EPA Registration Jacket 2517‐134
From: 

Date: 

Subject: 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHEMICAL SAFETY 

ANO POLLUTION PREVENTION 

INTERNAL USE ONLY - DO NOT CITE OR RELEASE 

Rosanna Louie-Juzwiak 

Review, Insecticide Branch 

November 5, 2010 

Note to File, #2517-134, Sergeant's Fipronil + Methoprene Squeeze-on for Dogs 

OutstandingIPending Items at Time of Registration: 

1. Efficacy Review completed October 27,2010 indicated that the "waterproof' claims 

must be removed from the proposed product labeL Because the me-too product (65331-

5) has the claim, it is not readily clear as to how this claim was supported, and it is out of 

the scope of this action to investigate the me-too product, the applicant was allowed to 

retain the claim provided they chose to do a selective cite-all and offer-to-pay for the 

efficacy guideline, 810.3300. This option was presented because all other efficacy data 

were cited, and deemed acceptable, from the current dataholder, Merial. 

2. When the Storage Stability and Corrosion Characteristics studies (830.6317/830.6320) 

studies are submitted for review by CHEMlTRB, include in the request that they review 

the previously submitted and accepted study to support the enforcement analytical 

method (830.1800), which was included in an updated data matrix, provided after the 

time that the product chemistry review was completed. As such, the product registration 

is contingent on the acceptability of this study to support this product. 

1

*Internal deliberative information*
21-Day Screen Completed by 

Contractor 

21-Day Expires on /-)..2 - /0 

, 

Jacket #j{!31 7 -t{;U 

MRID# ----

Content Screen: Recommended to 

~Fail 

86-5 Review: Passed/Failed/§7 

Transfer This Jacket to: 

2
Comments: 

o C ( }'l -- -t ~ 

"0--1 '"i 

", ) -; 

I I 

! !] 

* N/A - 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 ~e 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, otherwise. 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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site [link to http://www.epa.gov/opprdQOl/inertsl1ists.html] and If the inert is not 

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

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

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

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

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

delays. 

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

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

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

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

new inerts except PIP inerts are reviewed by IIAB. 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/oppbppdl/biopesticides/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 http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included 

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

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

mixture or fragrance may need to provide this infonnation 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 infonnation 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 1 ~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 information_and data needed for the Agency to approve the 

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

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

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

category estimated); or 

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

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

25% ofthe full fee ofthe category identified. 

Conventional New Product Applications 

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

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

inert approval (R3!1, R312 or R313), it will contact the applicant with the 

following-options: 

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

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

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

approved for the application's uses; or 

2. Submit the 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 

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

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

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

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

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

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

options: 

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

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

approved; or 

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

unapproved inert. If an inert ingredient tolerance exemption petition is 

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

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 ofthe above options is selected and implemented during the 21 day 

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

the fee. 

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

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

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

)( 

(864744<- ~ _____ " _________________________________________________________ N __ __ 

This package includes the following 

@New Registration 

°Amendment 

DStudies? o Fee Waiver? 

o vol pay % Reduction: __ 

,---------------------------- -------------- --------------------

for Division 

OAD 

oBPPD 

@RD 

Risk Mgr. [J]J 

l__ _____________ ............ ______ _ _______ .... _ 

Receipt No. s-I 864744 

EPA File Symbol/Reg. No. I 2517-RGU 

Pin-Punch Date: I 12/22/2009 

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

--------ft;ctionCm1e-:-----· ParenUChild Decisions: 

Requested: I "f.,:,c= 

Granted: I 'R'3co 

'I Amount Due: $ ,\,:' (."s:-. =-: 

~t--i'.k~I!2jL'..,rJ"~! __ ,L(;%J~_LI~ILD ___ '- ------------------------------------ . • i ~-

)6 Inert Cleared for Intended Use 0 Uncleared Inert in Product 

Reviewer: ~ b()~~ Date: \ 2 --"3F ' C' '-, 

Remarks: 

7
I 

, 

I 

l 

! 

