# EPA Registration Jacket 2517

‐ 137

# To the Document Center (ITRMD)

*Please transfer jacket /mini-jacket to Product

Manager Team circled below:

Minor Use Section 

# PM-5

Insecticide Branch 

# PM-i0 PM-13

Herbicide Branch 

# PM-23 PM-25

Fungicide Branch 

# PM-2i PM-22

Insect /Rodent Br. 

# PM-i PM-7

*Reminder to PM

- If applicable pick-up data

from Screening Room.**proce~** 

# by RO's Completeness Check T a .

- --;;?

< 

### I----fL 

## --"--7'-f-"-- 

# (Team Member Signature) (Da e)

# 21-Day Screen Completed by

Contractor



# 21-Day Expires on /- 1;2.- /6



# Jacket #

MRID#

___ _

Content Screen: Recommended to

[jilSsrFail

86-5 Review: passed/FailedlNAJ



# Transfer This Jacket to:

## PRIA 2 - 21 Day Content Screen Review Worksheet

(EP AlOPP Use Only)

{(? 

### 3/23/09

21 Day Screen Start Date: 

# I - '- 1.

- 

# 01 /'

Experts In-Processing Signature: 1"1 f tlOltll-lNbTnv 

### Date**l~LI-** 

### I 0 

### Fee Paid: Yes 

# _v_

Division management contacted on issues No Yes Date

______ _

EPA Reg. Number: 

# U; 11- 

# RGT EPA Receipt Date: 

# 1.- z. ?-

- 

# a q

Items for Review Yes No N/A"



### 1 Application Form (EPA Form 8570-1)(link to fonn) signed & 

### complete 

# X including package type

Confidential Statement of Formula all boxes completed, fann signed, and 

# X

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

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

# X

Footnote A)

3 

### Certification with 

### Respect to Citation of Data (EPA Fonn 8570-34) (Link to 

# X form) completed and signed (N/A iflOO% repack)

Certificate and data matrix consistent 

# X

If applicant is relying on data that are compensable, is the offer yes no

to pay statement included. (see Footnote B)

If applicable, is there a letter of Authorization for exclusive use onJy.

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

4 completed and signed (NIA 

### if source is unregistered or applicant owns the 

# X

technical)

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

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

repack)

yes no 

# I"

i> ."

5 

# I:r a) Selective Method (Fee category experts use) 

# <. /"--,

b) Cite-All (Fee category experts use) 

# :x. '.

',",,'

.,



## ..**,{~;,** .,

. 

## .

c) Applicant owns all data (Fee category experts use) .. . 

## \'"



# :..

. 

# ',':':'

. ,.

..



### 5 Copies of Label (link to httQ:llwww.eQa.gov/oIIQfeadlllabelintV1rmD 

# X

6 (Electronic labels on CD are encouraged and guidance is available)( link to

http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm#Jabels

I )



### I

### 7 Is the data package consistent with PR Notice 86RS 

### (link to PRN 86-5)

# ~

Notice of Filing (link 

### to

8 httQ:I/www.eI23.gov/I!esticides/regulatilllvtolerance uetitions.htm) included 

# X with petitions (link to**http://w\Vw.~a.govlPesticides/rl'gulatillgitolerances.htIU)**



### 9 If·applicable for conventional applications, reduced risk rationale (link to 

# X http://,,

...



### w. e pa.gov/opprdOOl/w o rkplanireducedrisk.html)

Required Data (link to

httQ://wWlv.ena.gov/uesticides/regulatin1!ldata reguirements.htm) and/or

data waivers. See Footnote C.

a) 

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



### 10

2

### Comments:

< • 

## k'I+-n

?\

o i j**~** 

# +0 -.!

### 'n'l~ ! I '-



# * NIA

- 

### Not Applicable

Footnotes

A. During the 21 day initial content review, all CSFs will be reviewed to determine

whether all inerts listed, including fragrances, are approved for the proposed uses. 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 of the 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, forms, data and

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

application withdrawn within the 21 day period, othenvise, the Agency will 

### reject the

application as described below.

To successfully complete this aspect of the 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

# \ site [link to http://www.epa.gov/opprd001Iinertsllists.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 CSFmust 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 (IIAB) at inertsbranch@epa.govandresolvetheissue. Copies of the

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

new inerts except PIP inerts are reviewed by nAB. 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://www.epa.gov/oppbppdllbiopesticides/contacts bppd.htmJ.

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 httpj/www.epa.gov/opprdOOllinertsitips.pdf]mustalsobeincluded

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 2 I-day 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 infoITIlation 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 accorrnnodate

the inert review/approval process;

4

### )

3. Withdraw the 

### application (the Agency retains 25% ot the full fee [or 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% ofthe full fee ofthe category identified.

Conventional New Product AJ!plications

"When 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

, R3l2 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 infonnation and data needed for the Agency to approve the

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

tolerance or exemption from a tolerance. (This option 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

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 appropriate fee for the new product-inert approval category.

PIP Applications

When 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 infonnation 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

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

Agency will discuss hannonizing the timeframe for both actions.

5

### 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 R301 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

# IFee 

# for Servicel

This package includes the following

@ 

# New Registration

oAmendment for Division 

# .If



# (864772?-

o 

# Studies? o Fee Waiver?

o volpay 

# % Reduction: Risk Mgr. 

# [J]J

Receipt No. 

# s-I 864772

EPA File Symbol/Reg. No.

1 

# 2517-RGT

Pin-Punch Date:

1 

# 12/22/2009



# o This item is NOT subject to FFS action.

----- 

# ,-------Action e(rdB"":---, Parent/Child Decisions:

Requested: 

# I

"I-, 

## "Soc,



## Granted: 

# I

'R 3cc>**G~** 

## : Amount Due: 

# $ \ 

# i3, 10 S-.

-

# ),~ (M""'"

, I 

# .1. 0

# ~j, {I 

# s//O

n**''=~j-I** 

# }Zl Inert Cleared for Intended Use 0 

## Uncleared Inert in Product

Reviewer:

# 6~**=-r;~** J

# ~

Remarks:

# Material to be added to an e-Jacket or Jacket

Reg. No.:.?-S-I 7 - 137

Description: 

# .Nt k-'

## ~**~** C 

# Sf'-s

1. 

# \sf

Placement within the e·Jacket/Jacket

. C(l17 

## Default: (chronological, top 

# = newest)



# dl File Location: (PDF page number)



## 2. 

# c:r Send to Data Extraction contractors this material: 

# (t7 Newly stamped accepted label



# o Notification 

# P

New CSF 'i\e.\f\ve..\.l>f"'- 

# (L. ')



# o other:



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

Attach this coversheet to the top of the material or jacket. It must be

well·organized and clipped together

- NOT STAPLED. Then give the

material with this coversheet to staff in the Information Services

Center (Room S-4900).



# Reviewer's Name: Rosanna Louie

Phone: 308.0037 Division: RD



# Date: 7**~~b** 'L{) 

# IiU.S. ENVIRONMENTAL PROTECTION

AGENCY

Office ofPeslicide Programs

Registration Division (7504P)

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460



### NOTICE OF PESTICIDE,



## o 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 158 1h Plaza

Omaha, NE 68130 EPA Registration No. Date oflssuance:

2517-137 January 28, 2011

Term of Issuance:

Conditional Registration**Time~Iimited:** see conditions below

Name of Pesticide Product:

Sergeant's Fipronil Spot-on for Cats

On the basis of information 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 of this 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 of a pesticide in accordance with the Act. The acceptance of any name in connection with the

registration of a 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 conditionaiIy registered in accordance with FIFRA §3(c)(7)(a) provided that:

1. 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 of the

date of this Notice of Registration. 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 of formula.

The"Agency may require this in the future. It is possible that no additional alternate formulations

or minor fonnulation amendments will be approved for this product in the future.

3. As a condition of registration for this product, within one year from the date of this 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**P~ge** Iof54. The approval of this registration is contingent on the Agency's review to detennine that the study

submitted on June 15,2010, to fulfill OCSPP Guideline 830.1800

- Enforcement Analytical

Method, is acceptable to support the registration.

5. Within one year of the date on this Notice of Registration, and prior to fonnulating this product,

you must provide the Agency the following;

a. The registration number and establishment number of the manufacturing or technical

product(s) from which the active ingredient is derived.

b. The name and address of the entity from which the manufacturing product(s) was

obtained; and

c. A copy of the bill of sale for this manufacturing product(s).

6. Within 30 days from the date of this 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 of their

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

7. You must submit quarterly enhanced incident reports and quarterly sales infonnation in doses

sold for this product for the quarter that begins 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 infonnation should be submitted to the

Registration Division (7504P), Immediate Office (attn: Ms. Kimberly Nesci).

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. (mm/dd/yyyy)

State in which the incident occurred. (standard 2 letter abbreviation)

Registrant case #

Species: dog, cat, other (specify)

Breed: (as reported by pet owner)

Age: months or years

Sex: M, F, or neutered

Weight: pounds

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

Body System: neurological, dennatological, Gl, 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

Page 2 of 5Misuse: use on incorrect species, overdose, too frequent dosing, other (describe)

Any known precondition

EPA Severity Code: death, major, moderate, minor

Outcome: died, recovered, still treated, unknown

8. Along with the enhanced incident reporting, you must submit an analysis of the incidents seen, to

include the following details:

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

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

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

routes of exposure, the order should be ocular> oral> dermal. In other words, an

incident with both oral and dermal exposure would be reported as oral exposure, and an

incident with both ocular and oral exposure would be reported as ocular exposure.

A similar summary table for dogs (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 cats 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, 

### 8yr, 9 yr, IOyr, 11 Yr, 12 yr, 13 yr, 14yr, 15 yr, >15 yr.

A summary table showing the number of cat incidents for each severity code for each pet

weight range on the product label (if applicable).

A summary table for cat weight showing number of incidents for each product weight

range. This table should show number of incidents in cats weighing less than that product

weight range, number of incidents in cats in lower half of weight range, number of

incidents in cats in upper half of weight range, and cats weighing more than the product

weight range (if applicable).

Table showing number of incidents for each cat breed, where provided.

Table showing number of incidents in cats for each clinical sign.

Table showing number of incidents in cats for each organ system.

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

9. You must submit and/or cite all data required for registration of your product under FIFRA

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

submit acceptable responses required for reregistration of your product under FIFRA §4.

Page 3 of5All labeling comments below are in reference to the proposed master label, dated January 20, 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:

10. On page I under Ticks, revise the claims (delete struck-out text and/or add underlined words) to

read as follows:

"fKills [all sffi,ges of] (deer) ticks [before they can] [thattf may transmit Lyme disease,]

(for up to (4 weeks] (1 month] (30 days]]]]"

II. On page 2 under Multiple Infestations, delete struck-out text in the claims to read as follows:

"Kills chewing lice and controls mites taa-t maj' cause sarcoptic mange"

"(Four](4] Way [Action] [Controll Protection, [kills fleas, ticks, mosquitoes, chewing

lice]"

"[Four (4) Week] (l month] [J.Q-da.y] [Flea, Tick, Mosquito, and Chewing Lice Control]"

12. On page 2 under All Others, delete struck-out text in the claims to read as follows:

"(Controls mites tHat may cause sarcoptie mange [infesta-tions]]"

"H3} applications]"

13. On page 4 under Back Panel, replace "30 days" from the second claim with 

### "[1 month] (4

weeks]" because the data does not support mosquito control for up to 30 days.

14. On page 5, delete "[and enclosed directions]" from the Directions for Use because this insert has

not been submitted to the Agency for review.

IS. On pages 5 and 7 under How to Apply, delete "[0.017 f1 oz] [0.50 mLl" so that the use directions

are more clear by stating "one tube

... " per application.

16. On page 6 under the Warranty, delete the optional brackets between "All such risks shall be

assumed by the user or buyer" and "Sergeant's is committed to providing

... " so that the warranty

is presented (along with the user'slpurchaser's rights) in its entirety.

17. On pages 7 and 8, per our discussion, delete "insert" since this text is part of the outer packaging,

instead of a separate insert to accompany the product.

18. For the text to be printed on the front of the tube, the net weight must be expressed in English

units, Le., "0.017 fl oz." Metric units may be expressed in addition to (adjacent) to the English

unit weight expression.

19. Revise the EPA Registration Number to read: "EPA Registration No. 2517-137."

If the Agency determines that future mitigation measures are necessary for all pet spot-on

products, you will be informed, and be expected to comply. If mitigation measures are necessary, the

Agency may take appropriate regulatory actions. Two copies of the finished 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 of the product

constitutes acceptance of these 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 an uestions.

Page 4 of5Enclosure: Sergeant's Fipronil**Spot~on** for Cats Label, Stamped Accepted with Comments 

# Q:

of Appcoving

## ~_

# -~ Date:



### 2B 

## j**~N\!J><\>-'<** 

## Loll



# -1'br

Richard Gebken, Product Manager (10)

Registration Division, Insecticide Branch

EPA Form 8570·6

Page 5 of 5

# Sergeant's Master Label

20 January 2011

Information in [ J is optional. Version 10.1

Page 1 of8 EPA No. 2517-RGT

[Optional text appears in brackets

- the final label may include some or all of the optional text on

front, back or side label panels J



## Sergeant's Fipronil Spot-On for Cats

[ABNs]

[(Sergeant's®V) (Sentry®) Frontier Gold (Spot On) for cats]

[(Sergeant's®) (Sentry®) Ectoadvance (Spot On) for cats]

[(Sergeant's®) (Sentry®) Gold FrontSpot (Spot On) for cats]

[SentryProline (Spot On) for cats] 

### ACCEPTED

with COMMENTS

In 

### EPA Letter Dated: [[SENTRY®] FIPROGUARDTM for cats]

[[Sergeant's] PRONYL OTCTM for cats] 

## JAN 2 8 2011

[For use ONLY on cats OF ALL WEIGHTS over 8 weeks of age]**Vnd~t** the Federal Insecticide

Fungicide, and Rodenticide**Ac~**

as 1,lmended. for the pesticide**reglSte~Jlnder** EPA Reg No 

### [Apply to kittens over 8 weeks old]

[Apply to kittens 8 weeks or older]**2.517~13Z** '.



### [Mosquitoes]

[- [Kills mosquitoes] [within 24 hours for up to 14 days] [and within 48 hours for

up to 28 days]

[Adult Fleas]

[Ticks] [-Kills adult fleas [for up to six weeks]]

[-Kills fleas, which may be a source of flea allergy dermatitis] [or flea bite

anemia]]

[. If cat is a high risk for flea reinfestation apply once a month]

[o.Kills Fleas [Up to 4 weeks] [I month] [30 days]!]

[-Kills ticks including those that may transmit Lyme disease]

[ 0 

### Kills Ticks for Up to [ 4 weeks] [ I month] [30 days]!]

[- Kills [all stages of] Deer Ticks [before they can] [that] [transmit Lyme disease,]

[for up to [4 weeks] [I month] [30 days 

## III

[0 Kills Ticks (Including Deer Ticks) for up to [4 weeks] [I month] [30 days]]



### [0 Kills [brown dog ticks], [American dog ticks,] [and lone star ticks]

[(Rhipicephalus sanguineus)] 

### [for up to [4 weeks] [I month] [30 dayslll



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

sanguineus)] 

### [for up to [4 weeks] [1 month] [30 days]]]

[- Kills American Dog Ticks [(Dermacentor variabilis)] 

### for up to [4 weeks] [1

month] [30 days]!]

# Sergeant's Master Label

20 January 2011

Infonnation in 

### I I is optional. Version 10.1

Page 2 of8



### [Multiple Infestations] EPA No. 2517-RGT



### [-Kills chewing lice 

### and controls mites that may cause saTcoptic mange]



### [. Flea 

### [&] [and] Tick Control for Cats 

### [&] [and] Kittens 8 weeks old and older]

[. Kills fleas, ticks, mosquitoes 

### [&] [and] [chewing lice]]

[. Kills fleas, ticks, chewing lice and mosquitoes]

[-Monthly flea, tick, mosquito, and chewing lice protection]

[- [Four] [4] Way Protection, kills fleas, ticks, mosquitoes and chewing lice]



### [. [4 Week] [I month] [30 day] [Flea and Tick [&] [and] Application]

[. [Four (4) Week] [I month] [30 day] [Flea Tick, Mosquito and Chewing Lice

Control]

[Once A Month Flea and Tick Application]

[-Use [brand name] monthly to control ticks and chewing lice]

[-Monthly flea, tick, mosquito, and chewing lice protection.]



### [. Kills Fleas and Ticks for up to [4 weeks] [I month] [30 days]!]

[(Brand Name) provides convenient and effective flea, tick, chewing lice and

mosquito control for cats and kittens over 8 weeks of age.]



### [All Others]

[-For Cats and Kittens 8 weeks of age or older]

[-Controls mites that may cause sarcoptic mange [infestations]]



### [. Waterproof]

[·Fast Acting]

[·Long Lasting]

[-Fast Action against chewing lice infestations]



### [. [Three] [3] Applications] andlor [3 Month Supply] or [12 Week Supply]

[- Best 

### if used year round!]



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

[·4 Week Dose!]

[. 1 Month Dose!]

[.30 day dose!]

[. Easy to Use [Application]]

[- Specially Formulated for Cats and Kittens Over 8 Weeks of Age]



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

[. Apply once every [4 weeks] [month] [30 days]!]

[f3} applications]

# Sergeant's Master Label

20 January 2011

Information in [ [is optional. Version 10.1

Page 3 of8



### [-Rapid elimination of chewing lice infestations 

## J

[-Effective after bathing and exposure to water and sunlight]

[-Effective even after bathing] EPA No. 2517-RGT



### [-Can be used on breeding, pregnant and lactating [queens], [female] [cats]]

[- [Free with purchase] [Free inside 

## J Monthly Application Reminder [Magnet]

[clip] [inside]

[-Can be used on kittens 8 weeks of age and older]

[-Monthly application reminder inside]

[. Fipronil (9.7%)]

[- Lift [here] for more information]

[Contains Fipronil[,] [-] the active ingredient used in Frontline Top Spot®*for



### Cats]

[* [Brand Name] is not manufactured 

### by or distributed 

### by Merial. Frontline Top

Spot® is a registered trademark of MeriaL]

[For use ONLY on cats]

[of ALL 

### weights]

[over 8 weeks of age]

[optional graphics: picture of all controlled pests with line through them]



### ACTIVE INGREDIENT:

Fipronil

............................................... 9.700/0



### OTHER INGREDIENT**

............. 90.30%

TOTAL 100.00%

[**diethylene glycol monoethyl ether]



### KEEP OUT OF REACH OF CHILDREN

CAUTION

See [Side] [or] [Back] Panel For Additional Precautionary Statements



### NET CONTENTS:

[Three] [3][three] 0.017 fl 

### oz (0.5 mL) applicators

{END

- FRONT PANEL}

# Sergeant's Master Label

20 January 20 11 EPA No. 2517-RGT

Infonnation in { 

### 1 is optional. Version 10.1

Page 4 of8



### [[brand name] contains Fipronil to effectively kill fleas and ticks [(including those

may transmit Lyme Disease)].

[The active ingredient in [brand name] features a sustained release fonnula developed for

fast acting [and long lasting] control of fleas, ticks, mosquitoes and chewing lice for 30

days on cats.]

[For use ONLY on cats OF ALL "WEIGHTS over 8 weeks of age]

READ ENTIRE LABEL BEFORE EACH USE

USE ONLY ON CATS AND KITTENS OVER 8 WEEKS OF AGE

[[Brand Name] provides four way protection that kills fleas, ticks, mosquitoes and

chewing lice. Kills deer ticks that may transmit Lyme disease. Kills brown dog ticks,

American dog ticks, and lone star ticks. Prevents flea reinfestation.]

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS. CAUTION. Harmful if swallowed. Causes eye irritation.

Avoid contact with skin, eyes or clothing. Wash hands thoroughly with soap and water

after handling and before eating, drinking, chewing gum, using tobacco or using the

toilet.



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

under 8 weeks of age. Individual sensitivities, while rare, may occur after using any

pesticide product. [Some cats may experience temporary startle effects when any product

is applied.] Cats may experience some temporary irritation at the site of product

applications. If signs persist, or become more severe within a few days of application,

consult a veterinarian immediately. Certain medications can interact with pesticides.

Consult a veterinarian before using on medicated, debilitated or aged cats. Call 1-800-

781-4738 for 24-hour assistance.

FIRST AID

If swallowed: Call a poison control center or a doctor immediately for treatment advice.

Have person sip a glass of water if able to swallow. Do not induce

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

give anything by mouth to an unconscious person.

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 treatment advice.

If on skin: Wash with plenty of soap and water. Get medical attention if irritation

persists.

HOTLINE NUMBER

Have the product container or label with you when calling a poison control center or doctor, or

going for treatment. You may also contact 1-800-781-4738 for emergency medical treatment

infonnation.

# Sergeant's Master Label

20 January2011

InformaIion in [ [is optional. Version 10.1

Page 5 of8



### DIRECTIONS FOR USE EPA No. 2517·RGT



### It 

### is a violation of Federal 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 CAT, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS]

BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY

STATEMENTS CAREFULLY. FOR EXTERNAL USE ON CATS ONLY. DO NOT

USE ON RABBITS. DO NOT USE ON OTHER ANIMALS.

Do not use on kittens under 8 weeks of agE:. [Do not split one tube between cats.] [Do not

use multiple tubes on one cat.] Consult a veterinarian before using this product on

debilitated, aged, medicated eats. Can be used on breeding, pregnant, or lactating [cats]

[female cats] [queens]. Consult a veterinarian before using on cats with known organ

dysfunction. Cats may experience some temporary irritation at the site of product

application. Certain medications can interact with pesticides. Sensitivities may occl,lr

after using ANY pesticide product on cats. If signs of sensitivity occur bathe your cat

with a mild soap and rinse with large amounts of water. If signs continue, consult a

veterinarian immediately.

(INSERT DIAGRAM THAT DEPICTS APPLICATION OF PRODUCT ON THE

CAT)

[Optional diagram mayor may not appear on finished label]

[(Outer Packaging)]

How to 

### open: Remove product tubes 

### [viall 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: While holding the cat with one hand, use the other hand to apply the

solution. Invert the tube 

### [vial} and use the narrow end to part the eat's hair. Apply

contents of one [0.017 

### fl oz] [0.50 mL] tube 

### [vial] of (Product Name) [as a stripe,

starting high on the back of the cat's neck to in front of the shoulder blades.][as a spot

between the shoulder blades]. Hold the cat for a few seconds to give the solution time to

be absorbed into the cat's coat. When finished, wrap the tube 

### [viall in paper and put into

the trash. Only one applicator per treatment is needed.

