

From: Information Services Branch, ITRMD

Your receipt ofthis data submission is not an

indication that MRIDs for the enclosed studies have

been posted to OPPIN.

We expect that it will be approximately 5 days

from the above date before the study-level data is

available in OPPIN.

Ifyou have any questions about this process,

please contact Teresa Downs (305-5363).

This is a: I1-fully accepted submission

o partially accepted submission

o rejected submission

78

Memorandum 

Date: 8" / It / / 0 

To: __ --'-P--'M~---'-/..J...O'-----,' Regulatory Manager 

From: Information Services Branch, ITRMD 

Your receipt of this data submission is not an 

indication that MRIDs for the enclosed studies have 

been posted 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 Teresa Downs (305-5363). 

This is a: I1J'ully accepted submission 

o partially accepted submission 

o rejected submission 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

August 16,2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158TH PLAZA

OMAHA, NE 68130-1703

Report of Analysis for Compliance with PR Notice 86-5

Thank you for your submittal of1I~AUG-10. Our staffhas completed a preliminary

analysis ofthe material. The results 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. Please use 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 been released.

79

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 of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal oflI-AUO-IO, Our staff has completed a preliminary 

analysis of the material. The results are provided as follows: 

Your submittal was found to be in full compliance with the standards for submission of 

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with 

Master Record ID's (MRIDs) assigned to each document submitted. Please use these numbers in 

all future references to these documents, Thank you for your cooperation. If you have any 

questions concerning this data submission, please raise them with the cognizant Product Manager, 

to whom the data have been released, 
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 ManlllgetTlent T'earn 10 'G:J

Product I:' 2511~RUG ' !Product Name: IsERGEA~T'S FIi>R0NIL + CYPHENOTHR~N + Ii

~-:-c--.--~---­

:::;;;-..:....-~·~·l.,-·~~- 'A

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

I

I

=-.JI

80
481889-00

Sergeant's Pet Care Products, Inc.

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

August 11,2010

Richard Gebken, PMI 0

Office ofPesticide Programs (7504P) (REGFEE)

U.S. Environmental Protection Agency

Document Processing Desk

Room 8-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs

EPA File Symbol 2517-NEW

Dear Mr. Gebken:

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

EPA Company Number 2517) is submitting an EPA registration application for the new end-use

product Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs [containing the 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);

Certification With Respect to Citation ofData (EPA Form 8570-34):

Data Matrix (EPA Form 8570-35) - EPA and Public Versions;

Product Label (Five Copies);

Letter ofAuthorization;

Child Resistant Packaging (CRP) Certification Statement;

Bridging Argument to Cite CRP Data;

Submission ofEPA Pesticide Registration Improvement Act Information;

Voluntary Small Business Certification Form;

PRIA Fee Waiver Certification Statement;

PRIA Fee Waiver Support Letter;

Recent EPA Approval of 50% Small Business Waiver Request (D-425455);

PRIA Category R31 0, Payment Confirmation Receipt; and

Three Copies of Supporting Studies.

The registration ofSergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs is a

selective citation registration for a new end-use product. Sergeant's is submitting new product

chemistry studies in support ofthis end-use product registration. Additionally, Sergeant's is

citing acute toxicity studies, companion animal safety data, and efficacy studies submitted to

I

81
Sergeant'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 on June 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 can be bridged across multiple fonnulated end-use products.

This registration application is considered a PRIA Category R310 (new end-use product) with a

PRIA review time of6 months. Sergeant's submitted a PRIA Small Business Waiver Request

under separate cover on April 14, 2010, and it was approved by EPA on May 4,2010. A copy of

this approval letter is enclosed.

We look forward to working with the Agency to register Sergeant's Fipronil + Cyphenothrin +

Nylar Squeeze-On for Dogs. If you have any questions or need additional infonnation regarding

this registration application, please contact me at 402-938~7079.

Sincerely,

~d- e-. Hoiuw.)btl

Kelly R. Hoskins

Manager ofTechnical Affairs

Enclosures

2

82
TRANSMITTAL DOCUMENT

NAME AND ADDRESS OF SUBMITTER:

Sergeant's Pet Care Products, Inc.

2625 South 158tl

' Plaza

Omaha, NE 68130-1770

CONTACT PERSON (Return to)

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South 158tl

' Plaza

Omaha, NE68130-l770

REGULATORY ACTION SUPPORTED BY THIS PACKAGE:

This submission is prepared to support an EPA registration application for the new end-use

product Sergeant's Fipronil + Cyphenothrin +Nylar Squeeze-On for Dogs.

SUBMITTAL DATE:

August 11,2010

Volume Study Title MRlDNo.

1 Administrative Materials ..- 2 Group A Product Chemistry For Sergeant's Fipronil +

Cyphenothrin + Nylar Squeeze-On For Dogs 48188901 .. ---- 3 Group B Product Chemistry For Sergeant's Fipronil + 48188902

ICyphenothrin + Nylar Squeeze-On For Dogs .. . -

3

83
'-"',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.: --'- _

The jacket for this action can be

requested through the J"-',CKETS system.

