EPA Registration Jacket 2517‐137
1

To the Document Center (ITRMD) 

*Please transfer jacket /mini-jacket to Product 

Manager Team circled below: 

Minor Use Section PM-5 

Insecticide Branch PM-i0 PM-13 

Herbicide Branch PM-23 PM-25 

Fungicide Branch PM-2i PM-22 

Insect /Rodent Br. PM-i PM-7 

*Reminder to PM - If applicable pick-up data 

from Screening Room. 

proce~ by RO's Completeness Check T a . 

---;;? < I----fL --"--7'-f-"--

(Team Member Signature) (Da e) 
2

21-Day Screen Completed by 

Contractor 

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

Jacket # 

MRID# ___ _ 

Content Screen: Recommended to 

[jilSsrFail 

86-5 Review: passed/FailedlNAJ 

Transfer This Jacket to: 
3

PRIA 2 - 21 Day Content Screen Review Worksheet 

(EP AlOPP Use Only) 

{(? 3/23/09 

21 Day Screen Start Date: I - '- 1. - 01 /' 

Experts In-Processing Signature: 1"1 f tlOltll-lNbTnv Date l~LI- I 0 Fee Paid: Yes _v_ 

Division management contacted on issues No Yes Date ______ _ 

EPA Reg. Number: U; 11- RGT EPA Receipt Date: 1.- z. ?- - a q 

Items for Review Yes No N/A" 

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

including package type X 

Confidential Statement of Formula all boxes completed, fann signed, and X dated (EPA Form 8570-4) (Link to form) 2 a) All inerts (link to http;!/www.epa.gov!opprdOOllinerts/), yes no 

including fragrances, approved for the proposed uses (see 

Footnote A) X 

3 

Certification with Respect to Citation of Data (EPA Fonn 8570-34) (Link to X form) completed and signed (N/A iflOO% repack) 

Certificate and data matrix consistent X 

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

to pay statement included. (see Footnote B) 

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

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

4 completed and signed (NIA if source is unregistered or applicant owns the X technical) 

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

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

repack) 

yes no I" i> ." 

5 

I:r 

a) Selective Method (Fee category experts use) <. /"--, 

b) Cite-All (Fee category experts use) :x. '. ',",,' ., 

.. ,{~;, ., . 

. 

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

:.. . ',':':' . ,. 

.. 

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

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

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

I ) 

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4

7 Is the data package consistent with PR Notice 86RS (link to PRN 86-5) ~ 

Notice of Filing (link to 

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

X with petitions (link to 

http://w\Vw.~a.govlPesticides/rl'gulatillgitolerances.htIU) 

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

http://,, ... w.epa.gov/opprdOOl/workplanireducedrisk.html) X 

Required Data (link to 

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

data waivers. See Footnote C. 

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

10 

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5

Comments: 

< • k'I+-n 

?\ 

o ij ~ +0 -.! ! I 'n'l~ '-

* NIA - Not Applicable 

Footnotes 

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

whether all inerts listed, including fragrances, are approved for the proposed uses. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

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

mistakes on the CSF, etc. or 2) provide the data to support OPP approval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

CSF and may require submission of data. All information, forms, data and 

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

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

application as described below. 

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

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

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

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6

\ 

site [link to http://www.epa.gov/opprd001Iinertsllists.html] and If the inert is not 

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

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

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

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

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

delays. 

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

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

Branch (IIAB) at inertsbranch@epa.govandresolvetheissue. Copies of the 

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

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

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

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

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdllbiopesticides/contacts bppd.htmJ. 

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

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

information [link to httpj/www.epa.gov/opprdOOllinertsitips.pdf]mustalsobeincluded 

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

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

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

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

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

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

cannot or are not identified or provided within the 2 I-day content review period, the 

Agency will reject the application. 

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

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

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified On a CSF, the Agency -will contact the 

applicant with the following options: 

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

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

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

approved for the application's uses; or 

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

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

request an extension in the PRIA decision review timeframe to accorrnnodate 

the inert review/approval process; 

4 
7

) 

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

category estimated); or 

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

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

25% ofthe full fee ofthe category identified. 

Conventional New Product AJ!plications 

"When the Registration Division identifies an unapproved inert on a CSF with an 

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

inert approval (R311 , R3l2 or R3l3), it will contact the applicant with the 

following'options: 

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

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

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

approved for the application's uses; or 

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

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

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

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

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

Agency within the 21 day content review period.) 

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

category estimated); or 

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

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

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

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

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

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

options: 

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

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

approved; or 

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

unapproved inert. If an inert ingredient tolerance exemption petition is 

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

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

Agency will discuss hannonizing the timeframe for both actions. 

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

category estimated); or 

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

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

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R301 or 

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

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

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

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

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IFee for Servicel 

This package includes the following 

@ New Registration 

oAmendment 

for Division 

.If 

(864772?-

o Studies? o Fee Waiver? 

o volpay % Reduction: 

Risk Mgr. [J]J 

Receipt No. s-I 864772 

EPA File Symbol/Reg. No. 1 2517-RGT 

Pin-Punch Date: 1 12/22/2009 

o This item is NOT subject to FFS action. -----

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

Requested: I "I-, "Soc, 

Granted: I 'R 3cc> 

G~ 

: Amount Due: $ \ i3, 10 S-. -

),~ (M""'" , I .1. 0 ~j, {I s//O n ''=~j-I 

}Zl Inert Cleared for Intended Use 0 Uncleared Inert in Product 

Reviewer: 6~ =-r;~ J ~ Remarks: 
10
11

Material to be added to an e-Jacket or Jacket 

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

Description: .Nt k-' ~ ~ C Sf'-s 

1. \sf Placement within the e·Jacket/Jacket 

. C(l17 Default: (chronological, top = newest) 

dl File Location: (PDF page number) 

2. c:r Send to Data Extraction contractors this material: 

(t7 Newly stamped accepted label 

o Notification P New CSF 'i\e.\f\ve..\.l>f"'- (L. ') 

o other: ----------------------

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

well·organized and clipped together - NOT STAPLED. Then give the 

material with this coversheet to staff in the Information Services 

Center (Room S-4900). 

Reviewer's Name: Rosanna Louie 

Phone: 308.0037 Division: RD 

Date: 7 ~~b 'L{) Ii 
12

U.S. ENVIRONMENTAL PROTECTION 

AGENCY 

Office ofPeslicide Programs 

Registration Division (7504P) 

1200 Pennsylvania Ave., N.W. 

Washington, D.C. 20460 

NOTICE OF PESTICIDE, 

o Registration 

o Reregistration 

(under the Federal Insecticide, Fungicide, 

and Rodenticide Act, as amended) 

Name and Address of Registrant (include ZIP Code): 

Sergeant's Pet Care Products, Inc. 

c/o Exponent, Inc. 

2625 South 1581h Plaza 

Omaha, NE 68130 

EPA Registration No. Date oflssuance: 

2517-137 January 28, 2011 

Term of Issuance: 

Conditional Registration 

Time~Iimited: see conditions below 

Name of Pesticide Product: 

Sergeant's Fipronil Spot-on for Cats 

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

Federal Insecticide, Fungicide and Rodenticide Act. 

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

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

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

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

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

This product is conditionaiIy registered in accordance with FIFRA §3(c)(7)(a) provided that: 

1. This registration is time~limited and expires two years from the date this product is first released 

for shipment. 

You must provide the Agency with a projected release for shipment date within 30 days of the 

date of this Notice of Registration. The Agency will calculate the expiration date based on the 

projected release for shipment date until an actual release for shipment date is provided in writing. 

2. Consider limiting the formulations of each product to one basic confidential statement of formula. 

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

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

3. As a condition of registration for this product, within one year from the date of this registration, 

you must submit the results of Storage Stability and Corrosion Characteristics studies, 

corresponding to OCSPP Guidelines 830.6317 and 830.6320, respectively, including interim 

P~ge Iof5 
13

4. The approval of this registration is contingent on the Agency's review to detennine that the study 

submitted on June 15,2010, to fulfill OCSPP Guideline 830.1800 - Enforcement Analytical 

Method, is acceptable to support the registration. 

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

you must provide the Agency the following; 

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

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

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

obtained; and 

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

6. Within 30 days from the date of this registration, in accordance with FIFRA §3( c)(I)(F) and 

3(c)(2)(B), you must submit a copy of all offers to pay compensation and evidence of their 

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

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

sold for this product for the quarter that begins on April 1,2011. The quarterly reports are due 

two months after each quarter ends. 

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

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

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

The following is a list ofinformation that must be included in the quarterly reports for each 

incident: 

EPA Registration Number 

Product name (brand name) 

Lot# 

Where purchased: internet, store, veterinarian 

Active Ingredient(s) 

Weight range for product 

Date on which incident occurred. (mm/dd/yyyy) 

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

Registrant case # 

Species: dog, cat, other (specify) 

Breed: (as reported by pet owner) 

Age: months or years 

Sex: M, F, or neutered 

Weight: pounds 

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

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

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

Time to Onset: (hours, days) 

Treated by veterinarian: yes or no 

First time product used: yes or no 

Page 2 of 5 
14

Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) 

Any known precondition 

EPA Severity Code: death, major, moderate, minor 

Outcome: died, recovered, still treated, unknown 

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

include the following details: 

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

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

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

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

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

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

A similar summary table for dogs (misuse or secondary exposure) showing number of 

incidents of each severity code for each route of exposure. 

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

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

A summary table for cats showing number of incidents for each severity code for these 

age ranges: <3 months, 3-6 months, 6-9 months, 9-12 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr, 6 

yr, 7 yr, 8yr, 9 yr, IOyr, 11 Yr, 12 yr, 13 yr, 14yr, 15 yr, >15 yr. 

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

weight range on the product label (if applicable). 

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

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

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

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

weight range (if applicable). 

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

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

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

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

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

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

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

Page 3 of5 
15

All labeling comments below are in reference to the proposed master label, dated January 20, 2011. 

These comments apply to all submitted draft labeling, including the master label. the color mock-up 

labels, and the proposed text and graphics for the stickers and magnet: 

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

read as follows: 

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

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

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

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

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

lice]" 

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

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

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

"H3} applications]" 

13. On page 4 under Back Panel, replace "30 days" from the second claim with "[1 month] (4 

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

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

not been submitted to the Agency for review. 

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

are more clear by stating "one tube ... " per application. 

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

assumed by the user or buyer" and "Sergeant's is committed to providing ... " so that the warranty 

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

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

instead of a separate insert to accompany the product. 

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

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

unit weight expression. 

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

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

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

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

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

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

constitutes acceptance of these conditions. A copy of your label stamped "Accepted with Comments" is 

enclosed for your records. Please contact Rosanna Louie-Juzwiak at (703) 308-0037 with an uestions. 

Page 4 of5 
16

Enclosure: Sergeant's Fipronil Spot~on for Cats Label, Stamped Accepted with Comments Q: of Appcoving ~_ 

-~ Date: 

2B j ~N\!J><\>-'< Loll 

-1'br 

Richard Gebken, Product Manager (10) 

Registration Division, Insecticide Branch 

EPA Form 8570·6 

Page 5 of 5 
17

Sergeant's Master Label 

20 January 2011 

Information in [ J is optional. 

Version 10.1 

Page 1 of8 

EPA No. 2517-RGT 

[Optional text appears in brackets - the final label may include some or all of the optional text on 

front, back or side label panels J 

Sergeant's Fipronil Spot-On for Cats 

[ABNs] 

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

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

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

[SentryProline (Spot On) for cats] ACCEPTED 

with COMMENTS 

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

[[Sergeant's] PRONYL OTCTM for cats] JAN 2 8 2011 

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

Fungicide, and Rodenticide Ac~ as 1,lmended. for the pesticide reglSte~Jlnder EPA Reg No [Apply to kittens over 8 weeks old] 

[Apply to kittens 8 weeks or older] 

2.517~13Z '. 

[Mosquitoes] 

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

up to 28 days] 

[Adult Fleas] 

[Ticks] 

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

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

anemia]] 

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

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

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

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

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

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

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

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

[(Rhipicephalus sanguineus)] [for up to [4 weeks] [I month] [30 dayslll 

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

sanguineus)] [for up to [4 weeks] [1 month] [30 days]]] 

[- Kills American Dog Ticks [(Dermacentor variabilis)] for up to [4 weeks] [1 

month] [30 days]!] 
18

Sergeant's Master Label 

20 January 2011 

Infonnation in I I is optional. 

Version 10.1 

Page 2 of8 

[Multiple Infestations] 

EPA No. 2517-RGT 

[-Kills chewing lice and controls mites that may cause saTcoptic mange] 

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

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

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

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

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

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

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

Control] 

[Once A Month Flea and Tick Application] 

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

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

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

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

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

[All Others] 

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

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

[. Waterproof] 

[·Fast Acting] 

[·Long Lasting] 

[-Fast Action against chewing lice infestations] 

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

[- Best if used year round!] 

[. (ICON Showing 4 Week Protection)] 

[·4 Week Dose!] 

[. 1 Month Dose!] 

[.30 day dose!] 

[. Easy to Use [Application]] 

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

[. [Free] Calendar Stickers Inside!] 

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

[f3} applications] 
19

Sergeant's Master Label 

20 January 2011 

Information in [ [is optional. 

Version 10.1 

Page 3 of8 

[-Rapid elimination of chewing lice infestations J 

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

[-Effective even after bathing] 

EPA No. 2517-RGT 

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

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

[clip] [inside] 

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

[-Monthly application reminder inside] 

[. Fipronil (9.7%)] 

[- Lift [here] for more information] 

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

Cats] 

[* [Brand Name] is not manufactured by or distributed by Merial. Frontline Top 

Spot® is a registered trademark of MeriaL] 

[For use ONLY on cats] 

[of ALL weights] 

[over 8 weeks of age] 

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

ACTIVE INGREDIENT: 

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

OTHER INGREDIENT** ............. 90.30% 

TOTAL 100.00% 

[**diethylene glycol monoethyl ether] 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

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

NET CONTENTS: 

[Three] [3][three] 0.017 fl oz (0.5 mL) applicators 

{END - FRONT PANEL} 
20

Sergeant's Master Label 

20 January 20 11 EPA No. 2517-RGT 

Infonnation in { 1 is optional. 

Version 10.1 

Page 4 of8 

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

may transmit Lyme Disease)]. 

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

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

days on cats.] 

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

READ ENTIRE LABEL BEFORE EACH USE 

USE ONLY ON CATS AND KITTENS OVER 8 WEEKS OF AGE 

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

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

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

PRECAUTIONARY STATEMENTS 

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

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

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

toilet. 

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

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

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

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

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

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

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

781-4738 for 24-hour assistance. 

FIRST AID 

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

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

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

give anything by mouth to an unconscious person. 

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

Remove contact lenses, if present, after the first 5 minutes, then continue 

rinsing eye. Call a poison control center or doctor for treatment advice. 

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

persists. 

HOTLINE NUMBER 

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

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

infonnation. 
21

Sergeant's Master Label 

20 January2011 

InformaIion in [ [is optional. 

Version 10.1 

Page 5 of8 

DIRECTIONS FOR USE 

EPA No. 2517·RGT 

It is a violation of Federal law to use this product in a manner inconsistent with its 

labeling. 

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

YOU AND YOUR CAT, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] 

BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY 

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

USE ON RABBITS. DO NOT USE ON OTHER ANIMALS. 

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

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

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

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

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

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

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

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

veterinarian immediately. 

(INSERT DIAGRAM THAT DEPICTS APPLICATION OF PRODUCT ON THE 

CAT) 

[Optional diagram mayor may not appear on finished label] 

[(Outer Packaging)] 

How to open: Remove product tubes [viall from the package. Separate one tube from the 

others. Holding the tube [vial} with notched end pointing up and away from the face and 

body, cut off the narrow end at the notches with scissors. 

How to apply: While holding the cat with one hand, use the other hand to apply the 

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

contents of one [0.017 fl oz] [0.50 mL] tube [vial] of (Product Name) [as a stripe, 

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

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

be absorbed into the cat's coat. When finished, wrap the tube [viall in paper and put into 

the trash. Only one applicator per treatment is needed. 
22

Sergeant's Master Label 

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

Information in ( I is optionaL Page 6 of8 

FREQUENCY OF APPLICATION 

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

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

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

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

[Brand name] remains effective, even after bathing, water immersion, or exposure to 

sunlight. Allow treated area to dry thoroughly. Do not reapply for 30 days. 

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

STORAGE AND DISPOSAL 

PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in 

a cool (below 77°F [25°C]) dry place inaccessible to children and pets. Do not 

refrigerate. Protect from direct sunlight. 

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

this container. Offer for recycling if available. If partly filled: Call your local solid 

waste agency for disposal instructions, Never place unused product do\VI1 any indoor or 

outdoor drain 

[WARRANTY 

Read the entire Directions for Use and Warranty before using this Product. By using this 

product, user or buyer accepts the following warranty. HThe directions for use of this 

product are believed to adequate and must.be followed carefully. It is impossible to 

eliminate all risks associated with the use' of this product. Unintended consequences may 

result because of unknown factors. All such risks shall be assumed by the user or 

buyer.H Sergeant's is committed to providing high quality products. To the extent 

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

merchantability or offitne,ss for a particular purpose or otherwise, that extend beYOl.).d 

statements on this label. To the extent consistent with applicable law, Sergeant's, the 

manufacturer, or the Seller shall not be liable for indirect, special, incidental or 

consequential damages. To the extent consistent with applicable law, the exclusive 

remedy of the user or buyer shall not exceed the purchase price paid.] 