# Sergeant's Master Label

20 January 201 1 Version 10.1 EPA No. 2517-RGT

Information in ( 

### I is optionaL Page 6 of8



### FREQUENCY OF APPLICATION

Use [brand name] monthly for complete control of flea, tick [and] chewing lice [and

mosquito] infestations. [Studies show that] [brand name] kills adult fleas for up to six

weeks. Apply monthly if your cat is at high risk for flea reinfestation [, or in a highly

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

[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.

[(Brand Name) can be used on breeding, pregnant and lactating (queens) (female cats).]

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: 

### 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 do\VI1 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 of unknown 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 offitne,ss for a particular purpose or otherwise, that extend beYOl.).d

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]

[SENTRy] Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.]

In Case of Emergency, call: 1-800-781-4738 Non-Emergency calI1-800-224-PETS

(7387) [Made in USA]

Distributed by:

Sergeant's Pet Care Products, Inc. [BAR CODE AREA]

P.O. Box 540399

Omaha, NE 68154-0399

EPA Reg. No. 2517-RGT

EPA Est. No. XXXXX-XX-XXX

{END

- BACK 

### I SIDE PANEL}

# Sergeant's Master Label

20 January 2011

Information in [ [is optional. Version 10.1

Page 7 of 8



### {START

- OPTIONAL INSERT OR PACKAGE COPY} EPA No. 2517-RGT



### [- How to Apply

- May contain graphics illustrating product use, e.g., cat

with a drop falling onto its neck from a vial on front, side, or back carton

label and/or applicator labeling.]

[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 off the narrow end at the

notches with scissors.

How to Ap ply:

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

2. Apply contents of one [0.017 fl 

### oel [0.50 

### mLl tube [vial} of {Product Name}

[as a stripe, starting high on the back of the cat's neck to in front of the

shoulder blades.J[as a spot between the shoulder bladesJSqueeze tube firmly

to apply all of the solution to the cat's skin.]

[Optional diagram_mayor may not appear on finished label]

# ~

# ~ [Look at the Label (Look at the Label icon) [Easy] 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]

[Brand Name]

[Monthly reminder card]

[3] [Month TreatmentTracker]

[3] [Month Application Tracker] [

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

[pe!"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:

MMIDD/YY)]

# Sergeant's Master Label

20 January 2011 Version 10.1 EPA No. 2517·RGT

Infonnation in [ 

### 1 is optional. Page 8 of8



### [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 of

reminder 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 of 30 days the reminder light \\fill 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.]



### {END

- OPTIONAL INSERT OR PACKAGE COPY}**~~--~** .4" ii-' 0,,--

### ~ 

### -

- 

# --**~---,-,**



### Front Label

{Brand Name} [For use only on catslkittens

8 weeks or older1

Fipronil9.7% 

### w/w



### 0_50 mL {label code} Back Label

KEEP OUT OF REACH OF CHILDREN

CAUTION: Read directions and precautions

before using. Use scissors to open.

EPA REG_ No_ 2517-RGT {label

code}LL 

### S1-B0 J 

### Ot 

# .O"HVn90 tI d l:l



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# FIPROGUARDTM

ART INSTRUCTION FOR THE PRINTER 

# •• Printer/Vei1dar. Dde.enl',

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!lAO: P!.!SUO

labels adhere to White Tubes

### JAN 2 8

Front

White tube / Blacktext on a white label/ Colored Strip

3B.tmm



# PRONYL OTCTM

Prinler/Vendar: Dale sent: ART INSTRUCTION FOR THE PRINTER



# --

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labels adhere to White Tubes 8mm



### ----+

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ART INSTRUCT10N fOR THE PR1NTER 

# •

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## 2f5\l-\",7

JAN 2 8 201\

### JAN 2 8 2011

ART !NSTRUCTION FOR THE PRINTER



# -- Printer/Yendor: Oote sent:

Addltionol Notes:

BlACK PMS2731/



# (L{; !t\j'<, 

# W VW\ 

# eN

# ~~AN~**CNW1Jc<~I'<2M~d ~--t** **V~**

## DATA PACKAGE BEAN SHEET

Date:**09~Nov-2010**

Page 1 of 1



## * * * Registration Information 

### '* '* '*

Registration: 2517-RGT**~** SERGEANT'S FIPRONIL**SPOT~ON** FOR CATS

Company: 2517

- SERGEANT'S PET CARE PRODUCTS,INC.

Risk Manager: RM 10

- Richard Gebken

- (703) 305-6701 Room# PY1 S-7237

Risk Manager Reviewer: Rosanna Louie RLOUIE

Sent Date: 01-Nov-2010 Calculated Due Date: Q4-Hov::2O'TO

Type of Registration: Product Registration

- Section 3 Decision 

### #: 425437

DP 

### #: (383875)



### PRIA

Parent DP 

### #:

Submission 

### #: 884814**Ed~ed** Due Date:

____ _

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

Ingredients: 129121, Fipronil(9.7%)



### '* '* '* Data Package Information 

## * * *

Expedite: 

## 0 Yes • No Date Sent: 09-Nov-2010 Due Back:

____ _

DP Ingredient: 129121, Fipronil

DP Hie: #2517-RGT: CRP Review

CSF Included: 

### 0 Yes. No Label Included: 

### 0 Yes. No Parent DP #:

____ _

Assigned To Date In Date Out 

### S'I IMK 

## 20 (0

Organization:**"RD=:c./~TR""B** _____ _ Lasl Possible Science Due Date: 05-0ct-2010

Team Name: Child Resistant Packaging Science Due Date:

____ _

Reviewer Name:

__________ _ Sub Data Package Due Date:

__ _

Contractor Name:

________ _



### '* '* '* Studies Sent for Review 

### '* 

## * *

No Studies



### '* 

## * * Additional Data Package for this Decision 

### '* 

## * *

Can be printed on its own page



### '* '* '* Data Package Instructions 

### * '* 

### *

RESUBMISSION

Attn Roz: Please review the attached CRP resubmission to support the proposed cat spot-on product, #2517-RGT. Contact Rosanna

Louie-.luzwiak with any questions.

Attachments:

Cover letter MRID 48279600

CRP Resubmission (1746-001) MRID 48279601

CD of the Study

### CHILD-RESISTANT PACKAGING REVIEW

Technical Review Branch

IN 

### 11/9/2010 OUT 

### 12/13/2010

## ~~~,;;!"~ RD, TRB, Reviewed by Rosalind L. Gross 

### 1211312010

EPA Reg. No. or File Symbol 2517-RGT & 2517-RGL

DP Barcode 383875 & 383881

Decision 

### # 425437 & 425454

EPA Petition or EUP No.

___ _

Date Division Received 

### -'.10"'1"'2"'9/"'1"'0'-

__ _

Type Product(s) Insecticide (flea product)

Data Accession No(s). 48279600 48279601

Product Mgr.lChemical Review Mgr/Contact Person RM 10 Rosanna Louie-Juzwiak

Division "R"D,-

__

Product Name(s) Sergeant's Fipronil Spot-On for Cats & 

### Sergeant's Fipronil 

### + SMethoprene Spot-On for Cats

Company Name(s) Sergeant's Pet Care Products, Inc.

Submission Purpose Review of CRP studies to determine if they are adequate to

support CRP certification for 2517-RGT & Review of CRP

studies EPA Reg. No. 2517-RGT to determine iftheyare

adequate to support eRP certification for 2517-RGL

Active Ingredient(s), PC code, & 

### % Fipronil9.7% (2517-RGD

Fipronil 9.8%

S-Methoprene 11.8%

Summary of Findings

In conclusion all the reqUirements for eRP have been met for EPA

Registration No, 2517-RGT and 2517-RGL, The directions on opening the

package given to consumers must be identical to those given to the seniors

during testing.

Should any human experiencelepidemiological 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.2



### Package

The package is a white plastic applicator in a rectangle of plastic. The

applicator consists of three parts, which are an applicator tip, a cap, and a main

chamber body. The applicator looks like a tube in a rectangle of plastic. At the top

area of the applicator extending from the cap there is a narrow (needle like) applicator

tip. In the rectangle of plastic surrounding the applicator in the narrow tip area there is

a notch on the left and a notch on the right. The package is opened by cutting off the

narrow tip area at the notches with scissors. There are three applicators with a colored

stripe on each applicator label connected to each other. The color of the stripe is

associated with the applicator size. The applicator, which is filled with water as a

placebo, comes in a 0.5ml size for these 2 products.

The instructions given to the seniors for opening the package during CRP

testing consisted of directions on a label on the back of the applicator stating "Use

scissors to open." and additional instructions stating "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."



### Toxicity

The toxicity of the product is based on the toxicity of Fipronil. The toxic or

harmful amount of Fipronil for an 11.4 kg child is 2.5mg/kg times 11.4kg, which equals

28.5mg. Access to a toxic or harmful am! 

# = 28.5mg 

# = 28.5mg divided by [1030mg/ml x

0.097 Fipronil] 

# = 0.285 ml 

# = 0.29 ml for Flpronil only Cat product EPA REG No.

2517-RGT. Access to a toxic or harmful amt 

### = 28.5mg 

### = 28.5mg divided by [1025

mg/ml x 0.098 Fipronil] 

# = 0.284 ml 

# = 0.28 ml for Fipronil & 

### S-Methoprene Cat

product EPA REG No. 2517-RGL. Access to one applicator represents a failure for a

child for all sizes equal to or greater than 0.28ml for EPA Reg. No. 2517-RGL, or

0.29ml for EPA Reg. No. 2517-RGT.

### Toxicity, Child Failure, and Package

EPA Reg I ml (1ml: Fl. Oz. (29.6ml Product % Fipronil mg Fipronil '# unit: tox

0.0338 fl. oz.) =1 n. oz.) Density g/ml !harmful amt

2517-RGT 0.5 0.017 1.030 9.7 49.96 1

2517-RGl 0.5 0.017 1.025 9.8 50.23 1



### Failure

For the purposes of CRP testing a child failure is access to one applicator for 0.5ml

size. Access to one applicator is more than 28.5mg of Fipronil for 0.5ml size. 3



### A unit failure for the child test was defined as opening the applicator or any partial or

complete access to the placebo (water).

A Senior Adult Use Effectiveness failure is failure to access the applicator in the

prescribed test time of 5 minutes for the first package or 1 minute for the second

package, not opening the applicator with scissors along the needle application tip,

cutting the applicator between the cap and the body of the main chamber, cutting into

the body of the main chamber of the applicator, cutting into the body of the main

chamber of the applicator at other locations, cutting off the bottom of the main chamber

of the applicator, or not separating a single applicator first and cutting open a second or

second and third applicator.

Analysis of Data and Conclusion

The CRP certifications submitted May 27,2010 for EPA Registration No. 2517-

RGT and 2517-RGL are acceptable. The labels submitted June 29, 2010 for EPA

Registration No. 2517-RGT and 2517-RGL have the same CRP directions as were

used in the CRP testing.

Child Study 3 white applicators with purple stripe on label size 0.5 ml size

(MRID 48279601 Perritt 1746-001) involved giving each child 1 set of 3 applicators

connected to each other and each applicator containing 0.5 ml of water at the start of

the test. A child failure was defined as access to one applicator. There were no child

### failures. This study was a pass according to the child sequential test in 16 CFR

1700.20. 4



### Senior Adult Use Effectiveness Study 3 white applicators with purple stripe

on label size 0.5 ml size (MRID 48279601 Perritt 1746-001) involved having the test

subjects open one applicator during a 5 minute test period and a one minute test

period. Scissors were made available during testing because the test directions given

to the seniors called for their use. Data Analysis showed 9 seniors failures with

package A and 1 senior failure with package B, which is the maximum number of

failures for a passed SAUE. The SAUE is 90%. The study is a pass of the senior

adult test in 16 CFR 1700.20 and the effectiveness specifications in 16 CFR

1700.15(b). The number of subjects per test site was corrected such that 9 subjects

(90-98) were coded as being tested at site H980 rather than site H902 (a different

location within a mall, a distinction not previously made). Site H902 now is 24% of test

subjects in accordance with 16 CFR 1700.20.

A bridging letter was submitted on June 30, 2010 for EPA Registration No. 2517-

RGl indicating the same size and color package would be used as was tested for 

### EPA

Registration No. 2517-RGT. On the basis of that information 

### EPA Registration No.

2517-RGl meets the CRP test requirements because EPA Registration No. 2517-

RGT meets the CRP test requirements.

For the details of each study refer to the attached summary chart

(summarycht2517 -135, 137resubmit.doc). A failure to market these products with

the identical size and color packages and 

### fill weight colors as were tested for

each size 

### will result in these products needing to submit additional data to



### establish that they are CRP.

In conclusion all the requirements for CRP have been met for 

### EPA

Registration No. 2517-RGT and 2517-RGL. 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.December13,2010CRPdatasummarychtEPAREG#2517-RGTSergeant'sFipronilSpotOnForCatsCompanyNameSergeant'sPetCareProducts,Inc.Chemical-Fipronil9,7%ASeniorAdultUseEffectivenessfailureisfailuretoaccesstheapplicatorintheprescribedtesttimeof5min.forthefirstpackageor1min.forthesecondpackage,notopeningtheapplicatorwithscissorsalongthe needleapplicationtip,cuttingtheapplicatorbetweenthecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthemainchamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailure',saccessto1unit.Accessto1unitismorethan28.5mgofFipronilforallsizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteaccesstotheplacebo(water).Accesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1030mg/mlx0.097Fipronil]=0.285ml=0.29mlforFipronilonlyCatEPAREG#2517-RGTAccesstoatoxicorharmfulamt=28,5mg=28.5mgdividedby[1025mg/mlx0.098Fipronil]=0.284ml=0,28mlforFipronil&SMethopreneCatEPAREG#2517-RGL%AI-Fipronil9.7%Note:Theapplicatoristhechild-resistantfeature,Theapplicatorsarefilledinml.11,2.3.10CRPstudiesweresubmittedbytheCompanytocoverthe5sizes(0.5,0.67,1.34,2,68,4,02ml)fortheFipronilonlyandtheFipronilandS-Methopreneproducts.Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFipronilandS-Methopreneproducts,whichappearedtobeidentical;andaJune30,2010letterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFipronilonlyandtheFipronilandS-MethopreneproductsaswasusedintheCRPtesting.2EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unitlpkg,childfail:;#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,tox/harm=#atBegineRsiveCompunitsTestReviewute,&whyAnalysis2517-RGT482796013whiteapplicatorswith15etof3ochildXCRECRPCertification5/27/10isacceptable.CatFipronilonly48959593purplestripeonlabelapplicatorsfailures:;assQciatLabeldated6/29/10sameCRPdirectionsas1746-001connectedtoeachother.connectedPass50edwithinstudy.Eachapplicator@O.5mltoeachchiidtestlowestDataAnatysisshowednochild failures.waterasplacebo.other.SAUEStudyisapassofthechildtestaccordingToX/harm:;1applicator,tothesequentiattestchartIn16CFRchitdfail=1applicator1700.20.2517-RGT482796013whiteapplicatorswith1setof390%XlowestCRPCertification5/27/10isacceptable.CatFipronilonly48059503purplestripeonlabelapplicatorsSAUESAUELabeldated6/29/10sameCRPdirectionsas1746-001connectedtoeach other.connectedinstudy.Eachapplicator@0.5mltoeachDataAnatysisshowed9seniorsfailureswithwaterasplacebo.other.packageAand1seniorfailurewithpackageTox/harm""1applicator,8,whichisthemaximumnumberoffailureschtldfall';;;1applicatorforapassedSAUE.TheSAUEis90%.ThestudyIsapassofthesenioradulttestin16CFR1700.20andtheeffectivenessspecificattonsin16CFR1700.15(b).Thenumberofsubjectspertestsitewascorrectedsuchthat9subjectswerecodedasbeingtestedatsiteH980ratherthansiteH902(adifferentlocationwithinamall,adistinctionnotpreviouslymade).SiteH902nowis24%oftestsubjectsinaccordancewith16CFR1700.20.-----CRPdatasummarychtEPAREG#2517-RGLSergeant'sFipronil+S-MethopreneSpotOnForCatsCompanyNameSergeant'sPetCareProducts,Inc.Chemical-Fipronil9.8%S-Methoprene11.8%3December13,2010ASeniorAdultUseEffectivenessfailureisfailuretoaccesstheapplicatorintheprescribedtesttimeof5min.forthefirstpackageor1min.forthesecondpackage,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicatorbetweenthecapandthebodyofthemain chamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthemainchamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailureisaccessto1unit.Accessto1unitismorethan28.5mgofFipronilforallsizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteaccesstotheplacebo(water).Accesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1030mg/mlx0.097Fipronil]=0.285ml=0.29mlforFipronilonlyCatEPAREG#2517-RGTAccesstoatoxicorharmfulam!=28.5mg=28.5mgdividedby[1025mg/mlx0.098Fipronil]=0.284ml=0.28mlforFipronil&SMethopreneCatEPAREG#2517-RGL%AI-Fipronil9.8%S-Methoprene11.8%Note:1.Theapplicatoristhechild-resistantfeature.2.Theapplicatorsarefilledinmi.3.10CRPstudiesweresubmittedbytheCompanytocoverthe5sizes(0.5,0.67,1.34,2.68,4.02ml)fortheFipronilonlyandtheFipronilandS-Methopreneproducts.Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFipronilandS-Methopreneproducts,whichappearedtobeidentical;andaJune30,2010letterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFipronilonlyandtheFipronilandS-MethopreneproductsaswasusedintheCRPtesting.4EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unitJpkg,ch'lldfail=#ChildGetatCRESAUEComprehOnlyincludeeRE&SAUEviacomputerunits,color,10x/harm=#BeginTestensiveComputeranalysisunitsReviewAnalysis&why2517-RGL482796013whiteapplicatorswith1se1of3CRPCertification5/27/10isCatFipronil+48959593purplestripeonlabelapplicatorsacceptable.Labeldated6/29/10Methoprene1746-001connected10eachother.connectedsameCRPdirectionsasinstudyEachapplicator@O.5mltoeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:Tax/harm=1applicator,MRID48279601(1746-001),EPAchildfail=1applicatorRegNo.2517-RGT.StudyIsapassofthechildtestaccordingtothesequentialtestchartin16CFR1700,20,TheSAUEis90%.ThestudyIsapassofthesenioradulttestin16CFR1700.20andtheeffectivenessspecificationsin16CFR1700,1S(b),BridgingLetter6/30/10indicatingsamesizeandcolorpackageas---_......._---testedis____._

## DATA PACKAGE BEAN**SHE~'T**

Date: 14-May-2010

Page 1 of 1



### * * * Registration Information 

### * * *

Registration: 2517-RGT

- SERGEANT'S FIPRONll SPOT-ON FOR CATS

Company: 2517

- SERGEANT'S PET CARE PRODUCTS, INC.

Risk Manager: RM 10

- Richard Gebken

- (703) 305-6701 Room# PY1 5-7237

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINlOS

Sent Date:

___ _ Calculated Due Date:

## o~" 1 \

Type of Registration: Product Registration

- Section 3 Decision #: 425437

DP 

### #: (377744)

PRIA

Parent DP 

### #:

Submission 

### #: 873353

Edited Due Date:

__ _

Action Desc: (R310) NEW PRODUGT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients: 129121, Fipronil(9.7%)



### * * 

### * Data Package Information 

### * * *

Expedite: 

## 0 Yes • No Date Sent:**14:~~-2010** Due Back:

____ _

DP Ingredient: 129121, Fipronil

DP Title:**=Eff~i="~'~,** ___**~~~~** _____**~** _______**~~~** ___ _

CSF Included: • Yes 

## 0 No label Included: • Yes 

### 0 No Parent DP #:

____ _

Assigned To Date In Date Out

Drganization:**cR=D~I~IB,-** ___**~~** __ _ _ ____ Last Possible Science Due Date: 05-0ct-2010

Team Name:**=Effi=,,~,~,~(I=B),--_~_~** __ _ Science Due Date:

___**~_**

Reviewer Name:

_______**~** __ _ Sub Data Package Due Date:

____ _

Contractor Name:



### -------

* * * Studies Sent for Review * * *

No Studies



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

Can be printed on its own page



### * * * Data Package Instructions * * *

For Your Review:

An R310 action, a new flpronil EP; presumably me-too of Merial's Frontline 65331-2.

Thx, baa

### Efficacy Review

Date: December 27, 2010

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

myers.clayton@epa.gov ,<:.



### 703-347-8874**"'\~** ,'}

\"-



### Risk Manager Rev.: Rosanna Louie

Products:

EPA Reg. #:

A.I.'s:



### Decision #s:



### DP#s:

Submissions:

MRIDs: Sergeants Fipronil Spot-on for Cats

2517-RGT

Fipronil, S-methoprene

425437

377744

R3l0, New Products, RD Science Review

Cited: 43121119, 43121120, 43121121, 45628101, 45628102, 45628103,

45638104,45628105

Overall Review of Label Claims and Directions:

Based upon the cited efficacy data for fipronil, claims are supported on cats for fleas,

mosquitoes, and chewing lice. Claims were not supported for ticks, or sarcoptic mange, as no

efficacy data for ticks or sarcoptic mange on cats were cited with this application, however these

claims may be retained provided the registrant cites the correct data required for support of such

claims. Repellence claims are not supported by any data submitted, cited, or on file, and thus

any and all repellence claims must be removed from the label. Claims against flea pupae are not

supported and must also be removed from the labeL

Line bv Line Review of Label Claims that Must be Removed:

-All 'repels' claims must be removed

-All claims against flea pupae must be removed

-"[brand name] contains Fipronil and to effectively kill [and repel] fleas (all stages) and ticks

[(including those that may transmit Lyme Disease)]. The active ingredient in [brand name]

works 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, ticks, mosquitoes, and chewing lice [for 30 days].

[diagram with visual of fipronil collecting and being released from hair follicle],,: 'repel' claim

must be deleted. The statement regarding movement and deposition offipronil through hair

follicles (and accompanying diagram) is deferred to the RM ReviewerlPM.

## DATA PACKAGE BEAN SHEET

Date: 14-May-2010

Page 1 of2



### * * * Registration Information 

## * * *

Registration: 2517-RGT

- SERGEANT'S FIPRONIL SPOT-ON FOR CATS

Company: 2517

- SERGEANTS PET CARE PRODUCTS, INC.