! , 

I I 

iSB'S Front-end PRIA Completeness Screen 

Draft 3; 10/25107 

L'P A RCCCI~~~D_at_:~/)-/-;.-·,p.-/-(l-?----'1 E-p-A-R-e-g Number: d 5/1 ~~-~=·--l 

Check List Item Yes Nil N/ A ---- -.~-+-- --. 

lias the PRIA Fcc been Paid; is a copy of the check or 

P<q.gov receipt included in the Submission Package? 

Is lIll Application Form (EPA Form 8570-1) Included in the 

') SubmissIon Package, is it completely filled out and signed / 

including paci<agc type? 

3 

b <I Confidential Statement of Formula (EPA Fonn 8570+ 

29) IllcJuocd in the Submission Package, is H completely ~ 

Ii lied out and signed (boxes 1·21)? 

I;.; a Formulator's Exemption Statement (EPA Fonn 8570+ / 

27) Included in the Submission Package? 

Is ,1 Certification with Respect to Citation of Hahl (EPA 

h)]Tll ~570<14) Included in the Submission Package? 

Is II Ih(a Matrix (EPA FOlm 8570-35) Included in the 

Submission Package? 

/ 

7 Is a Lahcllncludcd in the Submission I'ackage? 

8
Material to be added to an e..Jacket or Jacket 

Reg. No. 2Sl1- l Y-\ 

1. rPlacement within the e-Jacket/Jacket 'F Default: (chronological, top = newest) 

2. If 

D File Location: (PDF page number) 

Send to Data Extraction contractors this material: 

Newly stamped accepted label 

Notification 

NewCSF (I"~) 

D 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: 5" Nov 20\ 0 

9
~\"';EOST..,~ U.S. ENVIRONMENTAL PROTECTION EPA Registmtion No, Date ofIssuance: 