[If you have questions or comments about this product, please write: [Sergeant's] 

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

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

(7387) [Made in USA] 

Distributed by: 

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

P.O. Box 540399 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-RGT 

EPA Est. No. XXXXX-XX-XXX 

{END - BACK I SIDE PANEL} 
23

Sergeant's Master Label 

20 January 2011 

Information in [ [is optional. 

Version 10.1 

Page 7 of 8 

{START - OPTIONAL INSERT OR PACKAGE COPY} 

EPA No. 2517-RGT 

[- How to Apply - May contain graphics illustrating product use, e.g., cat 

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

label and/or applicator labeling.] 

[Application Instructions] [Directions for Use] 

[How to Open: 

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

2. Separate one tube from the others. Holding the tube [vial] with notched end 

pointing up and away from the face and body, cut off the narrow end at the 

notches with scissors. 

How to Ap ply: 

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

2. Apply contents of one [0.017 fl oel [0.50 mLl tube [vial} of {Product Name} 

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

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

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

[Optional diagram_mayor may not appear on finished label] 

~ 

[Look at the 

~ Label (Look at the Label icon) [Easy] 6 Step [Easy] [Spot On] [Squeeze-On] 

[Topical] Checklist 

• Read the label completely and follow directions 

• Weigh your pet 

• Do NOT use dog products on cats 

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

• Separate animals after treatment to avoid chance of ingestion 

• Do NOT split tubes between pets] 

[Brand Name] 

[Monthly reminder card] 

[3] [Month TreatmentTracker] 

[3] [Month Application Tracker] [ 

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

[pe!"s Name (Empty blank for owner to fill in name)] 

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

[Dose] [Treatment] [Application](Empty blank for owner to fill in date)(Date: 

MMIDD/YY)] 
24

Sergeant's Master Label 

20 January 2011 Version 10.1 EPA No. 2517·RGT 

Infonnation in [ 1 is optional. Page 8 of8 

[calendar stickers with brand name] [Place stickers on your calendar as a reminder to 

reapply [brand name] in 30 days.][Monthly Application Reminder Magnet (image of 

reminder magnet)] 

[Enclosed for your convenience is an application reminder magnet. Push the (reset) 

button, and the reminder light will blink twice. The reminder tag is now set for 30 days. 

At the end of 30 days the reminder light \\fill blink, reminding you to reapply [Brand 

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

this will reset the timer for another 30 days.] 

{END - OPTIONAL INSERT OR PACKAGE COPY} .4" 

~ 

~~--~ ii-' 0,,-- - - -- ~---,-, 

Front Label 

{Brand Name} [For use only on catslkittens 

8 weeks or older1 

Fipronil9.7% w/w 

0_50 mL {label code} 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

CAUTION: Read directions and precautions 

before using. Use scissors to open. 

EPA REG_ No_ 2517-RGT {label 

code} 
25

LL 

S1-B0 JOt 

.O"HVn90 tI d l:l 

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u.. 

'~""""'PI"O,""""'''''''''''''I'I""",,"~ 

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1VSOdSIG aN\f3.~~QlS 

FIPROGUARD" For use ONLY on cats 

Of ALL weights 

over 8 weeks of age for cats 

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28

Front Tube Labels 

38.1mm 

JAr! 2 8 

Bmm 

+-----+ 

10mm 

FIPROGUARDTM 

ART INSTRUCTION FOR THE PRINTER 

•• Printer/Vei1dar. Dde.enl', 

Additional Nate.: !lAO: P!.!SUO 

labels adhere to White Tubes 
29

JAN 2 8 

Front 

White tube / Blacktext on a white label/ Colored Strip 

3B.tmm 

PRONYL OTCTM 

Prinler/Vendar: Dale sent: 

ART INSTRUCTION FOR THE PRINTER 

--IlACK 1M51.0 Additional Noles: 

labels adhere to White Tubes 

8mm 

----+ 

tomm 
30

Back 

White tube f Black text on a white paper label 

ART INSTRUCT10N fOR THE PR1NTER 

• BLACK Additional NCt01: 

Printer/Vendor: Dote $~nt: 

labels adhere to White Tubes 

2">l7-IS 7 

JAN 2 8 'i 

38.1mm 

Smm 

+-+ 

tomm 
31

25'17-137 

JA , ~I 2 8 7"1" _\ .. , 

@ Fleas 

@ Ticks 

@ Mosquitoes 

@ Chewing Lice 
32

25n-137 

JAN 2 8 2011 

~ Fleas 

~ Ticks 

~ Mosquitoes 

't Chewing Lice 
33

2f5\l-\",7 

JAN 2 8 201\ 
34

JAN 2 8 2011 

ART !NSTRUCTION FOR THE PRINTER 

--

Printer/Yendor: Oote sent: 

Addltionol Notes: BlACK PMS2731 
35

/ 

(L{; !t\j'<, W VW\ eN 

~~AN~ CNW1Jc<~I'<2M~d ~--t V~ 
36

DATA PACKAGE BEAN SHEET 

Date: 09~Nov-2010 

Page 1 of 1 

* * * Registration Information '* '* '* 

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

Company: 2517 - SERGEANT'S PET CARE PRODUCTS,INC. 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 S-7237 

Risk Manager Reviewer: Rosanna Louie RLOUIE 

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

Type of Registration: Product Registration - Section 3 

Decision #: 425437 

DP #: (383875) 

PRIA 

Parent DP #: 

Submission #: 884814 

Ed~ed Due Date: ____ _ 

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

Ingredients: 129121, Fipronil(9.7%) 

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

Expedite: 0 Yes • No Date Sent: 09-Nov-2010 Due Back: ____ _ 

DP Ingredient: 129121, Fipronil 

DP Hie: #2517-RGT: CRP Review 

CSF Included: 0 Yes. No Label Included: 0 Yes. No Parent DP #: ____ _ 

Assigned To Date In Date Out S'I IMK 20 (0 

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

Team Name: Child Resistant Packaging Science Due Date: ____ _ 

Reviewer Name: __________ _ Sub Data Package Due Date: __ _ 

Contractor Name: ________ _ 

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

No Studies 

'* * * Additional Data Package for this Decision '* * * 

Can be printed on its own page 

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

RESUBMISSION 

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

Louie-.luzwiak with any questions. 

Attachments: 