Risk Manager: RM 10

- Richard Gebken

- (703) 305-6701 Room# PY1 S-7237

Risk Manager Reviewer: Bonaventure Akintosotu BAKtNLOS

Sent Date: Catculated Due Date: 04-Nov-2010



### --

Type of Registration: Producl Registration

- Section 3 ) Decision 

### #: 425437

DP 

### #: (377739)

PRIA

Parent DP 

### #:

Submission 

### #: 873353

Ediled Due Date:

____ _

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

Ingredients: 129121, Fipronil(9.7%)



### * * * Data Package Information 

## * * *

Expedite: 

## 0 Yes • No Date Sent: 14-May-2010 Due Back:

____ _

DP Ingredienl: 129121, Fipronil

DPTitle:**,C~R~P** ___________________________ _

CSF tncluded: • Yes 

## 0 No Labellncludecl: • Yes 

## 0 No Parent DP #:

____ _

Assigned To Date Out

Organization:**~R~D~I~TR~B,,-** _______ _ 

# Y/Z8"lI1i--

Last Possible Science Due Date: 05-0ct-2010

Team Name: Child Resistant Packaging Science Due Oate:

____ _

Reviewer Name:

__________ _ Sub Data Package Oue Date:

Contractor Name:

__________ _



### * * 

### * Studies Sent for Review 

### * 

## * *

Printed on Page 2



### * 

### * * Additional Data Package for this Decision 

### * 

## * *

Can be prinled on its own page



### * * * Data Package Instructions 

## * * *

For Your Review:

- MRtD 48059503 for an R310 action, a fipronil EP

- Presumably me-too of Merial's Frontline 65331-2.

- Same review presumably for 2517-RGl

Thx, baa) Page 2

OP#: (377739) * * * Studies Sent for Review * * * Decision#: (425437) 

# I

Poison

Products, Inc

.. Project Number:

prepared by Perritt Laboratories, lnc. 28 p.

### CHILD-RESISTANT PACKAGING REVIEW



### Technical Review Branch

IN 5/14/2010 

### OUT 9/28/2010

## ~./ 

# -**/J_-.fl,;e:~** RD, TRB, Reviewed by

### Rosa(;~' 9/28/2010



### EPA Reg. No. or File Symbol 2517-RGT and 2517-RGA

DP Barcode DP377739 &377717

Decision 

### # 425437 & 425455

EPA Petition or EUP No.

___ _

Date Division Received 4/12/2010



### Type Product(s) Insecticide (fiea product)

Data Accession No(s). 48059503,48059803,48059804,48059805,48059806

Product Mgr.lChemical Review MgrlContact 

### Person RM 10 Bonaventure Akinlosotu

Division "R",D,-

__

Product Name(s) Sergeant's FiRronil Spot-On for Cats & 

### Sergeant's Fipronil SgueezeOn for Dogs

Company Name(s) Sergeant's Pet Care Products, Inc.



### Submission Purpose Review of CRP studies to determine if they are adeguate to

sYPPOrt CRP certification for these products

Active Ingredient(s), PC code, & 

### % Fipronil 9.7%

Summary of Findings



### In conclusion all the requirements for CRP have been met for EPA

Registration No. 2517-RGA and 2517-RGU. The directions on opening the

package given to consumers must be identical to those given to the seniors



### during testing. EPA Registration No. 2517-RGT and 2517-RGL do not meet all the

requirements for CRP. The SAUE study for EPA Registration No. 2517-RGT

exceeds the maximum number of subjects pertest site (24%) per 16 CFR

1700.20(a)(3)(1). Therefore, the test data is unacceptable. The senior adult test

must be corrected by replacing the last 9 test subjects from site 902 or redoing

the entire senior adult test. If the last 9 test subjects from site 902 are replaced,

the criteria for the entire 100 test subjects must conform to the criteria in 16 CFR

1700.20(a)(3)(i) regarding age and sex distribution, the number of test subjects

### per test site and per tester. The corrected/new study and a new electronic CD for

it will need to be submitted. For details see Analysis of Data and Conclusions

section below.



### 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.

Package

The package is a white plastic applicator in a rectangle of plastic. The

applicator consists of three parts. which are an applicator tip, a cap, and a main

chamber body. The applicator looks like a tube in a rectangle of plastic. At the top

area of the applicator extending from the cap there is a narrow (needle like) applicator

tip. In the rectangle of plastic surrounding the applicator in the narroW tip area there is

a notch on the left and a notch on the right. The package is opened by cutting off the

narrow tip area at the notches with scissors. There are three applicators wrth a colored

stripe on each applicator label connected to each other. The color of the stripe is

associated with the applicator size. The applicator, which is filled with water as a

placebo, comes in 5 different sizes (0.5. 0.67.1.34.2.68,4.02 ml).

The instructions given to the seniors for opening the package during CRP

testing consisted of directions on a label on the back of the applicator stating "Use

scissors to open." and additional instructions stating "HOW TO OPEN: Remove

product tubes [vial] from the package. Separate one tube from the others. Holding the

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



### narrow end at the notches with scissors."

Toxicitv

The toxicity of the product is based on the toxicity of Fipronil. The toxic or

harmful amount of Fipronil for an 11.4 kg child is 2.5mg/kg times 11.4kg, which equals

28.5mg. Access to a toxic or harmful ami**~** 

### 28.5mg**~** 

### 28.5mg divided by [1 030mg/ml x

0.097 Fipronil]**~** 

### 0.285 ml**~** 

### 0.29 ml for Fipronil only Cat product EPA REG No.

2517-RGT. Access to a toxic or harmful ami**~** 

### 28.5mg**~** 

### 28.5mg divided by [1020mg/ml

x 0.097 Fipronil]**~** 

### 0.288 ml**~** 

### 0.29 ml for Fipronil only Dog product EPA REG No.

2517-RGA. Access to a toxic or harmful amt**~** 

### 28.5mg**~** 

### 28.5mg divided by [1025

mg/ml x 0.098 Fipronil]**~** 

### 0.284 ml**~** 

### 0.28 ml for Fipronil 

### & S-Methoprene Cat

product EPA REG No. 2517-RGL. Access to a toxic or harmful ami**~** 

### 28.5mg**~** 

### 28.5mg divided by [1020mg/ml x 0.098 Fipronil]**~** 

### 0.285 ml**~** 

### 0.29 ml for Fipronil 

### & SMethoprene Dog product EPA REG No. 2517-RGU. Access to one applicator

represents a failure for a child for all sizes equal to or greater than 0.28ml for EPA Reg.

No. 2517-RGL, or 0.29ml for EPA Reg. No. 2517-RGT, 2517-RGA, and 2517-RGU.3



### Toxicity, Child Failure, and Package

EPA Reg # ml (1ml= Flo Oz. (29.6ml Product % Fipronil mg Fipronil # unit= tox

0.0338 fl. Oz.) =1 fl. oz.) Density gfml fharmful amt

2517-RGT 0.5 0.017 1.030 9.7 49.96 1

2S17-RGA 0.67 0.023 1.020 9.7 66.29 1

2517-RGA 1.34 0.045 1.020 9.7 132.58 1

2517-RGA 2.68 0.091 1.020 9.7 265.16 1

2517-RGA 4.02 0.136 1.020 9.7 397.74 1

2517-RGL 0.5 0.017 1.025 9.8 50.23 1

2517-RGU 0.67 0.023 1.020 9.8 66.97 1

2517-RGU 1.34 0.045 1.020 9.8 133.95 14

EPA Reg # ml (lml= Fl. Oz. (29.6ml Product % Fipronil mg Fipronll # unH '" tox

0.0338 fl. oz.) =111. oz.) Density simi Iharmful am1

2517·RGU 2.68 0.091 1.020 9.8 267.89 1

2517-RGU 4.02 0.136 1.020 9.8 401.84 1



### Failure

For the purposes of CRP testing a child failure is access to one applicator for all sizes.

Access to one applicator is more than 28.5mg of Fipronil for all sizes.

A unit failure for the child test was defined as opening the applicator or any partial or

complete access to the placebo (water).

A Senior Adult Use Effectiveness failure is failure to access the applicator in the

prescribed test time of 5 minutes for the first package or 1 minute for the second

package, not opening the applicator with scissors along the needle application tip,

cutting the applicator between the cap and the body olthe main chamber, cutting into

the body of the main chamber of the applicator, cutting into the body of the main

chamber of the applicator at other locations, cutting off the bottom of the main chamber

of the applicator, or not separating a single applicator first and cutting open a second or

second and third applicator.

Analysis of Data and Conclusion

The CRP certifications submitted May 27,2010 for EPA Registration No. 2517-

RGA and 2517-RGU are acceptable. The CRP certifications submitted May 27,2010

for EPA Registration No. 2517-RGT and 2517-RGL are not acceptable, because the

CRP Senior Adult Use Effectiveness (SAUE) test is not acceptable. The labels

submitted June 29,2010 for EPA Registration No. 2517-RGA and 2517-RGU have the

same CRP directions as were used in the CRP testing. The labels submitted June 29,

2010 for EPA Registration No. 2517-RGT and 2517-RGL have the same CRP

directions as were used in the CRP testing.

A screening of CRP studies (MRID numbers 48059503,48059803,48059804,

48059805, and 48059806) revealed the CRP study associated with the lowest SAUE

was MRID number 48059503 and the lowest child-resistant effectiveness (CRE) was

### MRID number 48059805. A comprehensive review was done for the lowest SAUE

including the CRE associated with it (MRID number 48059503) and the lowest CRE

including the SAUE associated with it (MRID number 48059805).

Child Study 3 white applicators with purple stripe on label size 0.5 ml size

(MRID 48059503) involved giving each child 1 set of 3 applicators connected to each

other and each applicator containing 0.5 ml of water at the start of the test. A child

failure was defined as access to one applicator. There were no child failures. This

study was a pass according to the child sequential test in 16 CFR 1700.20. 5



### Senior Adult Use Effectiveness Study 3 white applicators with purple stripe

on label size 0.5 ml size (MRID 48059503 which is the lowest SAUE) involved

having the test subjects open one applicator during a 5 minute test period and a one

minute test period. Scissors were made available during testing because the test

directions given to the seniors called for their use. Data Analysis showed 9 seniors

failures with package A and 1 senior failure with package B, which is the maximum

number of failures for a passed SAUE. The SAUE is 90%. However, one test site

(902) had 33% of the test subjects. This exceeds the maximum number of

subjects per test site (24%) per 16 CFR 1700.20(a)(3)(i). Therefore, this CRP test

data is unacceptable. The senior adult test must be corrected by replacing the last 9

test subjects from site 902 or redoing the entire senior adult test. If the last 9 test

subjects from site 902 are replaced, the criteria for the entire 100 test subjects must

conform to the criteria in 16 CFR 1700.20(a)(3)(i) regarding age and sex distribution,

the number of test subjects per test site and per tester.

Child Study 3 white applicators with red stripe on label size 2,68 ml size

(MRID 48059805 which is the lowest CRE) involved giving each child 1 set of 3

applicators connected to each other and each applicator containing 2.68 ml of water at

the start of the test. A child failure was defined as access to one applicator. The

results were two child failures, a 43 month old male accessed 2 applicators before the

demonstration and a 51 month old female accessed 1 applicator after the

demonstration. This study was a pass according to the child sequential test in 16

CFR 1700,20,

Senior Adult Use Effectiveness Study 3 white applicators with red stripe on

label size 2.68 ml size (MRID 48059805) involved having the test subjects open one



### applicator during a 5 minute test period and a one minute test period. Scissors were

made available during testing because the test directions given to the seniors called for

their use. The results of the study were 98% SAUE. The study is a pass of the

Senior Adult test in 16 CFR 1700.20 and the effectiveness specifications in 16

CFR 1700.15(b),

Based on the CRE and SAUE values the registrant reported for MRID numbers

MRID numbers 48059803,48059804, and 48059806 along with a computerized

analysis of the data these studies pass the CRE sequential test chart and SAUE

### requirements in 16 CFR 1700.20 and the effectiveness specifications in 16 CFR

1700.15(b). For the details of each study refer to the attached summary chart

(summarycht2517 -134, 135, 136, 137 .doc). 6



### A bridging letter was submitted on June 30, 2010 for EPA Registration No. 2517-

RGL and 2517- RGU indicating the same size and color package would be used as

was tested for EPA Registration No. 2517-RGT (MRID number 48059503) and 2517-

RGA (MRID numbers 48059803, 48059804, 48059805, and 48059806). On the basis

of that information:

• EPA Registration No. 2517-RGL does not meet the CRP test requirements

because EPA Registration No. 2517-RGT does not meet the CRP test

requirements.



### • EPA Registration No. 2517-RGU meets the CRP test requirements because EPA

Registration No. 2517-RGA meets the CRP test requirements.

For the details of each study refer to the attached summary chart

(summarycht2517-134,135,136,137.doc). A failure to market these products with

the identical size and color packages and fill weight colors as were tested for

each size will result in these products needing to submit additional data to



### establish that they are CRP.

In conclusion all the requirements for CRP have been met for EPA

Registration No. 2517-RGA and 2517-RGU. The directions on opening the

package given to consumers must be identical to those given to the seniors

during testing. EPA Registration No. 2517-RGT and 2517-RGL do not meet all the

requirements for CRP. The SAUE study for EPA Registration No. 2517-RGT

exceeds the maximum number ofsubjects pertest site (24%) per 16 CFR

1700.20(a)(3)(i). Therefore, the test data is unacceptable. The senior adult test

must be corrected by replacing the last 9 test subjects from site 902 or redoing

the entire senior adult test. If the last 9 test subjects from site 902 are replaced,

the criteria for the entire 100 test subjects must conform to the criteria in 16 CFR

1700.20(a)(3)(i) regarding age and sex distribution, the number of test subjects

per test site and per tester. The corrected/new study and a new electronic CD for

it will need to be sUbmitted.

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.CRPdatasummarychtEPAREG#2517-RGTSergeant'sFipronilSpotOnForCatsEPAREG#2517-RGASergeant'sFipronilSqueezeOnForDogsCompanyNameSergeant'sPetCareProducts,Inc.Chemical-Fipronil9.7%September28,2010ASeniorAdultUseEffectivenessfailureisfailuretoaccesstheapplicatorintheprescribedtesttimeof5min.forthefirstpackageor1min.forthesecondpackage,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicatorbetweenthecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthemainchamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailureisaccessto1unit.Accessto1unitismorethan28.5mgofFipronilforallsizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteaccesstotheplacebo(water).Accesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1030mgimlx0.097Fipronil]=0.285ml=0.29mlforFipronilonlyCatEPAREG#2517-RGTAccesstoatoxicorharmfulam!=28.5mg=28.5mgdividedby[1020mgimlx0.097Fipronil]=0.288ml=0.29mlforFipronilonlyDogEPAREG#2517-RGAAccesstoatoxicorharmfulam!=28.Smg=28.5mgdividedby[1025mgimlx0.098Fipronil]=0.284ml=0.28mlforFipronil&SMethopreneCalEPAREG#2517-RGLAccesstoatoxicorharmfulamt=28,Smg=28.5mgdividedby[1020mgimlx0.098Fipronil]=0.285ml=0.29mlforFipronil&SMethopreneDogEPAREG#2517-RGU%AI-Fipronil9.7%Note:Theapplicatoristhechild-resistan!feature.Theapplicatorsarefilledinml.11,2.3.10CRPstudiesweresubmittedbytheCompanytocovertheSsizes(O.S,0.67,1,34,2.68,4,02ml)fortheFipronilonlyandtheFipronilandS-Methopreneproducts.Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFipronilandS-Methopreneproducts,whichappearedtobeidentical;andaJune30,2010letterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFipronilonlyandtheFipronilandS-MethopreneproductsaswasusedintheCRPtesting.,-,'2EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#uniUpkg,childfail=#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,cotor,tax/harm=#atBeginensiveCampunitsTestReviewuter&whyAnatysis2517-RGT480595033whiteapplicatorswith1setof3ochildXCRECRPCertification5/27/10isacceptable.CatFipronilonly1746-001purplestripeonlabelapplicatorsfailures=associatLabeldated6/29/10sameCRPdirectionsasconnectedtoeachother.connectedPass50edwithinstudy.Eachapplicator@O.5mttoeachchildtestlowestDataAnaJysisshowednochildfailures.waterasplacebo.other.SAUEStudyisapassofthechildtestaccordingtoTax/harm=1applicator,thesequentialtestchartin16CFR1700.20.childfail:;1applicator2517-RGT480595033whiteapplicatorswith1setof390%XlowestCRPCertification5/27/10isacceptable.CatFipronilonly1746-001purplestripeonlabelapplicatorsSAUESAUELabeldated6129/10sameCRPdirectionsasconnectedtoeachother.connectedinstudy.Eachapplicator@0.5mltoeachDataAnalysisshowed9seniorsfailureswithwaterasplacebo.other.packageAand1seniorfailurewithpackageTox/harm=tapplicator,B,whichisthemaximumnumberoffailureschildfail:;1applicatorforapassedSAUE.TheSAUEis90%.However,onetestsite(902)had33%ofthetestsubjects.Thisexceedsthemaximumnumberofsubjectspertestsite(24%)per16CFR1700.20(a)(3)(1).Therefore,thisCRPtestdataisunacceptable.Thesenioradultteslmustbecorrectedbyreplacingthelast9testsubjectsfromsite902orredoingtheentiresenioradulttest.Ifthelast9testsubjectsfromsite902arereplaced,thecriteriafortheentire100testsubjectsmustconformtothecriteriain16CFR1700.20(a)(3)(i)regardingageandsexdistribution,thenumberoftestsubjectsperItestsiteandpertester.3EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#uniVpkg,childfail:::#ChHdGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,tox/harm=#atBeginensiveCampunUsTestRev'lewuter&whyAnalysis2517-RGA480598033whiteapplicatorswith15etof3ochildXCRPCertification5/27/10isacceptable.DogFipronil1746-002orangestripeonlabelapplicatorsfailures:::Labeldated6/29/10sameGRPdirectionsasonlyconnectedtoeachother.connectedPass50instudy.Eachapplicator@toeachchildtestDataAnalysisshowednochildfailures.O.87mlwaterasplacebo.other.Studyisapassofthechild1estaccordingto-Tox/harm:::1applicator,thesequential1estchartin16CFR1700.20.childfail::;1applicator2517-RGA480598033whiieapplicatorswith1setof398%XCRPCertification5/27/10isacceptable,DogFipronil1746-002orangestripeonlabelapplicatorsSAUELabeldated6/29/10sameCRPdirectionsasonlyconnectedtoeachother.connectedinstudy.Eachapplicator@toeachDataAnalysisshowed2seniorsfailed100.67mlwaterasplacebo.other,openpackageA.SAUEis98%,ThestudyisTox/harm::;1applicator,apassof1hesenioradulttestin16CFRchildfaU::;1applicator1700,20andtheeffectivenessspecificationsin16CFR1700.15(b).2517-RGA480598043whiteapplicatorswith1se1of3ochildXCRPCertification5/27/10isaccep1able.DogFipronil1746-003greenstripeonlabelapplicatorsfailures::;Labeldated6/29/10sameCRPdirectionsasonlyconnectedtoeachother,connectedPass50instudy,Eachapplicator@toeachchild1estDataAnalysisshowednochildfailures.1.34mlwaterasplacebo.other.StudyisapassofthechildtestaccordingtoTox/harm::;1applicator,thesequentialtestchartin16CFR1700.20.childfail::;1applicator2517-RGA480598043whiteapplicatorswith1setof395%XCRPCertification5/27/10isacceptable.DogFipronil1746-003greenstripeonlabelapplicatorsSAUELabeldated6/29/10sameCRPdirectionsasonlyconnectedtoeachother.connectedinstudy.Eachapplicator@10eachDataAnalysisshowed4seniorsfailedtoopen1.34mlwaterasplacebo.other.packageAand1seniorfailedtoopenTox/harm::;1applicator,packageB.SAUEis95%.Thestudyisachildfail::;1applicatorpassofthesenioradulttestin16CFR1700.20andtheeffectivenessspecificationsin16CFR1700.15(b).-_._--4EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unitlpkg,childfail:::#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,tax/harm;::;#atBeginensiveCampunitsTestReviewoler&whyAnalysis,2517-RGA480598053whi1eapplicatorswith1setof32childXlowestCRPCertification5/27/10isacceptable.DogFipronil1746-004reds1ripeon[abelapplica10rsfailures:::CRELabeldated6/29/10sameCRPdirectionsasonlyconnectedtoeach other.connectedPass50instudy.Eachapplica10r@10eachchildtestDataAnalysisshowed2childfailures,a432.68mlwaterasplacebo.other.mon1holdmaleaccessed2applicatorsbeforeTax/harm:::1applicator,thedemonstrationanda51montholdfemalechildfail:::1applicatoraccessedoneapplicatorafterthedemonstration.S1udyisapassof1hechild1es1accordingtothesequentialtestchartin16CFR1700.20.2517-RGA480598053whiteapplicatorswith1setof398%XSAUECRPCertification5/27/10is acceptable.DogFipronil1746-004redstripeonlabelapplicatorsSAUEassociatLabeldated6/29/10sameCRPdirectionsasonlyconnectedtoeach01her.connectededwithinstudy.Eachapplicator@toeach10wes1DataAnalysisshowed2eniorsfailedtoopen2.68mIwa1erasplacebo.other.CREpackageA.SAUEis98%.ThestudyisaTox/harm:::1applicator,passofthesenioradul11estin16CFRchildfaii:::1applica10r1700.20andtheeffectivenessspecificationsin16CFR1700.15(b).2517-RGA480598063whi1eapplicatorswith1setof31childXCRPCertification5/27/10isacceptable.IDogFipronil1746-005bluestripeonlabelapplicatorsfailUre:::Labeldated6/29/10sameCRPdirectionsasonlyconnectedtoeach01her.connectedPass50instudy.Eachapplicator@toeachchild1estDataAnalysisshowedoneagecalculation4.02mlwaterasplacebo.other.error,a44montholdmalewasreportedas45Tox/harm:::1applicator,monthsold.Theagedistributionisnotinchildfail:::1applicatoraccordancewith16CFR1700.20.Thestudy resultsarenotaffected.Therewas1childfailure,a44montholdmaleaccessed1applica10rafterdemonstra1ion.Studyisapassofthechildtestaccordingtothesequentialtestchartin16CFR1700.20.5EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unit/pkg,childfail=#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,taX/harm=#atBeginensiveCampunitsTestReviewuter&whyAnalysis2517-RGA480598063whiteapplicatorswith1setof397%XCRPCertification5/27/10isacceptable.DogFipronil1746-005bluestripeonlabelapplicatorsSAUELabeldated6/29/10sameCRPdirectionsasonlyconnectedtoeachother.connectedinstudy.Eachapplicator@toeachDataAnalysisshowed1birthdatewas4.02mlwaterasplacebo.other.missing.UponfindingitinthehardcopyofToX/harm=1applicator,datatheagecalculationwasokay.Thestudychildfail=1applicatorresultsarenotaffected.Therewasoneagecalculationerror,butthetestsubjectremainedinthesameagegroup.Thestudyresultsarenotaffected.Theresultsshowed3seniorsfailedtoopenpackageA.SAUEis97%.Thestudyisapassofthesenioradulttestin16CFR1700.20andtheeffectivenessspecificationsin16CFRt700.15(b).6September28,2010CRPdatasummarychtEPAREG#2517-RGLSergeant'sFipronil+S-MethopreneSpotOnForCatsCompanyNameSergeant'sPetCareProducts,Inc.Chemical·Fipronil9.8%S·Methoprene11,8%ASeniorAdultUseEffectiveness failureisfailuretoaccesstheapplicatorintheprescribedtesttimeof5min.forthefirstpackageor1min.forthesecondpackage,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicatorbetweenthecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthemainchamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailureisaccessto1unit.Accessto1unitismorethan28.5mgofFipronilforallsizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteaccesstotheplacebo(water).Accesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1030mg/mlx0.097Fipronil]=0.285ml=0.29mlforFipronilonlyCatEPAREG#2517-RGTAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1020mg/mlx0.097Fipronil]=0.288ml=0.29mlforFipronilonlyDogEPAREG#2517-RGAAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1025mg/mlx0.098Fipronil]=0.284ml=0.28mlforFipronil&SMethopreneCatEPAREG#2517-RGLAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1020mg/mlx0.098Fipronil]=0.285ml=0.29mlforFipronil&SMethopreneDogEPAREG#2517-RGU%AI-Fipronil9.8%S-Methoprene11.8%Note:1.2.3.Theapplicatoristhechild-resistantfeature.Theapplicatorsarefilledinmi.10CRPstudiesweresubmittedbytheCompanytocoverthe5sizes(0.5,0.67,1.34,2.68,4.02ml)fortheFipronilonlyandtheFipronilandS-Methopreneproducts.Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFipronilandS-Methopreneproducts,whichappearedtobeidentical;andaJune30,2010leiterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFipronilonlyandtheFipronilandS-MethopreneproductsaswasusedintheCRPtesting.7EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#uniUpkg,childfail=#ChildGetatCRESAUEComprehOnlyincludeeRE&SAUEviacomputerunits,color,tax/harm=#BeginTestensiveComputeranalysisunitsReviewAnalysis&why2517-RGL3whiteapplicatorswith1setof3CRPCertification5/27/10isCatFipronil+purplestripeonlabelapplicatorsacceptable.Labeldated6/29/10Methopreneconnectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicator@O.5mltoeachmentionedbelow.Sizenotacceptedwaterasplacebo.other.basedon:ToX/harm=1applicator,MRID48059503(1746-001),EPAchildfail=1applicatorStudyisapassofthechildtestaccordingtothesequentialtestchartin16CFR1700.20.TheSAUEis90%.However,onetestsite(902)had33%ofthetestsubjects.Thisexceedsthemaximumnumberofsubjectspertestsite(24%)per16CFR1700,20(a)(3)(;).Therefore,thisCRPtestdataisunacceptable.BridgingLetter6/30/10indicatingsamesizeandcolorpackageaspackagetestedisokay.8September28,2010CRPdatasummarychtEPAREG#2517-RGUSergeant'sFipronil+S-MethopreneSqueezeOnForDogsCompanyNameSergeant'sPetCareProducts,Inc.Chemical-Fipronil9.8%S-Methoprene8.8%ASeniorAdultUseEffectivenessfailureisfailuretoaccesstheapplicator·,ntheprescribedtesttimeof5min.forthei,rstpackageor1min.forthesecondpackage,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicatorbetweenthecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthemainchamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailureisaccessto1unit.Accessto1unitismorethan28.5mgofFipronilforallsizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteaccesstotheplacebo(water).Accesstoatoxicorharmfulam!=28.5mg=28.5mgdividedby[1030mg/mlx0.097FipronilJ=0.285ml=0.29mlforFipronilonlyCatEPAREG#2517-RGTAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1020mg/mlx0.097FipronilJ=0.288ml=0.29mlforFipronilonlyDogEPAREG#2517-RGAAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1025mg/mlx0.098FipronilJ=0.284ml=0.28mlforFipronil&SMethopreneCatEPAREG#2517-RGLAccesstoatoxicorharmfulam!=28.5mg=28.5mgdividedby[1020mg/mlx0.098FipronilJ=0.285ml=0.29mlforFipronil&SMethopreneDogEPAREG#2517-RGU%AI-Fipronil9.8%S-Methoprene8.8%Note:1.2.3.Theapplicatoristhechild-resistantfeature.Theapplicatorsarefilledinmi.10CRPstudiesweresubmittedbytheCompanytocoverthe5sizes(0.5,0.67,1.34,2.68,4.02milfortheFipronilonlyandtheFipronilandS-Methopreneproducts.Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFipronilandS-Methopreneproducts,whichappearedtobeidentical;andaJune30,2010letterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFipronilonlyandtheFipronilandS-MethopreneproductsaswasusedintheCRPtesting.9-EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unit/pkg,childfail=#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputerunits,color,tox/harm=#atBeginensiveComputeranalysisunitsTestReviewAnalysis&why2517-RGU3whiteapplicatorswith1setof3CRPCertification**5/27/10**isDogFipronil+S-orangestripeonlabelapplicatorsacceptable.labeldated**6/29/10**Methopreneconnected10eachother.connectedsameCRPdirectionsasinstudyEachapplicator@O.67mltoeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:Bridgingletter**6/30/10**Tox/harm=1applicator,indicatingsamesizeandcolorchildfail=1applicatorpackageaspackagetested;andpassingeRE&SAUEvaluesper16CFR1700forMRID48059803(1746-002)EPARegNo.2517-RGA.2517-RGU3whiteapplicaiorswith1setof3CRPCertification**5/27/10**isDogFipronil+S-greenstripeonlabelapplicatorsacceptable.Labeldated**6/29/10**Methopreneconnected10eachother.connectedsameCRPdirectionsasinstudyEachapplicator@1.34mltoeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:Bridgingletter**6/30/10**Tox/harm=1applicator,indicatingsamesizeandcolorchildfail=1applicatorpackageaspackage1ested;andpassingCRE&SAUEvaluesper16CFR1700forMRID48059804(1746-003)EPARegNo.2517-RGA.2517-RGU3whiteapplicatorswith1setof3CRPCertification**5/27/10**isDogFipronil+S-redstripeonlabelapplicatorsacceptable.labeldated**6/29110**Methopreneconnectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicaior@2.6Bmltoeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:Bridgingletter6/30/10ToX/harm=1applicator,indicatingsamesizeandcolorchildfail=1applicatorpackageaspackage1ested;andpassingCRE&SAUEvaluesper16CFR1700forMRID48059805(1746-004)EPARegNo.2517-RGA.10EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unitlpkg,childfaU=#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputerunits,color,tox/harm=#atBeginensiveComputeranalysisunitsTestReviewAnalysis&why2517·RGU3whiteapplicatorswith1setof3CRPCertification5/27/10isDogFipronil+SMbluestripeonlabelapplicatorsacceptable.Labeldated6/29/10Methopreneconnectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicator@4.02mltoeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:BridgingLetter6/30/10Tox/harm=1applicator,indicatingsamesizeandcolorchildfail,=1applicatorpackageaspackagetested;andpassingeRE&SAUEvaluesper16CFR1700forMRID48059806(1746·005)EPARegNo.2517·RGA... .ProductToxicitybasedonFipronilToxicityAccesstoatoxicorhannfulamt=28.5mgFipronilAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1030mg/mlx0.097Fipronil]=0.285ml=0.29mlforFipronilonlyCatEPAREG#2517-RGTAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1020mg/mlx0.097Fipronil]=0.288ml=0.29mlforFipronilonlyDogEPAREG#2517-RGAAccesstoatoxicorharmfulam!=28.5mg=28.5mgdividedby[1025mg/mlx0.098Fipronil]=0.284ml=0.28mlforFipronil&5-MethopreneCatEPAREG#2517-RGLAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1020mg/mlx0.098Fipronil]=0.285ml=0.29mlforFipronil&5-MethopreneDogEPAREG#2517-RGU11EPAReg#ml(ml=flooz.(fl.oz.Product%FipronilrngFipronil#unit:=taxIharmfulamt0.0338fl.29.6ml)Density**g/m**Ioz.)2517-RGT0.5 0.0171.0309.749.9612517·RGA0.670.0231.0209.766.2912517-RGA1.340.0451.0209.7132.5812517-RGA2.680.0911.0209.7265.1612517-RGA4.020.1361.0209.7397.7412517-RGL0.50.0171.0259.850.2312517-RGU0.670.0231.0209.866.9712517-RGU1.340.0451.0209.8133.9512517-RGU2.680.0911.0209.8267.8912517-RGU4.020.136·1.0209.8401.841

