# EPA Registration Jacket 2517

‐ 135

# /



# 21-Day Screen Completed by

Contractor



# 21-Day Expires 

# on /- /2-/ 0



# Jacket # ;?5J7-/fbL



# MRID#

___ _

Content Screen: Recommended to 

# t!

a s3 F 

# ail

86-5 Review: Passed/FaiIedlB"A]



# Transfer This Jacket to:

# )



# To the Document Center (ITRMD)

*Please transfer jacket jmini-jacket to Product

Manager Team circled below:

Minor Use Section 

# PM-5

Insecticide Branch 

# PM-l0 M-13

Herbicide Branch 

# PM-23 PM-25

Fungicide Branch 

# PM-21 PM-22

Insect /Rodent Br. 

# PM-l PM-7

*Reminder to PM

- If applicable pick-up data

from Screening Room.

proces 

# L /

by

# ~eteness**~he** _C-'--,:f.-<T(l-..l.i.c...::......_

(Team

# Memb~r Signature) ( at )

## )



## PRIA 2 - 21 Day Content Screen Review Worksheet

(EP AlOPP Use Only)

3/23/09



### 21 Day Screen Start Date: I 

### t

- Z '2

- 0 

## 'i

Experts In-Processing Signature: }'V/ 

### E

## ;/1!/l.d/N6/(J~ Date J

.... 

# y. -/0 Fee Paid: Yes /

Division management contacted on issues No Yes Date

______ _

EPA Reg. Number:

## 2~n- 

# Q&L EPA Receipt Date: 

# I?.-z. 

# '2-{)'i

Items for 

### Review Yes No N/A*

1 

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

### complete 

# X- including package type

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

# X

dated (EPA FOIm 8570-4) (Link 

### to fonn)

2 

### a) All inerts (link to http://www.epa.gov/opprdOOl/inelis/), 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 

# A:- form) completed and signed (N/A 

### if 100% repack)

Certificate and data matrix consistent 

# K

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 only.

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

4 

### completed and signed (N/A if source is unregistered or applicant owns the 

# )(

tecbnical)

Data Matrix (EPA Fonn 8570-35) (Liok to fonn) both internal aod external 

# X ccpies (PR 98-5) (Link 

### to PR 98-5) completed and signed (N/A 

### iflOO%

repack)'



### 5 ves no 

## "i,':y.Q'

a) Selective Method (Fee category experts use) >}'

... --.

# :\~V"F;:";t .' b) Cite-All (Fee category experts use) 

# >;.

# :.~:. . ••......• 

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

. 

## ..

5 Copies of Label (link to httQ://www.eI!a.gov/ol2I!feadlllabeling/lrm[) 

# )< 6 

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

httpJ/www .epa.gov/pesticides/regulating/reg·lstering/submisslons/index.htm#!abels 

# 11

I.!.

,-



### 7 Is the data package consistent with PRNotice 86-5 (link to PRN 86-5) 

# X

Notice of Filing Qink to



### 8 httQ://www.eQa.gov/Qestisides/regulatin2ltolerance I!etitions.htm) included 

# >:- with petitions (link to

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

9 If 

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

# X http://,,,ww.epa.gov/opprdOOllworkplanireducedrisk.html)

Required Data (link to**htto://'''~-w.eRa.gov/[!:esticides/regulatin2ldata** 

### reguirements.htm) and/or

data waivers. See Footnote C.

a) 

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



### 10

2

### Comments: 

# There Glr\C 

## no sf 

# r.;c/;**~1J**

r Jf I

1 C/ C i'l**~** T I**~**



### ,if (! 

## c



# * NI A - Not Applicable

Footnotes**Qj'J~O** 

## c! a.f'''d

c, ( ( c 

## t,J f / J! , j '/

. j • 

## J

! / 6 

### !A

. ; u



### 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 \Vith an approved inert, submitting

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

mistakes on the eSF, 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 infonnation, forms. data and

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

application withdrawn within the 21 day period, otherwise, the Agency will reject the

application as described below.

To successfully complete this aspect ofllie 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/opprdOOl/inertsllists.html] and If the inert is not

approved, to obtain the necessary inert approval prior to submitting an application

to register a pesticide product containing that inert ingredient. Some inert

ingredients are no longer approved for food uses or certain types of uses. The name

and/or CAS number on a CSF Inust 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 IIAB resolving the issue should accompany the application. All

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

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

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

Microbial Pesticides Branch [Link to



### http:// www.epa.gov/oppbWdllbiopesticideslcontactsbppd.htm ].

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

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

information [link to http://www.epa.gov/opprdOOl/inerts/tips.pdf) must also be included

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

mixture (including a fragrance) must be identified. 

### In some cases, the supplier of the

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

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

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

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

cannot or are not identified or provided within the 21**~day** 

### content review period, the

Agency will reject the application.

Dupng 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 infonnation and data needed for the Agency to approve the

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

request an extension in the PRIA decision review timeframe to accommodate

the inert review/approval process;

4

## ')

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

category estimated); or

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

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

25% of the full fee of the category identified.

Conventional New Product Applications

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 (R31 I, R312 or R313), it will contact the applicant with the

following'options:

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

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

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

approved for the application's uses; or

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

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

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

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

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

Agency within the 21 day content review period.)

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

category estimated); or

Ifnone 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 information and data needed for the Agency to approve the

unapproved inert. If an inert ingredient tolerance exemption petition is

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

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

Agency will discuss hannonizing the 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 (similarlidentical) new product, R300 or A530, an application

without the necessary authorizations of offers to pay 

### will be placed into either R301 or



### AS31. The Agency reconunends 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 

# /

{864749ZThis package includes the following



# @New Registration

o Amendment

o Studies? o 

# Fee Waiver?

o volpay 

# % Reduction: for Division

.



# OAD

oBPPD

@RD

Risk Mgr. 

# [JQJ

Receipt No. 

# s-I 864749

# ~=====::::==:== EPA File Symbol/Reg. No.

1 

# 2517-RGL

Pin-Punch Date: 1 

# 12/22/2009

This item is NOT subject to FFS action. 

# I**~** 

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

# ·-------fjArrc.fution-eudB: 1 j 

# Parent/Child Decisions:

Requested: 

# I '¥:,'}60

Granted: 

# I \1.-3==

Amount Due: 

# $ \,31;,5.

# c~ I 

# I"

.1 

# J 

# n' 

# I

c 

# I

# ~-- ________ 

# ...-J**_vl,~ {'1l'~..y-zL..,.,**  

# ';. le,,"",- J 

# t2-i-f]JJ_-

o i4 Inert Cleared for Intended Use

Reviewer: 

# tlrc be>**~**

Remarks: 

## Uncleared Inert in Product

Date: I?-.- 30 -c<;

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



# Reg. No. ?:')Il

- I 

## 3S

Description:

__

# NL"-"Qv-:J""",_~=-=,-,=---~~C:::::..:.s-,-h.-=--_(-,-;J_)~ ______

# ~

1. 

# f15

Placement within the e-Jacket/Jacket 

# r

Default: (chronological, top 

# = newest)



# o File Location: (PDF page number)

2. 

# W

Send to Data Extraction contractors this material: 

# ]V Newly stamped accepted label



# o Notification



# rp New CSfS, 

# (?,')**ff)iUv\v'Ll~**



# 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 5-4900).



# Reviewer's Name: Rosanna Louie

Phone: 308.0037 Division: RD



# Date: 

# "7 'rclo ""20\)U.S. ENVIRONMENTAL PROTECTION

AGENCY

Office of Peslicide Programs

Regislration Division (7504P)

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460



### NOTICE OF PESTICIDE,

0" Registration



## o Reregistration

(under the Federal Insecticide, Fungicide,

and Rodenticide Act, as amended)

Name and Address 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 of Issuance:

2517-135 January 28, 2011

Tenn of Issuance:

Conditional Registration

TimeRlimited: see conditionS below

Name of Pesticide Product:

Sergeant's Fipronil 

### + Methoprene Spot R

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 ofa 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 conditionally registered in accordance with FIFRA §3(c)(7)(a) provided that:

1. This registration is timeR 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 3 

# °

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 fonnulations 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 fonnulations

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

at and 12 month intervals.**P~ge** 10f54. The approval of this registration is contingent on the Agency's review to determine 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 formulating 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)(l)(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 information in doses

sold for this product for the quarter that begins on April I, 2011. The quarterly reports are due

two months after each quarter ends.

Please flag any Confidential Business Information as such. Enhanced incident reporting should

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

### to the

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

The following is a list of information 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. (mmldd/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: dermal, oral, other animal, inhalation, other

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

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

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, I yr, 2 yr, 3 yr, 4 yr, 5 yr, 6

yr, 7 yr, 8 yr, 9 yr, 10 yr, II yr, 12 yr, 13 yr, 14 yr, IS yr, > 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 Multiple Infestations, revise the claims per our discussion (delete struck-out text

and/or add underlined words) to read as follows:

"Kills chewing lice <lad eontrols mites that may cause saF€sfJtic mange]"

"[Kills fleas, ticks, mosquitoes, chewing lice, flea eggs, [and] flea larvae [and prevents

the development of flea pupae]]"

"[Breaks the Flea Life cycle [fer tl:fl to three mORthsH"

"[Seven][7] Way fAction] [Control] Protection, [kills fleas, ticks, mosquitoes, chewing

lice, flea eggs, flea larvae and prevents the development of flea pupae]]"

"[6][Six] Way PFoteetion, [Action] [Control] [kills fleas, ticks, mosquitoes, chewing lice,

flea eggs, flea eggs & larvaeH"

"[Four (4) Week] [1 month] [W-6ay] [Flea, Tick, Mosquito, and Chewing Lice Control]"

11. On page 2 under Ticks, revise the claims (delete struck-out text and/or add underlined words) to

read as follows:

"[Kills [all stages of] Deer Ticks (vector of that may carry Lyme disease) for up to [4

weeksJ[1 month][30 days]]"

"[Kills [all stages of Edeer) ticks [before tHey can] [that) [transmit Lyme disease,] [for up

to [4 weeks] [1 moRth] [3Q days] per af3fJlieation]]]"

12. On page 2 under Flea Eggs and Larvae, revise the claims (delete struck-out text and/or add

underlined words) to read as follows:

"[Kills adult fleas, flea eggs, flea larvae and prevents the development of pupae [for up to

six weeks]]"

"[Kills all stages of the flea (adult fleas, flea eggs, flea larvae and prevents 1M

development of flea pupae)]"

"[Kills flea eggs [larvae] [and prevents the development of pupae] for up to six weeks]"

"Kills Flea Eggs & Flea Larvae for [(mUQ six weeks)]!]"

"Kills all stages of the flea life eJ'ele"

13. On page 3 under All Others, delete struck-out text in the claims to read as follows:

"[Controls mites tflat may cause sareol'ltic mange [iHfestations]]"

"ff3} applications]"

14. On page 5 under Back Panel, replace "30 days" from the second claim with "[ I month] [4

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

15. On page 6, delete "[and enclosed directions]" from the Directions for Use because this insert has

not been submitted to the Agency for review.

16. On pages 6 and 8 under How to Apply, delete "[0.017 fl oz] [0.50 mLl" so that the use directions

are more clear by stating "one tube

... " per application.

17. On a e 7 under the Warran ,delete the a tional brackets between "All such risks shall be

Page40f5assumed by the user or buyer" and "Sergeant's is committed to providing

... " so that the warranty

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

18. On page 8, modifY the word "insert" to indicate that this text is part of the outer packaging,

instead of a separate insert to accompany the product.

19. For the text on the front of the tube, the net weight must be expressed in English units, i.e., "0.017



### fl oz." Metric units may be expressed in addition to (adjacent) to the English unit weight

expression.

20. Revise the EPA Registration Number to read: "EPA Registration No.**2517~135."**

lfthe Agency detennines that future mitigation measures are necessary for all pet**spot~on** products, you will be infonned, and be expected to comply. 

### If mitigation measures are necessary, the

Agency may take appropriate regulatory actions. Two copies of the finished labeling must be submitted

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

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

constitutes acceptance 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 any questions.

Enclosure: Sergeant's Fipronil 

### + Methoprene**Spot~on** for Cats Label, Stamped Accepted with Comments

# Si~n~_ 

# 1\

_**~_** 

# -{;( uP

Richard Gebken, Product Manager (1 0)

Registration Division, Insecticide Branch

EPA Form 8570·6

Page 5 of 5 Date:

# Sergeant's Master Label

20 January 2011 Version 10.1 EPA No. 2517-RGL

Information in [ 

### J is optional. Page 1 of9

[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 

# + Methoprene Spot-On for Cats

[ABNs]

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

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

[SentryProline (Spot On) for cats]

[[SENTRY®] FIPROGUARDTM PLUS for cats]

[[Sergeant's] PRONYL OTC'M PLUS for cats]

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

[Apply to kittens over 8 weeks old]

[Apply to kittens 8 weeks or older]

[Mosquitoes 

## J ACCEPTED

with COMMENTS

In EPA Letter Dated:



## JAN 2 8 2011

Under the Federal Insecticide,

Fungicide, and RodenticldeAct,

as amended, for the pesticide

registered under EPA Reg. No.

_ 21;)1 J-13 

# s:

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

up to 28 days]

[Adult Fleas]

[. [Kills adult fleas [for up to six weeks]]

[. Kills Fleas [Up to [4] [6] weeks]!]

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

anemia]

[Multiple Infestations]

[. Kills chewing lice and controls mites that may cause sarco}'ltic mange]

[. Flea [&] [and] Tick Control for Cats [&] [and] Kittens 8 weeks old and older]

[·Kills fleas, flea eggs, ticks, chewing lice 

### [&] [and] mosquitoes]

[-Kills fleas, ticks, mosquitoes, chewing lice, flea eggs, [and] flea larvae [and

prevents flea pupaeJJ

[·Breaks the Flea Life Cycle [for Ujl 

# '0

three mOHilis]]

[-Monthly flea, tick, mosquito, chewing lice, and flea egg protectionJ

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

[-Kills fleas, ticks, mosquitoes, flea eggs, and chewing lice]

[- [Seven] [7J Way Protection, kills fleas, ticks, mosquitoes, chewing lice, flea

eggs, flea larvae and prevents flea pupae]]

[- 6 [SixJ Way Protection] kills fleas, ticks, mosquitoes, chewing lice, flea eggs &



### flea larvae]

[. [4 Week] [1 month] [30 day] [Flea and Tick [&] [and] Treattnent]

[. [Four (4) Week] [1 month] [30 day] [Flea, Tick, Mosquito and Chewing Lice

Control]

[·Use [brand name] monthly to break the flea life cycle.]

# Sergeant's Master Label

20 January 2011 Version 10.1

Page 2 of9 EPA No. 2517-RGL

Information in [ J is optional.



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

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



### [0 [4 week] [1 month] [30 day] Flea and Tick Treatment!]

[Once A Month Flea and Tick Treatment]



### [0 Kills Fleas and Ticks for up to [4 weeks] [1 month] [30 days]!]



### [0 Kills Fleas, Ticks, Flea Eggs & 

### Flea Larvae for up to [4 Weeks] [1 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.]

[- Controls reinfestation of fleas for up to six weeks]

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



### [0 Kills Ticks for Up to [4 weeks]!]



### [0 Kills [all stages of] Deer Ticks (vector of Lyme disease) for up to [4 weeks] [1

month] [30 days]]



### [0 [Kills [all stages of] (deer) ticks [before they can] [that] [transffiit LYffie

disease,3 [for up 

### to [4 wecks] [1 ffioHlfl] [30 

### days3 [per application]]]



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

[Flea Eggs and Larvae]

[-Controls flea reinfestation [for up to six weeks]]

[- Kills adult fleas, flea eggs, flea larvae and prevents pupae [for up to six weeks]]

[-Kills all stages 

### of the flea (adult fleas, flea eggs, flea larvae and prevents flea



### pupae)]

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

[-Kills flea eggs [larvae] [and prevents pupae] for up to six weeks]



### [0 With (S)-methoprene [Insect Growth Regulator] [IGR] which Breaks the Flea

Life Cyclc]



### [0 With (S)-mcthoprene to Break Flea Lifc Cycle]



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



### [0 Dual Action 

### [I]: Fipronil with (S)-methoprenc [insect growth regulator] [IGR]

Effectively Breaks the Flea Life Cycle]



### [0 Dual Action 

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



### [0 Kills Flea Eggs & 

### Flea Larvae for [(six weeks)]!]

[- Prevents Flea Eggs From Developing Into Biting Adults]



### [0 Kills all stages of the flea lire cycle]

# Sergeant's Master Label

20 January2011 Version 10.1

Information in [ 

### 1 is optional. Page 3 of 9



### [All Others]

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

[-Stops and prevents infestations of listed pests]

[. F or Cats and Kittens 8 weeks of age or older]

[·Past Acting]

[-Effective even after bathing]

[. Long Lasting]

[-Once a month treatment]

[-Past Action against chewing lice infestations] EPA No. 2517·RGL



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

[. Best 

### if used year round!]

[. (rCON Showing [4 Week] [I month] [30 day] Protection)]

[. [4 Week] [I month] [30 day] Dose!]

[. I Month Dose!]

[. Easy to Use [Application]]

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

[. [Pree] Calendar Stickers Inside!]