Cover letter MRID 48279600 

CRP Resubmission (1746-001) MRID 48279601 

CD of the Study 
37

CHILD-RESISTANT PACKAGING REVIEW 

Technical Review Branch 

IN 11/9/2010 OUT 12/13/2010 

~~~,;;!"~ RD, TRB, Reviewed by Rosalind L. Gross 1211312010 

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

DP Barcode 383875 & 383881 

Decision # 425437 & 425454 

EPA Petition or EUP No. ___ _ 

Date Division Received -'.10"'1"'2"'9/"'1"'0'-__ _ 

Type Product(s) Insecticide (flea product) 

Data Accession No(s). 48279600 48279601 

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

Division "R"D,-__ 

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

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

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

support CRP certification for 2517-RGT & Review of CRP 

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

adequate to support eRP certification for 2517-RGL 

Active Ingredient(s), PC code, & % Fipronil9.7% (2517-RGD 

Fipronil 9.8% 

S-Methoprene 11.8% 

Summary of Findings 

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

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

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

during testing. 

Should any human experiencelepidemiological evidence indicate a 

problem once the product is in the marketplace, the Agency reserves the right to 

reexamine this data comprehensively and to question the child resistance of the 

package involved. 
38

2 

Package 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

narrow end at the notches with scissors." 

Toxicity 

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

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

28.5mg. Access to a toxic or harmful am! = 28.5mg = 28.5mg divided by [1030mg/ml x 

0.097 Fipronil] = 0.285 ml = 0.29 ml for Flpronil only Cat product EPA REG No. 

2517-RGT. Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1025 

mg/ml x 0.098 Fipronil] = 0.284 ml = 0.28 ml for Fipronil & S-Methoprene Cat 

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

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

0.29ml for EPA Reg. No. 2517-RGT. 
39

Toxicity, Child Failure, and Package 

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

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

2517-RGT 0.5 0.017 1.030 9.7 49.96 1 

2517-RGl 0.5 0.017 1.025 9.8 50.23 1 

Failure 

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

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

3 

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

complete access to the placebo (water). 

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

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

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

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

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

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

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

second and third applicator. 

Analysis of Data and Conclusion 

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

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

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

used in the CRP testing. 

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

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

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

the test. A child failure was defined as access to one applicator. There were no child 
40

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

1700.20. 

4 

Senior Adult Use Effectiveness Study 3 white applicators with purple stripe 

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

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

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

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

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

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

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

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

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

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

subjects in accordance with 16 CFR 1700.20. 

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

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

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

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

RGT meets the CRP test requirements. 

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

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

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

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

establish that they are CRP. 

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

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

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

during testing. 

Should any human experience/epidemiological evidence indicate a 

problem once the product is in the marketplace, the Agency reserves the right to 

reexamine this data comprehensively and to question the child resistance of the 

package involved. 
41

Dece

CRPdatasummarycht 

EPA REG # 2517-RGT Sergeant's Fipronil Spot On For Cats 

Company Name Sergeant's Pet Care Products, Inc. 

Chemical- Fipronil 9,7% 

A Senior Adult Use Effectiveness failure is failure to access the applicator in the prescribed test time of 5 min. 

or 1 min. for the second package, not opening the applicator with scissors along the needle application tip, cuttin

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

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

a single applicator first and cutting open a second or second and third applicator. 

A child failure ',s access to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

A unit failure is opening the applicator or any partial or complete access to the placebo (water). 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1030mg/ml x 0.097 Fipronil] = 0.285 ml = 0.29 m

Cat EPA REG # 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 m

Methoprene Cat EPA REG # 2517-RGL 

% AI - Fipronil 9.7% 

Note: 

The applicator is the child-resistant feature, 

The applicators are filled in ml. 

1, 

2. 

3. 10 CRP studies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1.34, 2,68, 4,0

only and the Fiproniland S-Methoprene products. This is based on the registrant's submiss

the applicator as tested and proposed to be marketed for the Fipronil only and the Fipronil a

products, which appeared to be identical; and a June 30, 2010 letter indicating the same app

and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methopren

used in the CRP testing. 
42

EPA REG # MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unitlpkg, child fail:; # Child Get CRE SAUE Compreh Only include eRE & SAU

units, color, tox/harm = # at Begin eRsive Comp units Test Review ute, 

& why Analy 

sis 

2517-RGT 48279601 3 white applicators with 15etof3 o child XCRE CRP Certification 5/

Cat Fipronil only 48959593 purple stripe on label applicators failures :; assQciat Label dated 6/29/10 

1746-001 connected to each other. connected Pass 50 ed with in study. 

Each applicator@ O.5ml to each chiid test lowest Data Anatysis show

water as placebo. other. SAUE Study is a pass of t

ToX/harm :; 1 applicator, to the sequentiat te

chitd fail = 1 applicator 1700.20. 

2517-RGT 48279601 3 white applicators with 1 set of 3 90% X lowest CRP Certification 5/2

Cat Fipronil only 48059503 purple stripe on label applicators SAUE SAUE Label dated 6/29/10 

1746-001 connected to each other. connected in study. 

Each applicator@ 0.5ml to each Data Anatysis show

water as placebo. other. package A and 1 sen

Tox/harm"" 1 applicator, 8, which is the maxim

chtld fall ';;; 1 applicator for a passed SAUE. 

study Is a pass of t

16 CFR 1700.20 and 

specificattons in 16 

number of subjects p

such that 9 subjects 

being tested at site H

H902 (a different loc

distinction not previo

now is 24% of test su

16 CFR 1700.20. 

-----
43

CRPdatasummarycht 

EPA REG # 2517-RGL Sergeant's Fipronil + S-Methoprene Spot On For Cats 

Company Name Sergeant's Pet Care Products, Inc. 

Chemical - Fipronil 9.8% 

S-Methoprene 11.8% 

A Senior Adult Use Effectiveness failure is failure to access the applicator in the prescribed test time of 5 min. f

1 min. for the second package, not opening the applicator with scissors along the needle application tip, cutting th

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

chamber of the applicator at other locations, cutting off the bottom of the main chamber of the applicator, or not seapplicator first and cutting open a second or second and third applicator. 

A child failure is access to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

A unit failure is opening the applicator or any partial or complete access to the placebo (water). 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1030mg/ml x 0.097 Fipronil] = 0.285 ml = 0.29 m

Cat EPA REG # 2517-RGT 

Access to a toxic or harmful am! = 28.5mg = 28.5mg divided by [1025 mg/ml x 0.098 Fipronil] = 0.284 ml = 0.28 m

Methoprene Cat EPA REG # 2517-RGL 

% AI - Fipronil 9.8% 

S-Methoprene 11.8% 

Note: 

1. The applicator is the child-resistant feature. 

2. The applicators are filled in mi. 

3. 10 CRP studies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1.34, 2.68, 4.02 

only and the Fipronil and S-Methoprene products. This is based on the registrant's submissi

the applicator as tested and proposed to be marketed for the Fipronil only and the Fipronil an

products, which appeared to be identical; and a June 30, 2010 letter indicating the same appl

and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methopren

used in the CRP testing. 
44

EPA REG# MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unitJpkg, ch'lld fail = # Child Get at CRE SAUE Compreh Only include eRE 

units, color, 10x/harm = # Begin Test ensive Computer analysis units Review Analysis 

& why 

2517-RGL 48279601 3 white applicators with 1se1of3 CRP Certific

Cat Fipronil + 48959593 purple stripe on label applicators acceptable. 

Methoprene 1746-001 connected 10 each other. connected same CRP d

Each applicator@ O.5ml to each mentioned b

water as placebo. other. based on: 

Tax/harm = 1 applicator, MRID 48279

child fail = 1 applicator Reg No. 251

pass of the 

the sequent

1700,20, Th

study Is a p

test in 16 C

effectivenes

CFR1700,1S

Bridging Let

same size a

-- - _ ....... _---

tes
45

DATA PACKAGE BEAN SHE~'T 

Date: 14-May-2010 

Page 1 of 1 

* * * Registration Information * * * 

Registration: 2517-RGT - SERGEANT'S FIPRONll SPOT-ON FOR CATS 

Company: 2517 - SERGEANT'S PET CARE PRODUCTS, INC. 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 5-7237 

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINlOS 

Sent Date: ___ _ Calculated Due Date: o~" 1 \ 

Type of Registration: Product Registration - Section 3 

Decision #: 425437 

DP #: (377744) 

PRIA 

Parent DP #: 

Submission #: 873353 

Edited Due Date: __ _ 

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

Ingredients: 129121, Fipronil(9.7%) 

* * * Data Package Information * * * 

Expedite: 0 Yes • No Date Sent: 14:~~-2010 Due Back: ____ _ 

DP Ingredient: 129121, Fipronil 

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

CSF Included: • Yes 0 No label Included: • Yes 0 No Parent DP #: ____ _ 

Assigned To Date In Date Out 

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

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

Reviewer Name: _______ ~ __ _ Sub Data Package Due Date: ____ _ 

Contractor Name: -------

* * * Studies Sent for Review * * * 

No Studies 

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

Can be printed on its own page 

* * * Data Package Instructions * * * 

For Your Review: 

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

Thx, baa 
46

Efficacy Review 

Date: December 27, 2010 

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

myers.clayton@epa.gov ,<:. 

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

\"-

Risk Manager Rev.: Rosanna Louie 

Products: 

EPA Reg. #: 

A.I.'s: 

Decision #s: 

DP#s: 

Submissions: 

MRIDs: 

Sergeants Fipronil Spot-on for Cats 

2517-RGT 

Fipronil, S-methoprene 

425437 

377744 

R3l0, New Products, RD Science Review 

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

45638104,45628105 

Overall Review of Label Claims and Directions: 

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

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

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

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

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

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

supported and must also be removed from the labeL 

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

-All 'repels' claims must be removed 

-All claims against flea pupae must be removed 

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

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

works by collecting in the hair follicles and skin oils. This product features a sustained-release 
47

formula that discharges from the animal's hair follicles using the natural skin oils, resulting in 

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

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

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

follicles (and accompanying diagram) is deferred to the RM ReviewerlPM. 
48

DATA PACKAGE BEAN SHEET 

Date: 14-May-2010 

Page 1 of2 

* * * Registration Information * * * 

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

Company: 2517 - SERGEANTS PET CARE PRODUCTS, INC. 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 S-7237 

Risk Manager Reviewer: Bonaventure Akintosotu BAKtNLOS 

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

Type of Registration: Producl Registration - Section 3 

) Decision #: 425437 

DP #: (377739) 

PRIA 

Parent DP #: 

Submission #: 873353 

Ediled Due Date: ____ _ 

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

Ingredients: 129121, Fipronil(9.7%) 

* * * Data Package Information * * * 

Expedite: 0 Yes • No Date Sent: 14-May-2010 Due Back: ____ _ 

DP Ingredienl: 129121, Fipronil 

DPTitle: ,C~R~P ___________________________ _ 

CSF tncluded: • Yes 0 No Labellncludecl: • Yes 0 No Parent DP #: ____ _ 

Assigned To Date Out 

Organization: ~R~D~I~TR~B,,-_______ _ Y/Z8"lI1i-- Last Possible Science Due Date: 05-0ct-2010 

Team Name: Child Resistant Packaging Science Due Oate: ____ _ 

Reviewer Name: __________ _ Sub Data Package Oue Date: 

Contractor Name: __________ _ 

* * * Studies Sent for Review * * * 

Printed on Page 2 

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

Can be prinled on its own page 

* * * Data Package Instructions * * * 

For Your Review: 

- MRtD 48059503 for an R310 action, a fipronil EP 

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

- Same review presumably for 2517-RGl 

Thx, baa 
49

) Page 2 

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

I 

Poison 

Products, Inc .. Project Number: 

prepared by Perritt Laboratories, lnc. 28 p. 
50

CHILD-RESISTANT PACKAGING REVIEW 

Technical Review Branch 

IN 5/14/2010 OUT 9/28/2010 

~./ - /J_-.fl,;e:~ RD, TRB, Reviewed by Rosa(;~' 9/28/2010 

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

DP Barcode DP377739 &377717 

Decision # 425437 & 425455 

EPA Petition or EUP No. ___ _ 

Date Division Received 4/12/2010 

Type Product(s) Insecticide (fiea product) 

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

Product Mgr.lChemical Review MgrlContact Person RM 10 Bonaventure Akinlosotu 

Division "R",D,-__ 

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

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

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

sYPPOrt CRP certification for these products 

Active Ingredient(s), PC code, & % Fipronil 9.7% 

Summary of Findings 

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

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

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

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

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

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

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

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

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

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

1700.20(a)(3)(i) regarding age and sex distribution, the number of test subjects 
51

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

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

section below. 

Should any human experience/epidemiological evidence indicate a 

problem once the product is in the marketplace, the Agency reserves the right to 

reexamine this data comprehensively and to question the child resistance of the 

package involved. 

Package 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

narrow end at the notches with scissors." 

Toxicitv 

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

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

28.5mg. Access to a toxic or harmful ami ~ 28.5mg ~ 28.5mg divided by [1 030mg/ml x 

0.097 Fipronil] ~ 0.285 ml ~ 0.29 ml for Fipronil only Cat product EPA REG No. 

2517-RGT. Access to a toxic or harmful ami ~ 28.5mg ~ 28.5mg divided by [1020mg/ml 

x 0.097 Fipronil] ~ 0.288 ml ~ 0.29 ml for Fipronil only Dog product EPA REG No. 

2517-RGA. Access to a toxic or harmful amt ~ 28.5mg ~ 28.5mg divided by [1025 

mg/ml x 0.098 Fipronil] ~ 0.284 ml ~ 0.28 ml for Fipronil & S-Methoprene Cat 

product EPA REG No. 2517-RGL. Access to a toxic or harmful ami ~ 28.5mg ~ 

28.5mg divided by [1020mg/ml x 0.098 Fipronil] ~ 0.285 ml ~ 0.29 ml for Fipronil & SMethoprene Dog product EPA REG No. 2517-RGU. Access to one applicator 

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

No. 2517-RGL, or 0.29ml for EPA Reg. No. 2517-RGT, 2517-RGA, and 2517-RGU. 
52

3 

Toxicity, Child Failure, and Package 

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

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

2517-RGT 0.5 0.017 1.030 9.7 49.96 1 

2S17-RGA 0.67 0.023 1.020 9.7 66.29 1 

2517-RGA 1.34 0.045 1.020 9.7 132.58 1 

2517-RGA 2.68 0.091 1.020 9.7 265.16 1 

2517-RGA 4.02 0.136 1.020 9.7 397.74 1 

2517-RGL 0.5 0.017 1.025 9.8 50.23 1 

2517-RGU 0.67 0.023 1.020 9.8 66.97 1 

2517-RGU 1.34 0.045 1.020 9.8 133.95 1 
53

4 

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

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

2517·RGU 2.68 0.091 1.020 9.8 267.89 1 

2517-RGU 4.02 0.136 1.020 9.8 401.84 1 

Failure 

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

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

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

complete access to the placebo (water). 

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

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

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

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

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

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

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

second and third applicator. 

Analysis of Data and Conclusion 

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

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

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

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

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

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

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

directions as were used in the CRP testing. 

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

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

was MRID number 48059503 and the lowest child-resistant effectiveness (CRE) was 
54

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

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

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

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

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

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

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

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

5 

Senior Adult Use Effectiveness Study 3 white applicators with purple stripe 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CFR 1700,20, 

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

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

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

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

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

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

CFR 1700.15(b), 

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

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

analysis of the data these studies pass the CRE sequential test chart and SAUE 
55

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

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

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

6 

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

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

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