## DAtA PACKAGE BEAN SHEET

Date: 14-May-2010

Page 1 of 1



### * * * Registration Information 

### * * *

Registration: 2517-RGT

- SERGEANT'S FIPRONIL SPOT-ON FOR CATS

Company: 2517

- SERGEANT'S PET CARE PRODUCTS, INC.

Risk Manager: RM 10

- Richard Gebken

- (703) 305-6701 Room# PY1 5-7237

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS

Sent Dale:

____ _ Calculated Due Oale: 04-Nov-2010

Type of Registration: Product Registration

- Section 3 Decision 

### #: 425437

DP #: (377737)



### PRIA

Parent DP 

### #:

Submission 

### #: 873353

Edited Due Date:

____ _

Action Desc: (R310) NEW PRODUCT;NON-FAST TRACK {INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients:**~912~,~F~ip~'~,"~iI~(9~.7~%~o),--** ________**~~** ____________ _

Expedite: 

## 0 Yes. No

DP Ingredient: 129121, Fipronil

DP Title: Tox: Similarity 

### * * 

### * Data Package Information 

### * * *

Dale Sent: 14-May-2010 Due Back:

____ _

CSF Included: • Yes 

## 0 No Label Included: • Yes 

## 0 No Parent DP #:

__ _

Assigned To Date In

Organization:**"R~D~/~T~R~B** _____ _ Date Out /

____ Last Possible Science Due Date: 05-0ct-2010

Team Name:TD**,~X"-** 

### _____**~** 

### ___ _ Science Due Date:

____ _

Reviewer Name:

------- Sub Data Package Due Date:

__ _

Contractor Name:



## * * * Studies Sent for Review 

## * * *

NO Studies



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

### * * *

Can be printed on its own page



### * 

### * * Data Package Instructions 

### * * *

For Your Review:

An R3tO action, a new fipronil EP; presumably me-too of Merial's Frontline 65331-2.

Thx, baa

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

September 16, 2010

MEMORANDUM OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION



### Subject: Name of Pesticide Product:

EPA Reg. No. IFile Symbol: SERGEANT'S FIPRONIL SPOT-ON FOR CATS

2517-RGT

DP Barcodes: DP 377737

Decision No.: 425437

Action Code: R310

PC Codes: 129121 (Fipronil: 9.7%)

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

Technical Review Branch

Registration Division (7505P) 

# O-r---'I:.'0...,..j--..

)s::.'< - \ 

## r..

- 1...c::>1...C>



### To: Bonaventure AkinlosotuiRichard Gebken RM 10

Insecticide Branch

Registration Division (7505P)

Registrant: SERGEANT'S PET CARE PRODUCTS, INC.

FORMULATION FROM LABEL:

Active Ingredient(s):

129121 Fipronil

Other Ingredient(s):

TOTAL

ACTION REQUESTED: The Risk Manager requests:

# ~

Bywt.

9.7%

90.3%

100.0%

"For Your Review: An R310 action, a new fipronil EP; presumably**me~too** 

### of Me rial's Frontline

65331-2."

Page 1 {lO

### BACKGROUND:

To support the registration of EPA File Symbol 2517-RGT, the registrant is citing 6 acute



### toxicity studies (MRlDs 43577705 through 43577710), as well as a number of companion animal

(cited under guideline reference number 870.7200) studies (MRlDS 43272401,43444904,

43577711,43577713,43577716, and 43863801). The material received for review also includes

a proposed label, a CSF dated 12/2112009, 

### and a copy ofa coverletter dated April 12, 2010.

COMMENTS AND RECOMMENDATIONS:



### 1. After a comparison of the CSFs, TRB concludes that 2517-RGT is substantially similar in



### toxicity to 65331-2, and that.the toxicity studies that supported the registration 0[65331-2

will also support the registration of2517-RGT.

2. MRlDs 43577705 through 43577710 were reviewed in a memorandum dated 

### 7117/95 from



### L. Markarian to R. KeigwiniA. Sibold; the formulation (9.7% Fipronil) was assigned to EPA



### Toxicity Category III for oral toxicity, eye irritation and primary dermal irritation. 

### It was

assigned to Category IV for dennal and inhalation toxicity. The product was negative for

dennal sensitization. These classifications are consistent with the precautionary labeling

statements on the last (March 9, 2010) accepted label for 65331-2 ("Harmful if swallowed.

Causes eye irritation. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap

and water after handling. ").

3. There is no record in IHAD of a review for the study in MRID 43272401. According to

OPPIN query the study is dated 1994 and is titled "Domestic Animal Safety Study of

RM1601C 0.25% Topical Spray in Juvenile Cats: Interim Report." The study was submitted

to support 65331-EUP-1.

4. The study in MRID 43444904, dated 1994 and titled "Domestic Animal Safety Study of

RM1601C Topical Spray (Frontline Spray Treatment) in Juvenile Cats, was reviewed by V.

Dobozy (TXR 0011405, review dated February 1, 1995) and classified as acceptable. The

study involved testing of groups of 

# s: 8 week old male and female kittens "and demonstrated

that RM160lC (0.25%) has at least a 5X margin ofsafety"in kittens."

5. There is no record in IHAD ofa review for MRID 43577711. According to OPPIN Query

MRID 43577711 is a 6-page document titled "Discussion in Support of Bridging Domestic

Animal Safety Data on Frontline Spray Treatment to Frontline Spot Treatment" which was

submitted in support of 65331-EUP-E.

6. The study in MRID 43577713 dated 1995 and titled "Positive Referenced and Untreated

Controlled Dose Confinnation Trial ofRM1601E 10% SPOT-ON Fonnu1ation Applied to

Cats for Control of the Cat Flea Ctenocephalides felis" is, according to OPPIN query, an

efficacy study (not a toxicity study).

Page 2 of3

### 7. The study in MRID 43577716, titled "Percutaneous Absorption and Distribution of RadioActivity in Hair, Skin, and Fat After Spot-On Application of 14C_RM160 1 in Cats" was

reviewed by V. Dobozy in an BED review (TXR 0011764, memorandum dated January 24,

1996) and classified as supplementary.

The proposed label for 25 1 7-RGT includes the following claim (based on the study in MRID

43577716?): "The active ingredient in [brand name] works 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 from 2517-RGT,

and the similar claim for 65331-2 ("Fipronil collects in the oils of the skin and hair follicles,

and continues to be released from hair follicles onto the skin and coat.

.. ") should be deleted

from the label of that product.

8. The study in MRID 43863801 titled "Domestic Animal Safety by Topical Administration to

Cats: Fipronil Spot Treatment" was reviewed by V. Dobozy in an RED review (TXR

0051187, dated 04/03/96) and classified as acceptable. From the review: "The study

demonstrated that RM1601E/62 (9.7% fipronil) has at least a 5x margin of safety in cats

greater than 24 weeks of age." The dose was 0.5 mL. From the cover memorandum:

"Toxicology Branch II concludes that the toxicology data base is complete for the spray

(0.25%) and spot-on (9.7%) fipronil formulations."

9. The proposed label for 2517-RGT includes the statement: "Can 

### be used on breeding,

pregnant and lactating [queens] [female cats]." In order to have this statement, the registrant

has to cite the study in MRID 45618502. This citation is not included in the data matrix for

2517-RGT. Except for this use, the toxicity data requirements for the registration of2517-

RGT have been adequately satisfied by the citations in the data matrix.

10. The proposed precautionary labeling and first aid statements for 2517-RGT are acceptable.

11. For the purposes of this action, TRB has not reevaluated previously reviewed data.

12. The CSF (dated 12/2112009) for 2517-RGT should also be reviewed and accepted by the

TRB Chemistry Team.

Page 3 of3

## DATA PACKAGE BEAN SHEET

Date:**14~Mayw2010**

Page 1 of 2



## * * * Registration Information 

## * * *

Registration: 2517-RGT

- SERGEANT'S FIPRONIL SPOT-ON FOR CATS

Company: 2517

- SERGEANT'S PEr CARE PRODUCTS, INC.

Risk Manager: RM 10

- Richard Gebken

- (703) 305-6701 Room# PY1 8-7237

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS

Sent Date:

____ _ Calculated Due Date: 04-Nov-2010

Type of Regislralion: Product Registration

- Section 3 Decision 

### #: 425437

DP 

### #: (377736)

PRIA

Parent DP 

### #:

Submission 

### #: 873353

Edited Due Dale:

____ _

Action Desc: (R31 0) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients: 129121, Fipronil(9.7%)



### * 

## * * Data Package Information 

## * * *

Expedite: 

## 0 Yes. No Date Sent: 14-May-2010 Due Back:

____ _

DP Ingredient: 129121, Fipronil

DP Title: Prod Chem

CSF Included: • Yes 

## 0 No Label tncluded: • Yes 

## 0 No Parent DP #:

__ _

Assigned To Date tn Date Out /

_____ Last Possible Science Due Date: 05-0ct-2010 Organization:**~R~D~/~TR=B** _____**~**

Team Name:**C~H~E~M",-** ________ _ Science Due Date:

__ _

Reviewer Name:

__________ _ Sub Data Package Due Date:

Contractor Name:

__________ _

'I< 'I< 'I< 

### Studies Sent for Review 'I< 'I< 

### *

Printed on Page 2



### *

'I< 

### * Additional Data Package for this Decision 

### * * 

### *

No Additional Data Packages

'I< 

### * * Data Package Instructions 

### * 

### *

'I<

For Your Review:

MRID 480595 -01 & 02 for an R310 action, a fipronil EP; presumably me-too of Merial's Frontline 65331-2.

Thx, baa 

## \Page 2

DP#: (377136) * * * Studies Sent for Review * * * Decision#: (425437)

04/10/10,

Care Products, Inc. p.

48059501 i , J. (2010) Group A Product Chemistry For Fipronil Cat 830.1750/Certified limits

Spot-On. Project Number: 04f10/11. Unpublished study prepared

by Sergeanfs Pet Care Products, Inc. 35 p.

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronl! Cat 830,6317fStorage stability of product

Spot-On. Project Number. 04/101tO. Unpublished study prepared

by Sergeant's Pet Care Products, Inc. 6 p.

48059502 Messina, J, (2010) Group B Product Chemistry for Fipronil Cat 830.63t3fStability to sunlight,

Spot-On. project Number: 04f10f1 O. Unpublished study prepared normal and elevaled temperatures,

by Sergeant's Pet Care Products, Inc. 6 p. metals, and metal ions

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronil Cat 830.6303/Physical state

Spot-On. Project Number: 04/10/10. Unpublished study prepared

by Sergeant's Pet Care Products, Inc. 6 p.

4805950t Messina, J. (2010) Group A Product Chemistry For Fipronil Cat 830.1550fProduct Identity and

Spot-On. Project Number: 04/10111. Unpublished study prepared composition

by Sergeant's Pet Care Products, Inc. 35 p.

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronil Cat 830.6319/Miscibility

Spot-On. Project Number: 04f10flO. Unpublished study prepared

by Sergeant's Pet Care Products, Inc, 6 p.

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronil Cat 830.6304/0dor

Spot-On, Project Number: 04/10/10. Unpublished study prepared

by Sergeant's Pet Care Products, Inc. 6 p.

48059501 Messina, J. (2010) Group A Product Chemistry For Fipronil Cat 830.1670fOiscussion of formation of

Spot-On. project Number: 04f10f11. Unpublished study prepared impurities

by Sergeant's Pet Care Products, Inc. 35 p.

48059501 Messina, J. (2010) Group A Product Chemistry For Fipronil Cat 830.1620lOescription of production

Spot-On. Project Number: 04f10/11. Unpublished study prepared process by Sergeant's Pet Care Products, Inc. 35 p.

48059501 Messina, J. (2010) Group A Product Chemistry For Fipronil Cat 830,1600lOescription of materials

Spot-On. Project Number: 04/10/11. Unpublished study prepared used to produce the product

by Sergeant's Pet Care Products, Inc. 35 p.

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronil Cat 830.6320/Corrosion characteristics

Spot-On. Project Number: 04/10/10. Unpublished study prepared

by Sergeant's Pet Care Products, Inc. 6 p.

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronl! Cat 830.7520/Particie size, fiber length,

Spot-On. Project Number: 04/tOf1 O. Unpublished study prepared and diameter distribution

by Sergeant's Pet Care Products, Inc. 6 p.

4805950t Messina, J. (2010) Group A Product Chemistry For Fipronil Cat 830.1650lOescription of formulation

Spot-On. Project Number: 04/10/11. Unpublished study prepared process by Sergeant's Pet Care Products, Inc. 35 p.

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronil Cat 830. 7300/0ensitylrelative density

Spot-On. Project Number: 04/10/10. Unpublished study prepared

by Sergeant's Pet Care Products, Inc. 6 p.

48059502 Messina, J. (2010) Group B Product Chemistry for FlpronU Cat 830.6302fColor

Spot-On. Project Number. 04/10/10. Unpublished study prepared

by Sergeant's Pet Care Products, Inc. 6 p.

48059502 Messina, J, (2010) Group B Product Chemistry for Fipronil Cat 830.6314fOxidizing or reducing

Spot-Dn. project Number: 04fl 0/1 O. Unpublished study prepared action

by Sergeant's Pet Care Products, Inc. 6 p.

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronil Cat 830.6315/Flammability

Spot-On. Project Number: 04f10f10. Unpublished study prepared

by Sergeant's Pet Care Products, Inc, 6 p.

48059502 Messina, J. (2010) Group B Product Chemistry for Fipronil Cat 830.7100Niscosity

Spot-On. Project Number: 04/10/10. Unpublished study prepared

by Sergeant's Pet Care Products, Inc. 6 p.