84
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

October 4, 2010

OFFlCEor

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

opp Decision Number: D-438363

EPA File Symbol or Registration Number: 2517-RUG

Product Name: 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 158TH PLAZA

OMAHA, NE 68130-1703

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee

Dear Registrant:

The Office of Pesticide Programs has received your application and certification of

payment. If you submitted data with this application, the results ofthe PRN-86-5 screen will be

communicated separately. During the administrative screen, the Office ofPesticide Programs

has detennined that this Action is subject to a Pesticide Registration Service Fee as defined in

the Pesticide Registration Improvement Act.

The Action previously identified as R320 has been reclassified as Action Code: R31 0

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.

If you 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 Management Division

85
UNITED 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

Product Name: 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 Subject to Registration Service Fee

Dear Registrant:

The Office of Pesticide 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 of Pesticide Programs has detennined

that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide

Registration Improvement Act.

The Action previously identified as R31 0 has been reclassified as Action Code: R320

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE

CITATIONS);

The fee associated with this action is $ 5,712 (50% of$ 11,424). Payment in the amount of

$ 2,289 has 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

86

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

August 30,2010 

PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT 

Or Pay On-Line at www.Pay.Gov (See Below for Details) 

OPP Decision Number: D-438363 

EPA File Symbol or Registration Number: 2517-RUG 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + NYLAR SQUEEZE-ON 

FOR DOGS 

EPA Receipt Date: ll-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 of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application for registration. If you 

submitted data with this application, the results of the PRN-86-5 screen will be communicated 

separately. During the administrative screen, the Office of Pesticide Programs has detennined 

that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide 

Registration Improvement Act. 

The Action previously identified as R31 0 has been reclassified as Action Code: R320 

NEW PRODUCT;NON-F AST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE 

CITATIONS); 

The fee associated with this action is $ 5,712 (50% of$ 11,424). Payment in the amount of 

$ 2,289 has 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 
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 order ofthe Environmental Protection Agency. To ensure proper credit, please

write the OPP DECISION NUMBER on your check, and enclose a copy ofthis letter with your

payment.

Effective November 1,2006, fees may be paid on-line via credit card or electronic fund

transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select

"search by fonn name." From the next page, select "P," then click on "Pesticide Registration

Improvement Act. Fee Payment" and complete the form, making certain to use the decision

number and registration number on the invoice you receive from the Pesticide Program in the

space provided.

You may be eligible for a partial waiver ofthe registration service fee if, for example, you

qualify as a small business or are applying for a minor use, or if your application is solely

associated with an IRA tolerance petition. Please be advised that ifyou intend to request a

waiver, you must do so in writing within 15 days ofreceipt ofthis invoice instead ofremitting

the amount indicated above. OPP will not consider waiver requests after the registration service

fee has been paid. Infonnation regarding eligibility and how th request 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 Pennsylvania Ave NW

Washington, DC 20460

By Courier:

Document Processing Desk (WAIVER)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room S4900 Potomac Yard 1

2777 S. Crystal Dr.

Arlington, VA 22202

87

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 order of the Environmental Protection Agency. To ensure proper credit, please 

write the OPP DECISION NUMBER on your check, and enclose a copy of this letter with your 

payment. 

Effective November 1,2006, fees may be paid on-line via credit card or electronic fund 

transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select 

"search by fonn name." From the next page, select "P," then click on "Pesticide Registration 

Improvement Act. Fee Payment" and complete the form, making certain to use the decision 

number and registration number on the invoice you receive from the Pesticide Program in the 

space provided. 

You may be eligible for a partial waiver of the registration service fee if, for example, you 

qualify as a small business or are applying for a minor use, or if your application is solely 

associated with an IRA tolerance petition. Please be advised that if you intend to request a 

waiver, you must do so in writing within 15 days of receipt of this invoice instead of remitting 

the amount indicated above. OPP will not consider waiver requests after the registration service 

fee has been paid. Infonnation regarding eligibility and how th request 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 Pennsylvania Ave NW 

Washington, DC 20460 

By Courier: 

Document Processing Desk (WAIVER) 

Office of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

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/or the

Agency receives certification that the outstanding fee has been paid. Ifthe Agency does not

receive certification of payment for this action or a fee waiver request within the next 30 days,

the Agency will presume that you no longer want to pursue this action. The Agency will then

reject your application and issue an invoice for any applicable outstanding fees.

If you have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308-9362.

Sincerely,

Management Division

88
PRIA 2 - 21 Day Content Screen Review Worksheet

(EPA/OPF Use Only)

3/23109

21 Day Screen Start Date: 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 Receipt Date: [i- f / - I()

Items for Review Yes No N/A*

1 Application Form (EPA Form 8570-1 )(link to form) signed & complete

including package type K

Confidential Statement ofFormula all boxes completed, form signed, and

2

dated (EPA Form 8570-4) (Link to form) :x

a) All inerts (link to 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 of Data (EPA Form 8570-34) (Link to

form) completed and signed (N/A if 100% repack) X

Certificate and data matrix consistent XIf applicant is relying on data that are compensable, is the offer yes no

to pay statement included. (see Footnote B)

If aoolicable, is there a letter ofAuthorization for exclusive use only.