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

of that information: 

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

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

requirements. 

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

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

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

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

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

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

establish that they are CRP. 

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

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

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

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

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

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

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

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

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

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

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

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

it will need to be sUbmitted. 

Should any human experience/epidemiological evidence indicate a 

problem once the product is in the marketplace, the Agency reserves the right to 

reexamine this data comprehensively and to question the child resistance of the 

package involved. 
56

CRPdatasummarycht 

EPA REG # 2517-RGT Sergeant's Fipronil Spot On For Cats 

EPA REG # 2517-RGA Sergeant's Fipronil Squeeze On For Dogs 

Company Name Sergeant's Pet Care Products, Inc. 

Chemical - Fipronil 9.7% 

Sep

A Senior Adult Use Effectiveness failure is failure to access the applicator in the prescribed test time of 5 min

or 1 min. for the second package, not opening the applicator with scissors along the needle application tip, cutti

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

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

a single applicator first and cutting open a second or second and third applicator. 

A child failure is access to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

A unit failure is opening the applicator or any partial or complete access to the placebo (water). 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1030mgiml x 0.097 Fipronil] = 0.285 ml = 0.29 

Cat EPA REG # 2517-RGT 

Access to a toxic or harmful am! = 28.5mg = 28.5mg divided by [1020mgiml x 0.097 Fipronil] = 0.288 ml = 0.29 

Dog EPA REG # 2517-RGA 

Access to a toxic or harmful am! = 28.Smg = 28.5mg divided by [1025 mgiml x 0.098 Fipronil] = 0.284 ml = 0.28 

Methoprene Cal EPA REG # 2517-RGL 

Access to a toxic or harmful amt = 28,Smg = 28.5mg divided by [1 020mgiml x 0.098 Fipronil] = 0.285 ml = 0.29 

Methoprene Dog EPA REG # 2517-RGU 

% AI - Fipronil 9.7% 

Note: 

The applicator is the child-resistan! feature. The applicators are filled in ml. 

1, 

2. 

3. 10 CRP studies were submitted by the Company to cover the S sizes (O.S, 0.67, 1,34, 2.68, 4,

only and the Fipronil and S-Methoprene products. This is based on the registrant's submis

the applicator as tested and proposed to be marketed for the Fipronil only and the Fipronil 

products, which appeared to be identical; and a June 30, 2010 letter indicating the same ap

and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methopre

used in the CRP testing. 
57

EPA REG# MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# uniUpkg, child fail = # Child Get CRE SAUE Compreh Only include eRE & SA

units, cotor, tax/harm = # at Begin ensive Camp units Test Review uter 

& why Anaty 

sis 

2517-RGT 48059503 3 white applicators with 1 setof3 o child XCRE CRP Certification 

Cat Fipronil only 1746-001 purple stripe on label applicators failures = associat Label dated 6/29/1

connected to each other. connected Pass 50 ed with in study. 

Each applicator @ O.5mt to each child test lowest Data AnaJysis sho

water as placebo. other. SAUE Study is a pass of 

Tax/harm = 1 applicator, the sequential test 

child fail :; 1 applicator 

2517-RGT 48059503 3 white applicators with 1 set of 3 90% X lowest CRP Certification 

Cat Fipronil only 1746-001 purple stripe on label applicators SAUE SAUE Label dated 6129/1

connected to each other. connected in study. 

Each applicator @ 0.5ml to each Data Analysis sho

water as placebo. other. package A and 1 s

Tox/harm = t applicator, B, which is the ma

child fail :; 1 applicator for a passed SAUE

However, one tes

test subjects. Th

number of subjec

16 CFR 1700.20(a

CRP test data is u

adult tesl must be 

last 9 test subjec

redoing the entire 

last 9 test subjects 

the criteria for the 

must conform to th

1700.20(a)(3)(i) re

distribution, the nu

I test site and per te
58

EPA REG# MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# uniVpkg, child fail ::: # ChHd Get CRE SAUE Compreh Only include eRE & SAU

units, color, tox/harm = # at Begin ensive Camp 

unUs Test Rev'lew uter 

&why Analy 

sis 

2517-RGA 48059803 3 white applicators with 15etof3 o child X CRP Certification 5

Dog Fipronil 1746-002 orange stripe on label applicators failures ::: Label dated 6/29/10 

only connected to each other. connected Pass 50 in study. 

Each applicator@ to each child test Data Analysis sho

O.87ml water as placebo. other. Study is a pass of t

Tox/harm ::: 1 applicator, the sequential1est 

child fail ::; 1 applicator 

2517-RGA 48059803 3 whiie applicators with 1 setof3 98% X CRP Certification 5

Dog Fipronil 1746-002 orange stripe on label applicators SAUE Label dated 6/29/10 

only connected to each other. connected in study. 

Each applicator @ to each Data Analysis sho

0.67ml water as placebo. other, open package A. S

Tox/harm::; 1 applicator, a pass of1he senio

child faU ::; 1 applicator 1700,20 and the eff

in 16 CFR1700.15(

2517-RGA 48059804 3 white applicators with 1 se1of3 o child X CRP Certification 5

Dog Fipronil 1746-003 green stripe on label applicators failures ::; Label dated 6/29/10 

only connected to each other, connected Pass 50 in study, 

Each applicator @ to each child 1est Data Analysis sho

1.34ml water as placebo. other. Study is a pass of t

Tox/harm::; 1 applicator, the sequential test 

child fail ::; 1 applicator 

2517-RGA 48059804 3 white applicators with 1setof3 95% X CRP Certification 5

Dog Fipronil 1746-003 green stripe on label applicators SAUE Label dated 6/29/10 

only connected to each other. connected in study. 

Each applicator @ 10 each Data Analysis sho

1.34ml water as placebo. other. package A and 1 se

Tox/harm::; 1 applicator, package B. SAUE 

child fail ::; 1 applicator pass of the senior a

1700.20 and the ef

in 16 CFR1700.15(

-_._- -
59

EPA REG # MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unitlpkg, child fail ::: # Child Get CRE SAUE Compreh Only include eRE & SA

units, color, tax/harm;::; # at Begin ensive Camp 

units Test Review oler 

& why Analy 

sis 

2517-RGA 48059805 3 whi1e applicators with 1 setof3 2 child X lowest CRP Certification 5

Dog Fipronil 1746-004 red s1ripe on [abel applica10rs failures ::: CRE Label dated 6/29/1

only connected to each other. connected Pass 50 in study. 

Each applica10r @ 10 each child test Data Analysis sho

2.68ml water as placebo. other. mon1h old male ac

Tax/harm::: 1 applicator, the demonstration 

child fail ::: 1 applicator accessed one appl

demonstration. S1

1es1 according to th

16 CFR 1700.20. 

2517-RGA 48059805 3 white applicators with 1 setof3 98% XSAUE CRP Certification 5

Dog Fipronil 1746-004 red stripe on label applicators SAUE associat Label dated 6/29/1

only connected to each 01her. connected ed with in study. 

Each applicator @ to each 10wes1 Data Analysis sho

2.68m I wa1er as placebo. other. CRE package A. SAUE 

Tox/harm ::: 1 applicator, pass of the senior 

child faii ::: 1 applica10r 1700.20 and the ef

in 16 CFR1700.15(

2517-RGA 48059806 3 whi1e applicators with 1 setof3 1 child X CRP Certification 5

Dog Fipronil 1746-005 blue stripe on label applicators failUre ::: Label dated 6/29/1

only connected to each 01her. connected Pass 50 in study. 

Each applicator @ to each child 1est Data Analysis sho

4.02ml water as placebo. other. error, a 44 month o

Tox/harm ::: 1 applicator, months old. The a

child fail ::: 1 applicator accordance with 

study results are n

child failure, a 44 m

applica10r after de

pass of the child te

sequential test cha
60

EPA REG# MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unit/pkg, child fail = # Child Get CRE SAUE Compreh Only include eRE & SA

units, color, taX/harm = # at Begin ensive Camp 

units Test Review uter 

& why Analy 

sis 

2517-RGA 48059806 3 white applicators with 1setof3 97% X CRP Certification 

Dog Fipronil 1746-005 blue stripe on label applicators SAUE Label dated 6/29/1

only connected to each other. connected in study. 

Each applicator @ to each Data Analysis sho

4.02ml water as placebo. other. missing. Upon find

ToX/harm = 1 applicator, data the age calcu

child fail = 1 applicator results are not affe

calculation error, b

in the same age gr

not affected. The 

failed to open pack

study is a pass of t

CFR 1700.20 and 

specifications in 16 
61

CRPdatasummarycht 

EPA REG # 2517-RGL Sergeant's Fipronil + S-Methoprene Spot On For Cats 

Company Name Sergeant's Pet Care Products, Inc. 

Chemical· Fipronil 9.8% 

S·Methoprene 11,8% 

A Senior Adult Use Effectiveness failure is failure to access the applicator in the prescribed test time of 5 min. 

1 min. for the second package, not opening the applicator with scissors along the needle application tip, cutting t

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

chamber of the applicator at other locations, cutting off the bottom of the main chamber of the applicator, or not s

applicator first and cutting open a second or second and third applicator. 

A child failure is access to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

A unit failure is opening the applicator or any partial or complete access to the placebo (water). 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1030mg/ml x 0.097 Fipronil] = 0.285ml = 0.29 m

Cat EPA REG # 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 m

Dog EPA REG # 2517-RGA 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1025 mg/ml x 0.098 Fipronil] = 0.284 ml = 0.28 

Methoprene Cat EPA REG # 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 m

Methoprene Dog EPA REG # 2517-RGU 

% AI - Fipronil 9.8% 

S-Methoprene 11.8% 

Note: 

1. 

2. 

3. 

The applicator is the child-resistant feature. 

The applicators are filled in mi. 

10 CRP studies were submitted by the Company to cover the 5 sizes (0.5,0.67,1.34,2.68,4.0

only and the Fipronil and S-Methoprene products. This is based on the registrant's submiss

the applicator as tested and proposed to be marketed for the Fipronil only and the Fipronil a

products, which appeared to be identical; and a June 30,2010 leiter indicating the same app

and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methopre

used in the CRP testing. 
62

EPA REG# MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# uniUpkg, child fail = # Child Get at CRE SAUE Compreh Only include eR

units, color, tax/harm = # Begin Test ensive Computer analysis 

units Review Analysis 

& why 

2517-RGL 3 white applicators with 1 set of 3 CRP Certif

Cat Fipronil + purple stripe on label applicators acceptable

Methoprene connected to each other. connected same CRP 

Each applicator @ O.5ml to each mentioned 

water as placebo. other. based on: 

ToX/harm = 1 applicator, MRID 4805

child fail = 1 applicator 

of the child 

sequential 

1700.20. T

However, 

33% of the 

exceeds th

subjects p

CFR 1700,

this CRP t

Bridging Le

same size 

package te
63

CRPdatasumma rycht 

EPA REG # 2517-RGU Sergeant's Fipronil + S-Methoprene Squeeze On For Dogs 

Company Name Sergeant's Pet Care Products, Inc. 

Chemical - Fipronil 9.8% 

S-Methoprene 8.8% 

A Senior Adult Use Effectiveness failure is failure to access the applicator ·,n the prescribed test time of 5 min. 

1 min. for the second package, not opening the applicator with scissors along the needle application tip, cutting t

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

chamber of the applicator at other locations, cutting off the bottom of the main chamber of the applicator, or not s

applicator first and cutting open a second or second and third applicator. 

A child failure is access to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

A unit failure is opening the applicator or any partial or complete access to the placebo (water). 

Access to a toxic or harmful am! = 28.5mg = 28.5mg divided by [1030mg/ml x 0.097 FipronilJ = 0.285 ml = 0.29 m

Cat EPA REG # 2517-RGT 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1020mg/ml x 0.097 FipronilJ = 0.288 ml = 0.29 m

Dog EPA REG # 2517-RGA 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1025 mg/ml x 0.098 FipronilJ = 0.284 ml = 0.28 m

Methoprene Cat EPA REG # 2517-RGL 

Access to a toxic or harmful am! = 28.5mg = 28.5mg divided by [1 020mg/ml x 0.098 FipronilJ = 0.285 ml = 0.29 m

Methoprene Dog EPA REG # 2517-RGU 

% AI - Fipronil 9.8% 

S-Methoprene 8.8% 

Note: 

1. 

2. 

3. 

The applicator is the child-resistant feature. The applicators are filled in mi. 

10 CRP studies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1.34, 2.68, 4.0

only and the Fipronil and S-Methoprene products. This is based on the registrant's submiss

the applicator as tested and proposed to be marketed for the Fipronil only and the Fipronil a

products, which appeared to be identical; and a June 30, 2010 letter indicating the same app

and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methopren

used in the CRP testing. 
64

-

EPAREG# MRID PKG Description Include # Pkges Com pany Data Data Conclusion 

ml per Pkg 

# unit/pkg, child fail = # Child Get CRE SAUE Compreh Only include eR

units, color, tox/harm = # at Begin ensive Computer analysis units Test Review Analysis 

& why 

2517-RGU 3 white applicators with 1 setof3 CRP Certif

Dog Fipronil + S- orange stripe on label applicators acceptable

Methoprene connected 10 each other. connected same CRP 

Each applicator @ O.67ml to each mentioned 

water as placebo. other. based on: 

T ox/harm = 1 applicator, indicating 

child fail = 1 applicator package a

passing eR

CFR 1700 

002) EPA 

2517-RGU 3 white applicaiors with 1 setof3 CRP Certif

Dog Fipronil + S- green stripe on label applicators acceptable

Methoprene connected 10 each other. connected same CRP 

Each applicator@ 1.34ml to each mentioned 

water as placebo. other. based on: 

T ox/harm = 1 applicator, indicating 

child fail = 1 applicator package a

passing CR

CFR 1700 

003) EPA 

2517-RGU 3 white applicators with 1 setof3 CRP Certif

Dog Fipronil + S- red stripe on label applicators acceptable

Methoprene connected to each other. connected same CRP 

Each applicaior @ 2.6Bml to each mentioned 

water as placebo. other. based on: 

ToX/harm = 1 applicator, indicating 

child fail = 1 applicator package a

passing C

CFR 1700 

004) EPA 
65

EPA REG # MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unitlpkg, child faU = # Child Get CRE SAUE Compreh Only include eR

units, color, tox/harm = # at Begin ensive Computer analysis 

units Test Review Analysis 

&why 

2517·RGU 3 white applicators with 1 setof3 CRP Certif

Dog Fipronil + SM blue stripe on label applicators acceptable

Methoprene connected to each other. connected same CRP 

Each applicator@ 4.02ml to each mentioned 

water as placebo. other. based on: 

Tox/harm = 1 applicator, indicating s

child fail, = 1 applicator package as 

passing eR

CFR 1700 

005) EPA 

. . . 
66

Product Toxicity based on Fipronil Toxicity 

Access to a toxic or hannful amt = 28.5mg Fipronil Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1030mg/ml x 0.097 Fipronil] = 0.285 ml = 0.29 m

Cat EPA REG # 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 m

Dog EPA REG # 2517-RGA 

Access to a toxic or harmful am! = 28.5mg = 28.5mg divided by [1025 mg/ml x 0.098 Fipronil] = 0.284 ml = 0.28 

Methoprene Cat EPA REG # 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 m

Methoprene Dog EPA REG # 2517-RGU 

EPA Reg # ml (ml = flo oz. (fl. oz. Product % Fipronil rng Fipronil 

0.0338 fl. 29.6ml) Density g/m I oz.) 

2517-RGT 0.5 0.017 1.030 9.7 49.96 

2517·RGA 0.67 0.023 1.020 9.7 66.29 2517-RGA 1.34 0.045 1.020 9.7 132.58 

2517-RGA 2.68 0.091 1.020 9.7 265.16 

2517-RGA 4.02 0.136 1.020 9.7 397.74 

2517-RGL 0.5 0.017 1.025 9.8 50.23 

2517-RGU 0.67 0.023 1.020 9.8 66.97 

2517-RGU 1.34 0.045 1.020 9.8 133.95 

2517-RGU 2.68 0.091 1.020 9.8 267.89 

2517-RGU 4.02 0.136 ·1.020 9.8 401.84 
67

DAtA PACKAGE BEAN SHEET 

Date: 14-May-2010 

Page 1 of 1 

* * * Registration Information * * * 

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

Company: 2517 - SERGEANT'S PET CARE PRODUCTS, INC. 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 5-7237 

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS 

Sent Dale: ____ _ Calculated Due Oale: 04-Nov-2010 

Type of Registration: Product Registration - Section 3 

Decision #: 425437 

DP #: (377737) 

PRIA 

Parent DP #: 

Submission #: 873353 

Edited Due Date: ____ _ 

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

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

Expedite: 0 Yes. No 

DP Ingredient: 129121, Fipronil 

DP Title: Tox: Similarity 

* * * Data Package Information * * * 

Dale Sent: 14-May-2010 Due Back: ____ _ 

CSF Included: • Yes 0 No Label Included: • Yes 0 No Parent DP #: __ _ 

Assigned To Date In 

Organization: "R~D~/~T~R~B _____ _ 

Date Out / 

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

Team Name:TD ,~X"-_____ ~ ___ _ Science Due Date: ____ _ 

Reviewer Name: ------- Sub Data Package Due Date: __ _ 

Contractor Name: 

* * * Studies Sent for Review * * * 

NO Studies 

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

Can be printed on its own page 

* * * Data Package Instructions * * * 

For Your Review: 

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

Thx, baa 
68

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

September 16, 2010 

MEMORANDUM 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Name of Pesticide Product: 

EPA Reg. No. IFile Symbol: 

SERGEANT'S FIPRONIL SPOT-ON FOR CATS 

2517-RGT 

DP Barcodes: DP 377737 

Decision No.: 425437 

Action Code: R310 

PC Codes: 129121 (Fipronil: 9.7%) 

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

Technical Review Branch 

Registration Division (7505P) 

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

)s::.'< - \ r.. - 1...c::>1...C> 

To: Bonaventure AkinlosotuiRichard Gebken RM 10 

Insecticide Branch 

Registration Division (7505P) 

Registrant: SERGEANT'S PET CARE PRODUCTS, INC. 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

129121 Fipronil 

Other Ingredient(s): 

TOTAL 

ACTION REQUESTED: The Risk Manager requests: 

~ 

Bywt. 

9.7% 

90.3% 

100.0% 

"For Your Review: An R310 action, a new fipronil EP; presumably me~too of Me rial's Frontline 

65331-2." 

Page 1 {lO 
69

BACKGROUND: 

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

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

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

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

a proposed label, a CSF dated 12/2112009, and a copy ofa coverletter dated April 12, 2010. 

COMMENTS AND RECOMMENDATIONS: 

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

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

will also support the registration of2517-RGT. 

2. MRlDs 43577705 through 43577710 were reviewed in a memorandum dated 7117/95 from 

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

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

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

dennal sensitization. These classifications are consistent with the precautionary labeling 

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

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

and water after handling. "). 

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

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

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

to support 65331-EUP-1. 

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

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

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

study involved testing of groups of s: 8 week old male and female kittens "and demonstrated 

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

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

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

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

submitted in support of 65331-EUP-E. 

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

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

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

efficacy study (not a toxicity study). 

Page 2 of3 
70

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

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

1996) and classified as supplementary. 

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

43577716?): "The active ingredient in [brand name] works by collecting in the hair follicles 

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