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

[. Waterproof]

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

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

[clip] [inside]]

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

[. Monthly application reminder inside]

[. Pipronil (9.8%) 

### + (S)-methoprene (11.8%)]

[. Lift [here] for more information]

[-Contains Fipronil[,][ -] and (S)-methoprene the active ingredients used in

Frontline Plus®*]

[* [Brand Name] is not manufactured by or distributed by MeriaL Frontline

Plus® is a registered trademark of Me riaL] 

## [f3t applications]

[Rapid elimination of chewing lice infestation]

[Effective after bathing and exposure to water and sunlight]

# Sergeant's Master Label

20 January 2011 Version 10.1

Information in [ ] is optional. Page 4 of9



### [For use ONLY on cats]

[of ALL weights]

[over 8 

### weeks of age]



### ACTIVE INGREDIENTS:

FiproniI

............................................... 9.80%**(S)~methoprene** 

### ............................... 11.80%

OTHER INGREDIENT**

......... 78.40 %

TOTAL 100.00%

[**diethylene glycol monoethyI cther[

KEEP OUT OF REACH OF CHILDREN

CAUTION EPA No. 25I7-RGL



### See [Side] [Back] Panel For Additional Precautionary Statement

NET CONTENTS:

[Three[ [3][three] 0.01711 oz (0.50 mL) applicators

{END

- FRONT PANEL}

# Sergeant's Master Label

20 January 2011 Version 10.1 EPA No. 2517-RGL

1nfonnation in 

### I 1 is optional. Page 7 of9



### 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**u~e.** 

### Store in

a cool (below 77°F[I][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. Neyer 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 tQ

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]

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

In Case of Emergency, call: 1-800-781-4738 Non-Emergency call1-800-224-PETS

(7387) [Made in USA] [US Patent 5,567,429]

Distributed by:

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

P.O. Box 540399

Omaha, NE 68154-0399

EPA Reg. No. 2517-RGL

EPA Est. No. XXXXX-XX-XXX



### {END

- BACK I 

### SIDE PANEL}20 January 20 II 

# Sergeant's Master Label

, Version 10.1 EPA No. 25I7-RGL

Infonnation in [ 

### 1 is optional. Page 8 of9



### {START

- OPTIONAL INSERT OR PACKAGE COPY}

[ How to Apply

- May contain graphics iIIustrating product use, e.g., cat with

a drop faIling onto its neck from a vial on front, side, or back carton label

and/or applicator labeling.1

[Application Instructions1 [Directions for Use1

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 Apply:

[Optional diagram mayor may not appear on finished label}

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

2. Apply contents of one [0.017 fl 

## a'l [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]. Squeeze tube

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

[Flea life cycle diagram] [Flea Life Cycle]

[Look at the Label (Look at the Label icon) [Easy] 6 Step [Easy] [Spot On] [SqueezeOn] [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}\



# Sergeant's Master Label

20 January 2011

Information in ( J is optional.



### [Brand NameJ

[Monthly reminder card]

[3J [Month Treatment TrackerJ Version 10.1

Page 90f9 EPA No. 2517-RGL



### [3J [Month Application TrackerJ[For year round protection apply [Brand NameJ

monthly.J

[Pet's Name (Empty blank for owner to fill in name)J

[FirstJ [lstJ [SecondJ [2ndJ [ThirdJ [3rdJ

[DoseJ [TreatmentJ [ApplicationJ(Empty blank for owner to fill in date)(Date:

MMlDDIYY)J

[calendar stickers 

### with brand name] (place stickers on your calendar as a reminder to

reapply Jl?rand nameJ in 30 days.J

[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 0[30 days the reminder light will blink, reminding you to reapply [Brand

Name]. Press the button once and the blinking light will stop. Press the button again and

this 

### will reset the timer for another 30 days.]



### {END

- OPTIONAL INSERT OR PACKAGE COPY}**g~.;I!~J!;~**

Front Label



### {Brand Name} [For use 'only on catslkittens

8 weeks or older}

Fipronil 9.8% w/w, (S)-methoprene 11.8% 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. 25l7-RGL {label code}

# -

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2517- \ 35 JAN 2 8 2011 38.1mm

8mm +->- +-+ 10mm PRONYL OTCTM PLUS ART INSTRUcnON FOR THE PRINTER --**~LACK** PMS 260

Printer/Vendor: Date sent: Additional Notes: Labels adhere to White Tubes (e (Q.lV l(\ 10 ,]A,.! W \ \**wwo~** 

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## DATA PACKAGE BEAN SHEET

Date: 09-Nov-2010

Page 1 of 1



### * * * Registration Information 

### * * * Decision 

### #: 425454

DP 

### #: (383881)

PRIA



### Parent DP 

### #:

Submission 

### #: 884815

Registration: 2517-RGL

- SERGEANTS FIPRONIL + S·METHOPRENE SPOT -ON FOR (

Company: 2517

- SERGEANT'S PET CARE PRODUCTS, INC.

Risk Manager: RM 10

- Richard Gebken

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

Risk Manager Reviewer:

### ~R~"~'~"~",~"~,":;'~R~"O~U~I~E~_~;;;;;~;;;;~~~,;;;;;;~;::.:-_ Sent Date:**~1-Nov.2010** Calculated Due Date: e4-Nov-ZU10**~J.AN''2.01t** Edited Due Date:

____ _

Type of Registration: Product Registration

- Section 3

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

Ingredients: 105402, S-Methoprene(11.8%)

129121, Fipronil(9.8%}



### * * 

### * Data Package Information 

### * * *

Expedite: 

## 0 Yes. No

DP Ingredient: 105402, S-Methoprene

129121, Fipronil

DP Title: #2517-RGl: CRP Stvdy Resubmission Date Sent: 09-Nov-2010 Due Back:

____ _

CSF Included: 

## 0 Yes. No label Included: 

### 0 Yes. No Parent DP #:

____ _

Assigned To Date Out

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

# {zI13/{tJ

last Possible Science Due Date:

# U5~Ct~~ 2-el0

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-RGl. Contact Rosanna

louie-Juzwiak 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

## ~&~.,Z~ RD, TRB, Reviewed by Rosalind L. Gross 12/13/2010

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 

### -'1,,01"'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 

### if they are

adeguate to support CRP certification for 2517-RGL

Active Ingredient(s), PC code, & % FiproniI9.7% {2517-RGTl

Fipronil 9.8%

S-Methoprene 11.8%

Summary of Findings

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.

### 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

are.a 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 Fiproni!. 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 amt 

### = 28.5mg 

### = 28.5mg divided by 

### [1030mg/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 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.

### 3



### Toxicity, Child Failure, and Package

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

0.0338 fl. oz.) "'1 fl. oz.) Density glml Iharmful 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.

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% oftest

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,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicator,"betweenthecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebody)fthemainchamberoftheapplicatoratotherlocations,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[1025mg/mlx0.098Fipronil]=0.284ml=0.28mlforFipronil&SMethopreneCatEPAREG#2517-RGL%AI-Fipronil9.7%Note:1.Theapplicatoristhechild-resistantfeature,..2.Theapplicatorsarefilledinml,13.10CRPstudiesweresubmittedbytheCompanytocoverthe5sizes(0.5,0,67,1.34,2,68,4.02ml)fortheFipronilonlyandtheFipronilandS·Methopreneproducts.Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFipronilandS·Methopreneproducts,whichappearedtobeidentical;andaJune30,2010letterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFipronilonlyandtheFipronilandS·MethopreneproductsaswasusedintheCRPtesting.2EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusion.mlperPkg#unitfpkg,childfail=#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,toxfharm=#atBeginens'lveCampunitsTestReviewuter&whyAnalysis2517-RGT482796013whiteapplicatorswith1setof3ochildXCRECRPCertification5/27/10isacceptable.Fipronilonly48059503purplestripeonlabelapplicatorsfailures=associatLabeldated6/29/10sameCRPdirectionsas1746-001connectedtoeachother.connectedPass50edwithinstudy.Eachapplicator@O.SmltoeachchildtestlowestOataAnalysisshowednochildfailures.waterasplacebo.other.SAUEStudyIsapassofthechildtestaccordingToX/harm=1applicator,tothesequentialtestchartin16CFRchildfail=1applicator1700.20.2517-RGT482796013whiteapplicatorswith1setof390%XlowestCRPCertification5/27/10isacceptable.CatFlpronilonly48059503purplestripeonlabelapplicatorsSAUESAUELabeldated6/29/10sameCRPdirectionsas1746-001connectedtoeachother.connectedinstudy.Eachapplicator@0.5mltoeachDataAnalysisshowed9seniorsfailuresWithwaterasplacebo.other.packageAand1seniorfailurewithpackageTox/harm=1applicator,B,whichisthemaximumnumberoffailureschildfail=1applicatorforapassedSAUE.TheSAUEis90%.Thestudyisapassofthesenioradulttestin16CFR1700.20andtheeffectivenessspecificationsIn16CFR1700.15(b).The/-numberofsubjectspertestsitewascorrectedsuchthat9subjects(90-98)werecodedasbeingtestedatsiteH980ratherthansiteH902(adifferentlocationwithinamall,adistinctionnotpreviouslymade).SiteH902nowis24%oftestsubjectsinaccordancewith16CFR1700.20.CRPdatasummarychtEPAREG#2517-RGLSergeant'sFipronil+S-MethopreneSpotOnForCatsCompanyNameSergeant'sPetCareProducts,Inc.Chemical-Fipronil9,8%S-Methoprene11.8%3December13,2010ASeniorAdultUseEffectiveness failureisfailuretoaccesstheapplicatorintheprescribedtesttimeof5min.forthefirstpackageor1min.forthesecondpackage,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicatorbetweenthecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthemainhamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailureisaccessto1unit.Accessto1unitismorethan28.5mgofFipronilforalisizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteaccesstotheplacebo(water).Accesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby[1030mg/mlx0.097Fipronil]=0.285ml=0.29mlforFipronilonlyCatEPAREG#2517-RGTAccesstoatoxicorharmfulamt=28.5mg=28.5mgdiv'ldedby[1025mglmx0.098Fipronil]:0.284ml=0.28mlforFipronil&SMethopreneCatEPAREG#2517-RGL%AI-Fipronil9.8%S-Methoprene11.8%.·Jllote:1,2.3.Theapplicatoristhechild-resistantfeature,Theapplicatorsarefilledinmi.10CRPstudiesweresubmittedbytheCompanytocoverthe5sizes(0.5,0.67,1.34,2.68,4.02ml)fortheFipronilonlyandtheFipronilandS-Methopreneproducts,Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFipronilandS-Methopreneproducts,whichappearedtobeidentical;andaJune30,2010letterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFipronilonlyandtheFipronilandS-MethopreneproductsaswasusedintheCRPtesting.4EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#uniUpkg,childfail:::#ChildGetatCRESAUEcomprehOnlyincludeeRE&SAUEviacomputerunits,color,tox/harm:::#BeginTestensiveComputeranalysisunitsReviewAnalysis&why2517-RGL482798013whiteapplicatorswith1setof3CRPCertification5/27/10isCatFipronil+8M48059503purplestripeonlabelapplicatorsacceptable.Labeldated6/29/10Methoprene1746-001connectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicator@0.5mltoeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:ToX/harm:::1applicator,MRID48279601(1746-001),EPAchildfail:::1applicatorRegNo.2517-RGT.Studyisapassofthechildtestaccordingtothesequentialtestchartin16CF-R1700,20.TheSAUEis90%.Thestudyisapassofthesenioradulttestin16CFR1700.20andtheeffectivenessspecificationsIn16CFR1700.1S(b).BridgingLetter6/30/10indicatingsamesizeandcolorpackageaspackagetestedisokay.

# ) 3> DATA PACKAGE BEAN SHEET

Date: 22-Jun-2010

Page! of 1



### * '* * Registration Information 

### * * * Decision 

### #: 425454

DP 

### #: (379385)

PRJA



### Parent DP 

### #:

Submission 

### #: 873355

Registration: 2517-RGL

- SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON 

### FORL4T

Company: 2517· SERGEANTS PET CARE PRODUCTS, INC.

Risk Manager: RM 10- Richard Gebken

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

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS

Sent Date: Calculated Due Dale: 04-Nov-2010

Type of Registration: Product Registration

_ Section 3 Edited Due Date:

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

Ingredients: 105402, S-Methoprene(11.8%)

129121, Fipronil(9.8%)



### * * '* Data Package Information 

### * '* 

## '*

Expedite: 

## 0 Yes. No Date Sent: 22-Jun-2010

DP Ingredient: 105402, S-Melhoprene

12912 I, Fipronil Due Back:

DP Title:**~CR~P~** ___**~** _____**~** ________________ _

CSF Included: • Yes 

## 0 No label Included: • Yes 

## 0 No Parent DP #:

Assigned To Date In

# _~ 

# I**~-z-I\O :d'~1'1A** 

# ~~ last Possible Science Due Date: 05-0cl-2010 Organization:**"R~D~I~T"R~B** ______ _

Team Name: Child Resistanl Packaging Science Due Dale:

___ _

Reviewer Name:

_____ _ Sub Data Package Due Date:

Contraclor Name:



### * * * Studies Sent for Review 

### * * *

No Studies



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

### * * *

Can be printed on its own page



### * 

### * * Data Package Instructions 

### * * * 

### 1

..

For your review: Application for a fipronilf3-melhoprene EP. presumably me-too of Merial's 65331-4 / 

# kJ**~**

Thx, baa 

# I

. ______________ _

### CHILD-RESISTANT PACKAGING REVIEW

Technical Review Branch

IN 6/22/2010 

### OUT 9/28/2010



### RD, TRB, Reviewed by

# RO~~10

EPA Reg. No. or File Symbol 2517-RGL

DP Baroode DP379385

Decision 

### # 425454

EPA Petition or EUP No.

___ _

Date Division Received 4/12/2010



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

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

Product Mgr.lChemical Review Mgr/Contact 

### Person RM 10 Bonaventure Akinlosotu

Division roR",D,-

__

Product Name(s) Sergeant's Fipronil + 

### S-Methoprene Spot-On for Cats

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

Submission Purpose Review of CRP studies EPA Reg. No. 2517-RGTto

determine if they are adequate to support CRP certification

for this product

Active Ingredient(s), PC oode, & 

### % Fipronil 9.8%

S-Methoprene 11.8%

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 per test 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. 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 plaslic. 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 olthe stripe is

associated with the applicator size. The applicator, which is filled with waler 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 eRP

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 Ihe 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 amt 

# = 28.5mg 

# = 28.5mg divided by [1030mg/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 amt 

### = 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 Fiproniij 

### = 0.284 ml 

### = 0.28 

### ml for Fipronil & 

### S-Methoprene Cat

product EPA REG No. 2517-RGL. Access to a toxic or harmful amt 

### = 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 :z FI. Oz. (29.6ml Produc1 % Fipronil mg Flpronll # uni1 "'tox

0.0338 II. oz.) =f II. oz.) Oensity g/ml Iharmful am1

2517-RGT 0.5 0.017 1.030 9.7 49.96 1

2517-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

2S17-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

2S17-RGU 1.34 0.045 1.020 9.8 133.95 1

### 4

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

0.0338 fl. oz.) =1 flo oz.) Density gfml {harmful amt

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 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-

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

direelions 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 O.S ml size

(MRID 480S9S03) 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 O.S ml size (MRID 480S9S03 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 subjecis per test site and per tester.

Child Study 3 white applicators with red stripe on label size 2.68 ml size

(MRID 480S980S 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 caBed 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 1700.1S(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 altached 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 altached 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 of subjects per test 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 subm ilted.