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

4 completed and signed (N/A ifsource is tmregistered or applicant O\Vl1S the

technical) X

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

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

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 of Label (link to 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

89
7 Is the data nacka!!e consistent with PR Notice 86-5 (link to PRN 86-5) X

Notice of Filing (link to

8 http://www.epa.gov/pesticides/regulatingitolerance petitions.htm) included \- with petitions (link to

http://www.epa.gov/pesticides/regulating/tolerances.htm)

9 If applicable for conventional applications, reduced risk rationale (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

90
Comments:

61\X'l\fS tDS..>Ccl \1\'(\.,U

. 0

\rn t:. C\{J yY\)'"'(cJ C\"bt 'I ,~; '\' ,""t U:LU

* N/A Not Applicable

Footnotes

A. During the 21 day initial content review, 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 it with an approved inert, submitting

documentation that EPA approved the inert for the proposed pesticidal uses, correcting

mistakes on the CSF, etc. or 2) provide the data to 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 of data. All information, fonns, data and

documentation resolving the inert issue must have been received by the Agency or the

application withdrawn ",rithin the 21 day period, otherwise, the Agency will reject the

application as described below.

To successfully complete this aspect ofthe 21 day initial content screen, applicants are

strongly encouraged to verify that all inert ingredients have been approved for the

application's uses even if a product is currently registered by consulting the inert Web

3

91
site [link to http://www.epa.gov/opprdOO1!inerts/lists.html] and ifthe inert is not

approved, to obtain the necessary inert approval prior to 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 of uses. The name

and/or CAS number on a CSF must match the name and CAS number on this web site.

Simple typographical errors in the name or CAS number have resulted in processing

delays.

If an inert is not listed on the inert ingredient web site and the applicant believes that the

inert has been approved, the applicant should contact the Inert Ingredient Assessment

Branch (lIAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe

correspondence with IIAB resolving the issue should accompany the application. All

new inerts except PIP inerts are reviewed by lIAB. The IIAB should also be contacted

for any questions on what supporting data needs to be submitted for and the Agency's

inert review process. Questions on PIP inerts should be directed to the Chief of

Microbial Pesticides Branch [Link to

http://v.'WW.epa.gov/oppbppdl/biopesticides/contactsbppd.htm].

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF,

additional information such as an alternate name ofthe inert, CAS number or other

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdfJ must also be included

to enable the Agency to determine ifit has been approved. Each component of an 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. Prior to the

Agency's receipt of an application, applicants must arrange with a proprietary mixture or

fragrance supplier to provide the component information to the Agency or promptly upon

EPA's request. Ifthe inert ingredients in a proprietary blend (including fragrances)

cannot or are not identified or provided within the 21 Mday content review period, the

Agency will reject the application.

During the 21 day content review, applicants should submit information to the individual

identified by the Agency when the applicant is informed of an unapproved 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

applicant with the following options:

1. Correct the application by, for instance, correcting the inert's identity or CAS

number, providing documentation that the inert has been approved, or

removing the unapproved inert from the CSF or replacing it with one that is

approved for the application's uses; or

2. Submit the information and data needed for the Agency to approve the

unapproved inert Ifthis option is selected and implemented, the Agency may

request an extension in the PRIA decision review timeframe to accommodate

the inert review/approval process;

4

92

site [link to http://www.epa.gov/opprdOO1linerts/lists.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to 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 of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicant should contact the Inert Ingredient Assessment 

Branch (lIAB) at inertsbranch@epa.gov and resolve the issue. Copies of the 

correspondence with IIAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by lIAB. The IIAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://v.rww.epa.gov/oppbppd l/biopesticides/contacts bppd.htm J. 

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional information such as an alternate name of the inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included 

to enable the Agency to determine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21 Mday content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit information to the individual 

identified by the Agency when the applicant is informed of an unapproved 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 

applicant with the following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert If this option is selected and implemented, the Agency may 

request an extension in the PRIA decision review timeframe 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

If none 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

Vlhen the Registration Division identifies an unapproved inert on a CSF with an

application for a new product that the applicant has not identified as requiring an

inert approval (R311, R312 or R313), it will contact the applicant with the

following options:

1. Correct the application by, for instance, correcting the inert's identity or CAS

number, providing documentation that the inert has been approved, or

removing the unapproved inert from the CSF or replacing it with one that is

approved for the application's uses; or

2. Submit the information and data needed for the Agency to approve the

unapproved inert, including any required petition to establish or amend a

tolerance or exemption from a tolerance. (This option may change the PRIA

category for the application, which could require a longer decision review

time and a larger fee. If additional fees are due, they must be received by the

Agency within the 21 day content review period.)

3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee

category estimated); or

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

content-review period, the Agency will reject the application and retain 25% of

the appropriate fee for the new product-inert approval category.

PIP Applications

Vlhen the Biopesticide and Pollution Prevention Division identifies an

unapproved inert on a PIP CSF and a request to approve the inert does not

accompany the application, it will contact the applicant with the following

options:

1. Correct the application by, for instance, correcting the spelling or name ofthe

inert to that in 40 CFR 174, or providing documentation that the inert has been

approved; or

2. Submit the information and data needed for the Agency to approve the

unapproved inert. If an inert ingredient tolerance exemption petition is

required, the petition must be 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

93

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

Vlhen the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R3l3), it will contact the applicant with the 

following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

Ifnone of the above options is selected and implemented during the 21-day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

Vlhen the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

1. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

v,rithin the 21 day period. If this option is selected and implemented, the 

Agency will discuss hannonizing the timefrarne for both actions. 