. • ft • . AGENCY P 7Q Office of Pesticidc Programs 

~~~ NOV -4 1010 Rcgistmtion Division (7504P) 2517-134 \, ~'f( 1200 Pennsylvania Ave., N.W. 

"'1- ~o Washington, D.C. 20460 ~l PRO"';~C 

Term ofIssuance: 

NOTICE OF PESTICIDE, Conditional Registration 

Ii:! Registration Time-limited: see conditions below 

D Reregistration 

Name of Pesticide Product: 

(under the Federal Insecticide, Fungicide, 

Sergeant's Fipronil + Methoprene and Rodenticide Act, as amended) 

Squeeze-on for Dogs 

Name and Address of Registrant (include ZIP Code): 

Sergeant's Pet Care Products, Inc. 

2625 South ISSth Plaza 

Omaha, NE 68130 

Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and 

accepted by the Registration Division prior to use of the label in cormnerce. In any correspondence on this product always refer 

to the above EPA registration number. 

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

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

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

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

for shipment. 

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

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

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

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

The Agency may require this in the future. It is possible that no additional alternate fonnulation,s 

or minor formulation 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 

reports made at 0, 3, 6, 9, and 12 month intervals. 

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 OPPTS Guideline 830.1800 ~ Enforcement Analytical 

Method, is acceptable to support the registration. 

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

you must provide the Agency the foHowing: 

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

product from which the active ingredient is derived. 

b. The name and address ofthe entity from which the manufacturing product was 

obtained; and 

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

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

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

two months after each quarter ends. 

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

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

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

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

incident: 

EPA Registration Number 

Product name (bmnd 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: dermal, oral, other animal, inhalation, other 

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

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

Time to Onset (hours, days) 

Treated by veterinarian: yes or no 

First time product used: yes or no 

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 

7. 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 dermal and ocular irritation reports. 

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

11
of exposure. Each incident should only be reported once. If one incident has several 

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

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

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

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

incidents of each severity code for each route of exposure. 

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

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

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

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

jT, 7yr, 8jT,9yr, IOjT, II yr, 12yr, 13jT, 14jT, 15jT,>15yr. 

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

weight range on the product label. 

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

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

product weight range, number of incidents in dogs in lower half of weight range, number 

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

product weight range. 

Table showing number of incidents for each dog breed. 

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

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

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

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

Section 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 section 

4. 

All labeling comments below are in reference to the master label: 

9. On page 2, delete "VetSpot" and "SentryVet" from the list ofaltemate brand names, because 

misleading tenns are not pennitted. 

10. On page 2 under the header Multiple Bugs, revise the first claim containing "controls sarcoptic 

mange" to read "controls mites that may cause sarcoptic mange." 

11. On page 4 under the header All Others, revise the claim "controls sarcoptic mange [infestations]" 

to "controls mites that may cause sarcoptic mange." 

12. On page 4 under the header All Others, add the qualifier "8 weeks of age or older" at the end of 

the statement after "puppies." 

13. On page 4 under the list of claims, delete the following claims because the Agency has not 

received or approved the proposed text or graphics on these inserts: 

12
Delete "clip" and "card" in the "Free with purchase" claim 

"Monthly application reminder card inside" 

14. On page 5 under the list of claims, replace the "X" in the last claim to read "3", since this is the 

only number of applications pennitted to be contained in a single package, which has been 

approved by the Agency. 

15. On page 5 in the last section of dog weights, delete the brackets between "puppies" and "8 weeks" 

because the qualifier "8 weeks of age or older" must accompany any reference to "puppies." 

16. On page 5 above the ingredient statement, delete "ingredient statement may be on front or back 

label" because the ingredient statement must be clearly printed on the front panel ofthe label, and 

EPA has not received any request or rationale from Sergeant's to consider an exception to this 

requiremen~ per 40 CFR 156.IO(g)(2)(i). 

17. On page 5 under Net Contents, delete the "6 [six]" and "9 (nine]" options because these number 

of doses were not submitted for approval by the Agency and are not pennitted as an option, until 

new Child Resistant Packaging testing that includes these number of applicators per package are 

submitted to the Agency. 