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-FiproniI9.7%September28,2010ASeniorAdultUseEffectivenessfailureisfailuretoaccesstheapplicatorintheprescribedtesttimeof5min.forthefirstpackageor1min.forthesecondpackage,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicatorbetweenthecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthemainchamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailureisaccessto1unit.Accessto1unitismorethan28.5mgofFipronilforallsizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteaccesstotheplacebo(water).Accesstoatoxicorharmfulamt;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-RGAAccesstoatoxicorhannfulamt;28.5mg;28.5mgdividedby[1025mg/mlx0.098FipronilJ;0.284ml;0,28mlforFipronil&SMethopreneCatEPAREG#2517-RGLAccesstoatoxicorharmfulamt;28.5mg;28.5mgdividedby[1020mg/mlx0.098FipronilJ;0.285ml;0.29mlforFipronil&SMethopreneDogEPAREG#2517-RGU%AI-Fipronil9.7%Note:Theapplicatoristhechild-resistantfeature.Theapplicatorsarefilledinmi.11,2,3.10CRPstudiesweresubmittedbytheCompanytocoverthe5sizes(0.5,0.67,1,34,2.68,4,02ml)fortheFipronilonlyandtheFipronilandS-Methopreneproducts,Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFipronilandS-Methopreneproducts,whichappearedtobeidentical;andaJune30,2010leiterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFipronilonlyandtheFipronilandS-MethopreneproductsaswasusedintheCRPtesting.2-EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unitfpkg,childfail=#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,tax/harm=#atBeginensiveCampunitsTestReviewuter&whyAnalysis2517-RGT480595033whiteapplicatorswith1setof3ochildXCRECRPCertification5/27/10isacceptable.Fipronilonly1746-001purplestripeonlabelapplicatorsfailures=assQciatLabeldated6/29/10sameCRPdirectionsasconnectedtoeachother.connectedPass50edwithinstudy.Eachapplicator@O.5mltoeachchildtestlowestDataAnalysisshowednochildfailures.waterasplacebo.other.SAUEStudyisapassofthechildtestaccordingtoTox/harm=1applicator,thesequentialtestchartin16CFR1700.20.childfail=1applicator2517-RGT480595033whiteapplicatorswith1setof390%XlowestCRPCertification5/27/10isacceptable.CatFipronilonly1746-001purplestripeonlabelapplicatorsSAUESAUELabeldated6/29/10sameCRPdirectionsasconnectedtoeach other.connectedinstudy.Eachapplicator@0.5mltoeachDataAnalysisshowed9seniorsfailureswithwaterasplacebo.other.packageAand1seniorfailurewithpackageTox/harm=1applicator,B,whichisthemaximumnumberoffailureschildfail=1applicatorforapassedSAUE.TheSAUEis90%.However,onetestsHe(902)had33%ofthetestsubjects.Thisexceedsthemaximumnumberofsubjectspertestsite(24%)per16CFR1700_20(0)(3)(i).Therefore,thisCRPtestdataisunacceptable.Thesenioradulttestmustbecorrectedbyreplacingthelast9testsubjectsfromsite902orredoingtheentiresenioradulttest.Ifthelast9testsubjec1sfromsite902arereplaced,thecriteriafortheentire100testsubjectsmustconformtothecriteriain16CFR1700.20(a)(3)(i)regardingageandsexdistribution,thenumberoftestsubjectspertestsiteandpertester.3EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unitfpkg,childfail=#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,toxfharm=#atBeginensiveCampunitsTestReviewuter&whyAnalysis25t7-RGA480598033whiteapplicatorswith1setof3achildXCRPCertification5/27/toisacceptable.DogFipronil1746-002orangestripeonlabelapplicatorsfailures=Labeldated6/291tosameCRPdirectionsasonlyconnectedtoeachother.connectedPass50instudy.-Eachapplicator@toeachchildtestDataAnalysisshowednochildfailures,O.67m]waterasplacebo.other.StudyisapassofthechildtestaccordingtoToX/harm=tapplicator,thesequentialtestchartint6CFRt700.20.childfail=tapplicator25t7-RGA480598033whiteapplicatorswith1setof398%XCRPCertification5/27/tOisacceptable.DogFipronilt746-002orangestripeonlabelapplicatorsSAUELabeldated6/29/tOsameCRPdirectionsasonlyconnectedtoeachother.connectedinstudy.Eachapplicator@toeachDataAnalysisshowed2seniorsfailedto0.67mlwaterasplacebo.other.openpackageASAUEis98%.ThestudyisToX/harm=tapplicator,apassofthesenioradulttestin16CFRchildfail=tapplicator1700.20andtheeffectivenessspecificationsint6CFRt700.15(b).25t7-RGA480598043whiteapplicatorswithtsetof3ochildXCRPCertification5/27/tOisacceptable.DogFipronil1746.(J03greenstripeonlabelapplicatorsfailures=Labeldated6/291tosameCRPdirectionsasonlyconnectedtoeachother.connectedPass50instudy.."-"Eachapplicator@toeachchildtestDataAnalysisshowednochildfailures.1.34mlwaterasplacebo.other.StudyisapassofthechildtestaccordingtoTox/harm=1applicator,thesequentialtestchartin16CFRt700.20.childfail=tapplicator25t7-RGA480598043whiteapplicatorswithtsetof395%XCRPCertification5/27/tOisacceptable.DogFipronil1746-003greenstripeonlabelapplicatorsSAUELabeldated6/29/tOsameCRPdirectionsasonlyconnectedtoeachother.connectedinstUdy.Eachapplicator@toeachDataAnalysisshowed4seniorsfailedtoopent.34mlwaterasplacebo.other.packageAandtseniorfailedtoopenToX/harm= 1applicator,package8.SAUEis95%.Thestudyisachildfall= 1applicatorpassofthesenioradulttestin16CFR1700.20andtheeffectivenessspecificationsint6CFR1700.t5(b).4EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unitlpkg,childfail;;;;#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,tox/harm;;;;#atBeginensiveCampunitsTestReviewuter&whyAnalysis2517·RGA480598053whiteapplicatorswith1setof32childXlowestCRPCertification5127/10isacceptable.DogFipronil1746·004redstripeonlabelapplicatorsfailures;;;;CRELabeldated6/29f10sameCRPdirectionsasonlyconnectedtoeach other.connectedPass50instudy./_.Eachapplicator@toeachchildtestDataAnalysisshowed2childfailures,a43I2.68mlwaterasplacebo.other.montholdmaleaccessed2applicatorsbeforeTax/harm;;;;1applicator,thedemonstrationanda51montholdfemalechildfail=1applicatoraccessedoneapplicatorafterthedemonstration.Study'ISapassofthechildtestaccordingtothesequentialtestchartin16CFR1700.20.2517·RGA480598053whiteapplicatorswith1setof398%XSAUECRPCertification5/27/10is acceptable.DogFipronil1746·004redstripeonlabelapplicatorsSAUEassociatLabeldated6/29/10sameCRPdirectionsasonlyconnectedtoeach other.connectededwithinstudy.Eachapplicator@toeachlowestDataAnalysisshowed2eniorsfailedtoopen2.68mlwaterasplacebo.other.CREpackageA.SAUEis98%.ThestudyisaToX/harm=1applicator,passofthesenioradulttestin16CFRchildfail=1applicator1700.20andtheeffectivenessspecificationsin16CFR1700.15(b).480598063whiteapplicatorswith1setof31childXCRPCertification5f27/10is acceptable.-,ogFipronil1746·005bluestripeonlabelapplicatorsfailure=Labeldated6/29/10sameCRPdirectionsasonlyconnectedtoeachother.connectedPass50instudy.Eachapplicator@toeachchildtestDataAnalysisshowedoneagecalculation4.02mlwaterasplacebo.other.error,a44montholdmalewasreportedas45Tox/harm.=1applicator,monthsold.TheagedistributionIsnotinchildfail=1applicatoraccordancewith16CFR1700.20.Thestudyresultsarenotaffected.Therewas1childfailure,a44montholdmaleaccessed1applicatorafterdemonstration.Studyisapassofthechildtestaccordingtothesequentialtestchartin16CFR1700.20.5EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unitfpkg,childfail:=:#ChildGeteRESAUEComprehOnlyincludeeRE&SAUEviacomputeranalysisunits,color,tax/harm=#atBeginensiveCampunitsTestReviewuter&whyAnalysis25t7-RGA480598063whiteapplicatorswith1setof397%XCRPCertification51271toisacceptable.DogFipronil1746-005bluestripeonlabelapplicatorsSAUELabeldated61291tosameCRPdirectionsasonlyconnectedtoeachother.connectedinstudy.Eachapplicator@toeachDataAnalysisshowedtbirthdatewas4.02mlwaterasplacebo.other.missing.UponfindingitinthehardcopyofTox/harm=tapplicator,datatheagecalculationwasokay.Thestudychildfail=tapplicatorresultsarenotaffected.Therewasoneagecalculationerror,butthetestsubjectremainedinthesameagegroup.Thestudyresultsarenotaffected.Theresultsshowed3seniorsfailedtoopenpackageA.SAUEis97%.Thestudyisapassofthesenioradulttestin16CFRt700.20andtheeffectivenessspecificationsin16CFRt700.15{b).6.September28,2010CRPdatasummarychtEPAREG#2517·RGLSergeant'sFipronil+S·MethopreneSpotOnForCatsCompanyNameSergeant'sPetCareProducts,Inc.Chemical·Fipronil9.8%S·Methoprene11.8%ASeniorAdultUseEffectivenessfailureisfailuretoaccesstheapplicatorintheprescribedtesttimeof5min.forthefirstpackageor1min.forthesecondpackage,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicatorbetweenthecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthema',n:hamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailureisaccessto1unit.Accessto1unitismorethan28.5mgofFipronilforallsizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteaccesstotheplacebo(water).Accesstoatoxicorharmfulam!=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&S·MethopreneCatEPAREG#2517·RGLAccesstoatoxicorharmfulam!=28,5mg=28.5mgdividedby[1020mg/mlx0.098Fipronil]=0.285ml=0.29mlforFipronil&S·MethopreneDogEPAREG#2517·RGUYoAI.Fipronil9.8%S·Methoprene11.8%Note:1.2.3.Theapplicatoristhechild·resistantfeature.Theapplicatorsarefilledinml.10CRPstudiesweresubmittedbytheCompanytocoverthe5sizes(0,5,0.67,1,34,2.68,4,02ml)fortheFipronilonlyandtheFipronilandS·Methopreneproducts,Thisisbasedontheregistrant'ssubmissionof:samplesoftheapplicatorastestedandproposedtobemarketedfortheFipronilonlyandtheFlpronilandS·Methopreneproducts,whichappearedtobeidentical;andaJune30,2010letterindicatingthesameapplicatorcolor(white)andfillweightcolorswillbeusedforboththeFlpronilonlyandtheFipronilandS·MethopreneproductsaswasusedintheCRPtesting.7EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#uniUpkg,childfail=#ChildGetateRESAUEComprehOnlyincludeeRE&SAUEviacomputerunits,color,tox/harm::#BeginTestensiveComputeranalysisunitsReviewAnalysis&why2517-RGL3whiteapplicatorswith1setof3CRPCertification5/27/10isCatFipronil+S-purplestripeonlabelapplicatorsacceptable.Labeldated6/29/10J\'1ethopreneconnectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicator@O.5mltoeachmentionedbelow.Sizenotacceptedwaterasplacebo.other.basedon:ToX/harm=1applicator,MRID48059503(1746-001),EPAchildfail:::1applicatorRegNo.2517-RGT.Studyisapassofthechildtestaccordingtothesequentialtestchartin16CFR1700.20.TheSAUEis90%.However,onetestsite(902)had33%ofthetestsubjects.Thisexceedsthemaximumnumberofsubjectspertestsite(24%)per16CFR1700,20(8)(3)(1).Therefore,thisCRPtestdataisunacceptable.BridgingLeUer6/30/10indicatingsamesizeandcolorpackageas,,---packagetestedisokay.8September28,2010CRPdatasummarychtEPAREG#2517-RGUSergeant'sFipronil+S-MethopreneSqueezeOnForDogsCompanyNameSergeant'sPetCareProducts,Inc.Chemical-Fipronil9.8%S-Methoprene8,8%ASeniorAdultUseEffectivenessfailureisfailuretoaccesstheapplicatorintheprescribedtesttimeof5min.forthefirstpackageor1min.forthe secondpackage,notopeningtheapplicatorwithscissorsalongtheneedleapplicationtip,cuttingtheapplicatorbetween.thecapandthebodyofthemainchamber,cuttingintothebodyofthemainchamberoftheapplicator,cuttingintothebodyofthemainhamberoftheapplicatoratotherlocations,cuttingoffthebottomofthemainchamberoftheapplicator,ornotseparatingasingleapplicatorfirstandcuttingopenasecondorsecondandthirdapplicator.Achildfailureisaccessto1unit.Accessto1unitismorethan28.5mgofFipronilforallsizes.Aunitfailureisopeningtheapplicatororanypartialorcompleteacoesstotheplacebo(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-RGUI.AI-Fipronil9.8%S-Methoprene8.8%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.9EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#unit/pkg,childfail=#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputerunits,color,tax/harm=#atBeginensiveComputeranalysisunitsTestReviewAnalysis&why2517-RGU3whiteapplicatorswith15etof3CRPCertification5/27/10isDogFipronil+S·orangestripeonlabelapplicatorsacceptable.Labeldated6/29/10Methopreneconnectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicator@O.67mltoeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:BridgingLetter6/30/10ToX/harm=1applicator,indicatingsamesizeandcolorchildfail=1applicatorpackageaspackagetested;andpassingeRE&SAUEvaluesper16CFR1700forMRID48059803(1746-002)EPARegNo.2517-RGA2517-RGU3whiteapplicatorswith1setof3CRPCertification5/27/10isDogFipronil+S-greenstripeonlabelapplicatorsacceptable.Labeldated6/29/10Methopreneconnectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicator@1.34m1toeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:BridgingLetter6/30/10ToX/harm-=1applicator,indicatingsamesizeandcolorchildfail=1applicatorpackageaspackagetested;andpassingCRE&SAUEvaluesper16CFR1700forMRID48059804(1746-.003)EPARe9No.2517-RGA.J17-RGU3whiteapplicatorswith1setof3CRPCertification5/27/10isDogFipronil+s-redstripeonlabelapplicatorsacceptable.Labeldated6/29/10Methopreneconnectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicator@2.68mltoeachmentionedbelow.Sizeacceptedwaterasplacebo.other.basedon:BridgingLetter6/30/10Tax/harm-=1applicator,indicatingsamesizeandcolorchildfail-=1applicatorpackageaspackagetested;andpassingCRE&SAUEvaluesper16CFR1700forMRID48059805(1746-004)EPARegNo.2517-RGA10EPAREG#MRIDPKGDescriptionInclude#PkgesCompanyDataDataConclusionmlperPkg#uniUpkg,childfail::;;#ChildGetCRESAUEComprehOnlyincludeeRE&SAUEviacomputerunits,color,tox/harm=#atBeginensiveComputeranalysisunitsTestReviewAnalysis&why2517-RGU3whiteapplicatorswith1setof3CRPCertification5/27/10isDogFipronil+S-bluestripeonlabelapplicatorsacceptable.Labeldated6/29/10Methopreneconnectedtoeachother.connectedsameCRPdirectionsasinstudyEachapplicator@4.02mltoeachmentionedbelow.Sizeaccepted-waterasplacebo.other.basedon:BridgingLetter6/30/10Tox/harm::;:1applicator,indicatingsamesizeandcolorchildfail:::1applicatorpackageaspackagetested;andpassingeRE&SAUEvaluesper16CFR1700forMRID48059806(1746-005)EPARegNo.2517-RGA.ProductToxicitybasedonFipronilToxicityAccesstoatoxicorharmfulamt=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-RGAAccesstoatoxicorharmfulamt=28.5mg=28.5mgdividedby(1025mg/mlx0.098Fipronil]=0.284ml=0.28mlforFipronil&5-MethopreneCatEPAREG#2517-RGLAccesstoatoxicorharmfulam!=28.5mg=28.5mgdividedby[1020mg/mlx0.098Fipronil]=0.285ml=0.29mlforFipronil&5-lethopreneDogEPAREG#2517-RGU11EPAReg#ml(ml=f1.oz.(f1.oz.:::::Product%FipronilmgFipronil#unit=toxIhannfulamt0.0338fl.29.6ml)Density**g/m**1oz.)2517-RGT0.50.0171.0309.749.9612517-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-RGU4.020.1361.0209.8401.841I

## DATA PACKAGE BEAN SHEET

Date:**12-May~201** 0

Page 1 of 1



## * * 

## * Registration Information 

### * * 

### * Decision 

### #: 425454

DP 

### #: (377644)



### PRIA

Parent DP 

### #:

Submission 

### #: 873355

Registration: 2517-RGL

- SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FOR (

Company: 2517· SERGEANT'S PET CARE PRODU.CTS, INC,

Risk Manager: RM to

- Richard Gebken· (703) 305-6701 Room# PY1 5-7237

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS -; \

Sent Date:

_____ Calculated Due Dale:**~ ~..,.-r**  Edijed Due Date:

____ _

Type of Registration: Product Registration

- Section 3

Action Desc: (R310) NEW PRODUCT:NON-FAST TRACK (INCLUDES REVIEWS?F PRODUCT CHEMISl

Ingredients: 105402, S-Methoprene(11.8%)

129121, Fipronil(9.8%)



### * * * Data Package Information 

### * 

## * *

Expedite: 

## 0 Yes. No Dale Sent: 12-May-2010 Due Back:

___ _

DP Ingredient: 105402, S-Methoprene

t29121, Fipronil

DPTitle:**"E~ffi~"~'~y** __________________________ _

CSF Included: • Yes 

## 0 No Label Included: • Yes 

## 0 No Parent DP #:

____ _

Assigned To Date In Date Out

Organization:**"R~D~I~IB,,--** ________**~** ____ Last Possible Science Due Dale: 05-0ct-2010

Team Name:**,E~ffi~,,~oy,,-,(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 fipronilJ3-methoprene EP: presumably me-too of Medal's Frontline 65331-4.

Thx, baa

### Efficacy Review

Date: 

### December 27, 2010

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

### myers.clayton@epa·gT~ --1:

### ~\~ 

### 703-347-8874

## ~ \'1-1-



### Risk Manager Rev.: Rosanna Louie

Products:



### EPA Reg, #:



### A.I.'s:

Decision #s:



### DP#s:

Submissions:



### MRIDs: Sergeants Fipronil 

### + S-methoprene Spot-on for Cats



### 2517-RGL

Fipronil, S-methoprene



### 425454

377644

R310, New Products, RD Science Review



### Cited: 44942010,44942011,45628101,45628102,45628103,45628104,

45628105,46019202

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 by Line Review of Label Claims that Must be Removed:

-All 'repels' claims must be removed

-All claims against flea pupae must be removed

-6 [Six] Way Protection, 7 [Seven] Way Protection: These claims are deferred to the RM

ReviewerlPM**~"[brand** 

### name J contains Fipronil and**S~Methoprene** 

### (insect growth regulator) (IGR) to

effectivelY kill [and repel] fleas (all stages) and ticks [(including those that may transmit Lyme

Disease)]. The active ingredients in [brand name] work 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~actingl** 

### and**long~lastingJ** 

### control of fleas,

ticks, mosquitoes, and chewing lice [for 30 days]. [diagram with visual offipronil collecting and

being released from hair follicle J": 'repel' claim must be 

### deleted. The statement regarding

movement and deposition of fipronil through hair follicles (and accompanying diagram) is

deferred to the RM Reviewer/PM.

## DATA PACKAGE BEAN SHEET

Date: 12-May-2010

Page 1 of2



### * * 

### * Registration Information 

### * * 

## * Decision 

### #: 425454

DP 

### #: (377642)

PRIA

Parent DP#:



### Submission #: 873355

Registration: 2517-RGL

- SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FOR (

Company: 2517

- SERGEANT'S PET CARE PRODUCTS, INC.

Risk Manager: RM 10

- Richard Gebken

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

Risk Manager Reviewer: Booaveolure Akinlosotu BAKINLOS

Sent Date:**~~~~~** CalCulated Due Date: 04-Nov-2010

Type of Registration: Product Registration

- Semion 3 Edited Due Dale:**~~~~~**

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

tngredients: 105402, S-Methoprene(11.8%)

129121, Fipronil(9.8%)



### * * 

### * Data Package Information 

### * * *

Expedite: 

## 0 Yes. No

DP Ingredient: 105402, S-Methoprene

129121, Fipronil

DP Tme: Prod Chem

CSF tncluded: • Yes 

## 0 No Date Sent: 12-May-2010

label Included: • Yes 

## 0 No Parent DP #: Due Back:**~~~~~**

Assigned To Date tn D.teO,' /**~~~~~** last Possible Science Due Da1e: 05-Dct-2010 Organization:**cR~D~I~TcR~B~~~~~~~_**

Team Name: CHEM Science Due Date:**~~~~~**

Reviewer Name:**~~~~~~~~~~_** Sub Data Package Due Date:**~~~~~**

Contractor Name:**~~~~~~_~~~_**



### * * * Studies Sent for Review 

### * * *

Prinled on Page 2



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

### * * *

No Additional Data Packages



### * * * Data Package Instructions 

### * * *

For Your Review: MRtD 480594 -01 & 02 for an R310 action, a fipronilf3-me\hoprene EP; presumably me-too of Meriafs Fron1line 65331-4.