5 
3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee

category estimated); or

If none ofthe above options is selected and implemented during the 21 day

content review period, the Agency will reject the application and retain 25% of

the fee.

B. A policy on documentation of offers 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 of offers to pay will be placed into either R30 1 or

A531. The Agency recommends that authorizations of offers to pay be submitted with

other PRIA applications to avoid delays in the Agency's decision.

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers

prior to submitting their application to the Agency. Documentation ofsuch discussions

should be submitted with the study waiver.

6

94

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offers 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 of offers to pay will be placed into either R30 1 or 

A531. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 
UNITeD 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

FOR DOGS

EPA Receipt Date: II-Aug-20 I0

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 of Application and 50% Small Business Waiver Request

Dear Registrant:

The Office of Pesticide Programs has received your application, 50% small business

waiver request, and cerification of payment. Ifyou submitted data with this application, the

results of the PRN-86-5 screen will be conununicated separately. During the administrative

screen, the Office of Pesticide Programs has determined that this Action is subject to a Pesticide

Registration Service Fee as defined in the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: R31 0

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY);

Your request for waiver has been forwarded for review. You will be notified in writing when a

detennination is made regarding your request. If your waiver request is approved, the decision

review time period will start on the date of approvaL If your 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

95

UNIT~O STATES ENVIRONMENTAL PROTECTIoN AGENCY 

WASHINGTON, O.C. 20460 

August 12,2010 

OPP Decision Number: D-438363 

EPA File Symbol or Registration Number: 2517-RUG 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FlPRONIL + CYPHENOTHRIN + NYLAR SQUEEZE-ON 

FOR DOGS 

EPA Receipt Date: II-Aug-20 I 0 

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 of Application and 50% Small Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has received your application, 50% small business 

waiver request, and cerification of payment. If you submitted data with this application, the 

results of the PRN-86-5 screen will be conununicated separately. During the administrative 

screen, the Office of Pesticide Programs has determined that this Action is subject to a Pesticide 

Registration Service Fee as defined in the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R31 0 

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); 

Your request for waiver has been forwarded for review. You will be notified in writing when a 

detennination is made regarding your request. If your waiver request is approved, the decision 

review time period will start on the date of approval. If your waiver request is denied, you will 

receive an invoice for the outstanding balance. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Sincerely, ~I 

7'.JUI.QA.&- Ua-u./Jv::L.. 

Front End Processing Staff 

Information Technology & Resources Management Division 
IFee for Servicel

.$

{880188Hl_ 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/IO

96
Regull!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

97
FEE FOR SERVICE

98

FEE FOR SERVICE 
Sergeant's Pet Care Products, Inc.

2625 South 1581h Plaza • Omaha, NE 68130·1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergoonts.com

August 11, 2010

Richard Gebken, PM10

Office of Pesticide 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 Improvement Act Information

Dear Mr. Gebken:

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

EPA Company Number 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 a new end-use product with supporting data and is considered an

R310, new end-use product, requires review of data package within RD, PRIA review time frame 6

months, and a fee of $4,578. Sergeant's qualifies for a PRIA fee waiver/reduction of50% (refer to

OPP Decision Number D-425455).

If you have any questions or need additional information regarding this registration application,

please contact me at 402-938-7079.

Sincerely,

~H:nstk~~!UT

Manager ofTechnical Affairs

99
Pay.goy w Online Payment

Online Payment

Step 3: Confirm Payment

Thank you.

Your transaction 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 Holder Sergean1'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

100

Pay.goy w Online Payment 

Online Payment 

Step 3: Confirm Payment 

Thank you. 

Your transaction 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 Holder Sergeanfs Pel Care Products, 

Name: Inc 

Payment Date: 0612112010 

Decision Number: 

Payment Amount: $2,289.00 Registration Number. 2517 -new 

Page 1 of 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 6118/2010 

*Commercial/financial information may be entitled to confidential treatment*
Please read rnstructfons on reverse before "-,npleting fonn Form Appro~ OMS No 20700060 - Approval expires 05-31 -98

United States ~_Registration OPP Identifier Number

EPA Environmental Protection Agency D,Amendment

Washington, DC 20460 D Other

Application for Pesticide Section I

1. company~ct Number 'f?u 6; 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 Check if this isa new address

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 Product Will Be Packaqed In:

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container

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

DPaper glued

.' .,

DStenCJled - Section IV - 1- Contact Point (Complete items direclfy below for fdentification of individual to be contacted, if necessary, to process,this ~pplicai'ot)" "

Name Title Telef-hone No. (Influde Area Code)

Kelly R. Hoskins Manager of Technical 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 of Technical Affairs '~(\

• Typed Name: 5. Date: 08111f2010

Kelly R, Hoskins

101
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 EPA registration application for the new end-use

product Sergeant's Fipronil + Cyphenothrin +Nylar Squeeze-On for Dogs.

SUBMITTAL DATE:

August 11, 2010

Volume Study Title MRIDNo.