animal's hair follicles using the natural skin oils ... " This should be deleted from 2517-RGT, 

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

and continues to be released from hair follicles onto the skin and coat. .. ") should be deleted 

from the label of that product. 

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

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

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

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

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

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

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

9. The proposed label for 2517-RGT includes the statement: "Can be used on breeding, 

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

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

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

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

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

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

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

TRB Chemistry Team. 

Page 3 of3 
71

DATA PACKAGE BEAN SHEET 

Date: 14~Mayw2010 

Page 1 of 2 

* * * Registration Information * * * 

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

Company: 2517 - SERGEANT'S PEr CARE PRODUCTS, INC. 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 8-7237 

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS 

Sent Date: ____ _ Calculated Due Date: 04-Nov-2010 

Type of Regislralion: Product Registration - Section 3 

Decision #: 425437 

DP #: (377736) 

PRIA 

Parent DP #: 

Submission #: 873353 

Edited Due Dale: ____ _ 

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

Ingredients: 129121, Fipronil(9.7%) 

* * * Data Package Information * * * 

Expedite: 0 Yes. No Date Sent: 14-May-2010 Due Back: ____ _ 

DP Ingredient: 129121, Fipronil 

DP Title: Prod Chem 

CSF Included: • Yes 0 No Label tncluded: • Yes 0 No Parent DP #: __ _ 

Assigned To Date tn Date Out / 

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

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

Reviewer Name: __________ _ Sub Data Package Due Date: 

Contractor Name: __________ _ 

'I< 'I< 'I< Studies Sent for Review 'I< 'I< * 

Printed on Page 2 

* 'I< * Additional Data Package for this Decision * * * 

No Additional Data Packages 

'I< * * Data Package Instructions * * 'I< 

For Your Review: 

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

Thx, baa 

\ 
72

Page 2 

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

04/10/10, 

Care Products, Inc. p. 

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

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

by Sergeanfs Pet Care Products, Inc. 35 p. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Spot-On. Project Number: 04/10/11. Unpublished study prepared process 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

by Sergeant's Pet Care Products, Inc. 6 p. 
73

EE 

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

PC Coders): 129121 ACTION CODE: R 310 

FOOD Use: NO NON-FOOD Use: YES 

DATE OUT: August 31, 2010 

SUBJECT: End Use Product Chemistry Review 

pr~uctN"Ille: SERGEANT'S FIPRONIL SPOT ON FOR CATS 

\ ~ ~1f'\'(O 

I~r 'Cairola ,--fL,-v"-''' .' 0 

Product Chemistry Team ?J I D 0\ \ 'Y' ') 

FROM: 

Technical Review Branch I Registration Division (7505P) 

TO: Richard Gebken IBonaventure Akinosotu PM 10 

Insecticide Branch I Registration Division (7505P) 

Company Name: SERGEANT' S PET CARE PRODUCTS INC 

Formulation Type: LIQUID 

INTRODUCTION: 

The applicant requested a new non food use) end use product. In support of the application, the 

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

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

chemistry data and the proposed basic and 1 alternate CSF. 

SUMMARY OF FINDINGS: 

1. Name of Active Ingredient Fipronil. 

2. All of the source materials of the active ingredient are derived from registered sources. 

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

labeled uses. 

4. Confidential Statement of Formula(s): 

[Xl Basic - 12/21109 Dated: resubmitted (email) - Dated: 08/31110 

[Xl Alternate # 1 Dated: 08/31110 

Alternate CSF(s) complies with 40CFR§152A3: [Xl Yes [l No 
74

DP BARCODE No.: 

PC Coders): 

FOOD Use: Yes 

5, Product label 

FILE SYMBOL No.: DECISION No.: 

Action Code: R 310, R 340, 345 

NON-FOOD Use: Yes 

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

(PR Notice 91-2) 

[X] Yes, if not, explain below: 

Metallic equivalent: [ 

Soluble arsenic: [ 

Isomeric ratios: 

Acid equivalent: 

[ 

[ 

1 Yes [ 

1 Yes [ 

1 Yes [ 

1 Yes [ 

1 NA; 

lNA 

lNA 

] NA; {name} acid equivalent = xx % 

b. Health related sub statements: Product contains? 

Petroleum distillate at> 10%: 

Methanol at> 4%: 

[ 1 Yes [Xl No [ 1 NA 

[ lYes [XlNo [ lNA 

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

for: flammability, explosive potential or electric insulator breakdown? 

[lYes [lNo 

Is the sub statement in compliance with PR Notice 97-6? [ ] Yes, ifnot, explain below: 

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

below: 

Applicant needs to submit Enforcement Analytical Method for Fipronil 

2 
75

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

PC Code(s): 

FOOD Use: Yes 

Action Code: R 310, R 340,345 

NON-FOOD Use: Yes 

6. Group A: Product Chemistry Data 

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

tables below. 

Data TRB's 

Guideline submitted Assessment 

No. Study Title Yes No of Data MRIDNos. 

Product Identity & 

830.1550 Composition X A 480595-01 

Description of materials used 

830.1600 to produce the product X A 480595-01 

Description of formulation 

830.1650 process X A 480595-01 

Discussion on the formation 

830.1670 of impurities X A 480595-01 

830.1700 PreliminalY analysis 

Standard 

certified 

Certified limits 

limits 

(158.350) Proposed Limits 

Justification for 

830.1750 \\fider limits 

Enforcement analytical 

830.1800 method G 

A::::: Acceptance, N = Not Acceptable, G = Data Gap, 

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

3 
76

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

PC Code(s): 

FOOD Use: Yes 

7. Group B: 

Guideline Study Title 

No. 

830.6303 Physical State 

830.6315 Flammability 

830.6316 Explodability 

830.7000 pH 

830.7300 Density (units) 

Action Code: R 310, R 340, 345 

NON-FOOD Use: Yes 

Value or Qualitative TRB's 

Description Assessment 

of Data 

Clear yellow liquid A 

>90°C A 

Not explosive A 

Product insoluble in water NA 

1.00-1.05g/mL A 

A = Acceptance, N = Not Acceptable, G = Data Gap, W = Waiver request, 

NA = Not applicable, I = In progress 

CONCLUSIONS: 

MRIDNos. 

480595-02 

480595-02 

480595-02 

480595-02 

480595-02 

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

has concluded: 

1. Basic CSF Dated: 08/31/10 is acceptable and attached. 

2. Alternate CSF#I Dated: 08/31/10 is acceptable and attached. 

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

Enforcement Analytical Method for Fipronil. 

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

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

registrant is required to generate one year storage stability & corrosion characteristics study. 

The recommended observations periods are 0,1,3,6,9, & 12 months intervals. 

5. The proposed label was screened as it pertains to the product chemistry requirements. The 

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

4 
77

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

May4,2010 

OPP Decision Number: D-425437 

EPA File Symbol or Registration Number: 2517-RGT 

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

EPA Application Receipt Date: !3-Apr-2010 

EPA Waiver Request Receipt Date: 13-Apr-20 1 0 

EPA Company Number: 2517 

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

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA,NE 68130-1703 

SUBJECT: Approval of50% Small Business Waiver Request 

Dear Registrant: 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

The Office of Pesticide Programs has approved your request for 50% waiver of the 

pesticide registration fee associated with the action referenced above. The decision review 

period for this action will begin on the date of this letter. 

The Action has been identified as Action Code: R310 

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

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); 

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

Ombudsman, at (703) 305-6249. 

Siiparely, 

Oscar 

Infonnation 

Morales, 

Technology 

i~ ~~ & Resources Management Division 

Office of Pesticide Programs 
78

\ 

) 

UNllED STATES ENVIRONMENTAL PROTECTIuN AGENCY 

WASHINGTON, D.C. 20460 

April 19, 2010 

OPP Decision Number: D-425437 

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

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

EPA Receipt Date: 22-Dec-2009 

EPA Company Number: 2517 

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

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158m PLAZA 

OMAHA, NE 68130-1703 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

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

Dear Registrant: 

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

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

results of the PRi'\f-86-5 screen will be communicated separately. During the administrative 

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

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

The Action has been identified as Action Code: R31 0 

NEW PRODUCT;NON-F AST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); 

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

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

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

overpayment as soon as is practicable. If your waiver request is denied, you will receive an 

invoice for the outstanding balance. 

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

Ombudsman at (703) 305-6249. 

Sincerely, 

7'MLM-~ 

Front End Processing Staff 

Infomlation Technology & Resources Management Division 
79

change PRIA code 

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

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

Hi JJ and Teresa, 

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

2517--RGU 

2517-RGL 

2517-RGA 

2517-RGT 

Linda Arrington 

Registration Division 

7033056249 

703 305 6920 (fax) 
80

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D,C, 20460 

April15,2010 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

Report of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXlC SUBSTANCES 

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

analysis ofthe material. The results are provided as follows: 

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

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

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

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

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

Manager, to whom the data have been released. 
81

480595·00 

Pet Care Products, Inc. 

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

April 12, 20 I 0 

Richard'Gebken, PMIO 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S·4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Sergeant's Fipronil Only Squeeze-On for Cats 

EPA File Symbol 2517·RGT 

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

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th Plaza, Suite 100, Omaha, 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

data in accordance with PR Notice 86-5. In addition, you must revise the data matrix as 

outlined in #1 above to reflect this change. 

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

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

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

and Sergeants listed themon the new enclosed data matrix. 
82

Sergeant's Pet Care Products, Inc. 

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

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

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

the referenced products listed on your 8570-1 form (block #6) are also not citable for 

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

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

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

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

new enclosed data matrix. 

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

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

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

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

1. Administrative materials: 

• Transmittal docmnent; 

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

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

• EPA Fonn 8570-35: Data Matrix Fonn - EPA and Public Versions; and 

• Additional PRlA Payment Confmnation Receipt. 

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

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

Purple Label Indicator (3x), scissors to open - f=l as a Poison Prevention Package for 

Sergeant's Pet Care Products, Inc. 

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

Sincerely, 

tell /bJk P--

Kenyf.Hoskins 

Manager of Teclmical Affairs 

Sergeant's Pet Care Products, Inc. 

Enclosures 
83

Sergeant's Pet Care Products, Inc. 

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

Data Transmittal Document: 

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

2625 South 158th Plaza 

Suite 100 

Omaha, NE 68130-1703 

Submittal Date: April 12, 2010 

Volume Study Title MRID 

I Group A Product Chemistry for Fipronil Cat Spot-On 

(25 I 7-RGT) 

48059501 

2 Group B Product Chemistry for Fipronil Cat Spot-On 48059502 (2517-RGT) 

3 Evaluation of the Cat Squeeze On 0.5 ml White 

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

open - F=l as a Poison Prevention Package for 

Sergeant's Pet Care Products, Inc .. 
84

) Please read Instructions, o;n reverse b~fore c:.u'mpleting form. Form Approve .... OMB No.:2070-0060. Approval expires 05-31-98 

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

EPA '. , ': , E'nvif:onmehtal Protection Agency D,Amendment 

Washington, DC 20460 o Other , . . 

Application for Pesticide - Section I 

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

2517-RGT Richard Gebken 

4. Company/Product (Name) 

Fipronil Only Spot-On FOf Cats 

PM#10 ~None DRestricted 

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

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

2625 South 1581h Plaza 

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

Product Name FRONTLINE TOPSPOT FOR CATS 

o Check if Ihis is a new address 

Section II 

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

~ Resubmission in response to Agency leiter dated 01-27-2010 D "Me Too" Application 

D Notification - Explain below. D Other - Explain below. 

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

Section III 

1. Material This Product Will Be Packaged In: 

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

~Yes~ k8] Yes DYes o Metal 

ONO o No Is:J No l'Zl Plastic 

If "Yes" No. per tt"Yes" No. per OGlass 

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

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

I D01her (Specify) Plastic Bag 

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

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

DOn Labeling accompanying producl 

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

OPaper glued 

OStenciled 

Section IV 

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

Name Title Telephone No. (Include Area Code) 

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

Certification 6. Date Application 

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

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

under applicable law. 

2. Signature 

jt!lll~L;b 3. Title 

BY: ~ 

Manager of Technical Affairs 

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

KellyR. Hoskins 00 I !~ /ZCIO 
85

F orm Approved o N MB 0<. 2070.-00 60; 2070-0057: 2070-010 7 2070-0 1 22 2070 0 164 

"'~", UNITED STATES ENV)RONMENTAl PROTECTION AGENCY (Al 5 1200 Pennsylvania Avenue, N.W. 

WASH)NGTON, D.C. 20460 

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

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

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

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

to this address. 

Certification with Respect to Citation of Data 

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

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

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

Fipronll 04/1212010 

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

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

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

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

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

be used for this purpose). 

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

0 I am using the die-ali method of support, and have included with this form [2] I am using the selective method of support (or dte-all option 

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

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

used). 

SECTtDN II: GENERAL OFFER TO PAY 

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

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

SECTION III: CERTtFICATIDN 

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

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

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

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

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

uses. 

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

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

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

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

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

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

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

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

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

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

FIFRA. 

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

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

Signature 16 JoJ)jJ/s$2- Date Typed or Pnnted Name and Title 

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

EPA Form 8570-34 ,j-;::-2oo3) Electronic and Paper versions available. Submij only P er version. 
86

Pay.gov - Online Payment Page lofl 

Online Payment 

Step 3: ConfIrm Payment 11213 

Thank you. 

Your transaction has been successfully completed. 

Pay,goy Tracking Infonnation 

Application Name: PRIA Service Fees 

Pay.goy Tracking 10: 250LG6U2 

Agency Tracking ID: 74110737347 

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

Payment Summary 

Account Holder Name: Sergeants Pet Care Products 

Payment Amount: $3,213.00 

Account Type: Business Checking 

Routing Number. 

Account Number. *

uu5483 

Payment Date: 04/1312010 

Decision Number: 

Registration Number: 2517-RGT 

Company Name: Sergeants Pet Care Produc 

Company Number: 2517 

Action Code: R310 

httos://www.nav.l!ov/oavs!Ov/navrnents/authorizeACHPavment.html 4/1212010 

*Commercial/financial information may be entitled to confidential treatment*
87

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

'" 401 M Street, S.W. 

WASIDNGTON, D.C. 20460 

l'lIpenvork Redllction Act Notice: The public reporting burden for this collection of information is cstimaJcd to average 0.25 hours per response for registration aClivitie5 a

reregistration and special review llClivities, including time for reading the instruction and completing the necessary forms. Send comments regarding the burden estimate or 

of information, including suggestions for reducing the burden to Director: OPPE lnfonnation Management Division (2137) U.S. Environmental Protection Agency, 401 M S

20460. Do not send the form to this address. 

DATA MATRIX 

Date: April 12,2010 EPA Reg No.fFi!e Symbol 2517· RG

Applicant's/Rcgistrant's Name & Addrcss Product: Fiproni! Only Spot-On For C

Sergeant's Pet Care ProdUcts, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 

In redients: Fi roni! 

Guideline Referencc Number Guidelinc Study Name MRlDNumber Submittcr 

- 830. I 550, 830.1600, 830.1620, Product Properties Data for Sergeant's Fiproni! Squeeze- New submission Sergeant's Pet Care Products, I

830.1650,830.1670,830.1700, On for Cats 

830.1750, 830.1800 

830.1800 Enforcement analytical method New submission Ser eant's Pet Care Prodllcts, I

830.6302,830.6303,830.6304, Product chemistry of Sergeant's Fiproni! Squeeze-On for New submission Sergeant's Pct Care Products, I830.7300, 830.7000, 830.6315, C," 830.7100,830.6320,830.6317 830.6317, 830.6320 Storage stability and corrosion characteristics To be submitted Sergeant '.'I Pet Care ProdUcts, I

upon completion 

870.1100 Acute oral toxicity 43577705 MERlAL LIMITED 

870.1200 Acute dermal toxicity 43577706 MERIAL LIMITED 870.1300 Acute inhalation toxicity 43577707 MERIAL LIMITED 870.1400 Primary eye irritation 43577708 MERIAL LIMITED 870.1500 Primary dermal irritation 43571709 MERlAL LIMITED 