# EE

DP BARCODE No.: 377736 FILE SYMBOL No.:2517-RGT DECISION No.: 425437

PC Coders): 129121 ACTION CODE: R 310

FOOD Use: NO NON-FOOD Use: YES

DATE OUT: August 31, 2010

SUBJECT: End Use Product Chemistry Review**pr~uctN"Ille:** 

### SERGEANT'S FIPRONIL SPOT ON FOR CATS

\

### ~**~1f'\'(O**

## I~r 'Cairola

,-- 

## fL,-v"-''' .' 

# 0

Product Chemistry Team 

# ?J I D 

# 0\ \

'Y' ') 

### FROM:

Technical Review Branch 

### I Registration Division (7505P)



### TO: Richard Gebken IBonaventure Akinosotu PM 10



### Insecticide Branch 

### I Registration Division (7505P)

Company Name: SERGEANT' S PET CARE PRODUCTS INC

Formulation Type: LIQUID

INTRODUCTION:

The applicant requested a new non food use) end use product. 

### In support of the application, the

applicant submitted product chemistry data corresponding to guideline 830 series, group A & 

### group

B (MRlD#s480595-01 and -02). TRB has been asked to detennine the acceptability of the product

chemistry data and the proposed basic and 1 alternate CSF.



### SUMMARY OF FINDINGS:

1. Name of Active Ingredient Fipronil.

2. All of the source 

### materials of the active ingredient are derived from registered sources.

3. All inert ingredients have been screened by IIAB and found to be approved for the proposed

labeled uses.

4. Confidential Statement of Formula(s):



## [Xl Basic

- 12/21109 Dated: resubmitted (email)

- Dated: 08/31110



## [Xl Alternate # 1 Dated: 08/31110

Alternate CSF(s) complies with 40CFR§152A3: [Xl Yes [l No

### DP BARCODE No.:

PC Coders):

FOOD Use: Yes

5, Product label 

### FILE SYMBOL No.: DECISION No.:

Action Code: R 310, R 340, 345

NON-FOOD Use: Yes

a. Ingredient statement: Nominal concentration of AI listed on CSF(s) concm 

### with product label



### (PR Notice 91-2)

[X] Yes, 

### if not, explain below:

Metallic equivalent: [

Soluble arsenic: [

Isomeric ratios:

Acid equivalent: 

### [

[ 

## 1 Yes [



## 1

Yes [



## 1 Yes [



## 1 Yes [ 

## 1 NA;

lNA

lNA

] NA; {name} acid equivalent = 

### xx %



### b. Health related sub statements: Product contains?



### Petroleum distillate at> 10%:

Methanol at> 4%: 

## [ 1 Yes [Xl No [ 

## 1 NA

[ lYes [XlNo [ lNA

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

### § 156.78

for: flammability, explosive potential or electric insulator breakdown?



### [lYes [lNo

Is the sub statement in compliance 

### with PR Notice 97-6? [ ] Yes, ifnot, explain below:

d. Label requires an additional Storage and Disposal statement: [ ] Yes [X] No; if yes explain

below:

Applicant needs to submit Enforcement Analytical Method for Fipronil

2

### DP BARCODE No.: FILE SYMBOL No.: DECISION No.:

PC Code(s):

FOOD Use: Yes Action Code: R 310, R 340,345

NON-FOOD Use: Yes

6. Group A: Product Chemistry Data

IRE's determination of the acceptability of the data for the proposed product is listed in the

tables below.



### Data 

### TRB's

Guideline submitted 

### Assessment



### No. Study Title

Yes No of Data 

### MRIDNos.

Product Identity &



### 830.1550 Composition X 

### A 480595-01

Description of materials used

830.1600 to produce the product 

### X 

### A 480595-01

Description of formulation



### 830.1650 process X 

### A 480595-01

Discussion on the formation

830.1670 of impurities X 

### A 480595-01

830.1700 PreliminalY analysis



### Standard

certified

Certified limits



### limits

(158.350) Proposed Limits

Justification for

830.1750 \\fider limits



### Enforcement analytical

830.1800 method G

A::::: Acceptance, N = 

### Not Acceptable, G = 

### Data Gap,



### W::::: Waiver Request, I::::: In Progress, NA::::: Not Applicable

3

### DP BARCODE No.: FILE SYMBOL No.: DECISION No.:

PC Code(s):

FOOD Use: Yes

7. Group B:



### Guideline Study Title

No.

830.6303 Physical State

830.6315 Flammability

830.6316 Explodability

830.7000 pH

830.7300 

### Density (units) 

### Action Code: R 310, R 340, 345

NON-FOOD Use: Yes



### Value or Qualitative 

### TRB's

Description Assessment

of Data

Clear yellow liquid A

>90°C A

Not explosive A



### Product insoluble in water NA

1.00-1.05g/mL A

A = 

### Acceptance, N = 

### Not Acceptable, G = 

### Data Gap, W = 

### Waiver request,

NA = 

### Not applicable, I = 

### In progress

CONCLUSIONS: MRIDNos.

480595-02

480595-02

480595-02

480595-02

480595-02

TRB has reviewed the CSF(s) and product chemistry data for the proposed end use product and

has concluded:



### 1. Basic CSF Dated: 

### 08/31/10 is acceptable and attached.

2. Alternate CSF#I Dated: 

### 08/31/10 is acceptable and attached.

3. All required Group A data were reviewed and determined to be Acceptable except

Enforcement Analytical Method for Fipronil.

4. All required Group B data were reviewed and detennined to be Acceptable; except

- guidelines 830.6317 (storage stability) and 830.6320 (corrosion characteristics). The

registrant is required to generate one year storage stability & 

### corrosion characteristics study.

The recommended observations periods are 0,1,3,6,9, & 

### 12 months intervals.

5. 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.

4UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460



### May4,2010

OPP Decision Number: D-425437

EPA File Symbol or Registration Number: 2517-RGT

Product Name: SERGEANT'S FIPRONIL SPOT-ON FOR CATS

EPA Application Receipt Date: !3-Apr-2010



### EPA Waiver Request Receipt Date: 13-Apr-20 1 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: Approval of50% Small Business Waiver Request

Dear Registrant: OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



### 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: R310



### NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY);

If you 

### have any questions, please contact the Pesticide Registration Service Fee

Ombudsman, at 

### (703) 305-6249.

Siiparely,

Oscar Morales,

# i~**~~** Infonnation Technology & 

### Resources Management Division

Office of Pesticide Programs

# \ )

UNllED STATES ENVIRONMENTAL PROTECTIuN AGENCY

WASHINGTON, D.C. 20460



### April 19, 2010

OPP Decision Number: D-425437

EPA File Symbol or Registration Number: 25 I 7-RGT

Product Name: SERGEANT'S FIPRONIL SPOT-ON FOR CATS

EPA Receipt Date: 22-Dec-2009

EPA Company Number: 2517

Company Name: SERGEANT'S PET CARE PRODUCTS, INC.

KELLY R. HOSKINS

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158m PLAZA

OMAHA, NE 68130-1703 OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



### 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 PRi'\f-86-5 screen will be communicated 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-F AST 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

determination is made regarding your request. If your waiver request is approved, the decision

review time period will start on the date of approval and we will process a refund of your $2,289

overpayment as soon as is practicable. 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) 305-6249.

Sincerely,

# 7'MLM-~ Front End Processing Staff

Infomlation Technology & 

### Resources Management Divisionchange PRIA code

Linda Arrington to: John Jamula 04/16/2010 11 :38 AM

Cc; Bonaventure Akinlosotu, Teresa Downs**~~.----~--~~~.**

Hi JJ and Teresa,

Please change the fo!!owing from R300 to R310. Company has submitted 1he difference in fee already.

2517--RGU

2517-RGL

2517-RGA

2517-RGT

Linda Arrington

Registration Division

7033056249

703 305 6920 (fax)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D,C, 20460



### April15,2010

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

TOXlC SUBSTANCES



### Thank: you for your submittal of 12-APR-l O. Our staff has completed a preliminary

analysis ofthe material. The results are provided as follows:

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

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.

### 480595·00

Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE**66130~1770** • Telephone 402.938.7000 • Fax 402,936.7091 • www.sergeants.com



### April 12, 20 I 0

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: 

### Sergeant's Fipronil Only Squeeze-On for Cats

EPA File Symbol 2517·RGT



### Response to the Agency's Letter Dated January 27, 2010

Dear 

### Mr. Gebken:



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

### Plaza, Suite 100, Omaha,

NE 68130·1703, EPA Company Number 2517) is submitting additional data to support the



### pending product registration for Sergeant's product Sergeant's Fipronil Only Squeeze-On for

Cats (EPA File Symbol 2517·RGD. The data are being submitted to EPA in response to the



### Agency's letter dated January 27, 2010 (please see enclosed copy). The Agency requested

Sergeant's to address deficiencies in the submission. Please see below the Agency's

comments (in italics) and Sergeant's response (in bold);

1. The data matrices for the above referenced products are incomplete. You must revise

each data matrix by listing out specific MRID's (where applicable) and study title names

that are used to support each applicable guideline. Instructions for completing the EPA,

form 8570-35 data matrix correctly can be found within PR Notice 98-5.



### Sergeants is submitting a new data matrix using the selective method of support

with this submission package to fulfill the Agency's requirements.

2. The "Cite-all" option for product chemistry is inadequate. You cannot cite product

chemistry data, since Sergeant's Pet Care Products, Inc. is the formulator of the

proposed products. As a result, you must submit acceptable end use product chemistry

data in accordance with PR Notice 86-5. 

### In addition, you must revise the data matrix as

outlined in #1 above to reflect this change.



### Sergeants is submitting new product chemistry data specific to Sergeants' spot on

product Sergeant's Fipronil Only Squeeze-On for Cats (EPA File Symbol 2517-

RGT). These new studies are being submitted in accordance with PR Notice 86-5

and Sergeants listed themon the new enclosed data matrix.

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

2625 South 1B81h Plaza • Omaha, NE 68130-1770 • TelephOne 402.938.7000 • Fax 402.938.7091 • www.sergeants.com



### 3. In accordance with 40 CFR §152.34, the submitted Child Resistant Packaging (CRP)

self-certification is unacceptable for each product. The currently approved eRP data for

the referenced products listed on your 8570-1 form (block 

### #6) are also not citable for

purposes of satisfYing the data requirements outlined in 40 CFR § 152.34. These CRP

tests are product package design specific and unrelated to your proposed package.

Sergeants is submitting a new Child Resistant Packaging study with this submission

package to fulfill the Agency's requirements. Sergeants listed this new study in the

new enclosed data matrix.

According to this letter, the Agency re-classified the original application from a R300 new

product; me-too fast track ($1,365), to a R31 0 new product; non-fast track application

($4,578). Please forward an invoice for the additional fee.

Please [md enclosed the following documentation in support of our response:

1. Administrative materials:

• Transmittal docmnent;

• EPA Form 8570-1: Application for Pesticide Form ;

• EPA Form 8570-34: Certification with Respect to Citation of Data Form;



### • EPA Fonn 8570-35: Data Matrix Fonn

- EPA and Public Versions; and

• Additional PRlA Payment Confmnation Receipt.

2. Data Volume 1 and 2: Product-specific product chemistry data.

3. Data Volume 3: Evaluation of the Cat Squeeze On 0.5 ml White Applicator with

Purple Label Indicator (3x), scissors to open

- f=l as a Poison Prevention Package for

Sergeant's Pet Care Products, Inc.

If you have any questions regarding this submission, please contact me.

Sincerely, 

# tell 

# /bJk 

# P--

Kenyf.Hoskins

Manager of Teclmical Affairs

Sergeant's Pet Care Products, Inc.

Enclosures

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

2625 South 156th Plaza • Omaha, NE**68130~1770** • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com



### Data Transmittal Document:

Submitter: Sergeant's Pet Care Products, Inc. (EPA Company Number 2517)

2625 South 158 th 

### Plaza

Suite 100

Omaha, NE 68130-1703

Submittal Date: April 12, 2010

Volume Study Title MRID



### I Group A Product Chemistry for Fipronil Cat Spot-On

(25 I 7-RGT) 48059501



### 2 Group B Product Chemistry for Fipronil Cat Spot-On 48059502 

### (2517-RGT)

3 Evaluation of the Cat Squeeze On 0.5 ml White

Applicator with Purple Label Indicator (3x), scissors to 48059603



### open

- F=l as a Poison Prevention Package for

Sergeant's Pet Care Products, Inc

..

## )

Please read Instructions, o;n reverse**b~fore** c:.u'mpleting form. Form Approve

.... OMB No.:2070-0060. Approval expires 05-31-98



# , l,Injted States**~_Regis~ration.** opp 'Identifier Number 

# EPA '.

, ':



### , E'nvif:onmehtal Protection Agency 

### D,Amendment

Washington, DC 20460 

# o Other ,



## .

.

Application for Pesticide

- Section I

1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification

2517-RGT Richard Gebken

4. Company/Product (Name)

Fipronil Only Spot-On FOf Cats PM#10

### ~None DRestricted

5. Name and Address of Applicant (Include ZIP Code) 6. Expedited Review. In accordance wi1h FIFRA Section 3( C )(J)(b)(I), my

Sergeant's Pet Care Products, Inc. product is similar or identlcal in composition and labeling to:

2625 South 158 1h Plaza

Omaha, NE 68130 EPA Reg. No. 65331-2

Product Name FRONTLINE TOPSPOT FOR CATS 

# o

Check if Ihis is a new address

Section II 

# D

Amendment

- Explain below. 

# D

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

### ~ Resubmission in response to Agency leiter dated 01-27-2010 

# D

"Me Too" Application 

# D

Notification

- Explain below. 

# D

Other

- Explain below.

Explanation: Use additional page(s) if necessary. (For section I and Section II.)

Section III

1. Material This Product Will Be Packaged In:

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container**~Yes~** k8] Yes DYes 

# o

Metal

ONO 

# o No 

# Is:J No 

# l'Zl

Plastic

If "Yes" No. per tt"Yes" No. per OGlass ·Certification must Unit Packaging wgt. Container Package wgt. Container

OPaper be submitted 0.017 fl oz (o.somI! 2,3,4,6 

## I D01her (Specify) Plastic Bag

3. loca1ion of Net Contents Information 4. Size(s) Retail Container 5 location of Label Directions

[Z]Label D Container 0.017 fl oz (O.SOmI) DOn Can

DOn Labeling accompanying producl

6. Manner in Which Label is Affixed to Product OLithograPh k8]Other

OPaper glued

OStenciled

Section IV

1. Conlact Point (Com lete items directly below for identlficalion of individual to be contacted, if necessary, to process this apolication.)

Name Title Telephone No. (Include Area Code)

Kelly R. Hoskins Manager ot Technical Affairs 402-938-7079

Certification 6. Date Application

I certify 1hat the statements I have made on this form and all attachments thereto are true, accurate and complete. I Received

acknowledge that any knowingly talse or misleading sta1ement may be punishable by fine or imprisonment or both (Stamped)

under applicable law.

2. Signature

# jt!lll~L;b 3. Title

BY:**~** Manager of Technical Affairs

4. Typed Name: (/ I 5. Date: 

# 00 

# I**!~** 

# /ZCIO

KellyR. HoskinsF A orm pproved MB 0<. o N 2070.-00 60; 2070-0057: 2070-010 7 2070-0 22 2070 0 1 164**"'~",** UNITED STATES ENV)RONMENTAl PROTECTION AGENCY 

## (Al 

# 5 1200 Pennsylvania Avenue, N.W.

WASH)NGTON, D.C. 20460

Paperwork RedoctionActNotice: The public reporting burden forthis coliecti01lofinfonnation is estimated to average t.25 hours per response for registration

and 0.25 hours per response forrelegistration and special review activities, including time for reading the instructions and compteting the necessary forms. Send

commems regarding wrdenestimate or any other aspect of this collectim ofinfonnation, including suggestions for reducing the burden to: Director, Collection

Strategies Division (2822T), V.S. Environmental Protection Agency, t200 Pennsylvania Avenue, NW., Washington, DC 20460. Do not send th:: completed form

to this address.

Certification with Respect to Citation of Data

ApplicanfsfRegistranfs Name, Address, and Te!ephOile Number EPA Registration Number/File Symbol

Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha, NE 68130 2517·RGT

Active Inoredient(s\ andfor reoresentative test comoound(s) Date

Fipronll 04/1212010

General Use Pat"m(s) (list all those claimed for this product using 40 CFR Part 158\ Product Name

Indoor non-food Sergeant's Fipronil Only Spot-On for Cats

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to

submit this form. You must submit the**Formulato~s** Exerrption Statement (EPA Form 8570-27).



# 0 I am responding \0 a Data-Call-In Notice, and have included wilh this form a list of companies sent offers of compensation (the Data Matnx form shouk:i

be used for this purpose).

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



# 0 I am using the die-ali method of support, and have included with this form 

## [2] I am using the selective method of support (or dte-all option

a list of companles sent offers of compensation (the Data Matrix form under the selective method), and have included with this form a

should be used for this purpose). completed tist of dala requirements (the Data Matrix form must be

used).

SECTtDN II: GENERAL OFFER TO PAY

(Required if using Ihe cite-all method or when uSing the cite-all option under the selective method to satisfy one or more dala requirements)



## [2] I hereby offer and agree to pay compensation, to other persons. wilh regard to the approval of this application, to the extent required by FIFRA.

SECTION III: CERTtFICATIDN

I certify Ihatthis application for registration, this form for reregislration, or this Data-Call-In response is supported by all data submitted or cited in the

application for registration, the form for reregislration, or Ihe Data-Call-tn response. In addition, if the cite-all option or dte-all option under the selective method is

indicaled in Section I, this application is supported by all data in the Agency's files Ihat (1) concem the properties or effects of this product or an identical or

substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that wouid be required \0 be submitted I.Jlder the data

requirements in effect on the date of approval of this application if the application sought the initial registralion of a product of identicat or similar composition and

uses.

t certify that for ead:! exdusive use study cited in support of this registratiQn or reregistration, that I am the original data submiller or that I have obtained

the wrijten pennission of the onginal data submitter to cHe that study.

I certify that for each study cijed in support of this registration or reregistration that is nQt an exclusive use study, either: (a) I am the original data

submitter; (b) I have obtained the permission of the original data submitter 10 use the study in SUpport ofthis application; (c) all periods of eligibilrty (or

compensalion have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have

offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) andfor 3(c)(2)(6) ofFIFRA: and Qi) to commence negotiations to detennine the

amount and terms of compensation, if any, to be paid for the use oftha study.

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence ot their delivery in

accordance with sections 3(c)(1)(F) and/or 3(c)(2)(6) of FIFRA are available and wilt be submitted to the Agency upon request. ShoiJd I fail to produce such

evidence \0 the Agency upon request, I understaiid that the Agency may initiate action to deny, cancel or suspend the registration of my product in con(onnily with

FIFRA.

t certify that the statements I haw made on this form and atl attachments to it are true, accurilB, ilnd complete. I acknoWedge thilt any

knowingly false or misleadlrg statement may be punishable by fine or imprisonment or both under applicable law.

Signature 

# 16 

# JoJ)jJ/s$2-

Date Typed or Pnnted Name and Title 

# Of/ll/W Kelly R. Hoskins, Manager of Technical Affairs

EPA Form 8570-34 ,j-;::-2oo3) Electronic and Paper versions available. Submij only P er version.

### Pay.gov

- Online Payment Page lofl

Online Payment

Step 3: ConfIrm Payment 11213

Thank you.

Your transaction has been successfully completed.

Pay,goy Tracking Infonnation

Application Name: PRIA Service Fees

Pay.goy Tracking 10: 250LG6U2

Agency Tracking ID: 74110737347

Transaction Date and Time: 04/12/2010 14:38 EDT

Payment Summary

Account Holder Name: Sergeants Pet Care Products

Payment Amount: $3,213.00

Account 

### Type: Business Checking

Routing Number.