1 Administrative Materials ..- 2 Group A Product Chemistry For Sergeant's Fipronil +

Cyphenothrin + Nylar Squeeze-On For Dogs -- ---- 3 Group B Product Chemistry For Sergeant's Fipronil +

Cvnhenothrin + Nylar Saueeze-On For Do"s .. --

3

102
Sergeant'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 of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Document Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Child Resistant Packaging Certification

Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze--On for Dogs

EPA File Symbol 25 I 7-Nffi¥ 1'-\;1.<:'

Dear Mr. Gebken:

I certifY that the packaging used for the following product meets the standards of40 CFR 157.32,

including the revised standards in 16 CFR 1700.15(b), when tested by the revised testing

procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995):

• Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs (EPA File Symbol

25 I 7-NEW)

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

EPA Company Number 2517) is submitting this child resistant packaging 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 product container and label language stating the product is not to be applied by

children.

If you have any questions, please contact me at 402-938-7079.

Sincerely,

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

Manager ofTechnical Affairs

cc: Larry Nouvel

103
Sergeant's Pet Care Products, Inc.

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

August 11,2010

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 (EPA FEe

Symbol: 2517-~) !l-iAl>,

Dear Ms. Gross:

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

EPA Company Number 2517) is submitting a request to rely on previously 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

EPA File Symbols: 2517-RGT, 2517-RGA, 2517-RGL, and 2517-RGU (an of which contain

Fipronil at 9.7-9.8%).

Sergeant's generated CRP data on a standard white applicator in sizes 0.67, 1.34, 2.68, and 4.02

mL. The following is a summary table ofthe applicators that were tested and submitted to EPA

in the CRP data:

Use Annlicator Base Color Fill Weioht (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 data is required for this new product because 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 configuration that is identical for this product. The Sergeant's Fipronil +

Cyphenothrin + Nylar Squeeze-On for Dogs product being submitted today also contains fipronil

at 9.8%. Additionally, Sergeant's already has dog squeeze-on products approved by 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 of fipronil,

I

104
sergeant's Pet Care Products, Inc.

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 +Cyphenothrin + Nylar Squeeze-On

for Dogs is marketed, it will utilize the same applicator color (white) and fill weight colors per

mL fill weight as was used in the submitted and referenced CRP testing. Based on available

information, the density range ofthe pending products on which the CRP data were generated is

the same as the new product (1.0-1.5 gr/cc). Therefore, Sergeant's is relying on MRID's:

48059803,48059804,48059805, and 48059806 to fulfill the eRP data requirements for

Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs.

If you have any questions, please contact me at 402-938-7079.

Sincerely,

~. '\L ~~~ /1:?r"l

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

2

105
Sergeant'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

Document Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs . 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,

EPA Company Number 2517) is submitting an EPA registration application for the new end-use

product Sergeant's Fipronil + Cyphenothrin + Nylar Squeeze-On for Dogs [containing the 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 of Formula (EPA Form 8570-4) (Two Copies);

Formulator's Exemption Statement (EPA Form 8570-27);

Certification With Respect to Citation ofData (EPA Form 8570-34):

Data Matrix (EPA Form 8570-35) - EPA and Public Versions;

Product Label (Five Copies);

Letter ofAuthorization;

Child Resistant Packaging (CRP) Certification Statement;

Bridging Argument to Cite CRP Data;

Submission ofEPA Pesticide Registration Improvement Act Infonnation;

Voluntary Small Business Certification Fonn;

PRIA Fee Waiver Certification Statement;

PRIA Fee Waiver Support Letter;

Recent EPA Approval of 50% Small Business Waiver Request (D-425455);

PRIA Category R31 0, Payment Confirmation Receipt; and

Three Copies of Supporting Studies.

The registration of Sergeant's Fipronil + Cyphenothrin + Nylar Squeez~n for Dogs is a

selective citation registration for a new end-use product. Sergeant's is submitting new product

chemistry studies in support ofthis end-use product registration. Additionally, Sergeant's is

citing acute toxicity studies, companion animal safety data, and efficacy studies submitted to

I

106
Sergeant'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 on June 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 can be bridged across multiple fonnulated end-use products.

This registration application is considered a PRIA Category R31 0 (new end-use product) with a

PRIA review time of6 months. Sergeant's submitted a PRIA Small Business Waiver Request

under separate cover on April 14, 2010, and it was approved by EPA on May 4, 2010. A copy of

this approval letter is enclosed.

We look forward to working with the Agency to register Sergeant's Fipronil + Cyphenothrin +

Nylar Squeeze-On for Dogs. If you have any questions or need additional infonnation regarding

this registration application, please contact me at 402·938-7079.

Sincerely,

~~ (L. HoiUk{):v+,

KelIy R. Hoskins

Manager ofTechnical Affairs

Enclosures

2

107
Form 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 applicant for registration of the product identified above, I certify that:

(1) This product contains the fotlowing active ingredient{s}:

Fipronil

Cyphenothrin

Pyriproxyfen

{2} Of these, each aclive ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing,

formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by

us from another person and meets the requirements of 40 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 of the 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 qualify for the formulator's exemption.

Source

Active Ingredient Product Name Registration Number

Fipronil Technical

Cyphenothrin

Pyriproxyfen

S~ 'k'- l~ iLl rh-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 copy

108 *Product ingredient source information may be entitled to confidential treatment*
Form Annroved OMS Nos. 207Q.-0060; 2070-0057; 2070-{lt07; 2070-{lt22; 2070-{lf64

f'~" (- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

<7lll!'Z ' 1200 Pennsylvania Avenue, N.W.