'- 870.1600 Dermal sensitization 43577710 MERIAL LIMITED 

Evaluation of the Cat Squceze On O.Sml White Applicator with New submission Sergeant's Pet Care Products, I

M Purple Label Indicator (3x), scissors to open - F=l as a Poison P""nti" P","g, [" S",,,,nt', P,t Cn" Pmd,,", I"" 

Signature:. ;f0,t,)y.,j 15;;). Name and Title 

Ke!!y R. Hoskins, Manager ofTochnical Affairs 

, 

EPA FornI t9.9VY'«lrOllic."d Paper V<yion, v,ilable Submit only P.!"', .... ,,;O". Agen<y lo!<
88

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401 M Street, S.W. 

0 WASHINGTON, D.C. 20460 

Paperwork Rcductioll Act Noticc: The public reporting burdell for this collcctioll of information is estimated to avcrage 0.25 hours per response for registralion activities a

reregistration and special review activities, illcluding time for reading the in2eregistmtioncompleting the necessary forms. Send comments regarding thc burden eSlimate or 

of info rmati 011, including suggestions for reducing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 40 I M S

20460. Do not scnd the form to this address. 

DATA MATRIX 

Date: April 12, 2010 EPA Reg No.lFile Symbol 2517- RO

Appl"lcant' s/Rcgistrant' s Name & Address Product: Fipronil Only Spot-On For C

Sergeant's Pet Carc Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 

Ingredients: Fipronil 

Guidelinc Rcference Number Guideline Stud Name MRID Numbcr Submitter 

870.7200 Schwartz, E, (I994) Domestic Animal Safety Study of 43272401 MERIAL LIMITED 

RMI601 C 0.25% Topical Spray in Juvenilc Cats: Interim 

Report: Lab Project Number: 94424. Unpublished study 

I prepared by White EagleToxicology Lab. 112 p. 

870.7200 Schwartz, E. (1994) Domestic Animal Safety Study of 43444904 MERIAL LIMITED 

RMI60lC Topical Spray (Frontlinc Spray Treatment) ill 

Juvenile Cats: Lab Project Number: 94424: PS-234DAS. 

Unpublished study prepared by White Eagle Toxicology Labs. 

168 p. 

870.7200 Walker, K. (1995) Discussion in Support of Bridging Domestic 43577711 MERIAL LIMITED 

Animal Safety Data on Frontline Spray Treatment to Frontline 

Spot Trcatment Data Packagc. Unpublished study preparcd by 

Rhone Mel" ieux, Inc. 6 o. 

870.7200 Everett, R.; Cunningham, J.; Tanner, P. (1995) Positive 43577713 MERIAL LIMITED 

Refercnced and Untreated Controlled Dose Confirmation Trial 

ofRMI60IE 10% SPOT-ON Formulation Applied to Cats for 

Control of the Cat Flea Ctenocephalides felis: Lab Project 

Numbers: RM VSR-250LT: ARC #RMCI94: P-250LT. 

Unpublished study preparcd by AgResearch Consultants, Inc. 

30D. 

870.7200 Villageliu, J.; Lopcz, S.; Germa, M.; et al. (1994) 43577716 MERIAL LIMITED 

Percutaneous Absorption and Distribution of Radioactivity in 

Hair, Skin, and Fat After Spot-On Application of (Carbon 14)-

RMI601 in Cats: Lab Project Numbcrs: CD-93/3748F. 

Unpublished study prepared by Centro de Investigacion y 

Dcsarrollo Aplicado, SAL. 42 p. 

Signaturc: j.- './ liD;., ;'0 h. ... Namc and Title 

II PI: Kelly R. Hoskins, Manager of Technical Affairs 

EPA F= 8170.J5 (9-97 f'J ehon;e aIld P.!"', Vet"? Available Suh";1 only Poper ver';on Ag,ncy 1o""
89

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401 M Street, S.W. 

0 WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is eslimaled to average 0.25 hours per response for registration activities a

rcregistratiOll and special review activities, including time for reading the in3eregislratiollcompletlng the necessary forms. Send comments regarding the burden estimale or 

of information, including suggestions for reducing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M S

20460. Do not send the form (0 this address. 

DATA MATRIX 

Date: April 12, 20 I 0 EPA Reg No.lFilc Symbol 2517- R

Applicant'slRegistrant's Name & Address Prodllct: Fipronil Only Spot-On For C

Sergeant's Pet Care Products, Inc. 2625 South I 58th Plaza, Suite 100, Omaha, NE 68130-l703 

In redients: Fi ronil 

Guideline Reference Numbcr Guideline Stud Name MRiDNumber Submittcr 

870.7200 Camcron, D.; Maltby, B. (l995) Domestic Animal Safety by 43863801 MERIAL LiMlTED 

Topical Administration to Cats: Fipronil Spot Treatment: Lab 

Project Number: MRX 24/950746. Unpublished study prepared 

by Huntingdon Research Ccntre, Ltd. 174 p. 

8l0.3300 Young, R (1993) A Preliminary Study to Evaluate Initial and 43121119 MERIAL LIMITED 

Residual Efficacy of Two RM l601 Spray Formulation Topically 

Applied for Control of the Cat Flea in the Cat: Lab Projcct 

Number: P-21ILT. Unpublished study preparcd by Young 

Veterinary Research. 28 p. 

810.3300 Cruthers, L. (I993) A Dose Confirmation Study to Verify the 43121120 MERIAL LIMlTED 

Optimal Spray Concentration ofRMI60 IC for Control of the Cat 

Flea Ctenocephalides felis in the Cat: Revised: Lab Projcct 

Number: PLRS 9303: P!224LT. Unpubrlshed study prcpared by 

Professional Labs and Research Serviccs, Inc. 31 p .. 

810.3300 Everett, R.; Cunningham, 1. (1993) Dose-Titration (Volume) of 43121121 MERIAL LIMITED 

RM 1601 Spray for Control oCthe Cat Flea Clenocephalides 

fclis in thc Cat: Revised: Lab Projcct Number: RMD 393: 

P!228L T. Unpublished study prepared by Agrcsearch 

Consultants, Inc. 41 p. 

810.3300 Poll meier, M. (1999) An Efficacy Study ofFrontlinc Top Spot 45628101 MERIAL LIMITED 

for thc Treatment and Control ofFelicola subrostratus in the Cat: 

Final Report: Lab Project Number: PR&D 0022201. 

UnpUblished study prepared by Centro Vcterinario Oriolo. 18 p. 

810.3300 i'ollmeier, M.; Pengo, G.; Barrick, R (2000) An Efficacy Study 45628102 MERIAL LlMlTED 

of Frontline Spray, Frontlinc Top Spot and ML-2,095,988 508Q 

for the Treatment and Control ofFelicola subrostratus in the Cat: 

Final Rcport: Lab Project Number: PR&D 003720 1_ 

Unpublished sludy prepared by Centro Veterinario Oriolo. 22 p. 

810.3300 Pollmeier, M.; Pengo, G. (2001) Studies to Confirm thc Efficaey 45628103 MERIAL LIMITED 

ofFipronil Against Liee in Cats Undcr Field Conditions: Final 

RepOlt: Lab Project Number: PR&D 0037501. Unpublished 

study prcpared by Centro Vcterinario Oriolo. 20 p. I Name and Title 

Kelly R. Hoskins, Managcr of Technical Affairs 

'n'O
90

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401 M Street, S.W. 

0 WASHINGTON, D.C. 20460 

Paperwork Reduction Acr Notice: Thc public reporting burden for this collection of infommtion is estimaled to average 0.25 hours per response for registration activities a

reregistratiOll and special review activitics, including lime for reading the in4eregistrationcompleting the necessary forms. Send commenlS regarding the burden estimate or 

of information, including suggestions for reducing the burden to Director: OPPE Information Management Division (2t37) U.S. Environmellla! Prolection Agency, 40 I M S

20460. Do not send the form to this address. 

DATA MATRIX 

Date: April 12, 20 lO EPA Reg No.lFile Symbol 2517- RG

Applicant'slRegistrant's Name & Address Product: Fipronil Only Spot-On For C

Sergeant's Pet Care Products, Inc. 2625 South I58th Plaza, Suite 100, Omaha, NE 68130-1703 

Ingredients: Fipronil 

Guideline Reference Number Guideline Stud Name MRID Number Submitter 

810.3300 Postal, J.; Le Nain, S.; Gonzalez, C.; et aI. (1999) Studies to 45628104 MERIAL LIMITED 

Asess the Efficacy of Frontline Spot-On (10% w/v Fipronil) in 

the Treatment of Fclinc Flea Allergy Dermatitis (FAD) Under 

Field Conditions: Final Report: Lab Project Number: ASR 

19012: CLl277. Unpublished study prepared by Merial, 64 p. 

810.3300 Alva, R.; Barrick, R. (1999) A Study to Determinc the Effect of 45628105 MERIAL LIMITED 

Trcatmcnt with Frontline TopSpot on the Prevalence and 

Severity of Fica Allcrgy Dermatitis in Cats: Final Report: Lab 

Projcct Number: PR&D 0012701-04: PR&D 00t2701: PR&D 

0012702, Unpublished study prepared by VCA StPctersburg 

Animal and AltamahaAnimal Clinc. 41 p. 

133-3 Mco, N.; Gonzalez, C,; Mester, T. (1997) Dermal and 44433302 MERIAL LIMITED 

Inhalation Exposurc of Commercial Pet Groomcrs During 

Application of Frontline Spray Treatment: Final Report: Lab 

Projcct Number: MERIAL-445-SAFXT046: SAFX046: 

PDA9705. Unpublished study prepared by ABC Labs., 

California and Aanimal Appeal Grooming Shop & Casc 

Vcterinary Hospital. lO66 p. 

133-3 Meo, N.; Gonzalez, C.; Belchcr, T. (1997) Dermal Exposure of 44433303 MERlAL LIMITED 

" ...... -

Commercial Pct Groomers Dur'lUg Applica(lOn of Front! ine Top 

Spot: Final Report: Lab Project Number: MERIAL-445· SAFXTQ47: SAFXT047: EC·97-390. Unpublished study 

prepared by ABC Labs., California and Aanimal Appeal 

Grooming Shop & Case Veterinary Hospital. 925 P. 

132·1 Hughes, D. (1997) Dislodgeable Residues ofFipronil following 44433304 MERIAL LIMITED 

Application of Frontline Top Spot to Cats: Final Rcport: Lab 

Project Numbcr: COY ANCE 6848-103: MERIAL METXT 

168: 90066D. Unpublished study prepared by Covance Labs. 

Inc. 118 p. 

S;""'" ;(tf!f/lt1it}X!J;t::. Name and Title 

Kelly R. Hoskins, Managcr of Technical Affairs 

EPA Form gS7()')S (9.97) IJrronic alJd P'pe, Ver'i n, Av.iloble, Submit ""Iy p,!"" ""rsioo Ag.n.y Int<'
91

.OW" ._ ••• 

. 011 and special review 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

• 401 M Street, S.W . 

• WASHINGTON, D.C. 

I 

-------

_____ .ion, including suggcsti ... lV' 

20460. Do not send ("rm t" thi, 

n for this collection of infonnation is eSlimated 10 average 0.25 hours per response fOr registrruion activities a

\ding the in5eregistralioncomplelillg the necessary forms. Send comments regarding tile burden estimate or 

Director. OPPE InformationManagemcril Division (2137) U.S. Environment,lI Protection Agency, 40 t M S

Date: April 12, 2010 

s Pet Care I 

-

........ 

--

132-\ 

132·1 132-1 

I NIA 

DATA 

5 Sout,/1158th Plaza, S,:!.i.te 100, Omah;:t,j\JE 

, 'I"V"'" v"v,",,,,,,, 

Application of Frontl inc Spot-On Treattnent to Cats: Final 

Study: Lab Project Number: MET4 17: 817/023B. 

'-' Ltd. <In..! 

de Fontenay, G.; Magloire, B.; Suberville, S. et aL (1997) 

Dislodgeable Residues ofFipronil Following a Topical 

Application of Frontline Spray Treatment to Cats: Final 

Report: Lab Project Number: MET415: MERIAL-480·MET415: 817/023A. Unpublished study prepared by Medal Ltd. 

1 Pr .. "lin'''al Serv"lccs·Europe. 71 p. 

"'l" )fCommercial and Veterinary Pet Groomers and I'et Uwners ot' Frontline Top Spot and Frontline 

Spray Treatment: Lab Project Number: MERIAL-445· 

SURVEY. Unpublished stlldy prepared by Wiese Rescarch 

Inc. 340 p. 

Hughes, D. (1997) Validation ofan Analytical Method for the 

lination ofFipronil, M&B45950, and M&B46513 in 

Dye-Free 100% Cotton Gloves: Final Rcport Lab Project 

Number: COVANCE 6848-1 04: 6848·lO4: MERIAL METXT 

169. Un ublished study rc ared b Covance Labs. Inc. 41 

[EPA Reg N(j:lFile 2517- RG

:: Fipronil Only Spot-On For C

[RID Number Submitter 

44433307 MERIAL LIMITED 44531201 44531202 

Polakoff, B.; Youngrcn, S. (1997) Non-Dietary Risk 44433309 MERIAL LIMITED 

Assessment Fipronil Use on Pets in a Residential Setting: Lab 

Projcct Number: FIPRONIL 97-09: MERIAL-445-NDRA. I .. ..! ol"..!" .. ..! h" N"v'o"." ."""""'--'P$, 

lfelkl/11IJIA k 

EPAF 

Name and Title 

KellyR._"· . I Affairs 
92

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

• 401 M Street, S.W . 

• WASHINGTON, D.C. 20460 

Paperwork Reduction Act NOliee: The public reporting burden for this collection ofinfonnaJion is estimated 10 average 0.25 hours per response for registration activities a

reregistration and spec"ml review acti\1ties, "Including time for reading tile in6eregistmfloncompleting the necessary fonus. Send commell\S regarding the burden estimate or 

of informatioll, including suggestions for reducing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 40 I M S

20460. Do not send the form to this address. 

DATA MATRIX 

Date: April 12,2010 EPA Reg No.lFilc Symbol 2517- R

AppJicant'sJRegistrant's Name & Address Product: Fipronil Only Spot-On For C

Ser!!:eanl's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 

In redients: Fi ronil 

Guideline Reference Number Grtideline Study Name MRJD Number Submitter 

Polakoff; B.; Youngren, S. (1997) Pet Groomer Exposure 44433310 MERIAL LIMITED 

Analysis and Risk Assessment: Frontline Top Spot and 

Frontline Spray Trealment: Lab Project Number: FIPRONIL 

97-11: MERIAL-445-PGRA. Unpublished sludy prepared by 

Novi!!:en Sciences, Inc. 17p. 

Wall, H. (1998) Frontline Products Reports of Suspected 44531205 MERIAL LIMITED 

Adverse Events Analysis of Breed, Age and Sex Distribution of 

Dogs and Cats. Unpublished study prepared by Merial Lid. 8 p. Polakoff, B.; Youngren, S.; Walls, C. (1998) Frontline 44531206 MERIAL LIMITED 

Top-Spot and Frontline Spray Treatment: Deflnil ive ShortTerm and Intennediate-Tenn Residential Non-Dietary Risk 

Assessment: Lab Project Number: FIPRONIL 98-04: 

MEIUAL-445-NDRA. Unpublished study prepared by Novigell 

Sciences, Inc. 35 o. 

Polakoff, B.; Youngren, S:, Walls, C. (1998) Frontline Top 44531207 MERIAL LIMITED 

Spot and Frontline Spray Treatment: Definitive Pet Groomer 

Exposure Analysis and Risk Assessmenl: Lab Project Number: 

FIPRONIL 98-07: MERIAL-445-LPERA. Unpublished study I prepared by Novigen Sciences, Inc. 21 p. 

Polakoff, B.; YOllngren, S. (1998) Frontline on Pets in a 44531208 MERlAL LIMITED 

Residential Selting: Risk Assessment of a Low Probability 

Event Post-Application Acute Exposure: Lab Project Number: 

FIPRONIL 98-06: MERIAL-445-PGRA. Unpublished study 

prepared bvNovigen Sciences, Inc. 18 p. 

Signature: J.?ffi IIdCJ!,J0 Iv Name and Title 

Kelly R. Hoskins, Manager of Technical Affairs 

EJ'AForm SS7()']S ·971 El on;< ""d P'n<1 V",j Avail.ble Submit onlv F'oe,ve"'M. A£.nev 1"I.e
93

,0, 

.10,(,& 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W . 

instruction and completing the necessary £Onns_ 

burden to Director: QPPE Information Management Division (2137) U.S. 

MATRIX 

Foe 

Care Products, 
94

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 

o 

burden to 

401 M Street, S.W. 

per response tor registration activities a

Send comments regarding the burden estimate or 

(2137) U.S. Environmental Protection Agency, 401 M S

-----'For
95

''--' 

o 

• 

AL 

401 M Street, S. W • 

INGTON, D.C .• """tVV 

AGENCY 

1 is estimated 10 average 0 25 hours per response for registration activities a

in3eregislrationcompleling the necessary forms. Send comments regarding the burden estimate or 

burden to Director: OPPE Information Management Division (2t37) U.s. Environmental Protection Agency, 40t M S

Suite NE 703 

Technical 
96

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W. 

o W 

_ per response 

for reading the in4crcgistrationcornplcting the necessary forms. Scud comments regarding the burden estimate or a

the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 40 I M S

1703 

-

-
97

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W. 

o D.C. 20460 

review reading the 

to Director: u,s. 

DATA 

Spot-On 
98

"-, 

"--

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

burden to 

• 401 M Street, S.W . 

• w D.C. 20460 

average 0.25 Il0Urs per response for registration activities a

in6eregistrationcompJeting the necessary fonns. Send comments regarding the burden estimate or 

. OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M S
99

/,&"'0.,.",\ 

~ ~ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

\; ~it' Washington, D.C. 20460 

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

Wednesday, January 27, 2010 

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

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

Registrant Name: Sergeant's Pet Care Products 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

Registrant Address: James Messina, Senior Managing Regulatory Consultant 

Exponent 

Subject: 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

Data Deficiency 

Product Name: Sergeant's Fipronil + Methoprene Squeeze-on for Dogs, 

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

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

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

Application Date: 

EPA Receipt Date: 

respectively_ 

December 21, 2009 

December 22, 2009 

Dear Mr. Messina: 

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

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

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

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

Pesticide Registration Improvement Renewal Act (PRlA 2). Your options under 40 CFR 

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

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

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

40 CFR 152.105: 

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

12, iOlO to provide a response concerning the deficiencies listed in this letter. Your response 
100

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

Agency of the date on which you expect to complete the application, or withdrawing your 

application. If you do not respond to this letter within 75 days or if you respond with a date on 

which you expect to complete the application but fail to meet that scheduled date, the Agency 

will treat the application as if you had withdra\¥Il it. Withdrawal concludes the Agency's review 

of your application. Any subsequent submission of the same application must then be submitted 

as a new application with a new deadline for EPA to make a determination on your application 

and subject to a new registration service fee. 

The deficiencies identified in the Agency's review at this time are as follows: 

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

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

used to support each applicable guideline. Instructions for completing the EPA form 8570-35 

data matrix correctly can be found within PR Notice 98-5. An electronic copy ofthis PR Notice 

can be obtained at the following Agency web site: 

http://www.epa.gov/opppmsdlIPR Notices/pr98-5.pdf. 

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

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

products. As a result, you must submit acceptable end use product chemistry data in accordance 

with PR Notice 86-5. In addition, you must revise the data matrix as outlined in #1 above to 

reflect thi-s change. 

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

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

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

satisfying the data requirements outlined in 40 CFR § 152.34. These CRP tests are product 

package design specific and unrelated to your proposed package. 

Further review of your application and your response to the deficiencies may identify 

additional deficiencies and you will be so informed. 

FIFRA Section 331PRIA: 

This application is also subject to a deadline for making a determination on the application 

under FIFRA Section 33, Pesticide Registration Service Fees, established under PRIA. The time 

frame for.the Agency to make a determination on this application ends on April 12, 2010 and 

you have the following three options: 

1. Withdraw the application: You may notify us not later than March 31, 2010 that 

you are withdrawing your application. As noted above, withdrawal concludes the 

Agency's review of your application; however, you may resubmit your application 

after the deficiencies have been addressed. Should you choose to resubmit your 

application, it would be subject to a new deadline for making a determination on your 

application and a new registration service fee. - Since a fee was paid with this 

application, the Agency will provide any applicable refund as soon as practicable. 
101

) 

2. Not respond: If you do not respond or fail to provide (a revised data matrix, 

acceptable product-specific chemistry data, and acceptable (CRP) data), on or before 

April 12, 2010, the Agency will administratively withdraw your application. 

3. Correct application deficiencies: All acceptable data and data matrix as outlined 

above must be submitted to the Agency on or before April 12, 2010. At that time, The 

Agency will fe-classify your applications from a R300 new product; me-too fast track, to 

a R31 0 new product; non-fast track. The Agency will then request additional PRIA fees 

accordingly, and processing will not proceed until all the deficiencies are satisfied and 

applicable PRIA fees are paid. 

Please respond to this letter by March 31. 2010 by contacting Mr. Bonaventure Akinlosotu at 

(703) 605-0653, or bye-mail at akinlostotu.bonaventure@epa.govduringthehoursof 7:00 am 

to 4:00 pm EST with a response and for any questions concerning this letter. When submitting 

infonnation or data in response to this letter, a copy of this letter should accompany the 

submission to facilitate processing. 

;vZcJ/UL 

Richard J. Gebken 

Product~anager(IO) 

Insecticide Branch 

Registration Division (7505P) 
102

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Washington, D.C. 20460 

Wednesday, January 27,2010 

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

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

Registrant Name: Sergeant's Pet Care Products 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

Registrant Address: James Messina, Senior Managing Regulatory Consultant 

Exponent 

Subject: 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

Data Deficiency 