Thx, baa4805940t

48059402

48059402

48059402

4805940t

48059402

4805940t

48059402

48059402

4805940t

48059402

4805940t

48059402

48059402

48059402 Page 2

Spot-On

Unpublished study 

# ,<e,"'" by

Inc. 40 p.

Messina, J. (20 to) Group A Product Chemistry for Fipronil Cat

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/10/14.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 40 p.

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

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/10/t5.**U~published** study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

Messina, J. (20 to) Group B Product Chemistry for Fipronil Cat

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/10/15.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

Messina, J. (20tO) Group B Product Chemistry for Fipronil Cat

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/10/t5.

Unplblished study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

Messina, J. (20 to) Group A Product Chemistry for Fipronil Cat

Spot-On I (25t7-RGL). Project Number. SERGEANT/S/04/fO/14.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 40 p.

Messina, J. (20tO) Group B Product Chemistry for Fipronil Cat

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/Q4/10/15.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

Messina, J. (20 to) Group A Product Chemistry for Fipronil Cat

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/fO/!4.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 40 p.

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

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/tO/t5.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

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

Spot-On I (25t7-RGL). Proiect Number: SERGEANT/S/04/10115.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

Messina, J. (2010) Group A Product Chemistry for Fipronil Cat

Spot-On I (2517-RGL). Project Number. SERGEANT/S/04/1Qf14.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 40 p.

Messina, J. (20 to) Group B Product Chemistry tor Fipronil Cat

Spot-On I (2517-RGL). Project Number. SERGEANT/S/04/tO/15.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

Messina, J. (2010) Group A Product Chemistry for Fipronil Cat

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/10/t4.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 40 p.

Messina, J. (20 to) Group B Product Chemistry for Fipronil Cat

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/tO/t5.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

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

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/10/15.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 6 p.

Messina, J. (20 to) Group B Product Chemistry for Fipronil Cal

Spot-On I (25t7-RGL). Project Number: SERGEANT/S/04/tO/t5.

Unpublished study prepared by Sergeant's Pet Care Products,

Inc. 6 p. 830. t670/Discussion of formation of

impurities

830.63 t3/Stability to sunlight,

normal and elevated temperatures,

metals, and metal ions

830.7 t OONiscosity

830.6303/Physical state

830. tSSO/Product Identity and

composition

830.6304/0dor

830. t7S0/Certified limits

830.6314/0xidizing or reducing

action

830.63 t 6/Explodability

830. t620/Description of production

process

830.6302/Color

830.1600/Description of materials

used to produce the product

830.631S/Flammability

830.63 t9/Miscibility

830. 730010ensitylrelative density

# FEE

DP BARCODE No.: 377642 FILE SYMBOL No.:2517-RGL DECISION No.: 425454

PC Coders): 129121 ACTION CODE: R 310

FOOD Use: NO NON-FOOD Use: YES

DATE OUT: August 31, 2010

SUBJECT:

FROM:

TO: End Use Product Chemistry Review

P:\duct Name:SERGEANT'S FIPRONIL+METHOPRENE SPOT ON FOR CATS

# \~\**b~h\O** 

# , [::aira Gairola

.

# ~ 

# q! -v.l ) U

Pra8uct Chemistry Team

Technical Review Branch I 

### Registration Division (7505P)

Richard Gebken !Bonaventure 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#s480594-0l and -02). TRB has been asked to detennine the acceptability of the product

chemistry data and the proposed basic anda.altemate CSF's.

SUMMARY OF FINDINGS:

1. Name of Active Ingredient(s): Fipronil and Methoprene

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 ofFormula(s):

[X] Basic

- 

### 12/21109 Dated:

[X] Alternate # 1 &# 2 - Dated: resubmitted (email)

- Dated 

### 08/31110:

submitted (email)

- Dated 08/31110

Alternate CSF(s) complies with 40CFR§152.43: 

### [X] Yes [] 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) concur with product label



### (PR 

### Notice 91-2)

[ ] Yes, 

### if not, explain below:

Metallic equivalent: [



### Soluble arsenic: [

Isomeric ratios:

Acid equivalent: [

[ 

## 1 Yes



## 1

Yes



# 1 Yes

lYes 

# [ 1 NA; 

## [ 1 NA 

## [ 1 NA

[ ] NA; {name} acid equivalent = 

### xx %



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

Petroleum distillate at 

### > 10%:



### Methanol at> 4%: [ lYes [ lNo [ lNA

[ lYes [ lNo [ 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

M 

### 6? [ ] Yes, 

### if not, explain below:

d. Label requires an additional Storage and Disposal statement: [ 

## J Yes [X] No; 

### if yes explain

below:

2

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

PC Coders):

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

NON-FOOD Use: Yes

6. Group A: Product Chemistry Data

TRB'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 MRlDNos.

Product Identity &



### 830.1550 Composition 

### X A 

### 480594-01

Description of materials used



### 830.1600 to produce the product 

### X A 

### 480594-01

Description of formulation



### 830.1650 process 

### X A 

### 480594-01

Discussion on the formation



### 830.1670 

### of impurities X A 

### 480594-01

830.1700 Preliminary analysis



### Standard

certified



### Certified limits



### limits

(158.350) Proposed Limits

Justification for



### 830.1750 wider 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. GroupB:



### Guideline Study Title

No.

830.6303 Physical State

830.6315 Flammability

830.6316 Explodability

830.7000 

### IpH

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

roduct 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.

480594-02

480594-02

480594-02

480594-02

480594-02

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

has concluded:



### 1. Basic CSF resubmitted (email)**~** 

### Dated 

### 08/31110 is acceptable and attached

2. Alternate CSF(s) #1  Dated 

### 08/31110 are Acceptable and attached

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

Enforcement analytical method.

4. AU 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.

4

## DATA PACKAGE BEAN SHEET

Date:**12~May~201** 0

Pagelof1



### * * * Registration Information 

### * 

### * * Decision 

### #: 425454

DP 

### #: (377643)

PRIA

Parent DP 

### #:

Submission 

### #: 873355

Registration: 2517-RGL

- SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FORCJi(S 

# (\}1. \.0

Company 2517

- SERGEANT'S PET CARE PRODUCTS, INC (,

## ~ \

Risk Manager RM 10

- Richard Gebken

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

# ~~ 

# V

Risk Manager Reviewer Bonaventure Aklnlosotu BAKINLOS / 

# 0-

Sent Date: Calculated Due Date: 04-Nov-2010 Edited Due Date:

____ _

Type of Registration: Product Registration

- Section 3

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

Ingredients: 105402, S-Methoprene(11.8%)

129121, Fipronil{9.8%)



### * * * Data Package Information 

### * * 

## *

Expedite: 

## 0 Yes. No

DP Ingredient: 105402, S-Methoprene

129121, Fipronil

DP Title: Tox: Similarity Date Sent: 12-May-2010 Due Back:

____ _

CSF Included: • Yes 

## 0 No Label Included: • Yes 

## 0 No Parent DP #:

____ _

Assigned To Date In Date Out /'

_____ Last Possible Science Due Date: 05-0ct·2010 / Organization:**cR~D~/~TcR~B** _______ _

Team Name:**~TO~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 R310 action, a new fipronil/3-methoprene EP; presumably me-too of Merial's Frontline 65331-4.

Thx, baa

### UNITED STATES ENVIRONMENTAL PROTECTlON AGENCY

WASHINGTON, D.C. 20460

September 15,2010

MEMORANDUM OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION



### Subject: Name of Pesticide Product: SERGEANT'S FIPRONIL 

### + S-METHOPRENE

SPOT-ON FOR CATS

EPA Reg. No. !File Symbol: 2517-RGL

DP Barcodes: DP 377643



### Decision No.: 425454

Action Code: R310

PC Codes: 129121 (Fipronil: 9.8%); 105402 (S-Methoprene:

11.8%)

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

Teclrnical Review Branch

Registration Division (7505P) 

# (7

# ~ 

# n

..-J.--..-,

### 5~V+ 

### - 

## lS-**_~'l-O\O** . 

# 1'1

To: Bonaventure Akinlosotu/Richard Gebken RM 10

____ ---

Insecticide Branch

Registration Division (7505P)

Registrant: SERGEANT'S PET CARE PRODUCTS, INC.

FORMULATION FROM LABEL:

Active Ingredient(s):

129121 Fipronil

105402 (S)-methoprene

Other Ingredient(s):

TOTAL

ACTION REQUESTED: The Risk Manager requests: Bywt.



### 9.8%

11.8%



### 78.4%

100.0%

"For Your Review: An R31 0 action, a new fipronillSMmethoprene EP; presumably me-too of

Medal's Frontline 65331-4."

Page 1 of3

### BACKGROUND:

To support the registration of EPA File Symbol 2517-RGL, the registrant is citing 5 acute

toxicity studies (MRIDs 44942004 through 44942008), as well as a number of companion animal

(referenced under guideline 870.7200) studies (MRIDS 43577711, 43577716, 44942009, and

45618502). The material received for review also includes a proposed label, a CSF dated

12/2112009, 

### and a copy of a cover letter dated April 12, 2010.

COMMENTS AND RECOMMENDATIONS:

1. 

### After a comparison of the CSFs, TRB concludes that 2517-RGL is toxicologically similar to

65331-4, and that the toxicity studies that supported the registration of 65331-4 will also

support the registration of 2517-RGL.

2. MRIDs 44942004 through 44942008 were reviewed and accepted in a memorandum dated



### December 12, 1999 from M. Hashim to A. 

### Sibold; the fonnulation (10% Fipronil and 12%

Methoprene) was assigned to EPA Toxicity Category III for oral toxicity, and to Category IV

for dermal toxicity, primary eye and dermal irritation. The inhalation toxicity study

requirement was waived, and, based on the precautionary label recommendations, the

product was assigned to Category IV by that exposure route. The product was negative for

dermal sensitization.

3. 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 HED review (TXR 0011764, memorandum dated January 24,

1996) and classified as supplementary.

The proposed label for 2517-RGL includes the following claim (based on the study in MRID

435777l6?): "The active ingredients in [brand name] work by collecting in the hair follicles

and skin oils. This product features a sustained-release formula that discharges from the

animal's hair follicles using the natural skin 

### oils

... " This should be deleted from 25l7-RGL,

and the similar claim for 65331-4 ("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.

4. In a IRB memorandum (M. Hashim & 

### B. Backus to A. Sib old) dated April 12, 2000, it

was stated that the interim report in MRID 44942009 (a study conducted on kittens that were

52-59 days old at the initiation of the study) was acceptable, assuming that there were no

additional adverse effects in the final report and with the stipulation that the dosage rate was

consistent with (no more than) the IX application rate in this study (0.5 mLlkg).

5. In a TRB memorandum (B. 

### Backus to A. 

### Sibold/A. Layne) of September 23, 2002 it was

stated that the study in MRlD 45620507 was acceptable, and that the findings of this study

were adequate to support the use of EPA Reg. No. 65331-4 at the dosage rate of 0.5 mLlcat

at 28-day intervals on breeding, pregnant and lactating female cats.

6. There is no record in IHAD of a review for MRID 43577711. According to OPPIN Query

Page 2 of3

### 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.

7. TRB concludes that these cited studies will satisfy the toxicity data requirements for the

registration of2517-RGL.

8. The proposed precautionary labeling and first aid statements for 2517 -RGL are acceptable.

9. For the purposes of this action, TRB has not reevaluated previouslY reviewed data.

10. The CSF (dated 12/2112009) 

### for 2517-RGL should also be reviewed and accepted by the

TRB Chemistry Team.

Page 3 of3UNITED ST ATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460



### April 19, 2010

OPP Decision Number: D-425454

EPA File Symbol or Registration Number: J517-RGL OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



### Product Name: SERGEANTS FIPRONIL 

### + S-METHOPRENE 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 I58TH PLAZA

OMAHA,NE 68130-1703

SUBJECT: Receipt of Application and 50% Small Business Waiver Request

Dear Registrant:

The Office of Pesticide Programs has received your application, 50% small business

waiver request, and cerification of payment. If you submitted data with this application, the

results of the**PRN~86-5** 

### screen will be communicated separately. During the administrative

screen, the Office of Pesticide Programs has detennined that this Action is subject to a Pesticide

Registration Service Fee as defined in the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: R310

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

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACy);

Your request for waiver has been forwarded for review. You will be notified in writing when a

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

overpaymen 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 al (703) 305-6249.

Sincerely,**~** 

# '/.i/WUt**~**

Front End Processing Staff

Infonnation Technology & 

### Resources Management Division

### change PRIA code

Linda Arrington to: John Jamula

Cc: Bonaventure Akinlosotu, Teresa Downs**--~'--'**

HOI JJ and Teresa, 04/16/201011:38 AM

Please change the following from R300 10 R310. Company has submitted 1he difference in fee already.

2517--RGU

2517-RGL

2517-RGA

2517-RGT

Linda Arrington

RegiS1ration Division

7033056249

7033056920 (fax)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460



### April 15, 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 OFFICEQF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



### Thank you for your submittal of 12-APR-1O. Our staff has completed a preliminary

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

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

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

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

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

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

Manager, to whom the data have been released.480594-00



### Pet Care Products, Inc.

2625 South 15Bth Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com



### April 12, 2010

Richard Gebken, PMl 0

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 

### + S-methoprene Squeeze-On for Cats

EPA File Symbol 25l7-RGL

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

Dear 

### Mr. Gebken:

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South l58 ili 

### Plaza, Suite 100, Omaha,

NE 68130-1703, EPA Company Number 2517) is 

### submitting additional data to support the

pending product registration for Sergeant's Fipronil 

## + S-methoprene Squeeze-On for Cats

(EPA File Symbol 25l7-RGL). 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. Yau 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. Instructionsfor 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 prodnct chemistry data specific to Sergeants' spot on

product Sergeant's Fipronil 

## + S-methoprene Squeeze-On for Cats (EPA File

Symbo12517-RGL). The new data are being snbmitted in accordance with PR

Notice 86-5 and Sergeants listed these studies in the new enclosed data matrix.

### Sergeant's 

### Pet Care Products, Inc.

2625 South 168th Fraza • 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/or each product. The currently approved CRP data/or

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

### #6) are also not citable for

purposes 

## 0/ 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 submitted a new Child Resistant Packaging study for review as part of

this package (an :MRID number has not been assigned). 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 find enclosed the following documentation 

### in support of our response:

1. Administrative materials:

• Transmittal document;

• 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 PRIA Payment Confirmation Receipt.

2. Product-specific product chemistry data.

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

Sincerely,

# ~ 

# 2. f.ksfLH 

# I z-i\ I

Kelly R. Hoskins

Manager of Technical Affairs

Sergeant's Pet Care Products, Inc.

EnclosuresSergeant's Pet Care Products, Inc.

2625 South 15Bth 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, ]nc. (EPA Company Number 2517)

2625 South 158 th 

### Plaza

Suite 100

Omaba, NE 68130-1703

Submittal Date: 

### April 12, 2010

Volume 

### Study Title 

### MRID

I Group A Product Chemistry for FiproniI Cat Spot-On I



### _(2517-RGL) 48059401



### 2 Group B Product Chemistry for Fipronil Cat Spot-On I 48059402 

### (2517-RGL)Please read Instructions on reverse before comp/etfng form. Form Approveu. OMB No. 2070-0060. Approval expi/es 05-31-98

United States

### ~_Registration OPP Identifier Number 

# EPA Environmental Protection Agency D.Amendment

Washington, DC 20460 

# o Other

Application for Pesticide

- Section I

1. Company/Product Number 2. EPA P/oducl Manager 3. P/oposed Classification

2517-RGL Richard Gebken

4. Company/Product (Name) 5.PM# 10

### ~None DResl/icted Semeants Fipronil + S-methoprene Spot-On For Cals

5. Name and Add/ess of Applicant (Include ZtP Code) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3)(b)(I), my

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

2625 South 158 th Plaza

Omaha, NE 68130 EPA Reg. No. 6533t-4

Product Name FRONTLINE PLUS FOR CATS

D Check ifthis is a new address

Section II 

# o

Amendment

- Explain below. 

# o

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

## [Xl Resubmission in response to Agency letter dated Ot·27-201 0 

# o

"Me Too" Application 

# o

Notification

- Explain below. 

# o

Other

- Explain below.

ExplanaJion: Use additional page(s) if necessary. (FOI section I and Section II.)

Section III

t. Material This Product Will Be Packaged In:

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type ot Container 

### cg] Yes· 

### cg] Yes DYes DMetal

DNO D No 

# I2J No 

### cg] Plastic

If "Yes" No. per If "Yes" No. per DGlaSs

·Certification must Unit Packaging wgt. Container Package wgt. Containel

Dpaper be submitted 0.017 fl oz (o.50m!r 2,3,4,6 

## I DOther (Specify) Plastic Bag

3. Loca)ion of Net Contents Info/mation 4. Size(s) Retail Container 5 Loca)ion ot Label Directions

### ~Label DContainel 0.017 f1 oz (O.50m!) Don Can

DOn Labeling accompanying product

6. Mannel in Which Label is Affixed to Product DLilhog/aph [gJOther

DPaper glved

DSlenciled

Section IV

1 Conlacl Point (Complete items directlv below for iden)iflcation of individual to be contacled, if necessary, to process this application.)