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 for reregistration and special review aclivities, including lime for rcading lhe inslruclions and complcting the necessary forms. Send

comments regarding buroen esriinati'- or'any other aspect ofthis cotlection of informalion, 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 not send 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 68 t3Q.-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 +Nylar Squeeze-On to

NOTE: If your product is a tOO% repackaging of another 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 of compensation (the Data Matrix form shout!

be used for this 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 of support (or cite--all option

a list of companies 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 of data requlremenls (the Data Ma1rix form must be

used).

SECTION It: GEtlERAL OFFER TO PAY

IRequired if using 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 of this 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, if the 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 or effects of this product or an identical or

substantially similar product, or one IX" more of the ingredients in this product: and (2) is a type of data that Would be required to be submitted Ulder the data

requirements in effect On the date of approval of this application if the application sought the initial registration ofa product of identical or similar composKion and

uses.

I certify that for each eXdusive use study cited in support of this regislration or reregistration, that I am the original data submitter or that I have obtained

the written pennission of the original data submitter to cite that study.

I certify that for each study eKed in support of this registration or reregistralion that is not an exdusive use study, either: (a) I am the original data

submitter: (b) I have obtained the poonission of the Ofiginal data submitter to use the study in support of this appUcation: (c) all periods of eligibilny for

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) of FIFRA: and (ii) to commence negotiations to determine the

amount and terms of oompensation, if any, to be paid for the use of the study.

I certify that in all instances where an offer of oompensation is required, ooples of aU offers to pay oompensation and evidence of their deUvery in

accordance with sections 3(c)(t)(F) and/or 3(c)(2)(B) of FIFRA are available and will 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 of my product in conformrty with

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 under applicabto taw.

Signature U olru ~. ~luA\/niT 0.- Typed or Printed Name and nle

A- 081t tl20tO Kelly R. HoskinS, Manager of TechnicatAffairs

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

109
R310

Must submit Group A and Bproduct 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 of formulation 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

830.6304 Odor

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

110
R 310

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 of Termite

810.3800 Baits

2

111
Sergeant's® Master Label ~\j\1.1

11 August 2010 Version 10.1 EPA Reg. No. 2517p

Information in [ ] is optional. Page 1 of 8

[CARTON LABEL - DRAFT MASTER LABEL 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 of age 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]]

[oFast Acting]

[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 of all 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)]

[- If dog 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]

112
Sergeant's® Master Label

11 August 2010 Version 10.1 EPA Reg. No. 25l7-XX

Information in I ]is optional. Page 2 of 8

[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® IGR Effectively 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 if used 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 Flea Eggs & 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

113
11 August 2010

Infonnation in [ ] is optional.

Sergeant's® Master Label

Version 10.1 EPA Reg. No. 2517-XX

Page 3 of8

[For Dogs & Puppies (12 weeks or older aud) 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 registered trademark ofMcLaughlin Gonnley King Company.

U.S. Patent No. 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] applicators

114
Version 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 growth regulator (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 of Fleas and Ticks [(in as little as I hour)], [and kills

mosquitoes] and chewing lice [for 30 days].

(diagram with visual of Fipronillcyphenothrin I Nylar collecting and being released from

hair follicle]

READ ENTIRE LABEL BEFORE EACH USE.

USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE.

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS, WARNING. Causes substantial

but temporary eye injury. Do not get in eyes or on clothing. Wash thoroughly with soap and

water after handling and before eating, drinking, chewing gum, or using tobacco. Remove and

wash contaminated clothing before reuse. Harmful ifswallowed. Hannful if absorbed 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, if present, after the first 5 minutes, then continue rinsing

eye.

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

If On Skin Or • Take off contaminated clothing.

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

• Call a noison control center or doctor for treatment advice.

If Swallowed • 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 if able 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 OR VETERINARIAN

Treat patient symptomatically

115
Version 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 of Federal law to use this product in a manner inconsistent with its labeling.

READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE.

DO NOT USE ON CATS. May be toxic and potentially fatal if applied to or ingested by cats.

FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks of age.

Weigh your dog to be sure you are applying the right dose formulated for the weight of your pet.

Do not treat your pet with more than one pesticide product at a time. Over dosing your animal

can result in serious illness and even death. Best if used year round. Certain medications can

interact with pesticides. Consult a veterinarian before using this product on debilitated, aged,

medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known

organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated

dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that

actively groom or engage in close physical contact with treated dog may be at risk ofserious

harmful effects. The most conunon signs of ingestion are excessive salivation and foaming at

the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your

pet for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats

exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately.

If your dog is exhibiting signs of and/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 product on pets. Ifsigns ofsensitivity occur

bathe your dog with a mild soap and rinse with large amounts of water. Ifsigns continue, consult a

veterinarian immediately by calling 1-800-781-4738.

[{Outer Packaging or Insert Copy}]

How to open: Remove product tubes [vial] from the package. Separate one tube from the others.

Holding the tube [vial] with notched end pointing up and away from the face and body, cut off

the narrow end at the notches with scissors.

How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to

apply all ofthe solution to the dog's skin, as directed below. Repeat application may be made if

necessary, but do not apply more often than once every 4 weeks.

FREQUENCY OF APPLICATION

Use [brand name] monthly for complete control of flea, 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. If your pet is at high risk for flea reinfestation [, or in a highly infested

environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing lice.