Product Name: Sergeant's Fipronil + Methoprene Squeeze-on for Dogs, 

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

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

EPA File Symbol: 25 I 7-RGU, 2517-RGL, 2517-RGA, 2517-RGT 

respectively. 

Application Date: December 21, 2009 

EPA Receipt Date: December 22, 2009 

Dear Mr. Messina: 

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

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

notification of those deficiencies and identifies your options under 40 CFR 152.105 and Section 

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

Pesticide Registration Improvement Renewal Act (PRIA2). Your options under 40 CFR 

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

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

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

40 CFR 152.105: 

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

12,2010 to provide a response concerning the deficiencies listed in this letter. Your response 
103

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

Agency ofthe date on which you expect to complete the application, or withdrawing your 

application. If you do not respond to this letter within 75 days or if you respond with a date on 

which you expect to complete the application but fail to meet that scheduled date, the Agency 

will treat the application as if you had withdrawn it. Withdrawal concludes the Agency's review 

of your application. Any subsequent submission of the same application must then be submitted 

as a new application with a new deadline for EPA to make a detennination on your application 

and subject to a new registration service fee. 

The deficiencies identified in the Agency's review at this time are as follows: 

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

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

used to support each applicable guideline. Instructions for completing the EPA form 8570-35 

data matrix correctly can be found within PR Notice 98-5. An electronic copy of this PR Notice 

can be obtained at the following Agency web site: 

http://www.epa.gov/opppmsdIIPR Notices/pr98-5.pdf. 

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

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

products. As a result, you must submit acceptable end use product chemistry data in accordance 

with PR Notice 86-5. In addition, you must revise the data matrix as outlined in #1 above to 

reflect this change. 

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

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

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

satisfying the data requirements outlined in 40 CFR § 152.34. These CRP tests are product 

package design specific and unrelated to your proposed package. 

Further review of your application and your response to the deficiencies may identify 

additional deficiencies and you will be so infonned. 

FIFRA Section 33/PRlA: 

This application is also subject to a deadline for making a determination on the application 

under FIFRA Section 33, Pesticide Registration Service Fees, established under PRIA. The time 

frame for the Agency to make a determination on this application ends on April 12, 2010 and 

you have the following three options: 

1. Withdraw the application: You may notify us not later than March 31,2010 that 

you are withdrawing your application. As noted above, withdrawal concludes the 

Agency's review of your application; however, you may resubmit your application 

after the defIciencies have been addressed. Should you choose to resubmit your 

application, it would be subject to a new deadline for making a detennination on your 

application and a new registration service fee. - Since a fee was paid 'With this 

application, the Agency will provide any applicable refund as soon as practicable. 
104

) 

2. Not respond: If you do not respond or fail to provide (a revised data matrix, 

acceptable product-specific chemistry data, and acceptable (CRP) data), on or before 

April 12, 2010, the Agency will administratively withdraw your application. 

3. Correct application deficiencies: All acceptable data and data matrix as outlined 

above must be submitted to the Agency on or before April 12, 2010. At that time, The 

Agency will re-classify your applications from a R300 new product; me-too fast track, to 

a R310 new product; non-fast track. The Agency will then request additional PRIA fees 

accordingly, and processing will not proceed until all the deficiencies are satisfied and 

applicable PRIA fees are paid. 

Please respond to this letter by March 31, 2010 by contacting Mr. Bonaventure Akinlosotu at 

(703) 605-0653, or bye-mail at akinlostotu.bonaventure@epa.govduringthehoursof 7:00 am 

to 4:00 pm EST with a response and for any questions concerning this letter. When submitting 

information or data in response to this letter, a copy of this letter should accompany the 

submission to facilitate processing. 

~wL Richard J. Gebken 

Product Manager (10) 

Insecticide Branch 

Registration Division (7505P) 
105

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

December 31, 2009 

opp Decision Number: D-425437 

EPA File Symbol or Registration Number: 2517-RGT 

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

EPA Receipt Date: 22-Dec-2009 

EPA Company Number: 2517 

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

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

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

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

communicated separately_ During the administrative screen, the Office of Pesticide Programs 

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

the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R300 

NEW PRODUCT;ME-TOO PRODUCT FAST TRACK; 

No additional payment is due at this time. 

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

Ombudsman at (703) 305-6249. 

Sincerely, 

Front E.~!'f5~;;;; 

In matio esources Management Division 
106

) 

Sergeant's Pet Care Products, Inc. 

2625 SOllth 158th Plaza • Omaha. NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7099 • www.sergeants.com 

December 21,2009 

Richard Gebken, PM I 0 

Office of Pesticide Programs (7504P) (REGFEE) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 Soutb Crystal Drive 

Al'lington, V A 22202 

Subject: Sergeant's Fipronil Spot~On for Cats 

EPA File Symbol 2517-NEW 

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. (Sergeants, EPA Company Number 2517) is submitting a 

"me-too" EPA registration application for the new product Sergeant's Fipronil Only Spot-On for 

Cats (containing the EPA registered active ingredient Fipronil (9.7%»). Please find enclosed the 

following documentation in support of this registration: 

(1) Application for Pesticide Fonn (8570-1); 

(2) Certification with Respect to Citntion of Data Fonn (8570-34); 

(3) Fonnulator's Exemption Statement Fonn (8570-27); 

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

(5) Confidential Statement ofFonnula (two copies); 

(6) Product Label (five copies); 

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

(8) Letter of Authorization. 

Sergeant's Fipronil Only Spot~On for Cats is substantially similar to Merial Limited's EPA 

registered product Frontline Top Spot for Cats (EPA Registration # 65331-2). Sergeant's has 

submitted offer to pay letters to all data submitters listed on the enclosed data matrix. 

, 

We look forward to working with the Agency to register this "me-too" product. 

questions, please contact me at 402-938-7079. 

If you have an)}" r', 

Sincerely, 

/~)[/-&L Kelly R. Hoskins 

Manager of Technical Affairs 

Enclosures 

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107

PI ea.~e rea dl tiS I rue r Ions on reverse e ore comp I e !' IfIg arm. F o,m A pprove d OMBN o. 2000060 7 - A pproval eXpires 05 ·3t-98 

I United States ~ Registration opp Identilier Number 

EPA Environmental Protection Agency o Amendment 

Washing lon, DC 20460 o Other 

Application for Pesticide - Section I 

t. COmpanYfPrOdUC~6~ 2. EPA Product Manager 3. Proposed Classification 

2517·NEW Richard Gebken 

4, CompanyfProduct (Name) 

Selqeanl's Fipronil Spol-On For Cats 

PM# to ~None DRestrieted 

5. Name and Address of Applicant (Incl(lde ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(C)(3)(O)(I), my 

Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling 10: 

2625 South 1SS/h Plaza 

Omaha, NE 68130 EPA Reg, No. 6533t·2 

Product Name FRONTLINE TOPSPOT FOR CATS 

o Check if Ihis is a new address 

Section II 

o Amendment· Explain below. o Final printed labels in response to Agency letter dated XX-XX·XX 

o Resubmission in response 10 Agency letter dated XX·XX·XX .~ "Me Too" Application 

I IS NotilicaUon· Explain below. o Other· Explain below. 

Explanalion; Use additional page(s) II necessary. (For section I and Section II.) 

Submission of a new end·use regislration applicalion, 

Section III 

Yteterial This Product Will Be Packaqed In: 

~,did·Resistant Packaging Unit PaCkaging Water Soluble Packaging 2. Type 01 Container 

fZ] Yes' [2J Yes ~Y" o Metal 

ONo o No No [8J Plastic 

II ''Yes'' No. per II "Yes' No. per OGlass 

·Certification must Unit Packaging wgt, Conlainer Packagewgt. Contruner 

DPaper be submitted 0.017 n oz (0.50mli 2,3,4,6 

I OOther (Specify) PlasHc BaQ 

3. Location of Net Contents InlormaHon 4. $i2e(s) Retail Container 5 Location ot Label Directions 

cg)Label D Container 0.0 t7 n oz (0.50ml) DOn Can 

DOn Labeling accompanying product 

6. Manner in Which Label is Atlixed 10 Produci DUlhograph !ZJOlher 

OPaper glued 

DStenciled 

Section IV -' ~ .... , 

!. Contacl Point (Comolele ilems directly below for identification of individual 10 be confacted. if necessatY. 10 orocess Ihis aoolicalion. "';'_ 

Name Tille Tetephone No, (InClude'AreaCode) -- Kelly R. HOSkins Manager 01 Technical Attairs : ' , :1d?~938· 7079 , 

.>---'---

Certification >,) . R, Date J,pp1i"'~jion 

I certtly that Ihe slatements I have madB on this torm and all allachments Ihereto ale tlue. accurate and com~ete. I , Recei¥Ejd '- , acknowledge that any knowingly talse or misleading statement may be punishable by tine or imprisonment or bolh '"' -- (Stg:mp.e~u) 

under appticable law. , .-,,",,-. , , 2 Signature 3. Title , > , , 

/{;'A./&~ , , BY: Manager ot Techn'lcal Atlairs , , , > 

, " 

TiPed Name: / 5, Date: t2f21f2009 - , , , , , , 

I j Kelly R. Hoskins 
108

) 

Pay.gov - Online Payment Page 1 of 1 

Online _~~¥~~_I1~ _~ 

Step 3: Confirm Payment 1 1213 

Thank you. 

Your transaction has been successfully completed. 

Pay.gov Tracking Information 

Application Name: PRIA SeNice Fees 

Pay.gov Tracking 10: 2505HOCT 

Agency Tracking 10: 74094010782 

Transaction Date and Time: 12121f2009 11:51 EST 

Payment Summary 

Payment Date: 12f22f2009 

Decision Number: 

Account Holder Name: Sergeants Pet Care Products 

Payment Amount: $1.365.00 

Account Type: Business Checking Registration Number: 

Routing Number: 

Account Number: **·"*5483 

Company Name: Sergeants Pet Care Produc 

Company Number: 2517 

Action Code: R300 

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h Ups:! Iwww.pay.gov/paygov/payments/authOlizeACHPayment.html 12121/2009 

*Commercial/financial information may be entitled to confidential treatment*
109

RH . .:h'lrd Cn.:bken 

PIWIUCl f\dantlgcr 12 

D(lCLl!11ent Pnlcessing Desk 

Office or Pcs(ieiuc PrognlillS 

I;.S. Environmental Prntection Agl'IWY 

Room S-4900. One Polomac YnrJ 

-::'777 SOU1h Cryslul Dm'(; 

Arling,t(ll1. VA 22202-4)01 

Scrgellllt's Pel Cnre Products, Inc. (S(;rger1)ll·s. 2()25 Sllulh I)S'" Plaza. Omuhn. Nebrllsbl 

681 :10-1770, EPA Company Number 2517), i1ullwrizes F:xpollcnt, Inc. (1150 Connecticlll 

Avenue, NW. Suitc II 00, Washmgton DC. 20(36) to act on ollr bclHll( liS ollr 

A urhorized R eprescl1Jativc, f(lr all necessary i nlenlc(i ons rega rdi ng ill I (I r our pmduc( 

registrn1ion applications nnd n:gistnHiulls. PlcHSC ]lo!c this doo..:s nol change the o..:UITCIll 

flied Authorized Agent for Scrgeant"s. 

The Ex-polltnl, Illc. conine! i" rlS t()llmvs: 

Cc: 

J::unts Messina ,-lI1d;or Rick Tillsworth 

Exponent. Inc. 

! 15(1 C'onnec!iclI{ Ave., NW 

Sui(e I I DO 

Washington, DC 20036 

(202) 772-4932 

(1(2) 772-4079 fnx 

jill e..,SI11iJr(/, ex p(ll1en\.CC'lll. 1'1 i ns\V( lr!!1(U:C:\pl '1Ie!l\. cdn; 

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110

) 

Sergeant's Pet Care Products, Inc. 

262S Soulh 1581h Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402,938.7091 • www.sergeanls.com 

December21,2009 

Richard Gebken, PMlO 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Documen t Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Certification 

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. certifies that the packaging used in the manufacture of the 

following products: 

• Sergeant's Fipronil Spot-On for Dogs; 

• Sergean1'5 Fipronil Spot-On for Cats: 

• Sergeant's Fipronil + S-methoprene Spot-On for Dogs; and 

• Sergeant's Fipronil + S-methoprene Spot-On for Cats. 

meets the standards of 40 CFR 157.32, including the revised standards in 16 CFR 1700.15(b). 

All product labels have language specifying the use of scissors to open the product container and 

label language stating the product is not to be applied by children. In addition, Sergeant's is in 

discussion with approved CRP testing labs to develop a protocol per the revised testing 

procedures in 16 CFR 1700.20. 

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

Sincerely, , , , > ~ , , , 

" , , , /~A~ " , " " , , 

" , , , , " , , , " 

Kelly R. Hoskins 

Manager of Technical Affairs , , 

, , " , , , , " 

" , , , cc: Larry Nouvel , " , 

" , , 

, , , , , 

, 

, 
111

Form approved. OMS No. 2070-0060, 2070_0057, 2070·0107, 2070-0122, 2070-0164. 

&EPA 

United States i Environmental Protection Agency 

Washington, DC 20460 

Formulator's Exemption Statement 

(40 CFR 152.85) 

Applicant's Name and Address EPA Fila SymboVRegisfration Number 

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

2625 South I 58th Plaza Product Name 

Omaha, NE 68130 Sergeant's Fipronil Spot-On for Cats 

Date of Confidential Statement of Formula (EPA Form 8S70-4) 

12/2112009 

As an aulhorized representative of the applicant for regislralion of the product idenlified above, I certify that 

(1) This product contains the following aclive ingredie01(s): 

Fipronil (9.7%) 

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active Ingredient in the manufacturing. 

formulation or repackagl ng anolher product which contains thaf acnve ingredient whiCh is registered under FIFRA Section 3, is purchased by 

us from another person and meets the requirements of 40 CFR section 158,50(a)(2) or (3). 

(3) Indicate by checking (A) or (8) below which paragraph applies: 

) 

01 (A) An accurate Confidenfial Statement of Formula (EPA FORM 8570.4) for tha abova idantified product is allached to this statement 

That formula statement inOlcateS, by company name, registration number, and product name, tha source of the active ingredient(s) listed in 

paragraph (1). 

OR 

, (8) The Confidential Statement of Formula (CSF)(EPA Form 8570·4) referenced above and on file with the EPA is comptete. current, eo 

accurate and contains the intormation required on the CUrrent CSF. 

(4) The following active ingredients in this product quatify for the formulator's exemption. 

Source 

Activa fngredient ProduC1 Name Registration NUmber , , Fipronil Technical ' • > > , • 

, 

" , , , , , " , , " , , , , , , 

, , " , , , , , , " , , , , , " 

" " , , , , " ' , , , " 

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Signature Name and 'Title Date '" , 

/~/!~ 

, , ", , Kelly R. Hoskins, Manager orTechnical Affairs 12/2112009 ~~~ 

, " 

EPA FOf"!l8570.27 (Rev. 06-2004) Copy1_EPA"" 

Copy 2 - Applicant copy 

*Product ingredient source information may be entitled to confidential treatment*
112

Form Approved OMS Nos. 2070·0060; 2070·0057', 2070.(11 07: 2070·0122: 2070-0t64 

II "';,. .... , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY \!!Zl 1200 Pennsylvania Avenue, N.W • . 

-" 

WASHINGTON, D.C. 20460 

Paperwork Reduclion ACI NOIic,,: The pUblic reporting burden for lhis collectinn of infonn.l;on ;s eSlimaled 10 avemgc 1,25 bows pcr response for registralion 

and 025 hoors per response for reregistrBlion nnd sp"d~1 review aClivilies, includiogtime for reading the instruClions and completing Ihe necessary forms. Send 

co:nmenlS rtgarding bunien estimale or any Olher aspcci oflhis collection ofinforrnalion, including suggestions for reducing Ihe bunitnlO: Dlfeclor, Colleclion 

Strategies Division (2822T). U,S. Environmentat Proleclion AgenCy. t200 Pennsytvania AverlJe. N.W., Washington, DC 20460. 00 nol send the compteled fonn 

to lhis address, 

Certification with Respect to Citation of Data 

Appllcanl'siReqistranl's Name. Address. and Telephone Number EPA Reqistration NumberfFile Symbol 

Sergeant's Pet Care Products, Inc., 2625 South f58th Plaza, Omaha, NE 68130 2517-NEW 

Active Inoredl!;lnt(s) andfor reoresenlative test comooundfs) Date 

Fipronil t212112009 

General Use Pattem(s) (ist all those claimed for this product usinq 40 CFR Part (58) PrOduct Name 

Indoor non·food Sergeant's Fipronil Spot-On for Cals 

NOTE: If your producl is a 100% repackagirtg of another purchased EPA'registered prrnjuct labeled for all the same uses on your label, you do not need to 

submit this form. You must submit the Fonnula\or's EXemption Statement (EPA Form 8570·27). 

0 I am responding to a Oata·Call-ln Nolice, and have incfuded wjlh this form a lisl of companies sent offers of compensation (the Data Matrix form should 

be used for this purpose), 

SECTtON); METHOD OF DATA SUPPORT (Check one method only) 

0 I am using the Cite-all melhod of support. and hava included with this form 0 t am us'mg the se~cUve method of support (or cite·all oplion 

a (isl of companies sent offers of compensation (Ihe Data Matrix form under the selective melhod). and have included with this form a 

should be USed for Ihis purpose)_ completed list of data requirements (the Data Matrix form must be 

used). 

, SECTlON II: GENERAL OFFER TO PAY 

IRequired if using the cite-all method or when using Ihe cite-all option under the selective methOd to satisfy one or more data requirementsl 

0 I hereby offer and agree 10 pay compensalion. to other persons, W·,th regard to the approvat of this applicatiOn, to the eJrtent required by FIFAA. 

SECT[ON ttl: CERTIFICATfON 

I certify that this application for regislration. this form for reregi5tra~On, or Ihis Data-Call·ln response is supporte-d by all data SUbmitted or c1(ed in the 

application for registra~on, the form for reregistratiOn, or the Dala-CalHn response. In addition, if the clte-al option or cite-all option under the seleclive malhod is 

indicaled in Section I. this application is supported by all data in Ihe Agency's f'les that (1) cOncern the properties or effects of Ihis product or an identical or 

substanUally similar prOducl. or One or more of the ingredients in this prcduct; and (2) IS a type of data lhat would be required to be submitted under the data 

requirements in effect on the date of approval of this application if the applicalion soughllhe initial registration of a product ot idenUcal or similar composilion and 

uses. 

I certify that for eaCh eXClusive use study died in support of thiS regislration or reregistration, thai I am the original data submitter or that t have obtained 

lhe written permission of the original dala SUbmitter to cite that study. > > , > > > , , 

I certify that for each stutJy dted in support of Ihis registralion or reregistratiOn that is not an exclusive use stUdY, either: (a) I am the original /Jala 

submitter: (b) I have obtained the permission of the original data submitter to use Ihe study in support of this applicalion; (c) all periods of eligibirlly for> , , compensat"lon have expired lor the study; (d) the study is in (he pubrlC literature; or (e) I have notified in writing the company that submitted Ihe sludy add h~aYf\ ' 

offered (I) to pay compensation to the e~tent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFAA: and (ii) to commence negotia~ons 10 determirte the 

amount and lerms of compensation, if any. to be paid for the use of the study. ~ , > ; , ; > , " > > , , I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidell~~bi lh.:lir deliv€;l'y in > • 

accordancewilh sections 3(c)(t )(F) and/or 3(c)(2)(B) of FIFRA are available and WIll be subm'llIed to the Agency upon request Should! fll!l (0 prodUt,e,suci'. 

evidence to the Agency upon request, t undersland that the Agency may initiale action to deny, cancel or suspend Ihe registralion of 1JIi' 9r9,-/uct in conjon-OilY,With 

~~ . . , " " > 

I certIfy that\he statements t have made on this form and all attachments to it are true, accurate, artd complete. t acknowledge ~lia(Jr;Y, 

knowingly false or misteadlng statement may be punlshabte by fine or imprisonment or both under applicable law. , , . " , " 

lA::A-'A/~ Date Typed or Printed Name and Title ,;-:7rt2f2 (/2009 Kelly R Hoskins, Manager of Technical Affairs 

EPA Form 8570-3.('(12·2003) Electronic and Paper versions available. Submit only Paper version. 
113

I'ormA

UNITED STATES ENVIRONMENTAL PROTEcnON AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paper\york Reduction Aet Noticc: The public reporting burden for thiS collection of inform:uion is cstimMed to hours perresponsc for regiSlrll1ion ndivities <'nd 0