Name Title Telephone No. (Include A/ea Code)

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

Certification 6. Date Application

I certify that the statements I have made on this torm and all attachments thereto are true, accurate and complete. I Received

acknowledge Ihat any knowingly false or misleading statemenl may be punishable by fine or imprisonment or both (Stamped)

under applicable law.

2. Signature

# tf.-l~ 

# /?::1tT 3. Title

BY 

# Jlolw 

# t· Manager of Technical Affai/s

4. Typed Name: 5. Date: 

# 41 n/lo

Kelly R. HoskinsForm Approved OMS Nos. 2070-0060; 207{)'''()057; 2070-0107: 2070-Ot22; 2070-0164

.-"""- UN/TEO STATES ENVIRONMENTAL PROTECTION AGENCY 

## (t) SIirl, 1200 Pennsylvania Avenue, N_W_



# -'

WASHINGTON, D_C_ 20460

Paperwork ReductionAct Notice: Tre public reporting burden for this coltectico ofinforrmtion is estimated to avernge t25 hours per response for registration

and 025 hours per response forreregistratico and special review activities, including time for reading rre instructions and completing the necessary fonns. Send

comments regarding burden estimate orany other asp::ctofthis collection ofinfonnation, inclu::ling suggestiollS for reducing the burden to: Director, CoIlec6on

Straregies Divislco (2B22T), U.S. Enviwnmentill ProtectionAgeocy, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the completed fonn

to rhis address.

Certrfication with Respect to Citation of Data

Applicants/Registranrs Name, Address, and Telephone Number EPA Rellistration NumberfFile Symbol

Sergeant's Pet Care Producls, Inc., 2625 Soulh t58th Plaza, Omaha, NE 68130 2St7-RGL

Active InQred[enlts) and/or reoresenlaUve test compound(s) Dale

Fiproni! and S-methoprene 04/1212010

General Use Patern(s) (Iisl**a~** those claimed for this product using 40 CFR Part 158) Product Name

Indoor non-food Sergeanl's Fiproni! +S-methoprene Spot-On tor Co

NOTE: If your product is a 100% repackaging of another purchased EPA-regislered 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).



# D I am responding \0 a Data-Call-In Nolice, and have included with this form a list of companies sent offers of compensation (the Data Malrix form should

be used for this purpose).

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



# D I am using the cile-all method of support, and have Included with this form 

# 0 I am using the selectrve method of support lor cile-all oplion

a lisl of companies senl offers of compensation (the Data IIi1atrix form under the selective method), and have Included wrth Ihis form a

should be used for this purpose). compleled list of data requirements (the Data MalJix fonn musl be

used).

SECTION II: GENERAL OFFER TO PAY

IRequired if using Ihe**c~e-an** method or when using the cite-all option under the selective melhod to satisfy one or more data requirements) 

# 0 I hereby offer and agree to pay compensation, 10 other persons, wilh regard to the approval of this application, to the extent required by FIFRA.

SECTION III: CERTIFICATION

I certify that this appl'lcation for regislration, this form for reregislrofion, Cf" this Data-Call-In response is supported by all data submitted or ciled in the

application for registration, the form for reregistration, or the Data-Call-In response. In**add~ion,** if the cite-all option Of dte-all option under the selective mel hod is

indica led in Section I, this application is supported by all data in Ihe Agency's files that (t) concern the properties or effects ot this product or an identical or

subslantially similar product, Of one or more Of the ingredients in this product; and (2) is a Iype of data that would be required to be submitted under the data

requirements in effect on the dale of approval of this application if the app'ication sought the initial registration of a product of idenUcal or similar composijion and

lIses

I certify Ihat for each eXdusive use study cited ill support of this registration or reregistration, that I am the original data submil\er orthall have obtained

the wrillen permission oflhe original data submitter to**c~e** that study.

I certify thai for each study**c~ed** in support Of this registralion or reregistration that Is not an eXdusive use study, either: (a) I am Ihe original data

submitter, (b) I have obtained the permission of Ihe original data submitter to use the study in support of this application; (c) all periods of eligibility for

compensation have expired for the study; (d) the study is in the public literature; or Ie) I have notmed in wrWng the company that submitted the study and have

offered (I) 10 pay compensation to the extent required by sections 3(c){1)(F) and/or 3(c)(2)(S) of FIFRA; and Oil 10 commence negotiations to delermine the

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

I certify thai in all inslances where an offer of compensation is required, copies of all offers to pay compensation and evidence oftheirdel'lvery in

accordance with sections 3(c1l1)(F) and/or 3(c)(2)(S) of FIFRA are available and will be submitted to the Agency upon request. Shoud I fail to produce such

evidence to the Agency upon requesl, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in contormity with

FIFRA.

I certify that the statements I have made on thiS form and all attachmilnts to it are true, accurae, and complete. I acknoVliedge that any

knowingly false or mlsleadirg statement may be pUnishable I7f nno or imprisonment or both under applicable law.

Signature 

# J./ ,/,-,-,**~.**

# f/.,s~ 

# /t:It 

# r Date Typed or Printed Name and Title



### rI- 

# 4/1'L/to Kelly R. Hoskins, Manager of Technical Affairs

. EPA Form 8570-34 (12 2003) ElectronIC and Paper versions available. Submrt only Paper version

.

### Pay.gov

- Online Payment

Online 

### Payment



### Step 3: Confirm Payment

Thank you. 

### Page 1 of!

11 2 13

Your transaction has been successfully completed.

Pay.gov Tracking Information

Application Name: PRIA Service Fees

Pay.gov Tracking ID: 250LG6HI

Agency Tracking 10: 74110736947

Transaction Date and Time: 04/1212010 14:35 EDT

Payment Summary

Account Holder Name: Sergeants Pet Care Products

Payment Amount: $3,213.00

Account Type: Business Checking

Routing Number:

ACcount Number: **-*5483 Payment Date: 0411312010

Decision Number:

Registration Number: 2517-RGL

Company Name: Sergeants Pet Care Produc

Company Number: 2517

Action Code: R310



### httvs:llwww,oav,eov/oave:ov/oavments/authorizeACHPavment.html 4/12/2010FormAppro",dOI>lBNo.20'10.-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY-401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Tilepublicreportingburdenforthiscolleclionofinfonnationiscslimatcd10average0.25ltoursperresponseforregistrationactivitiesand025hoursperresponseforreregistrationandspecialreviewactivities,includinglimeforreadingtheinstructionandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinfonnation,includingsuggestionsforreducingtheburden10Director:OPPEInfonl13lionManagementDivision(2137)U.S.EnvironmentalProtectionAgency,40I MStreet,S.W.,Washington,DC20460,Donotsendtheformtothisaddress.DATAMATRlXDate:Ari112,2010EPARegNo.lFileSymbol2517-RGLPageIof5Applieant'slRegistrant'sName&AddressProduct:Scrgeant'sFipronE+MethoprcncSpotSergcant'sPetCareProducts,Inc.2625South158thPlaza,Suite100,Omaha,NE68130-1703OnforCalsIngrcdients:Fiproni!,MethopreneGuidelineReferenceNumberGuidelineStudyNameMRlDNumberSubmitterStatusNotc830.1550,830.1600,830.1620,ProductPropertiesDataforSergcant'sFipronil+NewsubmissionScrgeant'sPetCareProducts,Inc.OWN830.1650, 830.1670, 830.1700,MethopreneSpot-OnforCats830.1750,830.1800830.1800EnforcementanalytiealmethodNewsubmissionSeeant'sPetCareProducts,Inc.OWN830.6302,830.6303,830.6304,ProductchemislryofScrgcant'sFipronil+MethoprcneNewsubmissionScrgeant'sPetCareProducts,Ine.OWN830.7300,830.7000,830.6315,Spot-OnforCats830.7100, 830.6320,830.6317830.6317,830.6320StoragestabilityandcorrosioncharacteristicsTobesubmittedSergcant'sPetCarcProducts,Inc.OWNuponcompletioll870.1100Acuteoraltoxieity44942004MERIALLIMITEDPAY870.1200Acutedcrmaltoxie"!ty44942005MERIALLIMITEDPAY870.1400Primaryeyeirritation44942006MERIALLIMITEDPAY870.1500Primarydennalirritation44942007MERlALLIMITEDPAY870.1600Dermalsensitizalion44942008MERlALLIMITEDPAYEvaluationofthcCatSqueezeOnO.5mlWhitcApplieatorwithNewsubmissionSergeant'sPctCareProducts,Inc.OWNPurpleLabellndieator(3x),scissorstoopen-F=IasaPoisonPreventionPackageforSergeant'sPelCareProducts,Inc.870.7200Walker,K.(1995)DiscussioninSupportofBridgingDomeslic43577711MERIALLIMITEDOLDAnimalSafetyDataonFrontlineSprayTreatmenttoFrontlincSpotTreatmentDataPackage.UnpublishedstudypreparedbyRhoneMerieux,Ine.6p.Signature:Vth.ubfostuA.IrAINameandTitleDateKellyR.Hoskins,ManagerofTeclmiealAffairs04112/2010EPAFQrmgS;CCJS(9-97),ndPap.rVersion,AvaH.hleSubmil<mlyP'l"',..,.,ion.Ag,n.y[n"rn,1U..CopyUNITEDSTATESENVIRONMENTALPROTECTIONAGENCYo401MStreet,S.W.o WASHlNGTON,D.C.20460FormAppro>ed01\IDNo.2070_00'0PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistralionactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforrcadingthein2crcgistrationcompletingthenecessaryforms.Scndcommentsregardingtheburdenestimateoranyotberaspecioftbiscollectionofinformation,includingsuggestionsforreducingtheburdentoDirector:OPPEInfonnationManagementDivision(2137)U.S.EnvironmenlalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthefonntothisaddress.DATAMATRlXDate:Aril12,2010EPARegNo.lFileSymbol2517-RGLPage2of5Applicant'sIRegistrant'sName&AddressProduct:Sergeant'sFipronil+MethoprenePetCareProducts,Inc.2625South158thPlaza,Suite100,Omaha,NE68130-1703Spot-OnforCatsInredients:Fironil,MethoreneGuidelineReferenceNumberGuidelineStudyNameMruDNumberSubmitterStatusNote870.7200VlIIage!iu,J.;Lopez,S.;Germa,M.;etal.(1994)43577716MERlALLJMITEDOLDPercutaneousAbsorptionandDistributionofRadioactivityinHair,Skill,andFatAfterSpot-OnApplicationof(Carbon14)-RM1601inCats:LabProjectNumbers:CD-9313748F.UnpublishedstudypreparedbyCentrodeInvestigacionyDesarroiloAplicado,S.A.L.42p.870.7200Clery,D.(1999)Fipronil/(S)-Methopreneffopicai/Solution/44942009MERIALLiMITEDPAVTargetSpeciesSafetyStudyintheCat:InterimFinalReport:LabProjectNumber:GBOl1199-00I:PR&D0023301.UnpublishedstudypreparedbyBiologicalLabs.EuropeLtd.127p.870.7200Godin,C.;Alva,R.(2000)ML-2,095,988508Q/CatiSolution/45618502MERJALLIMITEDPAVTopicallSafetyfroIerancelReproduction,Reactions:FinalReport:LabProjectNumber:PR&D0020301:WEL99886.UnpublishedstudypreparedbyWhiteEagleToxicologyLaboratory.88p.810.3300Voung,D.(1999)DoseTitrationStudyof(S)-Methopreneby44942010MERIALLIMITEDPAYTopicalAdministrationtoCats:FinalReport:LabProjectNumber:PR&D0010001.UnpublishedstudypreparedbyVoungVeterinaryResearchServices.42o.810.3300Marchiondo,A.(1999)DoseContinnationStudyofTopically44942011MERIALLIMITEDPAYAdministeredFipronil/(S)-MethopreneAgainstAdult(Ctenocephalidesfelis)inCats:FinalReport:LabProjectNumber:PR&D0023201.UnpublishedstudypreparedbySillelairResearchCenter,Jnco46p.810.3300Pollmeier,M.(1999)AnEfficacyStudyofFrontlineTopSpot45628101MERlALLIMITEDPAVfortheTreatmentandControlofFelicolasubrostratusintheCat:FinalReport:LabProjectNumber:PR&D0022201.UnpublishedstudypreparedbyCentroVeterinarioOriolo.18p.Signature:**VI**LLLJ....1.I , /"2_NameandTitleDaterNJKellyR.Hoskins,ManagerofTechnicalAffairs0411212010EPAFOLm857(1.)5(9.97)EI,tjnio."dPaperVersion,M.il,ble.SuomitonlyP'p<rveL>"JflAge"oylnl<rn.lU"CopyFo,,,,ApprovedOMJINo.20'101.0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY•401MStreet,S.W.•WASHINGTON,D.C.20460PapenvorkReductionActNotice:Thepublicreportingburdcnfbrdliscollectionofinformationiscstimatedtoavcragc0.25hoursperresponscforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimcforreadingthein3eregistrationcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdentoDirector;OPPEInformationManagementDivision(2137)U.S.EnvironmentalPrOleetionAgency,40tMStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRlXDate:April12,2010EPARegNo.lFileSymbol2517-RGLPage3of5Applicant'sJRegistrant'sName&AddressProduct:Sergeant'sFiproniJ+MethoprenePetCareProducts,Inc.2625South158thPlaza,Suite100,Omaha,NE68130-1703Spot-OnforCatsIngredients:Fipronil,MethoprcneGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote810.3300POllmeier,M.;Pengo,G.;Barrick,R.(2000)AnEfficacyStudy45628102MERIALLIMITEDPAYofFrontlineSpray,FrontlineTopSpotandML-2,095,988508QfortheTreatmentandControlofFelicolasubrostratusin(heCat:PinalReport".LabProjectNumber:PR&D0037201.UnpublishedstudypreparedbyCentroVctcrinarioOriolo.22p.810.3300Pollmcier,M.;Pengo,G.(2001)StudiestoConfinntheEfficacy45628103MERIALLIMITEDPAYofFiproniiAgainstLiceinCatsUnderFieldConditions:FinalReport:LabProjectNumber:PR&D0037501.UnpublishedstudypreparedbyCentroVeterinarioOriolo.20p.810.3300Pos(al,1.;LeNain,S.;Gonzalez,C.;e(a1.(1999)Studiesto45628104MERlALLIMITEDPAYAsess(licEfficacyofFrontlineSpot-On(10%w/vFipronil)inthcTreatmentofFelineFleaAllergyDennatitis(FAD)UnderFieldConditions:FinalReport:LabProjectNumber:ASH.19012:CLl277.UnpublishedstudypreparedbyMedaL64p.{OPPTS810.3300)810.3300Alva,R.;Barrick,R.(1999)AStudytoDetenninetheEffectof45628105MERlALLIMITEDPAYTreatmentwithFrontlineTopSpoton(hePrevalenceandSevcrityofFleaAllergyDcrmatitisinCats:FinalReport:LabProjectNumber:PR&D0012701-04:PR&D0012701:PR&D0012702.UnpublishedstudypreparedbyVCAStPetersburgAnimalHospitalandAltamahaAnimalClinc.41P.810.3300McCall,1.(2003)AStudytoEvaluatetheEfficacyofFrontline46019202MERlALLIMITEDPAYPlusforControlofMosquitoes,Aedesaegypti,onCats:FinalReport.ProjectNumber:PR!DI00951OI,009510LUnpublishedstudypreparedbyTRSLaboratories,luc.26p.133-3Meo,N.;Gonzalez,C.;Mester,T.(1997)DcnnalandInhalation44433302MERIALLIMITEDPAYExposureofCommercialPetGroomersDuringApplicationofFrOntlineSprayTreatment:FinalReport:LabProjectNumber:MERlAL-445-SAFXT046:SAFX046:PDA9705.UnpublishedstudypreparcdbyABCLabs.,CaliforniaandAanimalAppeal&CaseVeterinaryHospitaL1066P.Sign"oe,YtiL'E-.f{QSb..I'-SL<:J=JNamcandTitleDateKellyR.Hoskins,ManagcrofTcchnicalAffairs04112/2010EPAForm85'10.35(9.97)Elc'f/'nic..PaperV."ion,Availablo.Subrni!onlyPaperv"ionAg.ncy1"!ff"A!U,.CopyFOFmApPFovodOMB1'10.1070.0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY0401MStreet,0WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenfurthiscollectionofinfurmationisestimatedtoavcrage0.25hoursperrcsponseforregistrationactiviliesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimcforreadingthein4eregistrationcompletingtheneccssaryforms.Sendcommentsregardingtheburdenestimaleoranyotlicraspectofthiscollectionofinfunnation,includingsuggestionsforreducingtheburdentoDireclo7:OPPEInformationManagementDivision(2137)U,S.EnvironmentalProtectionAgency,401MStreet,S.W.,Wasllington,DC20460.Donotsendthefom)tothisaddress.DATAMATRlXDate:AprilI2,2010EPARegNo.IFHeSymbol2517-RGLPage4of5Applicant'slRegistrant'sName&AddressProduct:Sergeant'sFipronil+MethopreneSergeant'sPetCareProducts,Inc.2625South158thPlaza,Suite100,Omaba,NE68130-1703Spot-OnforCatsIngredients:Fipronil,MethoprcneGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote133-3Meo,N.;Gonzalez,c.;Belcher,T.(1997)DermalExposureor44433303MERIALLIMITEDPAYCommercialPetGroomersDUringApplicationofFrontlineTop"--Spot:FinalReport:LabProjectNumber:MERIAL-445-SAFXT047: SAFXT047:EC-97-390.UnpublishedstudypreparedbyABCLabs.,CaliforniaandAanimalAppealGroomingShop&CaseVeterinaryHospital.925P.132-1Hughes,D.(I997)DislodgeableResiduesofFiproniiFollowing44433304MERIALLMITEDPAYApplicationofFrontlineTopSpottoCats;FinalReport:LabProjectNumber:COVANCE6848·103:MERIALMETXT168:90066D.UnpublishedstudypreparedbyCovanceLabs.Inc.118p.132-1Hughes,D.(1997)DislodgeableResiduesofFipronilFollowing44433307MERIALLIMITEDPAYApplicationofFrontlineSprayTreatmenttoCats:FinalReport:LabProjectNumber:COVANCE6848·102:MERIALMETXT167:6848·I02.UnpublishedstudypreparedbyCovanceLabs.Inc.129p.132·1deFontenay,G.;Magloire,B.;Suberville,S.etal.(1997)44531201MERIALLIMITEDPAYDislodgeableResiduesofFipronilFollowingaTopicalApplicationofFrontlineSpot·OnTreatmenttoCats:FinalStudy:LabProjectNumber:MET417:817/023B.UnpublishedstudypreparedbyMerialLtd.andChrysalis.69p.132-1deFontenay,G.;Magloire,8.;Suberville,S.etal.(I997)44531202MERIALLiMITEDPAYDislodgeableResiduesofFiproniiFollowingaTopicalApplicationofFrontlineSprayTreatmenttoCats:FinalReport:LabProjectNumber:MET415:MERIAL-480·MET415:817f023A.UnpublishedstudypreparedbyMerialLtd.andChrysalisPreclinicalServices-Europe.7Ip.N/AIrwin,1.(1997)UseSurveyofCommercialandVeterinaryPet4443330IMERIALLIMITEDPAYGroomersandPetOwnersofFrOntlineTopSpotandFrontlineSprayTreatment:LabProjectNumber:MERIAL·445·SURVEY.UnpublishedstudypreparedbyWieseResearchAssociates,Inc.340p.Signature:1/,11....f...f!&sIti-:1NameandTitleDateKellyRHoskins,ManagerofTechnicalAffairs04/12/2010EPAForm8570-3519·971ElecU-<""dP'ne,V"'''O"'A..,lable.Submitonl,P,o"",e1,iOll,In..'n.1U"COI'YI'.r",Appr.v<dNo.2070·0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY•401MStreet,S.W.•WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscoliectionofinfonnationisestimatedtoaverage0.25hoursperresponseforregistrationaclivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingthein5ercgislratiollcomplctingthenecessaryfoms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinfimnation,includingsuggestionsforreducingtheburdentoDirector:OPPElnfonna!ionManagementDivision(2137)U.S.EnvimnmentalProtectionAgency,4QtMStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDate:Aril12,2010EPARegNoJFileSymbol2517-RGLPage5of5Applieant's/Registrant'sName&AddressProduet:Sergeant'sFiproni!+MethopreneSergeant'sPetCareProduets,Ine.2625South158thPlaza,Suite100,Omaha,NE68130-1703Soot-OnforCatsIngredients:Fipronil,MethoreneGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNoteHughes,D.(1997)ValidationofanAnalytiealMethodforthe44433308MERIALLIMITEDPAYDeterminationofFiproni!,M&B45950,andM&B46513inDye-Free100%CottonGloves:FinalReport:LabProjeetNumber:COVANCE6848-104:6848-104:MERIALMETXT169.UnoublishedstudypreparedbyCovaneeLabs.Inc.41o.Polakoff,B.;Youngren,S.(1997)Non-DietaryRisk44433309MERIALLIMITEDPAYAssessmentFipronilUseonPetsinaResidentialSetting:LabProjectNumber:FIPRONIL97-09:MERlAL-445-NDRA.UnpublishedstudypreparedbyNovigenSeienees,Inc.27P.Polakoff,8.;Youngren,S.(1997)PetGroomerExposure44433310MERIALLIMITEDPAYAnalysisandRiskAssessment:FrontlineTopSpotandFrontlineSprayTreatment:LabProjeetNumber:FIPRONIL97-11:MERIAL-445-PGRA.UnpublishedstudypreparedbyNovigenSciences,Ine.17D.Wall,H.(1998)FrontlineProduetsReportsofSuspected44531205MERIALLIMITEDPAYAdverseEventsAnalysisofBreed,AgeandSexDistributionofDogsandCats.UnpublhihedstudypreparedbyMeria!Ltd.8p.Polakoff,8.;Youngren,S.;Walls,C.(1998)Frontline44531206MERIALLIMITEDPAYTop-SpotandFrontlineSprayTreatment:DefinitiveShortTermandIntermediate-TermResidentialNon-DietaryRiskAssessment:LabProjeetNumber:FIPRONIL98-04:MERlAL-445-NDRA.UnpublishedstudypreparedbyNovigenScienees,lne.35p.Polakoff,B.;Youngren,S.;Walls,C.(1998)FrontlineTop44531207MERIALLIMITEDPAYSpotandFrontlineSprayTreatment:DefinitivePetGroomerEXposureAnalysisandRiskAssessment:LabProjectNumber:FIPRONIL98-07:MERIAL-445-LPERA.UnpublishedstudypreparedbyNovigenScienees,Inc.21p.Polakoff,B.;Youngreu,S.(1998)FrontlineonPetsina44531208MERIALLIMITEDPAYResidentialSetting:RiskAssessmeutofaLowProbabilityEventPost-ApplicationAcuteExposure:LabProjeetNumber:FIPRONIL98-06:MERlAL-445-PGRA.Unpublishedstudy,preparedbyNovigenSeienees,Ine.18p.Signature:VAil.{L/'7"-(NameandTitleDateKellyR.Hoskins,ManagerofTechnicalAffairs0411212010EPAFormS,7G-l,(9-97)Elec,"1#<""dP'pe,A.v.il.ble.Submitonlyp.t><'rv<rSio"In",,,.!U"Copy'--\'!'foiUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.estimateforreadingtheinstructionandcompletingthenecessary[oms.SendburdentoDirector:OPPElnfonnationManagementDivision(2137)U.s.Agency,401MStreet,S.W.,Sergeant'sPetCareProducts,Inc.2625South158thPlaza,Suite100,Omalia,NE68130-1703Sergeant'sOnforCatscollectionDC'....UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY•401MStreet,S.W.•necessaryforms.ili,.toDirector:Division(2t37)U.S.Agency,401MStreet,S.W.,+MethoprcneDCUNITEDSTATESENVIRONMENTALPROTECTIONAGENCYo401MStreet,S.W.oHNGTON,D.'ionisestimatedtoaverareregistrationandspecialIOfreatllnglhemJereglstralioncompJelingmenecessaryforms.Sendcommentsregardingtheburdenestimateoranyolheraspectofinformation,includingburdentoDirector:OPPEInformaliollManagementDivision(2137)U.S.EnvironmentalProtectionAgency,40\MStreet,S.W.,Washingtoll,DCUNITEDSTATESENVIRONMENTALPROTECTIONAGENCYooburdentoDirector:401MStreet,S.W.perresponsetorreglstrallonactivitiesandhOursperresponseSendcommenlSregardingtheburdenestimateoranyOlheraspectofthiscollection(2137)U.S.EnvironmentalProlectionAgency,40I MStreet,S.W.,Washington,DCPAY'-..reregistrationofinfonnation,UNITEDSTATESENVIRONMENTALPROTECTIONAGENCYthe'toDirector:••401MStreet,S.W.D.C.estimateoranyother.EnvironmentalProtectionAgency,40tMStreet,S.W.,PAY