[Brand name] kills mosquitoes within 24 hours for the first 7 days after treatment, then within 48

hours for up to 28 days. [Brand name] remains effective, even after bathing, water immersion, or

exposure to sunlight. Allow treated area to dry thoroughly. Do not reapply for 30 days.

116
Version 10.1

Page 6 of 8

Sergeant's@ Master Label

EPA Reg. No. 2517-XX

] is optionaL

II August 2010

Information in [

For Dogs 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 spot to the dog's back between the shoulder blades]

[from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 23-44 Ibs.

{For cartons containing 1.34 ml (0.045 fl. oz.) applicator tube}

[Apply two tubes (.67ml)(0.023 fl. oz.) as a spot on the dog's back between the shoulder blades]

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

blades.] [from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 45-881bs.

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 a point 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 not refrigerate. Protect from direct sunlight.

PESTICIDE DISPOSAL AND CONTAINER HANDLING: Non~refiJlable container. Do not reuse or

refill this container. If empty: Place in trash or offer for recycling if available. If partly 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. [[The directions for use of this product are believed to adequate

and must be followed carefully. It is impossible to eliminate all risks associated with the use of this

product. Unintended consequences may result because of unknown factors. All such risks shall be

assumed by the user or buyer.] [Sergeant's is committed to providing high quality products. To the

extent consistent with applicable law, Sergeant's makes no warranties, express or implied, of

merchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this

labeL To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not

be liable for indirect, special, incidental or consequential damages. To the extent consistent with

applicable law, the exclusive remedy of the user or buyer shall not exceed the purchase price paid.]

(If you have questions or comments about this product, please write: Sergeant's Consumer Response,

P.O. Box 540399, Omaha, NE 68154-0399.]

In Case of Emergency, call: 1-800-781-4738 (For more information] [Visit us at] [www.sergeants.com]

Non-Emergency call l-800-224-PETS (7387) [Made in USA]

117
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 or package copy]

[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 back carton label and/or applicator

labeIlng_1

[{Outer Packaging or Insert Copy}]

How to open

1. Remove product tubes [vial] from the package.

2. Separate one tube from the others. Holding the tube [vial] with notched end pointing up

and away from the face and body, cut offthe narrow end at the notches with scissors.

How to apply:

1. invert tube over dog and use open end to part dog's hair.

2. Squeeze tube firmly to apply all ofthe solution to the dog's skin [as a spot to the dog's

back between the shoulder blades.] [or] [from the back ofthe neck to a point midway

between the neck and tail.]

[Flea life cycle diagram]

[Look at the Label (Look at the Label icon) 6 Step [Easy] [Spot On] [Squeeze-Onl [Topical]

Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

• Do NOT treat with more than one pesticide product at a time

• Separate animals after treatment to avoid chance of ingestion

• Do NOT split tubes between pets]

[Brand Namel

[Monthly reminder card]

[Apply [Brand Name] monthly for continuous protection against Fleas (in as little as I hour),

Ticks (in as little as I hour), [and] chewing lice [and mosquitoes].]

[pet's Name (Empty blank for owner to fill in name)]

[First [dose] [Treatment] (Empty blank for owner to fill in date)]

[Second [dose] [Treatment] (Empty blank for owner to fill in date)]

[Third [dose] [Treatmeut] (Empty blank for owner to fill in date)]

[calendar stickers with brand name] [place stickers on your calendar as a reminder to reapply

[brand name] [in 30 days.]

118
11 August 2010

Infonnation in [

Sergeant's® Master Label

Version 10.1 EPA Reg. No. 2517-XX

[ is optional. Page 8 of 8

[Monthly Application Reminder Magnet (image of reminder magnet)

Enclosed for your convenience is an application reminder magnet. Push the (reset) button to

start the clock. After 30 days the magnet will flash (and beep) reminding you to reapply [Brand

Name]. This application reminder can be used for future treatments. Just press the reset button

and in another 30 days the reminder magnet will flash (and beep) reminding you 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 mayor may not be found on the printed label]

119
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 or Registration Number: 2517-RUG

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + NYLAR SQUEEZE-ON

FOR DOGS

EPA Application Receipt Date: II-Aug-20 I0

EPA Waiver Request Receipt Date: ll-Aug-2010

EPA Company Nmnber: 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: Approval of 50% Small Business Waiver Request

Dear Registrant:

The Office ofPesticide Programs has approved your request for 50% waiver ofthe

pesticide registration fee associated with the action referenced above. The decision review

period for this action will begin on the date ofthis letter.

The Action has been identified as Action Code: R320

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE

CITATIONS);

If you have any questions, please contact the Pesticide Registration Service Fee

Ombudsman, at (703) 308-9362.

Oscar Morales, Director

Infonnation Technology & Resources Management Division

Office of Pesticide Programs

120

UN, J STATES ENVIRONMENTAL PROTECl ,uN AGENCY 

WASHINGTON, D.C. 20460 

September 7, 2010 

opp Decision Number: D-438363 

EPA File Symbol or Registration Number: 2517-RUG 

OFFICE OF 

PREVENTION, PESTICIDES AL'JD 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S F1PRONIL + CYPHENOTHRIN + NYLAR SQUEEZE-ON 

FOR DOGS 

EPA Application Receipt Date: 11-Aug-20 1 0 

EPA Waiver Request Receipt Date: ll-Aug-2010 

EPA Company Nmnber: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. 