for reregistmlion pnd special review "elivitie., inctudillg time for reatting the instruction completing the necessary forms. Send comments regarding Ihe burden estimate or a

coUeclion of informot'lOn. including suggcstio", for reducing Ihe hurdcn to D'lreclor. OPPE Informalinn ManagClncnl Divi,ion (2137) U.S. E"vironmcnt.t Pmlccfmn Agcncy. 

Wash;n on. DC 20460. Do not send the form 10 this nddrcss. 

DATA MATRIX 

Date: 12121/2009 EPARe No.lFIle S mbol: 2517·NEW 

Appticanl's/Registrant's Name & Address: 

Sergeant's Pet Care Products, Inc Product: Sergeanl's Flpronit Only Spot-On tor Cats 

2625 South 1S81h Plaza, Omaha. NE 68t30-1703 

Ingredient: Fipronil 

Guideline Relerence Guideline Study Name MRID Number SUbmitter Stat

Number 

Cile·all Syngenla Crop Protection, Inc (# 100) 

PO Box t8300 

Greensboro, NC 27419 

Cile-all Sayer CropScience LP (#264) 

2 T.W.Alexander Drive 

Research Triangle Park, NC 27709 

Cite-all Bayer Environmental Science (#432) 

PO Box 12014 

Research Trianqle Park, NC 27709 

Cite-all Reckitl Benckiser tnc (#3282) 

Morris Corporate Center IV 

399 Interpace ParkWay 

ParsiDDan ,NJ 07054 

Cite-all J.J. Mauget Co. (#7946) 

t2733 Director's Loop 

Woodbrid!=le, VA 22192 

Cile-all BASF Corporation (#7969) 

Agricultural Producls 

PO Box 13528 Research Trianqte Park, NC 27709 

S-Ignalure - ---: Name and Title 

Kelty R. Hoskins. Manager 01 Technical AUairs 

,,,, ." .... " .Q7\ VN, .. _A=;t,",. ,.,hm;' • .en'. 'n'"".o

w., 
114

WA !'o<m (9.9() EI""o"" ""d P'P'" ""iI,"k U"1y 1'>1"" '''''''" In"rno< 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

illslruolion and completing Ihe necessary forrm. Send comments regilrding Ihe burden estimate or n

Director. OPPE Information Mnnagemen! Division (2137) U.S. Ellviron1llentnl PrOiection Agency, 40

68130-1703 

Product: Sergeanf's Fipronil Only Spol·On for Cals 

Division .... , '-"'''" .... PO Box •• 

5903 Genoa-Red 

Pasadena, TX 77507 

76162 

em" 

UNrfED STATES ENVIRONMENTAL PROTECTION AGENCY 
115

W. "" 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Rcduc(ion Ac( Notice: The public reporting butdcn for this collection of inform uti On is e,(imated to avcmge 0,25 hours per response for regislJ-alion activities untl 

rCll)gistrmion unrl speciul revicw ac(ivities, including (ime for reading the instruction and cnmpleting (hc nccess;uy form<. Send coutmcn(s regarding burden es(imatc or any 

of informatiOn, including ';UgJ:estions for reducing the burden to Direc(or: OPPE Information MonagemcUl Division (2137) U.S. Enviromnental Protection Agcncy, 401 M 5tree

20460. Do nct send (hc form (0 (his address. 

DATA MATRIX 

Date: t2/21f2009 EPARe No.lFite S mbot: 25t7-NEW 

Applicant's/Registrant's Name & Address: 

Sergeant's Pel Care Products, Inc Product: Sergeant's Fipronil Only Spot-On lor Cats 

2625 South t581h Plaza, Omaha. NE 68t30-1703 

In redient: 

Guideline Relerence Guidelina Study Name MRID Number Submitter 

Number 

Cite-all Outdoor Residential Exposure Task Force 

(#71754) 

1350 t Street, N.W. 

Washi,!!gton, DC 20005 

Cite-all AgriCultural Reentry Task Force (#71755) 

1350 I Street, N.W. 

WashinQton, DC 20005 

Cite-all Ambrands (#73342) 

118 Y.. East Main Street, Suite 1 

Salem, VA24153 

Cite-all Innovative Pesl Control Products (#73766) 

PO Box 880216 

Boca Raton, FL 33488 

Cite-all FIFRA Endangered SpeCies Task Force 

(#73989) 

CIO Harold Himmelman (Beveridge & 

Diamond) 

1350 I Street, NW 

Washi.rlgton, DC 20005 

Cite-all Residential Exposure Joint Venture (#74888) 

900 17'h Street, NW, Suite 300, 

Washi!!91on, DC 20006 

Cite-all Agricultural Handlers Exposure Task Force 

(#75234) 

PO Box 509 

,. - ''':L , Macon, MO 63552 

. 

Name and Tille 

Kelly R. Hoskins. Manager 01 Technical Affairs 
116

ft 

-

for rcregi>tration and 

collection of infonnalion, 

'" . " 

, • 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S. W. 

" 

this collection of information is estimated to average 0.25 hours per response for registration activities a

reading the instruction and completing the llCCesSary forms. Send comments regarding the burden estimate 

the burden to Director' OPPE Infonna!ion Management Division (2137) U.S_ Environmental Protection Agency

Product: Sergeant's Fipronil Only Spot-On for Cats 
117

ft 

Products, Inc 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

• 

401 M Street, S. W. 

0.25 hours per response for registration activities a

for reading the instruction and completing the necessary forms. Send comments regarding the burden estimate 

the burden to Director: QPPE Information Management Division (2137) U_S. Environmental Protection Agency

Product: Sergeant's Fipronil Only Spot-On for Cats 

. "" 

Corp 

500, LOC 1068 
118

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W . 

. The public reporting burden for Ihis collection of inform arion is estimaled to average 0.25 hours per response for registration activities a

review activities, including time for reading the instruction and completing the necessary forms. Send comments regarding the burden estimate or 

suggestions for reducillg Ihe burden to Director", OPPE Informal ion Management Division (2131) U.S. Environmental Protection Agency, 401 M S

loc 

NE 68130-1703 

Sergeant's Fipronil Only Spot-On for Cats 

(#73989) 

C/O Harold Himmelman (Beveridge & 

Diamond) 

1350 I street, NW 

:":';,'::::""" 300, 

Kelly R Manage! of Technical Affairs 
119

Sergeant's Master Label t-c,/ 

21 December 2009 EPA Submission 

Infonnation in [ [is optional. Page 1 of7 

EPA No. 2517-XX 

21 December 2009 

FRONT PANEL CAT SPOT ON 

JliPRON:!L 

[Optional text appears in brackets - the final label may include some or all of the optional text on 

front, back or side label panels] 

Sergeant's Fipronil Spot-On for Cats 

[ABNsJ 

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

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

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

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

[(Sergeant's) (Sentry) Frontguard (Spot On) for cats (and kittens)1 

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

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

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

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

[(Sergeant's) (Sentry) Gold FrontSpot (Spot On) for cats (and kittens)J 

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

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

[Mosquitoes] 

[. [Kills [and] [&] [Repels] mosquitoes] [within 24 hours] 

[- Kills ([and] [&] repels) mosquitoes that may transmit heartwonn] 

[Adult Fleas] 

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

[-Kills [and repels] fleas, source of flea allergy dermatitis] [, flea bite anemia] 

[and tapewonn infestations] 

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

needed] 

[. Kills [&J [and] [Repels] Fleas [Up to 4 weeksJ [I month] [30 days:J!j:': 

, , , , , , > • 

, 

" , " , , " 

" . ,"L>,> '" 

[Ticks J '" ' '" 

[-Kills [and] [&] [repels] ticks including those that may transmit Lyme>d:..sease]~ • >,' 

[. Kills [and] [&] [Repels J Ticks for Up to [4 weeks] [I month] [30 d",<j'!] , [. Kills [and] [&] [repels] [all stages of] Deer Ticks [before they can] [that] ,,,, 

, , , , [transmit Lyme Disease,] for up to [4 weeks] [I monthJ [30 daysJ] , " 

[. Kills [and] [&] [repels] Ticks (Including Deer Ticks) for up to [4 weeks] [I ',:,,' 

month] [30 days]] 

[. Kills [andJ [&] [repelsJ [Brown], [American,] [and Lone Star ]Dog Ticks 

[(Rhipicephalus sanguineus)] for up to [4 weeksJ [I month] [30 days]J 

[. Kills [&] [andJ [Repels] American Dog Ticks [(Dermacentor variabilis)] for up 

to [4 weeks] [I month] [30 daysJ'] 
120

) 

Sergeant's Master Label 

21 December 2009 EPA Submission 

Informalion in I I is optional. Page 2 of7 

EPA No. 2517-XX 

21 December 2009 

FRONT PANEL . CAT SPO;rON 

FIPRQNIL 

[Multiple Infestations] 

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

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

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

[·Kills [and] [&] [repels] fleas, ticks, mosquitoes, and (chewing) lice] 

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

[. [Four] [4] Way Protection [Kills fleas, ticks, mosquitoes, and (chewing) lice] 

[. [4 Week] [I month] [lD day] [Flea and Tick [&] [and] Treatment] 

[. [Four (4) Week] [1 month] [10 day] [Flea Tick, Mosquito and Lice Control] 

[Once A Month Flea and Tick Treatment] 

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

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

[. Kills [&] [and] Repels Fleas and Ticks for up to [4 weeks] [ 1 month] [10 

days]!] 

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

mosquito control for cats and kittens.] 

[All Others] 

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

[-Controls Sarcoptic Mange [infestations]] 

[-Cats can be bathed 24 hours after treatment] 

[·Waterproof] 

[·Fast Acting] 

[·Long Lasting] 

[-Once month treatment recommended] 

[-A once monthly application is recommended for chewing lice.] , , 

[-Fast Action against [chewing] lice infestations] : •• ~,. 

[- Three Applications {for cartons with 3 applicators}] and/or [3 Month SupplyJ', '. 

or [12 Week Supply] """ ':' 

[- Four Applications {for cartons with 4 applicators}] and/or [4 Month .:supply] AT , 

[16 Week Supply] "~n; ; ~.," 

[. Six Applications {for cartons with 6 applicators}] andlor [6 Month Supply] clr', " 

[24 Week Supply] ~:_:::, ':' 

[- Best if used year round!] , , , , 

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

[. 4 Week Dose!] : ,", 

[·1 Month Dose!] 

[·10 day dose!] 

[. Easy to Use [Application]] 

[- Specially Formulated for Cats and Kittens] 

[. [Free] Calendar Stickers Inside!] 

[- [Free] Brochure Inside!] 

[- [Free] Brochure and Calendar Stickers Inside] 

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

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

, , > , 
121

Sergeant's Master Label 

21 December 2009 EPA Submission 

1nfonnation in I I is optional. Page 3 of7 

EPA No. 2517-XX 

2! December 2009 

FRONT PANEL CAT SPOT ON 

FIPRONIL 

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

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

[clip] [insert] [inside] 

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

[-Monthly application reminder card inside] 

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

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

ACTIVE INGREDIENTS: 

Fipronil .................................................. 9.7% 

INERT INGREDIENTS .................... 9o.3% 

TOTAL 100.0% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

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

NET CONTENTS: 

One ITwo][Three] [Four] [Six] 0.017 fl oz (O.SOml) applicators 

{END - FRONT PANEL} 

, >" " , • •• 

• • 

)) , , , 

• " , )) 

, . , • > , • > 

• 

,. 

" . . · " 

" , ., . · " ... 

•• • · .. 

'" , '" , 

· .. · . '" , 
122

Sergeant's Master Label 

21 December 2009 EPA Submission 

Informal Ion in [ I is optional. Page 4 of7 

BACKPANEL 

EPA No. 2517-XX 

21 December 2009 

[brand nameJ contains Fipronil to effectively kill [and repelJ fleas and ticks [(including 

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

collecting in the hair follicles and skin oils. This product features a sustained-release 

fonnula that discharges from the animal's hair follicles using the natural skin oils, 

resulting in fast-acting [and 10ng-lastingJ control of fleas, ticks, mosquitoes and chewing 

lice [for 30 days]. 

[diagram with visual offipronil collecting and being released from hair follicle] 

READ ENTIRE LABEL BEFORE EACH USE 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS. CAUTION. Harmful if swallowed. Causes eye irritation. 

A void contact with skin, eyes or clothing. Wash thoroughly with soap and water after 

handling. 

HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on kittens 

under 8 weeks of age. Individual sensitivities, while rare, may occur after using any 

pesticide product. Pets may experience some temporary irritation at the site of product 

applications. If signs persist, or become more severe within a few days of application, 

consult a veterinarian immediately. Certain medications can interact with pesticides. 

Consult a veterinarian before using on medicated, debilitated or aged animals. Call 1-

800·224·PETS [7387] for 24·hour assistance. 

PHYSICAL OR CHEMICAL HAZARDS 

FLAMMABLE~ Keep away from heat and open flame 

FIRST AID 

If swallowed Call a poison control center for a doctor immediately for treatment ~p.v,i~~. 

Have person sip a glass of water if able to swallow. Do not induce:. 

vomiting unless told to do so by a poison control center or doctor. :Do;'0t 

give anything by mouth to an unconscious person. ' ,., , " , , , , . . " , 

If in eyes Hold eye open and rinse slowly and gently with water flJT>16:QO , . m~hute-8~ 

Remove contact lenses, if present, after the first 5 minutes, 'then couti,nl1~ 

rinsing eye. Call a poison control center or doctor for t{~f.{tll)cnt advice." 

If on skin Wash with plenty of soap and water. Get medical attention if , ' , '" , 

irritation persists. ' > , , 

'-'7- • . , HOTLINE NUMBER ' , ~.' 

Have the product container or label with you when calling a poison control center or doctor, or 

going for treatment. You may also contact 1-800-224-PETS [7387J for emergency medical 

treatment information. 
123

Sergeant's Master Label 

21 December 2009 EPA Submission 

InformaIion in [ I is optional. Page 5 of7 

EPA No. 2517-XX 

21 December 2009 

BACK PANEL CAT SPQT ON 

FIPRONIL 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner inconsistent with its 

labeling. 

Do not allow children to apply product. TO PREVENT HARM TO YOU AND YOUR 

PET, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH 

USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS 

CAREFULLY. FOR EXTERNAL USE ON CATS ONLY. DO NOT USE ON 

RABBITS. DO NOT USE ON OTHER ANIMALS. 

Do not use on kittens under 8 weeks of age. Best if used year round. Consult a 

veterinarian before using this product on debilitated, aged, medicated cats. Can be used 

on breeding, pregnant, or nursing (female cats) (queens). Consult a veterinarian before 

using on cats with known organ dysfunction. Pets may experience some temporary 

irritation at the site of product application. Certain medications can interact with 

pesticides. Sensitivities may occur after using ANY pesticide product on pets. If signs of 

sensitivity occur bathe your cat with a mild soap and rinse with large amounts of water. 

If signs continue, consult a veterinarian immediately. 

(INSERT DIAGRAM THAT DEPICTS APPLICATION OF PRODUCT ON THE 

CAT) 

HOW TO APPLY AND OPEN CHILD RESISTANT PACKAGE: 

Remove product tube [vial] from the package. Holding tube [vial] with notched end 

pointing up and away from the face and body, cut off the narrow end at the notches with 

scissors. While holding the cat with one hand, use the other hand to apply the solution. 

Invert the tube [vial] and use the narrow end to part the cat's hair. Apply contents of one 

(0.017 fl oz) tube [vial] of {Product Name} as a stripe, starting high on the back ofthe • , 

cat's neck to in front of the shoulder blades. Hold the cat for a few seconds to give the: > >}' ~ 

solution time to be absorbed into the cat's coat. When finished, wrap the tube [vial] in i', > ~ 

paper and put into the trash. Only one applicator per treatment is needed. , ) ) ) , , " , 

, " ) > >, 

, , FREQUENCY OF APPLICATION ":": '" 

Use [brand name] monthly for complete control of flea, tick [and] chewing lice land ; >. 

mosquito] infestations. [Studies show that] [brand name] kills fleas for up tq !1).T,~e " , 

months. If your pet is at high risk for flea reinfestation [, or in a highly infested , , ; , 

environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing""" 

lice. [Brand name] remains effective, even after bathing, water immersion, or exposure (0, ' > " 

sunlight. Allow treated area to dry thoroughly. Do not reapply for 30 days. , , " 

(Brand Name) can be used on breeding, pregnant and lactating (queens) (female cats). 
124

Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in [ I is optional. Page 6 of? 

EPA No. 2517-XX 

21 December 2009 

BACK PANEL CAT SPOT ON ... FIPRbNiIl 

STORAGE AND DISPOSAL 

PESTICIDE STORAGE: Do not remove tube from the pack until ready to use, Store in 

a cool (below 77°F [25°CD dry place inaccessible to children and pets. Do not 

refrigerate. Protect from direct sunlight. 

CONTAINER DISPOSAL: If empty: Non-refillable container. Do not reuse or refill 

this container. Offer for recycling if available. If partly filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain 

[WARRANTY 

Read the entire Directions for Use and Warranty before using this Product. By using this 

product, user or buyer accepts the following warranty. [[The directions for use of this 

product are believed to adequate and must be followed carefully. It is impossible to 

eliminate all risks associated with the use of this product. Unintended consequences may 

result because of unknown factors. All such risks shall be assumed by the user or buyer.] 

] Sergeant's is committed to providing high quality products, To the extent consistent 

with applicable law, Sergeant's makes no warranties, express or implied, of 

merchantability or of fitness for a particular purpose or otherwise, that extend beyond 

statements on this labeL To the extent consistent with applicable law, Sergeant's, the 

manufacturer, or the Seller shall not be liable for indirect, special, incidental or 

consequential damages. To the extent consistent with applicable law, the exclusive 

remedy of the user or buyer shall not exceed the purchase price paid.] 

[If you have questions or comments about this product, please write: Sergeant's 

Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.J 

, , 

, .. , , . , 

In Case of Emergency, call: 1-800-781-4738 

( www.sergeants.com ] 

Non-Emergency call 1-800-224-PETS (7387) 

(For more infonnation] [Visiru6a-1:] 

[Made in USAJ 

, " 

, 

, " 

, 

" , 

, 

, 

" 

, 

" 

, 

" 

Distributed by: 

Sergeant's Pet Care Products, Inc. 

P.O. Box 540399 

[BAR CODE AREAj::: ' 

, " , , 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-XX 

EPA Est. No. XXXXX-XX-XXX 

{END - BACK I SIDE PANEL) 

{START - OPTIONAL INSERT OR PACKAGE COPY) 

[- How to Apply - May contain graphics illustrating product use, e.g., cat 

with a drop falling onto its neck from a vial on front, side, or back carton 

label and/or applicator labeling.] 

[How to Apply 

1. Remove product tube from package. Holding tube with top end pointing up 

and away from face and body, cut off top end with scissors. [image of tube 

and end being cut off] 

> • , , 
125

Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in [ [is optional. Page 7 of7 

EPA No. 2517-XX 

21 December 2009 

BACK PANEL CAT SPQT ON 

FIPRDNIL 

2. Invert tube over cat and use open end to part eat's hair. 

3. Apply contents of one (0.017 fl oz) tube [vial] of {Product Name} as a stripe, 

starting high on the back of the eat's neck to in front of the shoulder blades. 

Squeeze tube firmly to apply all of the solution to the eat's skin 

[Flea life cycle diagram] 

[Look at the Label (Look at the Label icon) 6 Step [Spot On] [Squeeze-On] [Topical] 

Checklist 

• Read the label completely and follow directions 

• Weigh your pet 

• Do NOT use Dog products on Cats 

• Do NOT treat with more than one pesticide product at a time 

• Separate animals after treatment to avoid chance of ingestion 

• Do NOT split tubes between pets] 

[Brand Name] 

[Monthly reminder card] 

[For year round protection apply [Brand Name] monthly.] 

[Pet's Name (Empty blank for owner to fil! in name)] 

[First [dose] [Treatment] (Empty blank for owner to fill in date)] 

[Second [dose] [Treatment] (Empty blank for owner to fil! in date)] 

[Third [dose] [Treatment] (Empty blank for owner to fil! in date)] 

[Fourth [dose] [Treatment] (Empty blank for owner to fdl in date)] 

[Fifth [dose] [Treatment] (Empty blank for owner to fill in date)] 

[Sixth [dose] [Treatment] (Empty blank for owner to fil! in date)] 

[calendar stickers with brand name] [Place stickers on your calendar as a rerninckr, to 

reapply [brand name] in 30 days. ; ); > » > > , , , 

" [Monthly Application Reminder Magnet (image of reminder magnet) ) , , _ , 

Enclosed for your convenience is an application reminder magnet. Push the'Eres~i) 

, , ,>,." 

, 

" , , 

, " 

" , , 

, " 

" , , 

, " 

button, and the reminder light will blink twice. The reminder tag is now set for 30 day~.~.' > > 

At the end of30 days the reminder light will blink, reminding you to reapply [Brand > >" 

Name]. Press the button once and the blinking light will stop. Press the button again anp: :: > 

this will reset the timer for another 30 days. 

{END - OPTIONAL INSERT OR PACKAGE COPY} 

TUBE I VIAL LABEL 

Front Label 

(Brand Name} 

FiproniI9.7% w/w, 

O.50mL 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

CAUTION: Read directions and precautions 

before using. Open with scissors. 

EPA REG. No. 25l7-XX 

(label code} 
126
Pages 27 through 29 contain the product confidential statement of formula and is n