Account Number. * uu 5483 Payment Date: 04/1312010

Decision Number:

Registration Number: 2517-RGT

Company Name: Sergeants Pet Care Produc

Company Number: 2517

Action Code: R310



### httos://www.nav.l!ov/oavs!Ov/navrnents/authorizeACHPavment.html 4/1212010F.<mAppmv,dO!l1l1No.1070·0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY'"401MStreet,S.W.WASIDNGTON,D.C.20460l'lIpenvorkRedllctionActNotice:ThepublicreportingburdenforthiscollectionofinformationiscstimaJcdtoaverage0.25 hoursperresponseforregistrationaClivitie5and0.25hoursperresponseforreregistrationandspecialreviewllClivities,includingtimeforreadingtheinstructionandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotllcraspectcollectionofinformation,includingsuggestionsforreducingtheburdentoDirector:OPPElnfonnationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:April12,2010EPARegNo.fFi!eSymbol2517·RGTPagelof6Applicant's/Rcgistrant'sName&AddrcssProduct:Fiproni!OnlySpot-OnForCatsSergeant'sPetCareProdUcts,Inc.2625South158thPlaza,Suite100,Omaha,NE68130-1703Inredients:Fironi!GuidelineReferenccNumberGuidelincStudyNameMRlDNumberSubmittcrStatusNote-830.I550,830.1600, 830.1620,ProductPropertiesDataforSergeant'sFiproni!Squeeze-NewsubmissionSergeant'sPetCareProducts,Inc.OWN830.1650,830.1670,830.1700,OnforCats830.1750,830.1800830.1800EnforcementanalyticalmethodNewsubmissionSereant'sPetCareProdllcts,Inc.OWN830.6302,830.6303,830.6304,ProductchemistryofSergeant'sFiproni!Squeeze-OnforNewsubmissionSergeant'sPctCareProducts,Inc.OWN830.7300,830.7000, 830.6315,C,"830.7100,830.6320,830.6317830.6317,830.6320StoragestabilityandcorrosioncharacteristicsTobesubmittedSergeant'.'IPetCareProdUcts,Inc.OWNuponcompletion870.1100Acuteoral toxicity43577705MERlALLIMITEDOLD870.1200Acutedermaltoxicity43577706MERIALLIMITEDOLD870.1300Acuteinhalationtoxicity43577707MERIALLIMITEDOLD870.1400Primaryeyeirritation43577708MERIALLIMITEDOLD870.1500Primarydermalirritation43571709MERlALLIMITEDOLD'-870.1600Dermalsensitization43577710MERIALLIMITEDOLDEvaluationoftheCatSqucezeOnO.SmlWhiteApplicatorwithNewsubmissionSergeant'sPetCareProducts,Inc.OWNPurpleLabelIndicator(3x),scissorstoopen-F=lasaPoisonMP""nti"P","g,["S",,,,nt',P,tCn"Pmd,,",I""Signature:.;f0,t,)y.,j15;;).NameandTitleDateKe!!yR.Hoskins,ManagerofTochnicalAffairs04112/2010,EPAFornIt9.9VY'«lrOllic."dPaperV<yion,v,ilableSubmitonlyP.!"',....,,;O".Agen<ylo!<m.lll..CopyPO'",OMBNo.lll70·0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY0401MStreet,S.W.0WASHINGTON,D.C.20460PaperworkRcductiollActNoticc:Thepublicreportingburdellforthiscollcctiollofinformationisestimatedtoavcrage0.25hoursperresponseforregistralionactivitiesand0.25hoursperrcsponsefurreregistrationandspecialreviewactivities,illcludingtimeforreadingthein2eregistmtioncompletingthenecessaryforms.SendcommentsregardingthcburdeneSlimateoranyotheraspectofthiscollectiollofinformati011,includingsuggestionsforreducingtheburdentoDirector:OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,40I MStreet,S.W.,Washington,DC20460.Donotscndtheformtothisaddress.DATAMATRIXDate:April12,2010EPARegNo.lFileSymbol2517-ROTPage20f6Appl"lcant's/Rcgistrant'sName&AddressProduct:FipronilOnlySpot-OnForCatsSergeant'sPetCarcProducts,Inc.2625South158thPlaza,Suite100,Omaha,NE68130-1703Ingredients:FipronilGuidelincRcferenceNumberGuidelineStudNameMRIDNumbcrSubmitterStatusNote870.7200Schwartz,E,(I994)DomesticAnimalSafetyStudyof43272401MERIALLIMITEDOLDRMI601C0.25%TopicalSprayinJuvenilcCats:InterimReport:LabProjectNumber:94424.UnpublishedstudyIpreparedbyWhiteEagleToxicologyLab.112p.870.7200Schwartz,E.(1994)DomesticAnimalSafetyStudyof43444904MERIALLIMITEDOLDRMI60lCTopicalSpray(FrontlincSprayTreatment)illJuvenileCats:LabProjectNumber:94424:PS-234DAS.UnpublishedstudypreparedbyWhiteEagleToxicologyLabs.168p.870.7200Walker,K.(1995)DiscussioninSupportofBridgingDomestic43577711MERIALLIMITEDOLDAnimalSafetyDataonFrontlineSprayTreatmenttoFrontlineSpotTrcatmentDataPackagc.UnpublishedstudypreparcdbyRhoneMel"ieux,Inc.6o.870.7200Everett,R.;Cunningham,J.;Tanner,P.(1995)Positive43577713MERIALLIMITEDOLDRefercncedandUntreatedControlledDoseConfirmationTrialofRMI60IE10%SPOT-ONFormulationAppliedtoCatsforControloftheCatFleaCtenocephalidesfelis:LabProjectNumbers:RMVSR-250LT:ARC#RMCI94:P-250LT.UnpublishedstudypreparcdbyAgResearchConsultants,Inc.30D.870.7200Villageliu,J.;Lopcz,S.;Germa,M.;etal.(1994)43577716MERIALLIMITEDOLDPercutaneousAbsorptionandDistributionofRadioactivityinHair,Skin,andFatAfterSpot-OnApplicationof(Carbon14)-RMI601inCats:LabProjectNumbcrs:CD-93/3748F.UnpublishedstudypreparedbyCentrodeInvestigacionyDcsarrolloAplicado,SAL.42p.Signaturc:j.-'./liD;.,;'0h....NamcandTitleDateIIPI:KellyR.Hoskins,ManagerofTechnicalAffairs04/1212010EPAF=8170.J5(9-97f'Jehon;eaIldP.!"',Vet"?AvailableSuh";1onlyPoperver';onAg,ncy1o""n.1U..Cop)'1'0<'"App'ov,dOMBNo.2ll70·0ll'OUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY0401MStreet,S.W.0WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationiseslimaledtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforrcregistratiOllandspecialreviewactivities,includingtimeforreadingthein3eregislratiollcompletlngthenecessaryforms.Sendcommentsregardingtheburdenestimaleoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdentoDirector:OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheform(0thisaddress.DATAMATRIXDate:April12,20I 0EPARegNo.lFilcSymbol2517-RGTPage3of6Applicant'slRegistrant'sName&AddressProdllct:FipronilOnlySpot-OnForCatsSergeant'sPetCareProducts,Inc.2625SouthI58thPlaza,Suite100,Omaha,NE68130-l703Inredients:FironilGuidelineReferenceNumbcrGuidelineStudNameMRiDNumberSubmittcrStatusNote870.7200Camcron,D.;Maltby,B.(l995)DomesticAnimalSafetyby43863801MERIALLiMlTEDPAYTopicalAdministrationtoCats:FipronilSpotTreatment:LabProjectNumber:MRX24/950746.UnpublishedstudypreparedbyHuntingdonResearchCcntre,Ltd.174p.8l0.3300Young,R(1993)APreliminaryStudytoEvaluateInitialand43121119MERIALLIMITEDOLDResidualEfficacyofTwoRMl601SprayFormulationTopicallyAppliedforControloftheCatFleaintheCat:LabProjcctNumber:P-21ILT.UnpublishedstudypreparcdbyYoungVeterinaryResearch.28p.810.3300Cruthers,L.(I993)ADoseConfirmationStudytoVerifythe43121120MERIALLIMlTEDOLDOptimalSprayConcentrationofRMI60ICforControloftheCatFleaCtenocephalidesfelisintheCat:Revised:LabProjcctNumber:PLRS9303:P!224LT.UnpubrlshedstudyprcparedbyProfessionalLabsandResearchServiccs,Inc.31p..810.3300Everett,R.;Cunningham,1.(1993)Dose-Titration(Volume)of43121121MERIALLIMITEDOLDRM1601SprayforControloCtheCatFleaClenocephalidesfclisinthcCat:Revised:LabProjcctNumber:RMD393:P!228LT.UnpublishedstudypreparedbyAgrcsearchConsultants,Inc.41p.810.3300Pollmeier,M.(1999)AnEfficacyStudyofFrontlincTopSpot45628101MERIALLIMITEDPAYforthcTreatmentandControlofFelicolasubrostratusintheCat:FinalReport:LabProjectNumber:PR&D0022201.UnpUblishedstudypreparedbyCentroVcterinarioOriolo.18p.810.3300i'ollmeier,M.;Pengo,G.;Barrick,R(2000)AnEfficacyStudy45628102MERIALLlMlTEDPAYofFrontlineSpray,FrontlincTopSpotandML-2,095,988508QfortheTreatmentandControlofFelicolasubrostratusintheCat:FinalRcport:LabProjectNumber:PR&D0037201_UnpublishedsludypreparedbyCentroVeterinarioOriolo.22p.810.3300Pollmeier,M.;Pengo,G.(2001)StudiestoConfirmthcEfficaey45628103MERIALLIMITEDPAYofFipronilAgainstLieeinCatsUndcrFieldConditions:FinalRepOlt:LabProjectNumber:PR&D0037501.UnpublishedstudyprcparedbyCentroVcterinarioOriolo.20p.INameandTitleDateKellyR.Hoskins,ManagcrofTechnicalAffairs0411212010'n'OTn.'""Cfln"Form....pP'ov<dOMBNo.1070·()(IGOIUNITEDSTATESENVIRONMENTALPROTECTIONAGENCYi0401MStreet,S.W.0WASHINGTON,D.C.20460PaperworkReductionAcrNotice:Thcpublicreportingburdenforthiscollectionofinfommtionisestimaledtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistratiOllandspecialreviewactivitics,includinglimeforreadingthein4eregistrationcompletingthenecessaryforms.SendcommenlSregardingtheburdenestimateoranyotheraspectofthiscollectiollofinformation,includingsuggestionsforreducingtheburdentoDirector:OPPEInformationManagement Division(2t37)U.S.Environmellla!ProlectionAgency,40I MStreet.S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:April12,20lOEPARegNo.lFileSymbol2517-RGTPage4of6Applicant'slRegistrant'sName&AddressProduct:FipronilOnlySpot-OnForCatsSergeant'sPetCareProducts,Inc.2625SouthI58thPlaza,Suite100,Omaha,NE68130-1703Ingredients:FipronilGuidelineReferenceNumberGuidelineStudNameMRIDNumberSubmitterStatusNote810.3300Postal,J.;LeNain,S.;Gonzalez,C.;etaI.(1999)Studiesto45628104MERIALLIMITEDPAYAsesstheEfficacyofFrontlineSpot-On(10%w/vFipronil)intheTreatmentofFclincFleaAllergyDermatitis(FAD)UnderFieldConditions:FinalReport:LabProjectNumber:ASR19012:CLl277.UnpublishedstudypreparedbyMerial,64p.810.3300Alva,R.;Barrick,R.(1999)AStudytoDeterminctheEffectof45628105MERIALLIMITEDPAYTrcatmcntwithFrontlineTopSpotonthePrevalenceandSeverityofFicaAllcrgyDermatitisinCats:FinalReport:LabProjcctNumber:PR&D0012701-04:PR&D00t2701:PR&D0012702,UnpublishedstudypreparedbyVCAStPctersburgAnimalandAltamahaAnimalClinc.41p.,133-3Mco,N.;Gonzalez,C,;Mester,T.(1997)Dermaland44433302MERIALLIMITEDPAY;InhalationExposurcofCommercialPetGroomcrsDuringApplicationofFrontlineSprayTreatment:FinalReport:LabProjcctNumber:MERIAL-445-SAFXT046:SAFX046:PDA9705.UnpublishedstudypreparedbyABCLabs.,CaliforniaandAanimalAppealGroomingShop&CascVcterinaryHospital.lO66p.133-3Meo,N.;Gonzalez,C.;Belchcr,T.(1997)DermalExposureof44433303MERlALLIMITEDPAY"......-CommercialPctGroomersDur'lUgApplica(lOnofFront!ineTopSpot:FinalReport:LabProjectNumber:MERIAL-445·SAFXTQ47:SAFXT047:EC·97-390.UnpublishedstudypreparedbyABCLabs.,CaliforniaandAanimalAppealGroomingShop&CaseVeterinaryHospital.925P.132·1Hughes,D.(1997)DislodgeableResiduesofFipronilfollowing44433304MERIALLIMITEDPAYApplicationofFrontlineTopSpottoCats:FinalRcport:LabProjectNumbcr:COYANCE6848-103:MERIALMETXT168:90066D.UnpublishedstudypreparedbyCovanceLabs.Inc.118p.S;""'";(tf!f/lt1it}X!J;t::.NameandTitleDateKellyR.Hoskins,ManagcrofTechnicalAffairs0411212010EPAFormgS7()')S(9.97)IJrronicalJdP'pe,Ver'in,Av.iloble,Submit""Iyp,!""""rsiooAg.n.yInt<'nolUr<Copy.OW"._•••.011andspecialreview1UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY•401MStreet,S.W.•WASHINGTON,D.C.I-------_____.ion,includingsuggcsti...lV'20460.Donotsend("rmt"thi,nforthiscollectionofinfonnationiseSlimated10average0.25hoursperresponsefOrregistrruionactivitiesand0.25hoursperresponsefor\dingthein5eregistralioncomplelillgthenecessaryforms.SendcommentsregardingtileburdenestimateoranyolheraspectoflhiscollectionDirector.OPPEInformationManagemcrilDivision(2137)U.S.Environment,lIProtectionAgency,40tMSireet,S.w.,Washington,DCDate:April12,2010sPetCareI-........--132-\132·1132-1INIADATA5Sout,/1158thPlaza,S,:!.i.te100,Omah;:t,j\JE,'I"V"'"v"v,",,,,,,,ApplicationofFrontlincSpot-OnTreattnenttoCats:FinalStudy:LabProjectNumber:MET417:817/023B.'-'Ltd.<In..!deFontenay,G.;Magloire,B.;Suberville,S.etaL(1997)DislodgeableResiduesofFipronilFollowingaTopicalApplicationofFrontlineSprayTreatmenttoCats:FinalReport:LabProjectNumber:MET415:MERIAL-480·MET415:817/023A.UnpublishedstudypreparedbyMedalLtd.1Pr.."lin'''alServ"lccs·Europe.71p."'l")fCommercialandVeterinaryPetGroomersandI'etUwnersot'FrontlineTopSpotandFrontlineSprayTreatment:LabProjectNumber:MERIAL-445·SURVEY.UnpublishedstlldypreparedbyWieseRescarchInc.340p.Hughes,D.(1997)ValidationofanAnalyticalMethodforthelinationofFipronil,M&B45950,andM&B46513inDye-Free100%CottonGloves:FinalRcportLabProjectNumber:COVANCE6848-104:6848·lO4:MERIALMETXT169.UnublishedstudyrcaredbCovanceLabs.Inc.41[EPARegN(j:lFile2517-RGT::FipronilOnlySpot-OnForCats[RIDNumberSubmitter44433307MERIALLIMITED4453120144531202Polakoff,B.;Youngrcn,S.(1997)Non-DietaryRisk44433309MERIALLIMITEDAssessmentFipronilUseonPetsinaResidentialSetting:LabProjcctNumber:FIPRONIL97-09:MERIAL-445-NDRA.I....!ol"..!"....!h"N"v'o"."."""""'--'P$,lfelkl/11IJIAkEPAFNameandTitleKellyR._"·.IAffairsIPAYIPAYIPAYIPAY..CopyIPagc50f6DatcIlJ.ll?1?1l10FoemAppro..dOMBNo.2070·0MOUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY•401MStreet,S.W.•WASHINGTON,D.C.20460PaperworkReductionActNOliee:ThepublicreportingburdenforthiscollectionofinfonnaJionisestimated10average0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspec"mlreviewacti\1ties,"Includingtimeforreadingtilein6eregistmfloncompletingthenecessaryfonus.Sendcommell\SregardingtheburdenestimateoranyoUleraspectofthiscollectionofinformatioll,includingsuggestionsforreducingtheburdentoDirector:OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,40I MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:April12,2010EPARegNo.lFilcSymbol2517-RGTPage6of6AppJicant'sJRegistrant'sName&AddressProduct: FipronilOnlySpot-OnForCatsSer!!:eanl'sPetCareProducts,Inc.2625South158thPlaza,Suite100,Omaha,NE68130-1703Inredients:FironilGuidelineReferenceNumberGrtidelineStudyNameMRJDNumberSubmitterStatusNotePolakoff;B.;Youngren,S.(1997)PetGroomerExposure44433310MERIALLIMITEDPAYAnalysisandRiskAssessment:FrontlineTopSpotandFrontlineSprayTrealment:LabProjectNumber:FIPRONIL97-11:MERIAL-445-PGRA.UnpublishedsludypreparedbyNovi!!:enSciences,Inc.17p.Wall,H.(1998)FrontlineProductsReportsofSuspected44531205MERIALLIMITEDPAYAdverseEventsAnalysisofBreed,AgeandSexDistributionofDogsandCats.UnpublishedstudypreparedbyMerialLid.8p.Polakoff,B.;Youngren,S.;Walls,C.(1998)Frontline44531206MERIALLIMITEDPAYTop-SpotandFrontlineSprayTreatment:DeflniliveShortTermandIntennediate-TennResidentialNon-DietaryRiskAssessment:LabProjectNumber:FIPRONIL98-04:MEIUAL-445-NDRA.UnpublishedstudypreparedbyNovigellSciences,Inc.35o.Polakoff,B.;Youngren,S:,Walls,C.(1998)FrontlineTop44531207MERIALLIMITEDPAYSpotandFrontlineSprayTreatment:DefinitivePetGroomerExposureAnalysisandRiskAssessmenl:LabProjectNumber:FIPRONIL98-07:MERIAL-445-LPERA.UnpublishedstudyIpreparedbyNovigenSciences,Inc.21p.Polakoff,B.;YOllngren,S.(1998)FrontlineonPetsina44531208MERlALLIMITEDPAYResidentialSelting:RiskAssessmentofaLowProbabilityEventPost-ApplicationAcuteExposure:LabProjectNumber:FIPRONIL98-06:MERIAL-445-PGRA.UnpublishedstudypreparedbvNovigenSciences,Inc.18p.Signature:J.?ffiIIdCJ!,J0IvNameandTitleDateKellyR.Hoskins,ManagerofTechnicalAffairs04112/2010EJ'AFormSS7()']S·971Elon;<""dP'n<1V",jAvail.bleSubmitonlvF'oe,ve"'M.A£.nev1"I.enalUseCOP,,0,.10,(,&UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.instructionandcompletingthenecessary£Onns_burdentoDirector:QPPEInformationManagementDivision(2137)U.S.MATRIXFoeCareProducts,Inc.S.W.,OLDOLD""UNITEDSTATESENVIRONMENTALPROTECTIONAGENCYooburdento401MStreet,S.W.perresponsetorregistrationactivitiesand0.25hourspcrresponseSendcommentsregardingtheburdenestimateoranyotheraspectofthiscollection(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washingtoll,DC-----'For,;'··A:-pprovrdOMIINo.I07{)..0060I''--'o•AL401MStreet,S.W •INGTON,D.C.•"""tVVAGENCY1isestimated10average025hoursperresponseforregistrationactivitiesand0.25hoursperresponseforin3eregislrationcomplelingthenecessaryforms.SendcommentsregardingtheburdenestimateoranyotheraspectofIhiscollectionburdentoDirector:OPPEInformationManagementDivision(2t37)U.s.EnvironmentalProtectionAgency,40tMStreet,S.W.,Washington,DCSuiteNE703PAYTechnicalUNITEDSTATESENVIRONMENTALPROTECTIONAGENCYo401MStreet,S.W.oW_perresponseforreadingthein4crcgistrationcornplctingthenecessaryforms.ScudcommentsregardingtheburdenestimateoranytheburdentoDirector:OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,40I MStreet,S.W.,1703PAY-PAY-PAYUNITEDSTATESENVIRONMENTALPROTECTIONAGENCYo401MStreet,S.W.oD.C.20460reviewreadingthetoDirector:u,s.DATASpot-OnPAYPAY"-,"--UNITEDSTATESENVIRONMENTALPROTECTIONAGENCYburdento•401MStreet,S.W.•wD.C.20460average0.25Il0Ursperresponseforregistrationactivitiesand0.25hoursperresponsein6eregistrationcompJetingthenecessaryfonns.Sendcommentsregardingtheburdenestimateoranyotheraspeetofthiscollection.OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DCPAY

# /,&"'0.,.",\**~ ~**  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



### \;

## ~it' Washington, D.C. 20460

" ",,,,,,<!""



### Wednesday, January 27, 2010

Certified Mail: (Article Number 7004-2890-0004-1896-4240)

opp 

### Decision Number: D-425453, D425454, D425455, D425437



### Registrant Name: Sergeant's Pet Care Products OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES



### Registrant Address: James Messina, Senior Managing Regulatory Consultant

Exponent



### Subject: Center for Chemical Regulation and Food Safety

1150 Connecticut Avenue, N.W.

Suite 1100

Washington, DC 20036

Data Deficiency

Product Name: Sergeant's Fipronil 

### + Methoprene Squeeze-on for Dogs,

Sergeant's Fipronil 

### + Mehoprene Squeeze-On for Cats, Sergeant's Fipronil

Squeeze-On for Dogs, Sergeant's Fipronil Spot-On for Cats

EPA File Symbol: 25l7-RGU, 25l7-RGL, 25l7-RGA, 25l7-RGT

Application Date:

EPA Receipt Date: 

### respectively_

December 21, 2009

December 22, 2009



### Dear Mr. Messina:

The Agency has received and begun its in-depth review of the subject application and has

determined that it is incomplete or that further information is needed. This letter is a written

notification ofthose deficiencies and identifies your options under 40 CFR 152.105 and Section

33 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), also known as the

Pesticide Registration Improvement Renewal Act (PRlA 

### 2). Your options under 40 CFR

152.105 and section 33 ofFIFRA are addressed separately because each involves a different

timeframe and set of options for responding to this letter. Please ensure that you consider each

of the sections below in detennining how and when you respond to this letter.

40 CFR 152.105:

Pursuant to 40 CFR 152.105, you are allowed 75 days from the date of this letter ending April

12, 

### iOlO to provide a response concerning the deficiencies listed in this letter. Your response

### may include making corrections or additions to complete the application, or notifying the

Agency of the date on which you expect to complete the application, or withdrawing your

application. If you do not respond to this letter within 75 days or if you respond with a date on

which you expect to complete the application but fail to meet that scheduled date, the Agency

will treat the application as if you had withdra\¥Il it. Withdrawal concludes the Agency's review

of your application. Any subsequent submission of the same application must then be submitted

as a new application with a new deadline for EPA to make a determination on your application

and subject to a new registration service fee.

The deficiencies identified in the Agency's review at this time are as follows:

1. The data matrices for the above referenced products are incomplete. You must revise

each data matrix by listing out specific MRID's (where applicable) and study title names that are

used to support each applicable guideline. Instructions for completing the EPA form 8570-35

data matrix correctly can be found within PR Notice 98-5. An electronic copy ofthis PR Notice

can be obtained at the following Agency web site:

http://www.epa.gov/opppmsdlIPR Notices/pr98-5.pdf.

2. The "Cite-all" option for product chemistry is inadequate. You cannot cite product

chemistry data, since Sergeant's Pet Care Products, Inc. is the formulator of the proposed

products. As a result, you must submit acceptable end use product chemistry data in accordance

with PR Notice 86-5. In 

### addition, you must revise the data matrix as outlined in #1 above to

reflect thi-s change.

3. In accordance with 40 CFR 

### § 152.34, the submitted Child Resistant Packaging (CRP)

self-certification is unacceptable for each product. The currently approved CRP data for the

referenced products listed on your 8570-1 form (block #6) are also not citable for purposes of

satisfying the data requirements outlined in 40 CFR 

### § 152.34. These CRP tests are product

package design specific and unrelated to your proposed package.

Further review of your application and your response to the deficiencies may identify

additional deficiencies and you will be so informed.

FIFRA Section 331PRIA:

This application is also subject to a deadline for making a determination on the application

under FIFRA Section 33, Pesticide Registration Service Fees, established under PRIA. The time

frame for.the Agency to make a determination on this application ends on April 12, 2010 and

you have the following three options:

1. Withdraw the application: 

### You may notify us not later than March 31, 2010 that

you are withdrawing your application. As noted 

### above, withdrawal concludes the

Agency's review of your application; however, you may resubmit your application

after the deficiencies have been addressed. Should you choose to resubmit your

application, it would be subject to a new deadline for making a determination on your

application and a new registration service fee.

- Since a fee was paid with this

application, the Agency will provide any applicable refund as soon as practicable.)