### FW: Response to EPA Letter

James Messina



### to:

Bonaventure Akinlosotu



### 03/311201001:15 PM

Show Details

Sorry I misspelled your name in the email address on the first email.

Regards,

Jim

From; James Messina



### Sent: Wednesday, March 31, 2010 1:11 PM

To: akin]ostotu.bonaventure@epa.gov

Cc: Gebken.Richard@epamail.epa.gov; KHoskins@SERGEANTS,comi Rick Trrisworth; Larry Nouvel



### Subject: Response to EPA Letter

Mr. Akinlosotu, 

### Page 1 of!

On behalf of our client, Sergeant's Pet Care Products, Inc. {Sergeant's}, Exponent is responding to EPA's letter



### dated January 27, 2010 regarding the following registration applications:

1. Sergeant's Fipronil 

### +**S~methoprene** Squeeze-On for Dogs (2S17-RGU)

2. Sergeant's Fipronil 

### + S-methoprene Squeeze-On for Cats (2S17-RGl)

3. Sergeant's Fipron'rl Squeeze-On for Dogs (2517-RGA)

4. Sergeant's Fipronil Squeeze-On for Cats (2517-RGT)

Sergeant's intends to continue the support of the above-referenced**~egistrations** and will submit supporting CRP

data, a revised data matrix and product chemistry data to EPA no later than April 12, 2010.

If you have any questions, please contact me.

Best Regards,

James Messina

Senior Managing Regulatory Consultant

Exponent

Center for Chemical Regulation and Food Safety

1150 Connecticut Avenue, N.W.

Suite 1100

Washington, DC 20036

202-772-4932

202-772-4979 fax

301-90B-11B1 cell

### \



### 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: 2517-RGU, 2517-RGL, 2517-RGA, 2517-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 infonnation is needed. TIlls letter is a Mitten

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 (PRIA 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

ofthe 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 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 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 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 of this PR Notice

can be obtained at the following Agency web site:

http://www.epa.gov/opppmsdlIPR Noticeslpr98-5.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 fonnulator 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 ctuTently approved CRP data for the

referenced products listed on your 8570-1 fonn (block #6) are also not citable for purposes of

satisfying the data requirements outlined in 40 CPR § 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 re-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 PRlA 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.govduringthehours of 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.



# Sn

rely

, 

# p/Ld/UL

Richard 

### J. Gebken

Product Manager (I 

### 0)

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

Exp:ment



### 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: 2517-RGU, 2517-RGL, 2517-RGA, 2517-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 infonnation 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 mown as the

Pesticide Registration Improvement Renewal Act (PRIA 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 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 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 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 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 

### MRlD'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/opppmsdl/PR Notices/pr98-5.pdf.

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

chemistry data, since Sergeant's Pet Care Products, Inc. is the fonnulator 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 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 re-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.govduringthehours of 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.

# ~UL

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-425454

EPA File Symbol or Registration Number: 2517-RGL OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



### Product Name: SERGEANTS FIPRONIL 

### + S-METHOPRENE 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

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 hnprovement 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 End

# ~c~**m~~** ----

Infonn i'6n'P 

### chnolo esources Management Division

### Pay.gov

- Online Payment**Onlil!~ P~Xf!:l~nt**  Step 3: Confirm Payment

Thank you.

Your transaction has been successfully completed.

Pay.gov Tracking Information

Application Name: PRIA SeNice Fees

Pay.gov Tracking 10: 2505H008

Agency Tracking 10: 74094011145

Transaction Date and Time: 12/21/2009 11:54 EST

Payment Summary

Payment Date: 12/2212009

Decision Number: Account Holder Name: Sergeants Pel Care Products

Payment Amount: $1,365.00 Registration Number: Page 1 of I



### 1 

## 1213

Account Type: Business Checking

Routing Number:

Account Number.**~"'··5483** Company Name: Sergeants Pet Care Produc

Company Number: 2517

Action Code: R30Q



### h

ttps:1 /www.pay.gov/paygoY/paymen1s/authorizeACHPayment.htm I 12/2112009PI d ease rea Insl{lJclions on reverse before completing form. FOlm Approved. OMB No. 2070-0060. Approval**a~pires** 05·31-98

Uniled Stales

### ~ Registration opp identitier Number 

# 'EPA Environmental Protection Agency 

# o Amendment

Washinglon, DC 20460 

# D Other



### Application for Pesticide

- Section I



### ,.**companYfPf(){j~AY&Z** 2. EPA Producl Manager 3. Proposed Classification

2517-r:teA1'" Richard Gebken

4, CompanyfProdUCI (Name) 5.PM# 10

### ~Nona DRestfic'ed Selqeants Flpronil + S"methoorene Spot- On For Cats

5. Name and Address 01 Applicanl (Include ZIP OxIe) 6. Expedited Review. In accordance with FIFRA Seclion 3(c)(3)(b)(l), my

Sergeant's Pet Care Products, Inc. produCI IS Similar or identical in composition and labeling 10:

2625 South 1SS Ih Plaza

Omaha, NE 68130 EPA Reg. No. 65331·4

Producl Name FRONTLINE PLUS FOR CATS 

# o

Check II Ihis IS a new address

Section II



# D

Amendmenl- Explain below. 

# o

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

# o

ResubmiSSion in response 10 Agency leller dated XX-XX-XX

### ~ "Me Too' Application 

# o

NOliticalion

- Explain below. 

# o

Olher

- Explain betow.

Explanation: Use additional pagels) it necessary. (For seclion I and Seclion II.)

Submission 01 a new end· use regislralion applicalion.

Section III

,iAaterial This Product Will Be Packaoed tn:

Child-Resistant Packaging Unil Packaging Waler Soluble Packaging 2. Type 01 Conlainer 

# IZJ

Yes' 

## !Zl

Yes DYes 

# o

Metal

ONo 

# o No 

### is;] No 

### [2J Plastic

II "Yes" No. per It "Yes" No. per DGlass 'Certification must Unil packaging wgl. Conlalner Package wg1. Conlainel

DPaper be submitted 0.017 fl on (O.5Omll 2,3,4,6 

## I OOlher (Specity) Plaslic Bag

3. Location 01 Net Conlenls Intormation 4. Size(s) Releil Conlainer 5. Localion 01 Label Direclions

IX!Labet 

# o

Container 0.017 

### n oz (O.SOmt) Don Cen

Don Label"lng accompanying prOduct

6. Manner in WhiCh lebel is Atlixed 10 ProduCI Duthograph [Z]Olher

DPaper glued

DSlenclled

SectIon IV 

### , ,

3 , , , > 3

,

,. Contact Poinl (Com lele ilems direcll below tor idrmlificalion of individual to be conlac/ed. if necess_ary, 10 prpcess Ihis "pplicalion.)



### , ,

Name 

# I

Tille 

# I '"

Telephone No. (Includi}**Are~** Code)

Kelly R. Hoskins Manager 01 TeChnical Allairs • ,**,)~.o"l:·938-7079** ,



# - Certification 

# ' J:

15. Dale**~ppldHun** I certily Ihallhe statemenls I have made on Ihis torm and all aUachmenlS thereto arelrue, accurale and complete. I """**Rece,~ed"** ackno\\lledge Ihal arr; knowingly talse or misleading stalemenl may be punishable by line or Imprisonmenl or bolh ' , " (St',lr'l1pe'cD

under eoolicable law.**,~** , J , , "

,

# :yS~~ /L 

# /j_ /. 3. TItle 

### ""

, 

### ,

",



### , Manager 01 Technical Affeirs , 

### ,

, , 3 , ,

Nped f\!.;'l"ffie: 5. Dale: I2I21/2009 

### " 

# I , , , '"

, Kell R. Hoskins

### Sergeant's Pet Care PrOfiocts, Inc,

........ 

# _ .. 

# _._-_

... 

# _ .. 

## _-**-.~----.~.-.-** ..**-.-~-.-~--.**

15**D~cciliber** 

### 10U9

RidUlnl Cichkcn



### Prodlici**rVlnn:lgcr:?:~** D()!.:UIlICI1!**[lrnct~~sil'lg** De"k

Off-jet' II!' Pesticide 

### I'rograms

l .S. En\-lronmo::ni31 Prclicciioll Agency

Rnom S-4l)()(i. On..; PlllOnl,ll' Y,ml

2777 Somil 

### Crystal DriV<.:

Arlington. V A 22202-450 I

DCll1" \11'. Gebken:



### SerC-'l'()n(s Pet 

### Cue Products. 

### Jne.**(S~r~c;:1I1i's;** 

### 261:' Sl)llill 

### \SW h 

### Plaza. Olllah:l. t\CbrilSb



## -

.**~** 6){ 130- 1770. I":PA COl llj1any N umher 25 11), ;111 i Imri leS r,x pOllenl. I lie. () ) 50 en IlIleetic1 II

Alenll..:. 1\'W. $(Iit.: 1100, Wllshingloll DC, 1()0361wl1Ci Oil Ullr bellilll: ,IS (Iur

Alllhorized 

### Representai i 

### \'e, fell' (II] neccssa 

### r')! IIlicructiol1:o.: rega rei i 

### ng ,III 1I 

### r lllir prod\lcl

regisif<1tinll applications mid rcgislrlliiolls, PlcclSC nuie**thi~** dtles not 

### change iilc CUITCn!



### Iilcd Authorizo:.:d 

### Ageni fl)r 

### Scrgcrmt"s.

The Exponl'nl, file. eon(ae! is as fullows:

Jmlles Messina <lnc]iclY Rick Tins\v(1nll

Exponl:nt. Inc.

1150 Conned!Cu( Ave., N\V**~lJilt:** 1100

\Vashingtl)11. DC 20036

(202) 772-4932

(202) 772-4979 tin**jnl~ss!nJ(i:j'expoIle!ll.Golll/nins\Vlmh(u:(;XpnlleJll.com Slnc(:l'el~"** 

# /?::~;/**.'//cn,"t.~f~**

- .:/ ;' 

### Kclly R.**II(lskill~** ManClg.cr orleeilnic'-II 

### Affair;.:

CC: ,lames Messiilll

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

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

December 21, 2009

Richard Gebken, PMI0

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Document Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Child Resistant Packaging Certification

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;

• Sergeant's 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, 

# IU:f;A'dL..

Kelly 

### R. Hoskins

Manager of Technical Affairs

cc: Larry NouvelSergeant's Pet Care Products, Inc.