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TI-I PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Approval of 50% Small Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has approved your request for 50% waiver of the 

pesticide registration fee associated with the action referenced above. The decision review 

period for this action will begin on the date of this letter. 

The Action has been identified as Action Code: R320 

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE 

CITATIONS); 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman, at (703) 308-9362. 

Oscar Morales, Director 

Infonnation Technology & Resources Management Division 

Office of Pesticide Programs 
h

~-

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 of inlollnalion 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 of 4 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, IGroup 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 of Rcquirement 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 of Spot-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 of Tolerance 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

S;g,""c< \lJJ:i ¥- \-\0 ~lu~ I?:-A"I

EPA form gi'ii):)lt9.97) £Ieo"oo,o and Pa"er Ve,,;o", A"a,I,bl, -S',-;~m,' ooly r.per ""ioo

Namc and Title

Kelly R. Hoskins, Manager ofTechnical Affairs

Ageo'l' '0""0" U,. Copy

Datc

08/11/2010

I{ - (2l~CT 121
EPA Foom 'S:'fiii:Bt9.97) flee'",' per Ver~o", Av,il.bl. Iy Paper ,~,n.y '",

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 Act Notice: Tile public reporting burden for Olis collcction of infomlation is estimated to avclage 0.25 hours pel respollsc for lcgi'\h'tion =ctiv:;ies hnd 0.23 hours pee resron~c fur lcrcgistratiOll

alld spceial review activities, including time for reading the instruction and cOinpletilig the 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 M Sheet, 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 160 IE)'

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 of Frontline Plus with 48129610 Sergeant's Pet Care Products, Inc. OWN

Cyphenothrin as a Squeeze-on against Fleas (Cteuacephalides felis)

and Ticks (Rln"nicenhalus saneuinens) on Do!':s MS 164 0

810.3300 Immediate Efficacy Following Application of Frontline 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 of Frontline with 48129612 Sergeant's Pct Care Products, Inc. OWN

Cyphenothrin Squeeze-on against Fleas (Ctellocephalides fe/is) and

Ticks (Rhiv'-cephalns SOlI.l;ninells) on Dogs MS 175 0

810.3300 Comparative efficacy evaluation of Sergeant's Squeeze-on and 48129613 Sergeant's Pet Care Products, Inc. OWN

Frontline Plus for thl.: treatment of adult 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

of the 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 08111/20 I0

,;0 """ U, ""hn,;' no',' P •...,. "",;,., A~.n'" 1",.,.".111« CO",

"25! .' f':

122
Z SI7 «: (All

'"

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 for this eOlieCliOl1 ofillformlltion is estilllated 10 average 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, including time for reading the instruction and completing the ncecssary fonns. Send comments regarding the bU:rden'~st'rnale or:my (It!;er aspect tJfthlS ,,:olleetion of

infonnalion, including suggeslions for reducing the burden to Director: OPPE Information Management Division (2137) U.s, Environmental Protection Agency, "Ot M Street, S.W., Washingion, OC 20460. Do

not send the fonn to this 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 of Bathing 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 of the 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 of Frontline 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 of Fipronil 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 of Shampoo 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: \Lib B- ftc,slu'-':. ('b!-r Name and Title Datc

Kelly R. Hoskins, Manager of Tcchnical Affairs 0811112010

EPA Form 8170-35 19·9)) Fled",n\< ",od P'D" W,,;o", '\yailabl< S..hmil onlv P,,,,,r Yer~o" A.e.", In,.en>1 U.e Com"

123
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 for tlris collcction of infonnation 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 completing the necessary fonns. Send comments regarding the l"I'!!~n e~'ima~~ or ,;.ny ollrer aspect "ftlric cr lIection 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 of 4

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 of a Pyriproxyfen Spot-On Formulation For Flea Ova 46346601 Sergeanl's Pel Care Products, Inc. OWN

Sterilization.

8103300 Analyses of efficacy 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 of the 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.

S;g"""," ).J J D1A;+ ~~LM'v-\ !?/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.. COny

i_517- (CV(:i

124
Sergeant'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 1581

, , 1. PI;17:a. Onwl1a. Nebraska

6S 130-1 770. EPA Company Number 25 ITl. authorizes Expollel1t. Inc. (! 150 Connecticut

i\ venlle. NW. Suite I 100. \Vashingtoll DC 1003(1) to act on our behalL as our

A uthorizcd Represelltali ve, fIr all necessary interad ions regarding nil of our 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 A vc.. NVv'

Suite 1100

\Vnshington, DC 200:)6

(]O]) 772-4932

(201) 771-4979 h'i

Jine5S In a({j~ ex pu nCIli .Cllm'" rtinswort h(fCex ponen1.c (\ 11')

lfyoll have any questions. pknsc eOll\~lct 11'\C at 402-93x-7079.

Sinccrd;.'.

!,,/ /)~) / j /)'

/(ei'j /! /~/~ /

Kelly R, Hoskins

ManaJ;cr ofTcdlllica! An:'lir~

cc: James Messina

125
126

*Confidential Statement of Formula may be entitled to confidential treatment*
_l

127

*Confidential Statement of Formula may be entitled to confidential treatment*