### 2. Not respond: If you do not respond or fail to provide (a revised data matrix,

acceptable product-specific chemistry data, and acceptable (CRP) data), on or before

April 12, 2010, the Agency 

### will administratively withdraw your application.

3. Correct application deficiencies: All acceptable data and data matrix as outlined

above must be submitted to the Agency on or before April 12, 2010. At that time, The

Agency 

### will fe-classify your applications from a R300 new product; me-too fast track, to

a 

### R31 0 new product; non-fast track. The Agency 

## will then request additional PRIA fees

accordingly, and processing 

### will not proceed until all the deficiencies are satisfied and

applicable PRIA fees are paid.

Please respond to this letter by 

### March 31. 2010 by contacting 

### Mr. Bonaventure Akinlosotu at

(703) 605-0653, or bye-mail at akinlostotu.bonaventure@epa.govduringthehoursof 7:00 am

to 4:00 pm EST with a response and for any questions concerning this letter. When submitting

infonnation or data in response to this letter, a copy of this letter should accompany the

submission to facilitate processing.



# ;vZcJ/UL

Richard 

### J. Gebken**Product~anager(IO)** 

### Insecticide Branch

Registration Division (7505P)

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

Washington, D.C. 20460

Wednesday, January 27,2010

Certified Mail: (Article Number 7004-2890-0004-1896-4240)



### opp Decision Number: D-425453, D425454, D425455, D425437



### Registrant Name: Sergeant's Pet Care Products OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES



### Registrant Address: James Messina, Senior Managing Regulatory Consultant

Exponent



### Subject: Center for Chemical Regulation and Food Safety

1150 Connecticut Avenue, N.W.

Suite 1100

Washington, DC 20036

Data Deficiency



### Product Name: Sergeant's Fipronil 

## + Methoprene Squeeze-on for Dogs,

Sergeant's Fipronil 

### + Mehoprene Squeeze-On for Cats, Sergeant's Fipronil

Squeeze-On for Dogs, Sergeant's Fipronil Spot-On for Cats

EPA File Symbol: 25 I 7-RGU, 2517-RGL, 2517-RGA, 2517-RGT

respectively.

Application Date: December 21, 2009

EPA Receipt Date: December 22, 2009

Dear 

### Mr. Messina:

The Agency has received and begun its in-depth review of the subject application and has

detennined that it is incomplete or that further information is needed. This letter is a written

notification of those deficiencies and identifies your options under 

### 40 CFR 152.105 and Section

33 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), also known as the

Pesticide Registration Improvement Renewal Act (PRIA2). Your options under 40 CFR

152.105 and section 33 ofFIFRA are addressed separately because each involves a different

timeframe and set of options for responding to this letter. Please ensure that you consider each

of the sections below in determining how and when you respond to this letter.

40 CFR 152.105:

Pursuant to 40 CFR 152.105, you are allowed 75 days from the date of this letter ending 

### April

12,2010 to provide a response concerning the deficiencies listed 

### in this letter. Your response

### may include making corrections or additions to complete the application, or notifying the

Agency ofthe date on which you expect to complete the application, or withdrawing your

application. If you do not respond to 

### this letter within 75 days or if you respond with a date on

which you expect to complete the application but fail to meet that scheduled date, the Agency

will treat the application as if you had withdrawn it. Withdrawal concludes the Agency's review

of your application. Any subsequent submission of the same application must then be submitted

as a new application with a new deadline for EPA to make a detennination on your application

and subject to a new registration service fee.

The deficiencies identified in the Agency's review at this time are as follows:

1. The data matrices for the above referenced products are incomplete. You must revise

each data matrix by listing out specific MRID's (where applicable) and study title names that are

used to support each applicable guideline. Instructions for completing the EPA form 8570-35

data matrix correctly can be found within PR Notice 98-5. An electronic copy of this PR Notice

can be obtained at the following Agency web site:

http://www.epa.gov/opppmsdIIPR Notices/pr98-5.pdf.

2. The "Cite-all" option for product chemistry is inadequate. You cannot cite product

chemistry data, since Sergeant's Pet Care Products, Inc. is the formulator of the proposed

products. As a result, you must submit acceptable end use product chemistry data in accordance

with PR Notice 86-5. In addition, you must revise the data matrix as outlined in #1 above to

reflect this change.

3. In accordance 

### with 40 CFR 

### § 152.34, the submitted Child Resistant Packaging (CRP)

self-certification is unacceptable for each product. The currently approved CRP data for the

referenced products listed on your 8570-1 form (block #6) are also not citable for purposes of

satisfying the data requirements outlined in 40 CFR 

### § 152.34. These CRP tests are product

package design specific and unrelated to your proposed package.

Further review of your application and your response to the deficiencies may identify

additional deficiencies and you will be so infonned.

FIFRA Section 

### 33/PRlA:

This application is also subject to a deadline for making a determination on the application

under FIFRA Section 33, Pesticide Registration Service Fees, established under PRIA. The time

frame for the Agency to make a determination on this application ends on April 12, 2010 and

you have the following three options:

1. Withdraw the application: You may notify us not later than March 31,2010 that

you are withdrawing your application. As noted above, withdrawal concludes the

Agency's review of your application; however, you may resubmit your application

after the defIciencies have been addressed. Should you choose to resubmit your

application, it would be subject to a new deadline for making a detennination on your

application and a new registration service fee.

- Since a fee was paid 'With this

application, the Agency will provide any applicable refund as soon as practicable.

## )

2. Not respond: If you do not respond or fail to provide (a revised data matrix,

acceptable product-specific chemistry data, and acceptable (CRP) data), on or before

April 12, 2010, the Agency will administratively withdraw your application.

3. Correct application deficiencies: All acceptable data and data matrix as outlined

above must be submitted to the Agency on or before April 12, 2010. At that time, The

Agency will re-classify your applications from a R300 new product; me-too fast track, to

a R310 new product; non-fast track. The Agency will then request additional PRIA fees

accordingly, and processing will not proceed until all the deficiencies are satisfied and

applicable PRIA fees are paid.

Please respond to this letter by March 31, 2010 by contacting Mr. Bonaventure Akinlosotu at

(703) 605-0653, or bye-mail at akinlostotu.bonaventure@epa.govduringthehoursof 7:00 am

to 

### 4:00 pm EST with a response and for any questions concerning this letter. When submitting

information or data in response to this letter, a copy of this letter should accompany the

submission to facilitate processing.

# ~wL

Richard J. Gebken

Product Manager (10)

Insecticide Branch

Registration Division (7505P)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460



### December 31, 2009

opp 

### Decision Number: D-425437

EPA File Symbol or Registration Number: 2517-RGT

Product Name: SERGEANT'S FIPRONIL SPOT-ON FOR CATS

EPA Receipt Date: 22-Dec-2009

EPA Company Number: 2517

Company Name: SERGEANT'S PET CARE PRODUCTS, INC.

KELLY R. HOSKINS

SERGEANT'S PET CARE PRODUCTS, INC.

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158TH PLAZA

OMAHA, NE 68130-1703 OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



### 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 of the PRN-86-5 screen will be

communicated 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: R300

NEW PRODUCT;ME-TOO PRODUCT FAST TRACK;

No additional payment is due at this time.

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

Ombudsman at (703) 305-6249.

Sincerely,

Front

### E.~!'f5~;;;; In matio esources Management Division

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

2625 SOllth 158th Plaza • Omaha. NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7099 • www.sergeants.com

December 21,2009

Richard Gebken, PM I 0

Office of Pesticide Programs (7504P) (REGFEE)

U.S. Environmental Protection Agency

Document Processing Desk

Room S-4900, One Potomac Yard

2777 Soutb Crystal Drive

Al'lington, V A 22202

Subject: Sergeant's Fipronil**Spot~On** for Cats

EPA File Symbol 2517-NEW

Dear Mr. Gebken:

Sergeant's Pet Care Products, Inc. (Sergeants, EPA Company Number 2517) is submitting a

"me-too" EPA registration application for the new product Sergeant's Fipronil Only Spot-On for

Cats (containing the EPA registered active ingredient Fipronil (9.7%»). Please find enclosed the

following documentation in support of this registration:

(1) Application for Pesticide Fonn (8570-1);

(2) Certification with Respect to Citntion of Data Fonn (8570-34);

(3) Fonnulator's Exemption Statement Fonn (8570-27);

(4) Data Matrix Fonn (8570-35)

- EPA and Public Versions;

(5) Confidential Statement ofFonnula (two copies);

(6) Product Label (five copies);

(7) PRIA category R300, Payment Confinnation Receipt; and

(8) Letter of Authorization.

Sergeant's Fipronil Only**Spot~On** for Cats is substantially similar to Merial Limited's EPA

registered product Frontline Top Spot for Cats (EPA Registration # 65331-2). Sergeant's has

submitted offer to pay letters to all data submitters listed on the enclosed data matrix.



### , We look forward to working with the Agency to register this "me-too" product.

questions, please contact me at 402-938-7079. If you have an)}" r',

Sincerely,

# /~)[/-&L

Kelly R. Hoskins

Manager of Technical Affairs

Enclosures 

### , , " 

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### ,PI**ea.~e** rea dl I r tiS rue Ions on reverse I !' e ore comp e IfIg arm. F o,m A pprove d OMBN 2000060 A o. 7 - pproval eXpires 05 98 ·3t-



### I United States

### ~ Registration opp Identilier Number 

# EPA

Environmental Protection Agency 

# o Amendment

Washing lon, DC 20460 

# o Other

Application for Pesticide

- Section I

t.**COmpanYfPrOdUC~6~** 2. EPA Product Manager 3. Proposed Classification

2517·NEW Richard Gebken

4, CompanyfProduct (Name)

Selqeanl's Fipronil Spol-On For Cats PM# 

### to

### ~None DRestrieted

5. Name and Address of Applicant (Incl(lde ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3)(O)(I), my

Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling 10:

2625 South 1SS/h Plaza

Omaha, NE 68130 EPA Reg, No. 6533t·2

Product Name FRONTLINE TOPSPOT FOR CATS



# o

Check if Ihis is a new address

Section II 

# o

Amendment· Explain below. 

# o

Final printed labels in response to Agency letter dated XX-XX·XX 

# o

Resubmission in response 10 Agency letter dated XX·XX·XX

### .~ "Me Too" Application 

# I IS

NotilicaUon· Explain below. 

# o

Other· Explain below.

Explanalion; Use additional page(s) II necessary. (For section I and Section II.)

Submission of a new end·use regislration applicalion,

Section III

Yteterial This Product Will Be Packaqed In:**~,did·Resistant** Packaging Unit PaCkaging Water Soluble Packaging 2. Type 01 Container



### fZ] Yes' 

### [2J Yes

## ~Y" 

# o

Metal

ONo 

# o No No 

### [8J Plastic

II ''Yes'' No. per II "Yes' No. per OGlass ·Certification must Unit Packaging wgt, Conlainer Packagewgt. Contruner

DPaper be submitted 0.017 n oz (0.50mli 2,3,4,6 

## I OOther (Specify) PlasHc BaQ

3. Location of Net Contents InlormaHon 4. $i2e(s) Retail Container 5 Location ot Label Directions

cg)Label D Container 0.0 t7 n oz (0.50ml) DOn Can

DOn Labeling accompanying product

6. Manner in Which Label is Atlixed 10 Produci DUlhograph !ZJOlher

OPaper glued

DStenciled



# - Section IV 

### '**~** 

# ....

,

!. Contacl Point (Comolele ilems directly below for identification of individual 10 be confacted. if necessatY. 10 orocess Ihis aoolicalion. "';'_



# --

Name Tille Tetephone No, (InClude'AreaCode)

Kelly R. HOSkins Manager 01 Technical Attairs : ' ,**:1d?~938·** 7079 

### ,

.>---'---

Certification >,)

. R, Date**J,pp1i"'~jion**

I certtly that Ihe slatements I have madB on this torm and all allachments Ihereto ale tlue. accurate and**com~ete.** I 

### , Recei¥Ejd

'- 

### , acknowledge that any knowingly talse or misleading statement may be punishable by tine or imprisonment or bolh '"'



### - 

## -**(Stg:mp.e~u)** under appticable law. ,

.-,,",,-. , , 2 Signature 3. Title , > , ,

# /{;'A./&~ , , BY: Manager ot Techn'lcal Atlairs , , , >



### , "

TiPed Name: / 5, Date: t2f21f2009



## - , ,

, 

### , , 

### ,

I j Kelly R. Hoskins

### ) Pay.gov

- Online Payment Page 1 of 1

Online**_~~¥~~_I1~ _~**  Step 3: Confirm Payment 

### 1 

## 1213

Thank you.

Your transaction has been successfully completed.

Pay.gov Tracking Information

Application Name: PRIA SeNice Fees

Pay.gov Tracking 10: 2505HOCT

Agency Tracking 10: 74094010782

Transaction Date and Time: 12121f2009 11:51 EST

Payment Summary

Payment Date: 12f22f2009

Decision Number: Account Holder Name: Sergeants Pet Care Products

Payment Amount: $1.365.00

Account Type: Business Checking Registration Number:

Routing Number:

Account Number: **·"*5483 Company Name: Sergeants Pet Care Produc

Company Number: 2517

Action Code: R300

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. .:h'lrd Cn.:bken

PIWIUCl f\dantlgcr 12

D(lCLl!11ent Pnlcessing Desk

Office or Pcs(ieiuc PrognlillS

I;.S. Environmental Prntection Agl'IWY

Room S-4900. One Polomac YnrJ

-::'777 SOU1h Cryslul Dm'(;

Arling,t(ll1. VA 22202-4)01

Scrgellllt's Pel Cnre Products, Inc. (S(;rger1)ll·s. 2()25 Sllulh I)S'" Plaza. Omuhn. Nebrllsbl

681 :10-1770, EPA Company Number 2517), i1ullwrizes F:xpollcnt, Inc. (1150 Connecticlll

Avenue, NW. Suitc II 00, Washmgton DC. 20(36) to act on ollr bclHll( liS ollr

A urhorized R eprescl1Jativc, f(lr all necessary i nlenlc(i ons rega rdi ng ill I (I 

## r our pmduc(

registrn1ion applications nnd n:gistnHiulls. PlcHSC ]lo!c this doo..:s nol change the o..:UITCIll

flied Authorized Agent for Scrgeant"s.

The Ex-polltnl, Illc. conine! i" rlS t()llmvs:



### Cc: J::unts Messina ,-lI1d;or Rick Tillsworth

Exponent. Inc.

! 15(1 C'onnec!iclI{ Ave., NW

Sui(e I I DO

Washington, DC 20036

(202) 772-4932

(1(2) 772-4079 fnx

jill e..,SI11iJr(/, ex p(ll1en\.CC'lll. 1'1 i ns\V( lr!!1(U:C:\pl '1Ie!l\. cdn;

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

262S Soulh 1581h Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402,938.7091 • www.sergeanls.com

December21,2009

Richard Gebken, PMlO

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Documen t Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Child Resistant Packaging Certification

Dear Mr. Gebken:

Sergeant's Pet Care Products, Inc. certifies that the packaging used in the manufacture of the

following products:

• Sergeant's Fipronil Spot-On for Dogs;

• Sergean1'5 Fipronil Spot-On for Cats:

• Sergeant's Fipronil 

### + S-methoprene Spot-On for Dogs; and

• Sergeant's Fipronil 

### + S-methoprene Spot-On for Cats.

meets the standards of 40 CFR 157.32, including the revised standards in 16 CFR 1700.15(b).

All product labels have language specifying the use of scissors to open the product container and

label language stating the product is not to be applied by children. In addition, Sergeant's is in

discussion with approved CRP testing labs to develop a protocol per the revised testing

procedures in 16 CFR 1700.20.

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

Sincerely,



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Manager of Technical Affairs

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,Form approved. OMS No. 2070-0060, 2070_0057, 2070·0107, 2070-0122, 2070-0164.



# &EPA

United States i

Environmental Protection Agency

Washington, DC 20460

Formulator's Exemption Statement

(40 CFR 152.85)

Applicant's Name and Address EPA Fila SymboVRegisfration Number

Sergeant's Pet Care Products, Inc. 2517-NEW

2625 South I 58th Plaza Product Name

Omaha, NE 68130 Sergeant's Fipronil Spot-On for Cats

Date of Confidential Statement of Formula (EPA Form 8S70-4)

12/2112009

As an aulhorized representative of the applicant for regislralion of the product idenlified above, I certify that

(1) This product contains the following aclive ingredie01(s):

Fipronil (9.7%)

(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.

formulation or repackagl ng anolher product which contains thaf acnve 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(a)(2) or (3).

(3) Indicate by checking (A) or (8) below which paragraph applies:

)

01 (A) An accurate Confidenfial Statement of Formula (EPA FORM 8570.4) for tha abova idantified product is allached to this statement

That formula statement inOlcateS, by company name, registration number, and product name, tha source of the active ingredient(s) listed in

paragraph (1).

OR



# , (8) The Confidential Statement of Formula (CSF)(EPA Form 8570·4) referenced above and on file with the EPA is comptete. current, eo

accurate and contains the intormation required on the CUrrent CSF.

(4) The following active ingredients in this product quatify for the formulator's exemption.

Source

Activa fngredient ProduC1 Name Registration NUmber



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### , Kelly R. Hoskins, Manager orTechnical Affairs 12/2112009

, 

### "**~~~** EPA FOf"!l8570.27 (Rev. 06-2004) Copy1_EPA""

Copy 2 - Applicant copyForm Approved OMS Nos. 2070·0060; 2070·0057', 2070.(11 07: 2070·0122: 2070-0t64



# II "';,.

.... , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### \!!Zl

1200 Pennsylvania Avenue, N.W •

. 

# "



# -

WASHINGTON, D.C. 20460

Paperwork Reduclion ACI NOIic,,: The pUblic reporting burden for lhis collectinn of infonn.l;on ;s eSlimaled 10 avemgc 1,25 bows pcr response for registralion

and 025 hoors per response for reregistrBlion nnd**sp"d~1** review aClivilies, includiogtime for reading the instruClions and completing Ihe necessary forms. Send

co:nmenlS rtgarding bunien estimale or any Olher aspcci oflhis collection ofinforrnalion, including suggestions for reducing Ihe bunitnlO: Dlfeclor, Colleclion

Strategies Division (2822T). U,S. Environmentat Proleclion AgenCy. t200 Pennsytvania AverlJe. N.W., Washington, DC 20460. 00 nol send the compteled fonn

to lhis address,

Certification with Respect to Citation of Data

Appllcanl'siReqistranl's Name. Address. and Telephone Number EPA Reqistration NumberfFile Symbol

Sergeant's Pet Care Products, Inc., 2625 South f58th Plaza, Omaha, NE 68130 2517-NEW

Active Inoredl!;lnt(s) andfor reoresenlative test comooundfs) Date

Fipronil t212112009

General Use Pattem(s) (ist all those claimed for this product usinq 40 CFR Part (58) PrOduct Name

Indoor non·food Sergeant's Fipronil Spot-On for Cals

NOTE: If your producl is a 100% repackagirtg of another purchased EPA'registered prrnjuct labeled for all the same uses on your label, you do not need to

submit this form. You must submit the Fonnula\or's EXemption Statement (EPA Form 8570·27).



# 0 I am responding to a Oata·Call-ln Nolice, and have incfuded wjlh this form a lisl of companies sent offers of compensation (the Data Matrix form should

be used for this purpose),

SECTtON); METHOD OF DATA SUPPORT (Check one method only)



# 0 I am using the Cite-all melhod of support. and hava included with this form 

# 0 t am us'mg the**se~cUve** method of support (or cite·all oplion

a (isl of companies sent offers of compensation (Ihe Data Matrix form under the selective melhod). and have included with this form a

should be USed for Ihis purpose)_ completed list of data requirements (the Data Matrix form must be

used).



# , SECTlON II: GENERAL OFFER TO PAY

IRequired if using the cite-all method or when using Ihe cite-all option under the selective methOd to satisfy one or more data requirementsl 

# 0 I hereby offer and agree 10 pay compensalion. to other persons, W·,th regard to the approvat of this applicatiOn, to the eJrtent required by FIFAA.

SECT[ON ttl: CERTIFICATfON

I certify that this application for regislration. this form for**reregi5tra~On,** or Ihis Data-Call·ln response is supporte-d by all data SUbmitted or c1(ed in the

application for**registra~on,** the form for reregistratiOn, or the Dala-CalHn response. In addition, if the clte-al option or cite-all option under the seleclive malhod is

indicaled in Section I. this application is supported by all data in Ihe Agency's f'les that (1) cOncern the properties or effects of Ihis product or an identical or

substanUally similar prOducl. or One or more of the ingredients in this prcduct; and (2) IS a type of data lhat would be required to be submitted under the data

requirements in effect on the date of approval of this application if the applicalion soughllhe initial registration of a product ot idenUcal or similar composilion and

uses.

I certify that for eaCh eXClusive use study died in support of thiS regislration or reregistration, thai I am the original data submitter or that t have obtained

lhe written permission of the original dala SUbmitter to cite that study.

> > , > > > , ,

I certify that for each stutJy dted in support of Ihis registralion or reregistratiOn that is not an exclusive use stUdY, either: (a) I am the original /Jala

submitter: (b) I have obtained the permission of the original data submitter to use Ihe study in support of this applicalion; (c) all periods of eligibirlly for>

, 

### , compensat"lon have expired lor the study; (d) the study is in (he pubrlC literature; or (e) I have notified in writing the company that submitted Ihe sludy add**h~aYf\** '

offered (I) to pay compensation to the**e~tent** required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFAA: and (ii) to commence**negotia~ons** 10 determirte the

amount and lerms of compensation, if any. to be paid for the use of the study.**~** , > ; , ; >



### , " >

> 

### , , I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and**evidell~~bi** lh.:lir deliv€;l'y in > •

accordancewilh sections 3(c)(t )(F) and/or 3(c)(2)(B) of FIFRA are available and WIll be subm'llIed to the Agency upon request Should! fll!l (0 prodUt,e,suci'.

evidence to the Agency upon request, t undersland that the Agency may initiale action to deny, cancel or suspend Ihe registralion of 1JIi' 9r9,-/uct in conjon-OilY,With**~~** 

# . .

, " " >

I certIfy that\he statements t have made on this form and all attachments to it are true, accurate, artd complete. t acknowledge**~lia(Jr;Y,** knowingly false or misteadlng statement may be punlshabte by fine or imprisonment or both under applicable law.