2625 South 15Bth Plaza • Omaha, NE**68130~** 1770 • Telephone 402.938.7000 • Fax 402.938.7099 • www.sergeanis.com

December 21,2009

Richard Gebken, PMl 0

Office of Pesticide Programs (7504P) (REGFEE)

U.S. Environmental Protection Agency

Document Processing Desk

Room**S~4900,** One Potomac Yard

2777 South Crystal Drive

Arlington, V A 22202

SUbject: Sergeant's Fipronil 

### +**S~methoprene** 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 applica1ion for the new product Sergeant's Fipronil 

### + S-methoprene

Spot-On for Cats (containing the EPA registered active ingredients Fipronil (9.8%) and**S~** methoprene (11.8%)). Please find enclosed the following documentation in support of this

registration:

(1) Application for Pesticide Form**(8570~1);** (2) Certification with Respect to Citation of Data Fonn (8570·34);

(3) Formulator's Exemption Statement Form (8570-27);

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

(5) Confidential S1atement of Formula (two copies);

(6) Product Label (five copies);

(7) PRIA category R300, Payment Confimwtion Receipt; and

(8) Letter of Authorization.

Sergeant's Fipronil 

### + S-methoprene Spot-On for Cats is substantially similar to Merial Limited's

EPA registered product FrontLine Plus for Cats (EPA Registration 

### # 65331-4). Sergeant's has

sent 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.**

Sincerely,

# !~i~/~

Manager of Technical Affairs

Enclosures 

### , , , , > > , ,



### "



### , If you have anY, ',,'



### "

, , 

### "



### , 

## -

,

"



### , , ,

, 

### , , 

### " 

### "

, ,



### ,

, 

### , "

,"



### , ,J"



### ,

, ,

"

"Form approved. OMS No. 2070·0060, 2070-0057. 2070-0107, 2070-0122, 2070-0164. 

# &EPA

, Uniled States

Environmental Protection Agency

Washinglon, DC 20460



### Formulator's Exemption Statement

(40 CFR 152.85)

Applicant's Name and Address EPA File Symbol/Registration Number

Sergeant's Pet Care Products,Inc. 2517-NEW

2625 South 158th Plaza Produci Name

Omaha, NE 68130 Sergeant's Fipronil 

### + S-methoprene Spot-On for Cats

Dale of Confldenlial Sialemeni of Formula (EPA Porm 8570·4)

12/2112009

As an aulhorized representalive 01 Ihe applicant for regislration of Ihe producl idenlified above, I certify Ihal:

(1) This product contains Ihe following active ingredlent(s}:

Fipronil (9,8%)

S-methoprene (11.8%)

(2) 01 Ihese, each aclive ingredientlisled in paragaph (4) is present solely as Ihe resull of the use of Ihat aclive 'Ingredient in Ihe manufacturing,

10rmulalion or repackaging anolher producl which conlains that aClive ingredienl which is regislered under FIFRA Seclion 3, is**purcha~d** by

us from another person and meels Ihe requiremenls of 40 CFR section 158_50(e)(2) or (3),

j (3) Indicale by checking (A) or {8} below which paragraph applias:

71 (A) An accurale ConOdential Sialemeni of Formula (EPA FORM 8570·4) for the above idenlified product is allached fo Ihis slatement.

Thai formula slalemenl indicates. by company name, registrallon number, and product name, the source of the aClive ingredienl(s) lisled in

paragraph (1).

OR



# , (8) The Confidential Stalement of Formula (CSF}(EPA Form 8570·4) referenced above and on fila wilh Ihe EPA is complele, currenl. an

accurale and contains the information required on the currenl CSF.

(4) The fonowing active ingredients in this producl qualify for Ihe formutator's exemption.

Source

Aclive Ingredienl Product Name Regislralion Number

Fipronil Teclmical



### , , "



### , , , 

### ,

,



### " ,



### , , ,

, " S-methoprene

, 

### , , ) " 

### ,



## , , , S-methoprene 

### " ,



### , , ,

, "

, " " 

### ,

, , , " " . 

### , 

### "

, , Signalure Name and Tille Dale 

### "



### , , 

## . ,

## ~L/l/!-AJ 

# . > , , >

Kelty R. Hoskins, Manager of Tecbnical Affairs 12/2112009 , 

### , '" ' 

### ! EPA FormUS70-27 (Rev. 06-2004) Copy 1 - EPJ< 

### "

, , Copy 2 -**Appllc3~LCDPY**Form Approued OMB Nos. 2070·0060' 2070-0057; 2070-0t07; 2070-0t22; 2070..()t54

/1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

1200 Pennsylvania Avenue, N.W.

WASHINGTON, D.C, 20460

paperwork Reduction ACl Notice: The pub(ic reporting rurdcn for this colleclion ofinfotDlBlion is**eslim~led** 10 aUerage t.25 hours p::r response for regisl,"lion

and 0.25 hours per respCflse for fercgistralian and speciat review activities, including lime for reading the instruclions and compleling Ihe necessary farms. Send

commCniS regarding burden estimate or allY olher**as~ct** of this collection of • Information, incll)(flng suggestions for reducing Ihe burden 10: DirCclOI, ColleClion

Stralegies Division (2S2ZT"), U.S. Environmcnlat Protection Agency, t200**Penn5ylvani~** Avenue, N.W., Washing'on, DC 20460. Do nOI send Ihe cOlilpleted form

10 lhis address.

Certification with Respect to Citation of Data

Appllcant's/Ref)istrant's Name, Address, and Telephone Number

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

Actiue Inoredient(s) and/or representatiue test compoundtsl

Fipronil and S-methoprene EPA Registretion Number/File Symbot

2517-NEW



# "'''

t212112oo9

Product Name General Use Pallern(s) (list all those claimed for this product usinQ 40 CFR Pert 158)

Indoor non-foOd Sergeant's Fipronit +S-methoprene Spot-On tOi Cats

NOTE: If your product is a 100% repackaging of enother purchesed EPA-registered produellabeted for ell the same uses on your label, you do not need to

submit this form. You must submit the Formuletor's Exemption Statement (EPA Form 8570-27).



# o

[2] I am responding to a Data-Call_In Notice, and have included with this form a lost of companies sent oilers of compensation (Ihe Data Matrix form should

be used for this purpose).

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

I am using the Cite-all method of support, and have included wilh this form

a list of companies sent offers of compensation (the Data Matrix form

Should be used for this purpose), 

# o I am using Ihe selective method of support (or cite-all oplion

under the selectiue method), and have included with this form a

completed list of data requirements (the Data Malrix form must be

used).

SECTION tt: GENERAL OFFER TO PAY

[Required it using the cite-all methOd or when using the cite-ell option under the selective method 10 satisfy one or more deta requirements] 

## 12] I hereby oller end agree to pay compensation, to other persons, with regard to the approval of this**applica~on,** to the extent required by FIFRA.

SECTION III: CERTtFtCATION

I certity that this application for registretion, Ihs form for reregistration, or this Data-Call-In response is supported by all data submilled or ciled in Ihe

epplication for re{lis(ration, the form for reregislration, or the Data-GaU-ln responSe. In addllion, jf the cite-all option or cile-all option under the selectiUe method is

indicated in Section t, this applicalion is supported by all data in tha Agency's roles that (1) ooncarn Ihe properties or eN'ects otthis product or an identical or

substantially Similar product, or orte or more ot the ingr6{lients in this product; and (2) Is a type of date that would be required to be submitted under the deta

requirements in etfee! on the date of epproual of th·os**appr,ca~on** if the appf,cai'lon sooghtthe -In',lial registralion of a product of identical or srmilar composition and

uses

I cartify that for each eXclusiue use study cited in supporl of this registraljon or reregistration, that t em the original data submiller or thet I haue obtained

the written permission otthe original data submitter 10 cite that study.

I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, eilher: (a) I am the originJI data,

submiller; (b) I haue obtained the permission of the onginal deta submller to use the study in support otthis applicelion; (c) all periods of eligibility fOJ}

, J , } compensation haue expired for Ihe study; (d) the study is in Ihe public literature; or (e) I haue nptifled in wriling the company that submilled Ihe study and ha.ve

offered (I) to pay**compensa~on** to the extent requirod by sections 3(c)( tXF) and/or 3(c)(2)(8) of FIFRA; and (Ii) to commenca negotianons to detemfn'e!he

, emount and terms of compensation. it any, to t::e 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 evio,llnce'of 'peir deli',E'JY In,

accordance with sections 3(c)(t)(F) and/or 3(c)(2){8) of FIFRA are auailabla and will be submitted to the Agency upon roquesL Should I fail 10**prod~ce'sys.h'** evidence to the Agencyupon rG'lJest, t understand that the Agency may inH'late ecflon to deny, cancel or suspend Ihe reg',slration 01 

### my prryjuci in conformity with

FIFRA. " ", "



### " "

, t certify that the stetements t have made on thts form and all allachmentsto it are true, accurala, ilnd compt8le, I**~{'}<(16wtedge** that,any

knOWingly false or mistoading statement may bo punishable by 1ine or imprisonment or both under applicilble law. • , } ,



### , , Kelly R. Hoskins, Manager of TeChnical Aflllrrs' Typed or Printed Name and Title " lure Dale 

# };;:Pd. /t. 

# /L**~,** 12/21/2009

EPA

# FOfl~~~5~~~h-2003) Electronic end

# ~eper verSions available. Submit only Paper version..WUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.nr'."1'forrnActNotice:TheInforIhis(__V.L.')hoursperforregistrarionaCliviliesand0.25L•.•,..•.._,..•..•_andcompletingthcnecessaryfo=.SendcommeniSregardingtheburdeneslimalc07anyotheraspeciofthis.OPPEInformallOnManagemenlDivision(2137)U.S.Environmenlall:'mleellonAgency.4U!MMreel.b.W..ntoIApplicant'siAegistrant'sName&!Sergeant'sPetCareProducts,Inc2625South1S81hPlaza,Omaha,NE!....,NumberCite-allj"eile-aliICile-allI:FipronilDATAMATRIX[EPAReQNolFileSvmbol;Product:Sergeant'sFipronil+S-methopreneSpot-OntorCatsIMRIDIItiyngentaCropProtection,Inc{N100}POBox18300l.NC27419I_._...__._••_alP(#264)2rw.AlexanderDriveResearchTrianglePark,NC27709r·StatusIN6ie·-BayerI::nvironmental(#432)POBox12014ResearchTrianqlePark,NC27709I I !ICite-allReckittBenckiserIncMorrisCorporateCenterIV399I.nterpaceParkwayII IParsiooaiw,NJ07054Cile-allJ.J.MaugetCo.(#7946)12733LoopI I IWoodbridqe,VA22192Cite-allBASFCorporalion(#7969)AgriculturalProductsPOBox13528ResearchTriannlaPark,NC27709Signature,_,NameandTilleJ..::J..o---"<AKellvR.Hoskins.ManaQerofTechnicalAllairs••""IOn.12f21/2009"g'''''yl"'-'FOhnApr",,,d1'1<>.2Il7n.nllMlUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY!:lS'H2401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNolice:ThepublicreportingburdenforthiscolleclionofinformalioniseSlimaled10avemgc0.25hour,;perresponsefOlregistralionaClivitiesand0.25hoursperrespon><:rorreregislmllOl1DadspecialreviewaClivilie>;,includillglimeforfC.ldingIheinslOlclionandoomplelingIhenecessaryforms.SendcommCniSregardingtheburdene'linmeoranyothcraspecloflhi.collectionofinfOlmalion.includingsugge>;l;onsforreducinglheburdenInDireclor:OPPEInfol7nnlionMnnagc=nlDivision(2137)U,S.EnvironmcnlalProleclionAgency,40I MStreet.S.W.•Wasllinlon,DC20460.DonOIsendlheformtoIhisaddress.DATAMATRIXDale:12121/2009EPAReNo.lFileSmbol;2517-NEWPae20f3Applicant's/Registrant'SName&Address:Sergean('sPetCareProducts,tnc2625Southt58lhPlaza,Omaha,NE68130-1703Product:Sergeant'sFipronil+S-methopreneSpot-OnforCatsInredient:Fironi!GuidelineReferenceGuidelineStudyNameMRIDNumberSubmitterStatusNoteNumberCite-allChemsico(#9688)DivisionofUnitedIndustriesCorpPOBoxt42642St.louis,MO63114Cite-allControlSolutions,tnc(#53883)5903Genoa-RedBluffPasadena,TX77507Cite-allVirbac(#54022)PO.Box16598FortWorth,TX76162Cite-allCombatInsectControlSystems(#64240)C/OHenkelConsumerGoodsInc.122CNW,Suite740Washinton,DC2000tCite-allMerialLimited(#6533t)3239SatelliteBlvd,Bldg500,LOC106BDuluth,GA30096Cite-allSprayDriftTaskForce(#66607)McKenna,Long&AldridgeLLP..--,.1900KStreet,NW---Washinaton,DC20006--8'9/2'p;-J,:y//'cNameandTitleDatet2121/2009KellyR.Hoskins,ManageratTechnicalAflails"0,'<10.,n,'...,hM"<.,"mu_"'.•.__."".•_.,"..1----F"....dOMBNo.wjiijiiii,OUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.reregislralion10Director:u,.Agency,401EPAReNo.lFiteS!!;!ot:2517·NEWPae3013AppUcanl's/Registrant'sName&Address:PelProducts,IncProdUctSergeant'sFipronit+S-meJhopreneSpot-OnlorCats(#71754)1350IStreet,N-W.Suite1(#73989)ClOHaroldHimmelman(Beveridge&NWKellyR.Hoskins,Manager01TechnicalAllairs12121/2009FO,mApp.o..No_UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY&401MStreet,S.W.WASHINGTOND.C.20460PaperworkRcductionActNotice:Thepublicreponingburdenforlhiscoilec(ionofinformntionisesli'lUUed(0average0.25hoursperresponseforregislralionactivitiesand0.25hoursperforreregistra(ionand.Ipecialreviowaelivilies.includingtimeforreadingIheinslrucrionandoomplelingthenecessaryforms.SendcommentsregardingtheburdenesdmrueOranyolheraspectofIhiscollec,innofinfnrma(ion,includingsuggestionsforreducing(heburden1.0Direc'or:OPPEManagementDivision(2137)U.S.EnvironmenlalPrOlec(ionAgency,401MS,reet.S.W.,Washilll1Jon,OC20460.DonOlsendtheform10Ihis-address.DATAMATRIXDate:12/21/2009EPAAeNo.lFilesvmbol:2517-NEWPaCie1013Applicanl'slRegistranl'sName&Address:Sergeant'sPelCareProoucts,Inc2625Soulh158'hPlaza,Omaha,NE68130-1703ProductSergeant's+S'methopreneSpot·OnlorCalsIngredient:S-methopreneGuidelineReferenceGuidelineStudyNameMAIDNumberSubmitterSialusNoteNumberCite-allADMAllianceNutrition,Inc.(#1157)1000North30'hStreet,BoxC IQuincv,Il62305Cile-allTheHartzMounlainCorp.(-#2596)Alln:RobertRosenwasser400PlazaDriveSecaucus,NJ07094Cile·allWellmarkInternational(#2724)1501E.WoodfieldRoad,Suite200WestSchaumburn,Il60173Cite-allChal1em,Inc.(#40086)Attn:DavidSchilling1715West38thStTN37409Clle-allEnlorcerProducts(#40849)ADivision01AcuitySpecialtyProducts1420SeaboardIndustrialBoulevardAtlanta,GA30318Cite-allControlSolutions,Inc.(#53883)5903Genoa-RedBluffPasadena,TX77507NameandTideDale12121/2009KellR.Hoskins,ManaaerofTechnicalAlfalrsEi'Ar;;·nn,no1»""Yo·","",",",",hie.""'O"PI"1"0,";00.In"'""!U",CopyFonnAvpn;Jv<tlOM81'1"ZIl7ll·fItJ(,uUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY&,401MStreet,S,W.WASHINGTOND.C.20460l'ilpcrworkReduClionAclNOlice:Thepublicreportingbutdenforthiscollectionofinformationisestimated10average0.25hour.;pcrresponseforregistrntionactivitiesMId0,25hoursperresponseforre.regi,tr..tionanaspecialreviewactivities,;nchKlingti"",forreadingthein,!ructionandcompletingtheforms.Sendcommentsregardingtheburdcnestimmeoranyotheraspectorthiscoltectionofinformation,includingsuggestionsforreducingIheburdentoDirector:OPPEInformationManagementDivisiont2137)U.S.EnvironmentalProtectionAgency,401MStTee!-.S.W.,Wnshinton,DC20460,Donotsend,heformtothisaddress.DATAMATRIXDate:12/21/2009EPAAeNo./FiteSmbol;2517-NEWPae20f3Apptican!'SfAegistrant'$Name&Address:Sergeant'sPetCareProducts,IncProduct:Sergeant'sFipronil+S-methopreneSpot-OntorCats2625South158thPlaza,Omaha,NE68130-1703Inredient:S-methoreneGuidelineReferenceGuidetineStudyNameMAIDNumberSubmitterStatusNoteNumberCite-aUManagementContractServices,Inc.(#63823)POBox5209Valdosta,GA3t603Cile-allMeriat(#65331)3239SatellileBlvd,Btdg500,lOC106BDuluth,GA30096Cite-allSprayDriftTaskForce(#66607)McKenna,Long&Aldridge,LLP1900KStreet,NWWashinoton,DC20006Cite-allB2ECorporation{#69554}150tEastWoodfietdAoadSuite200WestIL60173Cite-allBabolnaBioenvironmentatCentreLtd(#70062)POBox5126Valdosta,GA31603Cite·all""",."EGtSPharmaceuticalsPublicLimitedCo.,"",(#72947l.".",".,.,''',t15018Street,NW,Suite1000.".,,.."'"Washinoton,DC20036SignatureNameandTille/[If/'12121/200900,..",. .,.".KellyA.Hoskins,ManagerotTechnicalAllairs"",EPAF"mlP-lS'"'"P."".,-Vo,,;o«<",""",,"',2"1)'.""At\<"<l'In""'.'U>oCep)'"'-Fom,Approo-..1OMDNo.Wll).lIOWUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet)S.W.WASHINGTOND.C.20460PaperworkActNotice:ThepubticreportinghumenforthisCDilecl;onofinfO!1ll8lionisestimated(0average0,25hom:5perforreglstratiollactivitiesand025hoursperlespollscforreregiSIOllionandspecialreviewactivities,includingtimeforI'elIdillg(heinstructionnndcOlllplcling(henecessaryforms.SendeommenlSregardingthehUldene.<;limalcoranyOlheraspectofthiscollectionofinformotion,includingsuggestionsforreducingtheburden(0Director;OPPElnfmrlllllionMnllugementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W..Washington,DC20460.Donoltheform(0Ihisaddress.DATAMATRIXDate:12/21/2009EPAReaNo.lFileSYmbol:2517-NEWPae3013Applicant'sfRegislrant'sName&Address:Sergeanl'sPelCareProducts,IncProductSergeanl'sFipronil+S-melhopreneSpol-OnforCals2625SoulhlS8lhPlaza,Omaha,NE68130-1703InredientS-melhoreneGuidelineReferenceGuidelineSiudyNamaMAIDNumberSubmillerStatusNoleNumberClle-allValentBiosciencesCorporation(#73049)870TechnologyWay,Suile1000IL60048Cite-allAMBRANDS(-#73342)118J-2.EastMainSireet,Suite1Salem,VA24153Cile-aUMarkelquest,Inc.,(#73510)118'hEastMainSireet,Sulle1Salem,VA24153Cite-allAMzaCorporalion(#74032)3330NoyacRoad,BuildingDSanHarbor,NY11963Cile-allResidentialExposureJoinlVenlure(#74888)gOO1ih?treet,NW,Suite300Washinqlon,DC20006Cile-allB2EBiolech,LLC(#75318)150IEastWood1ieldRoad,Suite200WestIL60173Cile-allZaCOAIncorporated(#82122)1001GSireet,NW,Suile500WestWashinqlon,DC20001SignaturewvvNameandnteDale..4'"/// '_KeUyA.Hoskins,ManagelofTechnicalAlfairs12/2112009EI'AF"""..P;1jl<"rV."ion,,,-.d,lo1o.S,1mi,,,:vw:u..Co]»,"••2f"MdofIncNEUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.toaverage0.25hourspcrresponseforregistrationactivitiesand0.25hoursperresponseforreadingtheinstruclionandcompletingrilenecessaryfonns.SendcomnlcntsregardingtheburdenestimateoranyotheraspectofthistheburdentoDirector:OPPElnfonnarionManagemcnrDivision(2137)U.S.EnvirollmenralProtectionAgency.401MStrcer,S.W.,DATAMATRIXlieSymbol:Product:Sergeant'sFipronil+S-methopreneSpot-OnforCatsPark,NC27709IV12121/2009-UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.Wreportingburdenforthiscollection01mtom13tionISestimated10average0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseincludinglimeforreadingtheinstructionandcompletingthenecessaryfonns.SendcommernsregardingtheburdenestimateoranyotheraspectofthisreducingtheburdentoDirector:OPPEIllfonnaliollManagementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,JJr:lI..I..n......,........Date:12/21/2009EPAReNo./FileSmbol:2S17-NEWPae2of3Applicant's/Registrant'sName&Address:Sergeant'sPetCareProducts,IncProduct:Sergeant'sFipronil+S-methopreneSpot-OnforCats,,"__. -IndustriesCorpPO.Box16598FortWorth,TX7616212/2112009UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.perresponsereregistrationandspecialreviewactivities,includingtilneforreadingtheinstructionandcompletjugthenecessaryforms_Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburden10D'irector:OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S,W.,Washington,DCProduct:sergeant'sFipronil+S-methopreneSpot-OnforCats•KellyR.Hoskins,ManagerofTechnicalAffairs1212112009n-UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.average0.25hoursperresponseforregistrationactivitiesand0.25hourspertheinstructionandcompletingthenecessaryforms.Send commentsregardingtheburdenestimateoranyotheraspectoftoDirector:OPPEInformationManagementDivision(2137)U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,DATAMATRlXDate:12/21/2009EPAReNo.lFileSmbal:25'Applicant'siRegistrant'sName&Address:Sergeant'sPetCareProducts,IncProduct:Sergeant'sFipronil+S-melhopreneSpot-OnforCats----- ._.-.NE68130-1703. .• •SU'lte200WestProducts12/21/2009()UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.10averageinstructionandcompletingthenecessaryforms_toDireclor:OPPEIliforrnationManagementDivision(2137)U.S.per1csponscestimatemanyotheraspectoflhisProtectionAgency,401MStreet,S.W.,Product:Sergeant'sFipronil+S-methopreneSpot-OnforCats1212112009n-review'00UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.toaveragetheinstructionandcompletingthenecessaryfonns.toDirector:OPPEInformationManagementDivision(2137)U.S.estimateoranyotheraspectofthiscollectionAgency,401MStreet,S.W.,Washington.DCProduct:Sergeant'sFipronil+S-melhopreneSpot-OnforCats...EastWoodfieldRoad,Suite200WestKellyR.Hoskins,ManagerofTechnicaJAffairs12/21/2009

# Sergeant's Master Label

21 December 2009 EPA Submission

InformaIion in I 1 is optional. Page 1 of8 

## U:,LEPA No. 2517-XX

2\ December 2009



### FRONT PANEL

,.... •.**c:~T** 

### Sp()'rQN

FlpRONIL+Wi:TI!QpRli'NE

[Optional text appears in brackels**~** the final label may include some or all of the optional text on

front, back or side label panelsi



# Sergeant's Fipronil 

# + Methoprene Spot-On for Cats

[ABNs]

[(Sergeant's) (Sentry) Frontspot Plus (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) Firstline Plus (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) Frontedge Plus (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) VetSpot Plus (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) Frontguard Plus (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) Frontier Gold (Spot On) for cats (and kittens)]

[(Sergeant's) (Sentry) Frontpronil Plus (Spot On) for cats (and kittens)]



### [(Sergeant's) (Sentry) Fiproline Plus (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)]

[SentryProline (Spot On) for cats (and kittens)]

[SentryVet (Spot On) for cats (and kittens)]

[Mosquitoes] , , ; :: :



### [. [Kills [and] [&] 

### [repels] mosquitoes] [within 24 hours]

, ""

[. Kills [and] 

### [& 

## J [repels] mosquitoes that may transmit heartworm:;'" : " ,



### [Adult Fleas]

[. [Kills adult fleas [for up to six weeks]]

[. Kills [&] 

### [and] [repels] Fleas [Up to [4] [6] weeks]!] , 

### , 

## ".".

, "



### , "



### ,

, 

### "

"



### ,



# . "

"



### , "

,



### , "



### , , 

# ..

, 

# . , 

# .

, 

# . , "



### ,

, > > >



### [. Kills [and] 

### [&] [repels] fleas source of flea allergy dennatitis, flea bite anemia,

and tapeworm infestation]

[Multiple Infestations]

[-Kills [chewing] lice and controls sarcoptic mange]



### [. Flea [&] 

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

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

[-Kills fleas, flea eggs, ticks, chewing lice 

### [&] [and] mosquitoes]



### [·Kills [and] [&] [Repels] fleas, ticks, chewing lice [&] [and] mosquitoes]

[-Kills fleas, ticks, mosquitoes, (chewing) lice, flea eggs, larvae and pupae]



### [·Breaks the Flea Life Cycle [for up to three months]]

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

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

[-Kills fleas, ticks, mosquitoes, flea eggs, and lice]

[- [Seven] 

### [7] Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea

larvae and flea pupae]]

[- 6 [Six] Way Protection! Kills fleas, ticks, mosquitoes, lice, flea eggs & 

### flea

larvae]



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

### [and] Treatment]

# Sergeant's Master Label

21 December 2009 EPA Submission

Information in I I is opl ionaJ. Page 2 of8 EPA No. 2517·XX

21 December 2009



## FRONT PANEL ••. •

..... CA:T.SPO.:r ON

## FjpRO~ILtMEfII:OPRENE [. [Four (4) Week] [I month] [30 day] [Flea Tick, Mosquito and Lice Control]

[oUse [brand name] monthly to break the flea life cycle.]

[oUse [brand name] monthly to control ticks and chewing lice]

[oMonthly flea, tick, mosquito, flea egg, flea larvae and chewing lice protection.]

[. [4 week] [I month] [30 day] Flea and Tick Treatment!]

[Once A Month Flea and Tick Treatment]

[. Kills [&] [and] Repels Fleas and Ticks for up to [4 weeks] [I month] [30

days]!]

[. Kills Fleas, Ticks, Flea Eggs & 

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

days]]



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

mosquito control for cats and kittens.]



### [0 Controls reinfestation [for up to six weeks]]

, 

### , , > • > ••



### , [Ticks] " ,

[oKills [and] [&] [repels] ticks including those that may transmit Lyme diseasei

.... [. Kills [and] [&] [repels] Ticks for Up to [4 weeks]!] :"; ", '

[. Kills [and] [&] [repels] [all stages of] Deer Ticks (vector

### ofLym~Jli",,~se) fur',:'

up to [4 weeks][1 month][30 days]] ',.' :',',

[. [Kills [and Repels] [all stages of] (Deer) Ticks [before they can] [thlltj (translnit"

Lyme Disease,] for up to [4 weeks] [1 month] [30 days] [per applicarl6hl] " :,

[. Kills [and] [&] [repels] [Brown], [American,] [and Lone Star Dog Ticks] ".,

[(Rhipicephalus sanguineus)] for up to [4 weeks] [I month] [30 days]] : ,",

[. Kills 

### [&] [and] [Repels] American Dog Ticks [(Dermacentor variabilis)] for 

## liP' '

to [4 weeks] [I month] [30 days]!]

[Flea Eggs and Larvae]

[oControls [flea] reinfestation [for up to six weeks]]



### [0 Kills adult fleas, flea eggs, flea larvae and pupae [for up to six weeks]]

[oKills all stages of the flea (adult fleas, flea eggs, flea pupae and flea larvae)]



### [0 If cat is a high risk for flea reinfestation a once a month application may be

needed]

[·Kills flea eggs [larvae] [pupae] for up to six weeks]

[. With (S)-methoprene [Insect Growth Regulator] [IGR] which Breaks the Flea

Life Cycle]

[. With (S)-methoprene to Break Flea Life Cycle]

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

[. Dual Action [!]. Fipronil with (S)-methoprene [insect growth regulator] [IGR]

Effectively Breaks the Flea Life Cycle]

[. Dual Action [!]. Effectively Breaks the Flea Life Cycle[!]]

[. Kills Flea Eggs & Flea Larvae for [(six weeks)]']



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



### [0 Kills all stages of the flea life cycle]

# Sergeant's Master Label

21 December 2009 EPA Submission

Information in [ J is optional. Page 3 of8 EPA No. 2517-XX

21 December 2009



### FRONT PANEL ...CATSPOTON

F.IPI{ONIL-jiMEjI'HOPI{ENE

[All Others]

[-Controls Sarcoptic Mange [infestations]

[·Stops and prevents infestations]

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

[. Fast Acting]

[·Cats can be bathed 24 hours after treatment]

[. Long Lasting]

[·Once a 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 Supply]

or [12 Week Supply]

[. Four Applications {for cartons with 4 applicators}] and/or [4 Month Supply], or •

[16 Week Supply] :'"''

[. Six Applications {for cartons with 6 applicators}] and/or [6 Month Supply]**~',** 

### '.

[24 Week Supply] , "

, 

### , , ) , 

### , [. Best if used year round!] ; ';

[. (ICON Showing [4 Week] 

### (! month] (30 day] Protection)]

.,., ,. • [. [4 Week] [I month] [30 day] Dose!] "

[. I Month Dose']

[. Easy to Use [Application]]

[. Specially Formulated for Cats and Kittens]

[. [Free] Calendar Stickers Inside!]

[. [Free] Brochure Insidet]

[. [Free] Brochure and Calendar Stickers Inside]

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

[. Cats can be bathed 24 hours after squeeze-on is applied]

[. Waterproof] ""



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### [·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 puppies 8 weeks of age and older

(·Monthly application reminder card inside]

[ingredient statement may appear on front label or back label]

ACTIVE INGREDIENTS:

Fipronil

.................................................. 9.8%

(S)-methoprene

................................... 11.8%

INERT INGREDIENTS,,,,,,,,,,,,,,,,.,,78A %



### TOTAL 100.00% "



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# Sergeant's Master Label

21 December 2009 EPA Submission

Information in [ [is optional. Page 4 of8 EPA No. 2517-XX

21 December2009



### FRONT PANEL '. '.

. ,.CATSPC)TON

FIPRONIL+i\i!!,,'l'HOPRENE

KEEP OUT OF REACH OF CHILDREN

CAUTION

See [Side] [Back] Panel For Additional Precautionary Statement



### NET CONTENTS:

One [TwoJ[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

lnfonnalion in [ [is 0Plional. PageS of8 EPA No. 2S17-XX

21 December2009



### BACK PANEL '" "," "CATSPOTON

F!l'll,!'llTIU+MEmOPl,l.ENE

[brand name] contains Fipronil and S-Methoprene (insect growth regulator) (IGR) to

effectively kill [and repel] fleas (all stages) and ticks [(including those that may transmit

Lyme Disease)]. The active ingredients in [brand name] work by collecting in the hair

follicles and skin oils. This product features a sustained-release formula that discharges

from the animal's hair follicles using the natural skin oils, resulting in fast-acting [and

long-lasting] control of fleas, ticks, mosquitoes and chewing lice [for 30 days].

(diagram with visual of fipronil collecting and being released from hair follicle]

READ ENTIRE LABEL BEFORE EACH USE

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS. CAUTION. HannfuI if

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



# ·



# . thoroughly 

### with soap and water after handling.

PHYSICAL OR CHEMICAL HAZARDS , , • > , •



### • 

### COMBUSTABLE: Do not use or store near heat or open flame. "



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## , FIRST AID • 

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### If swallowed Call a poison control center for a doctor inunediately fOl'lreatmeni adVice.

Have person sip a glass of water if able to swallow. 

### D<;N1q(**induc~** > •• : ' 

### vomiting unless told to do so by a poison control center ,dr,doctor. Do not

give anything by mouth to an unconscious person. '



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### If in eyes Flush eyes with plenty of water. Call a doctor if irritation persists.: "



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### 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 1-800-224-PETS [7387] for emergency medical

treatment information.

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 PRECAUTIONAR Y 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

# Sergeant's Master Label

21 December 2009 EPA Submission

Informal ion in I I is optional. Page 6 of 8 EPA No.2517-XX

21 December 2009



### BACK P Al'/EL >,' 

### CAT SPOT ON 

# !lmii!:>:NiIJ+MJi;TJIOFRENE

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 

### [via!J 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 

### [via!J of {Product Name} as a stripe, starting high on the back of the; •

,. :.

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 imo the cat's coat. When finished, vvrap the tube 

### [vial] in! ••••

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 lie'i ld11d '**,~** 

### mosquito] infestations. [Studies show that] [brand name] kills all stages ofthe'iH::a for ul?,:

,

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

### ,**,~~** 

### •

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



### lice. [Brand name] 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 [2soCJ) 

### 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 buyeLj

# Sergeant's Master Label

21 December 2009 EPA Submission

Information in I I is optionaL Page 7 of8



### BACK PANEL EPA No.**2517~XX** 21 December 2009



### .' CAT SPOT ON

I,]PRPN!L+)V!jl(1'JlOJilU:NE

[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 Hable 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.J

[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** 

### [For more tnformationJ [Visit us atJ

[www .sergeants.com J



### , , Non-Emergency call1-800-224-PETS (7387) [Made in USAJ , , > ) , ,



### ,

Distributed by:

Sergeant's Pet Care Products, Inc.

P.O. Box 540399

Omaha, NE 68154-0399

EPA Reg. No. 2517-XX 

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### EPA Est. No. XXXXX-XX-XXX ",



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{END

- BACK/ SIDE PANEL}

{START

- OPTIONAL INSERT OR PACKAGE COPY} , , , ,

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### [e How to Apply and Open Child Resistant Package

- 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.J

[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]

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

3. Apply contents of one (0.017 

### fl oz) tube 

### [vialJ of {Product Name} as a stripe,

starting high on the back of the cat's neck to in front of the shoulder blades.

Squeeze tube firmly to apply all of the solution to the cat's skin

[Flea life cycle diagram J

# Sergeant's Master Label

21 December 2009 EPA Submission

Informalion in [ [is optional. Page80fB EPA No. 2517-XX

2 I December 2009



### BArK P 

# Al\IEL

[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 fill in name)]

[First [dose] [Treatment] (Empty blank for owner to fill in date)]

[Second [dose] [Treatment] (Empty blank for owner to fill in date)]

[Third [dose] [Treatment] (Empty blank for owner to fill 

### in date)] '" :"

[Fourth [dose] [Treatment] (Empty blank for owner to fill 

### in date)] """



## , [Fifih [dose] [Treatment] (Empty blank for owner to fill 

### in date)] "

[Sixth [dose] [Treatment] (Empty blank for owner to fill 

### in date)] ":",

[calendar stickers with brand name] [Place stickers on your calendar as a**re~i~a~r** 

### to

reapply [brand name] in 30 days.

[Monthly Application Reminder Magnet (image of reminder magnet) 

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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 will blink, reminding you to reapply [Brand

Name]. Press the button once and the blinking light will stop. Press the button again and

this will 

### reset the timer for another 30 days.



### {END

- OPTIONAL INSERT OR PACKAGE COPY}

TUBE / VIAL LABEL

Front Label



### {Brand Name}

Fipronil9.8% w/w, 

### (S)-methoprene 11.8% w/w



### 0.50 mL Back Labe!

KEEP OUT OF REACH OF CHILDREN 

## I

CAUTION: Read directions and precautions 

# I

before using. Open with scissors.

EPA REG

.. No. 2517-XX

{label code}