, , 

# . "



### , "

# lA::A-'A/~ Date Typed or Printed Name and Title 

## ,;-:7rt2f2 (/2009 Kelly R Hoskins, Manager of Technical Affairs

EPA Form 8570-3.('(12·2003) Electronic and Paper versions available. Submit only Paper version.I'ormAppro>'«lOM8No.UNITEDSTATESENVIRONMENTALPROTEcnONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460Paper\yorkReductionAetNoticc:ThepublicreportingburdenforthiScollectionofinform:uioniscstimMedtohoursperresponscforregiSlrll1ionndivities<'nd0.25hourspcrresponseforreregistmlionpndspecialreview"elivitie.,inctudillgtimeforreattingtheinstructioncompletingthenecessaryforms.SendcommentsregardingIheburdenestimateoranyotheraspectofthiscoUeclionofinformot'lOn.includingsuggcstio",forreducingIhehurdcntoD'lreclor.OPPEInformalinnManagClncnlDivi,ion(2137)U.S.E"vironmcnt.tPmlccfmnAgcncy.MSI=I.S.W..Wash;non.DC20460.Donotsendtheform10thisnddrcss.DATAMATRIXDate:12121/2009EPAReNo.lFIleSmbol:2517·NEWPae10t3Appticanl's/Registrant'sName&Address:Sergeant'sPetCareProducts,IncProduct:Sergeanl'sFlpronitOnlySpot-OntorCats2625South1S81hPlaza,Omaha.NE68t30-1703Ingredient:FipronilGuidelineRelerenceGuidelineStudyNameMRIDNumberSUbmitterStatusNoteNumberCile·allSyngenlaCropProtection,Inc(#100)POBoxt8300Greensboro,NC27419Cile-allSayerCropScienceLP(#264)2T.W.AlexanderDriveResearchTrianglePark,NC27709Cite-allBayerEnvironmentalScience(#432)POBox12014ResearchTrianqlePark,NC27709Cite-allReckitlBenckisertnc(#3282)MorrisCorporateCenterIV399InterpaceParkWayParsiDDan,NJ07054Cite-allJ.J.MaugetCo.(#7946)t2733Director'sLoopWoodbrid!=le,VA22192Cile-allBASFCorporation(#7969)AgriculturalProduclsPOBox13528ResearchTrianqtePark,NC27709S-Ignalure----:NameandTitleOm,1212t12009KeltyR.Hoskins.Manager01TechnicalAUairs,,,,."....".Q7\VN,.._A=;t,",.,.,hm;'•.en'.'n'"".o'])...('On.w.,WA!'o<m(9.9()EI""o""""dP'P'"""iI,"kU"1y1'>1""'''''''"In"rno<U""COI'Y•UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.pcrrcsponscillslruolionandcompletingIhenecessaryforrm.SendcommentsregilrdingIheburdenestimateornnyrnhe!ofthisDirector.OPPEInformationMnnagemen!Division(2137)U.S.Ellviron1llentnlPrOiectionAgency,401MStreet,S.W.>68130-1703Product:Sergeanf'sFipronilOnlySpol·OnforCalsDivision....,'-"'''"....POBox••5903Genoa-RedPasadena,TX7750776162em"UNrfEDSTATESENVIRONMENTALPROTECTIONAGENCY12121/2009Fer.,OMBNc.""W.401MStreet,S.W.WASHINGTON,D.C.20460PaperworkRcduc(ionAc(Notice:ThepublicreportingbutdcnforthiscollectionofinformutiOnise,(imatedtoavcmge0,25hoursperresponseforregislJ-alionactivitiesuntl0.25hourspcrreoponseforrCll)gistrmionunrlspeciulrevicwac(ivities,including(imeforreadingtheinstructionandcnmpleting(hcnccess;uyform<.Sendcoutmcn(sregardingburdenes(imatcoranyotheraspectof(hisCOllCClionofinformatiOn,including';UgJ:estionsforreducingtheburdentoDirec(or:OPPEInformationMonagemcUlDivision(2137)U.S.EnviromnentalProtectionAgcncy,401M5tree(,S,W"Washington.DC20460.Donctsend(hcform(0(hisaddress.DATAMATRIXDate:t2/21f2009EPAReNo.lFiteSmbot:25t7-NEWPa3013Applicant's/Registrant'sName&Address:Sergeant'sPelCareProducts,IncProduct:Sergeant'sFipronilOnlySpot-OnlorCats2625Southt581hPlaza,Omaha.NE68t30-1703Inredient:GuidelineRelerenceGuidelinaStudyNameMRIDNumberSubmitterStatusNoteNumberCite-allOutdoorResidentialExposureTaskForce(#71754)1350tStreet,N.W.Washi,!!gton,DC20005Cite-allAgriCulturalReentryTaskForce(#71755)1350IStreet,N.W.WashinQton,DC20005Cite-allAmbrands(#73342)118Y..EastMainStreet,Suite1Salem,VA24153Cite-allInnovativePeslControlProducts(#73766)POBox880216BocaRaton,FL33488Cite-allFIFRAEndangeredSpeCiesTaskForce(#73989)CIOHaroldHimmelman(Beveridge&Diamond)1350IStreet,NWWashi.rlgton,DC20005Cite-allResidentialExposureJointVenture(#74888)90017'hStreet,NW,Suite300,Washi!!91on,DC20006Cite-allAgriculturalHandlersExposureTaskForce(#75234)POBox509,.''':LMacon,MO63552-,.NameandTilleDateKellyR.Hoskins.Manager01TechnicalAffairs12121/2009ft-forrcregi>trationandcollectionofinfonnalion,'"."•,UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W."thiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponsereadingtheinstructionandcompletingthellCCesSaryforms.SendcommentsregardingtheburdenestimateoranyotheraspectofthistheburdentoDirector'OPPEInfonna!ionManagementDivision(2137)U.S_EnvironmentalProtectionAgency,401MStreet,S.W.>Product:Sergeant'sFipronilOnlySpot-OnforCats12/2112009ftProducts,IncUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY•401MStreet,S.W.0.25hours perresponseforregistrationactivitiesand0.25hours perresponscforreadingtheinstructionandcompletingthenecessaryforms.SendcommentsregardingtheburdenestimateoranyotheraspectofthistheburdentoDirector:QPPEInformationManagementDivision(2137)U_S.EnvironmentalProtectionAgency,401MStreet,S.W.,Product:Sergeant'sFipronilOnlySpot-OnforCats.""Corp500,LOC1068Dme1212112009UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W..ThepublicreportingburdenforIhiscollectionofinformarionisestimaledtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponsereviewactivities,includingtimeforreadingtheinstructionandcompletingthenecessaryforms.SendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionsuggestionsforreducillgIheburdentoDirector",OPPEInformalionManagementDivision(2131)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.•Washington,DClocNE68130-1703Sergeant'sFipronilOnlySpot-OnforCats(#73989)C/OHaroldHimmelman(Beveridge&Diamond)1350Istreet,NW:":';,'::::"""300,KellyRManage!ofTechnicalAffairs12/21/2009

# Sergeant's Master Label t-c,/

21 December 2009 EPA Submission

Infonnation in [ [is optional. Page 1 of7 EPA No. 2517-XX

21 December 2009



### FRONT PANEL CAT 

# SPOT ON 

# JliPRON:!L

[Optional text appears in brackets

- the final label may include some or all of the optional text on

front, back or side label panels]



## Sergeant's Fipronil Spot-On for Cats

[ABNsJ

[(Sergeant's) (Sentry) Frontspot (Spot On) for cats (and kittens)J

[(Sergeant's) (Sentry) Firstline (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) Frontedge (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) VetSpot (Spot On) for cats (and kittens)J

[(Sergeant's) (Sentry) Frontguard (Spot On) for cats (and kittens)1

[(Sergeant's) (Sentry) Frontier Gold (Spot On) for cats (and kittens)J

[(Sergeant's) (Sentry) Frontpronil (Spot On) for cats (and kittens)J

[(Sergeant's) (Sentry) Fiproline (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) Ectoadvance (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) Gold FrontSpot (Spot On) for cats (and kittens)J

[SentryProline (Spot On) for cats (and kittens)J

[SentryVet (Spot On) for cats (and kittens)J

[Mosquitoes]

[. [Kills [and] [&] [Repels] mosquitoes] [within 24 hours]

[- Kills ([and] [&] 

### repels) mosquitoes that may transmit heartwonn]

[Adult Fleas]

[- Kills adult fleas [for up to six weeks]]

[-Kills [and repels] fleas, source of flea allergy dermatitis] [, flea bite anemia]

[and tapewonn infestations]

[- If cat is a high risk for flea reinfestation a once a month application may be

needed]

[. Kills [&J [and] [Repels] Fleas [Up to 4 weeksJ [I month] [30 days:J!j:': , , , , , , > •



### , "



### , 

### "

,

, 

### "

"



# . ,"L>,> '" 

### [Ticks J '" ' '"

[-Kills [and] 

### [&] [repels] ticks including those that may transmit**Lyme>d:..sease]~** 

### • >,'



### [. Kills [and] [&] [Repels J Ticks for Up to [4 weeks] [I month] [30 

## d",<j'!]

, [. Kills [and] [&] [repels] [all stages of] Deer Ticks [before they can] [that]

,,,,

, , , , 

### [transmit Lyme Disease,] for up to 

### [4 weeks] [I monthJ [30 daysJ] , "

[. Kills [and] [&] [repels] Ticks (Including Deer Ticks) for up to [4 weeks] [I ',:,,'

month] [30 days]]

[. Kills [andJ [&] [repelsJ [Brown], [American,] [and Lone Star ]Dog Ticks

[(Rhipicephalus sanguineus)] 

### for up to [4 weeksJ [I month] [30 days]J

[. Kills [&] [andJ [Repels] American Dog Ticks [(Dermacentor variabilis)] 

### for up

to [4 weeks] [I month] [30 daysJ']

### ) 

# Sergeant's Master Label

21 December 2009 EPA Submission

Informalion in 

### I I is optional. Page 2 of7 EPA No. 2517-XX

21 December 2009



### FRONT PANEL

. CAT SPO;rON 

# FIPRQNIL

[Multiple Infestations]

[-Kills [chewing] lice and controls sarcoptic mange]

[. Flea 

### [&] [and] Tick Control for Cats 

### [&] [and] Kittens 8 weeks old and older]

[·Kills [and] 

### [&] [repels] fleas, ticks, chewing lice 

### [&] [and] mosquitoes]

[·Kills [and] 

### [&] [repels] fleas, ticks, mosquitoes, and (chewing) lice]

[-Monthly flea, tick, mosquito, and (chewing) lice protection]

[. [Four] [4] Way Protection [Kills fleas, ticks, mosquitoes, and (chewing) lice]

[. [4 Week] [I month] [lD day] [Flea and Tick [&] [and] Treatment]

[. [Four (4) Week] [1 month] [10 day] [Flea Tick, Mosquito and Lice Control]

[Once A Month Flea and Tick Treatment]

[-Use [brand name] monthly to control ticks and chewing lice]

[-Monthly flea, tick, mosquito, and chewing lice protection.]

[. Kills [&] [and] Repels Fleas and Ticks for up to [4 weeks] [ 1 month] [10

days]!]

[(Brand Name) provides convenient and effective flea, tick, chewing lice and

mosquito control for cats and kittens.]

[All Others]

[-For Cats and Kittens 8 weeks of age or older]

[-Controls Sarcoptic Mange [infestations]]

[-Cats can be bathed 24 hours after treatment]

[·Waterproof]

[·Fast Acting]

[·Long Lasting]

[-Once month treatment recommended]

[-A once monthly application is recommended for chewing lice.]

, , [-Fast Action against [chewing] lice infestations] : ••**~,.** 

### [- Three Applications {for cartons with 3 applicators}] and/or [3 Month SupplyJ', '.

or [12 Week Supply] """ ':'

[- Four Applications {for cartons with 4 applicators}] and/or [4 Month .:supply] AT

, [16 Week Supply]**"~n;** 

### ;**~.,"** 

### [. Six Applications {for cartons with 6 applicators}] andlor [6 Month Supply] clr', "



### [24 Week Supply]**~:_:::,** 

### ':'

[- Best if used year round!]

, , , , [. (ICON Showing 4 Week Protection)] ""

[. 4 Week Dose!] : ,",

[·1 Month Dose!]

[·10 day dose!]

[. Easy to Use [Application]]

[- Specially Formulated for Cats and Kittens]

[. [Free] Calendar Stickers Inside!]

[- [Free] Brochure Inside!]

[- [Free] Brochure and Calendar Stickers Inside]

[. Apply once every [4 weeks] [month] [lD days]!]

[- Cats can be bathed 24 hours after spot-on is applied] , , > ,

# Sergeant's Master Label

21 December 2009 EPA Submission

1nfonnation in 

### I I is optional. Page 3 of7 EPA No. 2517-XX

2! December 2009



### FRONT PANEL CAT SPOT ON

FIPRONIL

[-Can be used on breeding, pregnant and lactating [queens], [female cats]]

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

[clip] [insert] [inside]

[-Can be used on kittens 8 weeks of age and older

[-Monthly application reminder card inside]

[optional graphics: picture of all controlled pests with line through them]

[ingredient statement may appear on front label or back label]



### ACTIVE INGREDIENTS:

Fipronil

.................................................. 9.7%



### INERT INGREDIENTS

.................... 9o.3%

TOTAL 100.0%

KEEP OUT OF REACH OF CHILDREN

CAUTION

See [Side] [or] [Back] Panel For Additional Precautionary Statements



### NET CONTENTS:

One ITwo][Three] [Four] [Six] 0.017 fl 

### oz 

### (O.SOml) applicators



### {END

- FRONT PANEL}

, >" " ,



### • 

### ••

• •

)) , 

### , , • "



### , )) 

### , 

# . , • > , • >



### • 

### "



# . ,. 

# . · "

"

, 

## ., 

# . · "



# ... •• 

### • 

# ·

..

'"



### , '"



### , 

# ·

.. ·



# .

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### ,

# Sergeant's Master Label

21 December 2009 EPA Submission

Informal Ion in [ 

### I is optional. Page 4 of7



### BACKPANEL EPA No. 2517-XX

21 December 2009



### [brand nameJ contains Fipronil to effectively kill [and repelJ fleas and ticks [(including

those that may transmit Lyme Disease)]. The active ingredient in [brand name] works by

collecting in the hair follicles and skin oils. This product features a sustained-release

fonnula that discharges from the animal's hair follicles using the natural skin oils,

resulting in fast-acting [and 10ng-lastingJ control of fleas, ticks, mosquitoes and chewing

lice [for 30 days].

[diagram with 

### visual offipronil collecting and being released from hair follicle]

READ ENTIRE LABEL BEFORE EACH USE

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS. CAUTION. Harmful if swallowed. Causes eye irritation.

A void contact with skin, eyes or clothing. Wash thoroughly with soap and water after

handling.

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

under 8 weeks of age. Individual sensitivities, while rare, may occur after using any

pesticide product. Pets may experience some temporary irritation at the site of product

applications. If signs persist, or become more severe within a few days of application,

consult a veterinarian immediately. Certain medications can interact with pesticides.

Consult a veterinarian before using on medicated, debilitated or aged animals. Call 1-

800·224·PETS [7387] for 24·hour assistance.

PHYSICAL OR CHEMICAL HAZARDS**FLAMMABLE~** 

### Keep away from heat 

### and open flame

FIRST AID

If swallowed Call a poison control center for a doctor immediately for treatment**~p.v,i~~.** 

### Have person sip a glass of water if able to swallow. Do not induce:.

vomiting unless told to do so by a poison control center or doctor. :Do;'0t

give anything by mouth to an unconscious person. '



### ,., , 

### "



## ,

, , 

## ,



# . . " , 

### If in eyes Hold eye open and rinse slowly and gently with water flJT>16:QO**m~hute-8~** 

### , 

# . Remove contact lenses, if present, after the first 5 minutes, 'then**couti,nl1~** 

### rinsing eye. Call a poison control center or doctor for**t{~f.{tll)cnt** 

### advice."

If on skin Wash with plenty of soap and water. Get medical attention if '



## , '"

, 

## , irritation persists. ' > , ,

'-'7- 

### • 

# . , HOTLINE NUMBER '



### ,**~.'**



### Have the product container or label with 

### you when calling a poison control center or doctor, or

going for treatment. You may also contact 1-800-224-PETS [7387J for emergency medical

treatment information.

# Sergeant's Master Label

21 December 2009 EPA Submission

InformaIion in [ 

### I is optional. Page 5 of7 EPA No. 2517-XX

21 December 2009



### BACK PANEL CAT 

### SPQT ON

FIPRONIL

DIRECTIONS FOR USE

It 

### is a violation of Federal 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

PET, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH

USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS

CAREFULLY. FOR EXTERNAL USE ON CATS ONLY. DO NOT USE ON

RABBITS. DO NOT USE ON OTHER ANIMALS.

Do not use on kittens under 8 weeks of age. Best if used year round. Consult a

veterinarian before using this product on debilitated, aged, medicated cats. Can be used

on breeding, pregnant, or nursing (female cats) (queens). Consult a veterinarian before

using on cats with known organ dysfunction. Pets may experience some temporary

irritation at the site of product application. Certain medications can interact with

pesticides. Sensitivities may occur after using ANY pesticide product on pets. If signs of

sensitivity occur bathe your cat with a mild soap and rinse with large amounts of water.

If signs continue, consult a veterinarian immediately.

(INSERT DIAGRAM THAT DEPICTS APPLICATION OF PRODUCT ON THE

CAT)

HOW TO APPLY AND OPEN CHILD RESISTANT PACKAGE:

Remove product tube [vial] 

### from the package. Holding tube [vial] 

### with notched end

pointing up and away from the face and body, cut off the narrow end at the notches with

scissors. While holding the cat with one hand, use the other hand to apply the solution.

Invert the tube [vial] 

### and use the narrow end to part the cat's hair. Apply contents of one

(0.017 

### fl oz) tube [vial] 

### of {Product 

### Name} as a stripe, starting high on the back ofthe • ,

cat's neck to in front of the shoulder blades. Hold the cat for a few seconds to give the:

> >}'**~** 

### solution time to be absorbed into the cat's coat. When finished, wrap the tube [vial] 

### in 

### i',

>**~**



### paper and put into the trash. Only one applicator per treatment is needed. , ) ) ) , , " ,

, "

) > 

### >,



## , , FREQUENCY OF APPLICATION ":": '"

Use [brand name] monthly for complete control of flea, tick [and] chewing lice 

## land ; >.



### mosquito] infestations. [Studies show that] [brand name] kills fleas for up tq

### !1).T,~e " ,

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] remains effective, even after bathing, water immersion, or exposure (0, ' > "



### sunlight. Allow treated area to dry thoroughly. Do not reapply for 30 days. , 

## , "

(Brand Name) can be used on breeding, pregnant and lactating (queens) (female cats).

# Sergeant's Master Label

21 December 2009 EPA Submission

Information in [ 

### I is optional. Page 6 of? EPA No. 2517-XX

21 December 2009



### BACK PANEL CAT SPOT ON



# ... FIPRbNiIl

STORAGE AND DISPOSAL

PESTICIDE STORAGE: Do not remove tube from the pack until ready to use, Store in

a cool (below 77°F [25°CD 

### dry place inaccessible to children and pets. 

### Do not

refrigerate. Protect from direct sunlight.

CONTAINER DISPOSAL: 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. [[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 of fitness 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.J 

### , ,

, 

# .. , , 

# .

,

In Case of Emergency, call: 1-800-781-4738

( www.sergeants.com ]

Non-Emergency call 1-800-224-PETS (7387) (For more infonnation] [Visiru6a-1:]

[Made in USAJ "



### ,

,

"



### ,

,



### "

,

, 

### , "



### , 

### "

, "



### Distributed by:

Sergeant's Pet Care Products, Inc.

P.O. Box 540399 [BAR CODE AREAj::: '



### , "



### , , Omaha, NE 68154-0399

EPA Reg. No. 2517-XX

EPA Est. No. XXXXX-XX-XXX



### {END

- BACK I 

### SIDE PANEL)

{START

- OPTIONAL INSERT OR PACKAGE COPY)

[- How to Apply

- May contain graphics illustrating product use, e.g., cat

with a drop falling onto its neck from a vial on front, side, or back carton

label and/or applicator labeling.]

[How to Apply



### 1. Remove product tube from package. Holding tube with top end pointing up

and away from face and body, cut off top end with scissors. [image of tube

and end being cut off] > • , ,

# Sergeant's Master Label

21 December 2009 EPA Submission

Information in [ [is optional. Page 7 of7 EPA No. 2517-XX

21 December 2009



### BACK PANEL CAT SPQT ON

FIPRDNIL

2. Invert tube over cat and use open end to part eat's hair.

3. Apply contents of one (0.017 

### fl oz) tube 

### [vial] of {Product Name} as a stripe,

starting high on the back of the eat's neck to in front of the shoulder blades.

Squeeze tube firmly to apply all of the solution to the eat's skin

[Flea life cycle diagram]

[Look at the Label (Look at the Label icon) 6 Step [Spot On] [Squeeze-On] [Topical]

Checklist



### • Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

• Do NOT treat 

### with more than one pesticide product at a time

• Separate animals after treatment to avoid chance of ingestion

• Do NOT split tubes between pets]

[Brand Name]

[Monthly reminder card]

[For year round protection apply [Brand Name] monthly.]

[Pet's Name (Empty blank for owner to 

### fil! in name)]

[First [dose] [Treatment] (Empty blank for owner to 

### fill in date)]

[Second [dose] [Treatment] (Empty blank for owner to 

### fil! in date)]

[Third [dose] [Treatment] (Empty blank for owner to 

### fil! in date)]

[Fourth [dose] [Treatment] (Empty blank for owner to fdl in date)]

[Fifth [dose] [Treatment] (Empty blank for owner to 

### fill in date)]

[Sixth [dose] [Treatment] (Empty blank for owner to 

### fil! in date)]

[calendar stickers with brand name] [Place stickers on your calendar as a rerninckr, to

reapply [brand name] in 30 days. ; );

> » > > ,



### , 

## ,

" 

### [Monthly Application Reminder Magnet (image of reminder magnet) ) , , _ ,

Enclosed for your convenience is an application reminder magnet. Push**the'Eres~i)** 

### , , ,>,."



### ,



### "

, ,

, "



### "

, ,

, "

"



### , ,

, 

### "

button, and the reminder light will blink twice. The reminder tag is now set for 30**day~.~.'** > >



### 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 

## anp: ::

>



### this will reset the timer for another 30 days.



### {END

- OPTIONAL INSERT OR PACKAGE COPY}

TUBE 

### I VIAL LABEL

Front Label

(Brand Name}

FiproniI9.7% w/w,

O.50mL Back 

### Label

KEEP OUT OF REACH OF CHILDREN

CAUTION: Read directions and precautions

before using. Open with scissors.

EPA REG. No. 25l7-XX

(label code}