18. On page 6 at the top of the Back Panel section, in order to retain the "sustained release formula" 

claim, the following revision must be made to the statement: 

"(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 up to 30 days on 

dogs.]" 

19. On page 7 under the Directions for Use section, make the statement "do not allow children to 

apply product" in all bold and capitalized letters. 

20. On page 7 under the Directions for Use section, delete "Insert Copy" as an option because all 

language under the Directions for Use must remain together on the labeled package. 

21. On page 7 under the How to Apply section, delete "Repeat application may be made if necessary, 

but" from the last statement so that the revised statement reads as follows: 

"Do not apply more than once every 4 weeks." 

22. On page 10 under the Brand Name section, delete "[6][9]" from the second and third claims, and 

delete all numbers after "yd" in the fifth claim. 

23. On page 1 0 in the list of claims starting with Brand Name, delete "monthly reminder card" 

because the Agency has not received or approved the proposed text or graphics. 

24. Revise the EPA Registration Number to read: "EPA Registration No. 2517-134" on page 10 of 

the label. 

If the Agency detennines 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. If these conditions are not complied with, the registration will 

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

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

enclosed for your records. If you have any questions concerning this action, please contact Rosanna 

13
Louie~Juzwiak at (703) 308~0037. 

Enclosure: 

- Sergeant's Fipronil + Methoprene Squeeze-on for Dogs Label, Stamped Accepted with Comments 

«~~vm[#C-- Date: 

NOV -4 2010 

Richard Gebken, Product Manager (10) 

Registration Division, Insecticide Branch 

EPA Form 8570-6 

14
Sergeant's Master Label 

20 October 20 I 0 

Information in ( ] is optional. 

FRONT PANEL 

Page 1 oflO 

EPA No. 25 1 7-RGU 

DOG SQUEEZE ON 

FIPRONIL+METHOPRENE 

The followiIlg pages contain the master label, including optional label text lbat may be found on 

final printed product labels. The CRP required text will not change. 

ACCEPTED 

with COMMENTS 

In EPA Letter Dated: 

NOV - 4 2010 

Under the Federsllnseeticide, 

Fungitide, and Rodetrticide Aet, 

as amended, for tbe pesticide 

registered under EPA Reg. No. 

2517- 13=t 

15
Sergeant's Master Label 

20 October 2010 EPA No. 25I7-RGU 

Information in [ ] is optional. Page 2 of 10 

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

text on front, back or side label panels] 

Sergeant's Fipronil + Methoprene Squeeze-On for Dogs 

[ABNs:] 

[(Sergeant's®) (Sentry®) VetSpotTM Plus (Spot On) for dogs] 

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

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

[Sentry Proline (Spot On) for dogs] 

[SentryVet (Spot On) for dogs] 

IISENTRY®] FIPROGUARD'" PLUS for dogs] 

IISergeant's®] PRONYL OTC'M PLUS for dogs] 

[Apply to puppies over 8 weeks old] 

[Apply to puppies 8 weeks or older] 

:@--~*~I 

[Mosquitoes] 

[. Kills mosquitoes] [within 24 hours] 

[-Kills [and] [repels] mosquitoes that may transmit heartworm] 

[Adult Fleas] 

[·Kills [adult] fleas [for up to three months.] 

[·Kills newly emerged adult Fleas before they lay eggs] 

[·Kills [and repels] Fleas, source of [flea allergy dermatitis] [, flea bit anemia] [and 

tapeworm infestations]] 

[. Kills [&] [and] [Repels] Fleas Up to [4 weeks] [1 month] [30 days]!] 

(. If dog is at high risk for flea reinfestation a once a month application may be needed] 

Multiple Infestations 

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

[. Flea [&] [and] Tick Control for Dogs [&] [and] Puppies 8 weeks old [&] [and] older] 

[·Kills [and] [&] repels] fleas, flea eggs, ticks, [chewing] lice [&] [and] mosquitoes] 

['Kills [and] [&] [repels] fleas, ticks, mosquitoes, [chewing] lice, flea eggs, flea larvae 

[&] [and] [flea pupae] 

[·Kills [&] [and] [Repels] Fleas, Ticks [&] [and] Mosquitoes] 

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

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

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

16
Sergeant's Master Label 

20 October 20 I 0 EPA No. 25 I 7-RGU 

Information in [ ] is optional. Page 3 of 10 

FRONT PANEL . DOG SQUEEZE ON 

FIPRONIL+METHOPRENE 

[Ticks] 

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

[. [Seven] [7] Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea larvae 

[&] [and] flea pupae]] 

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

larvae] 

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

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

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

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

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

[Once A Month Flea and Tick Treatment] 

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

[. Kills [&] [and] Repels Fleas, [and] Ticks [and mosquitoes] for up to [4 weeks] [1 

month] [30 days]!] 

[. Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to [4 Weeks] [I month] [30 days]] 

[-[Images of the different kinds of bugs killed with a line drawn through each bug]] 

[-Kills [and] [&] repels] Ticks including those that may transmit Lyme disease] 

[. Kills [and] [ &] repels] Ticks for Up to [4 weeks] [I month] [30 days]!] 

[. [Kills [and Repels] [all stages of] (deer) ticks [before they can] [that] [transmit Lyme 

disease,] [for up to [4 weekS] [I month] [30 days] [per application]]] 

[. Kills [and1 [&] repels] Ticks (Including Deer Ticks) for up to [4 weeks] [I month] [30 

days]] 

[. Kills [and] [&] repels] [brown dog ticks,] [American dog ticks,] [and lone star ticks] 

[and deer ticks] [(Rhipicephalus sanguineus)] [for up to [4 weeks] [I month] [30 days]] 

[. Kills [&] [and] Repels] American Dog Ticks [(Dermacentor variabilis)] for up to [4 

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

[Flea Eggs and Larvae] 

[·Controls [flea] reinfestation [for up to [12 weeks] [3 months]]] 

[.Kills adult fleas, flea eggs, flea larvae and pupae for up to [three months] [12 weeks].] 

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

[. If dog is a high risk for flea reinfestation a once month application may be needed] 

[.Kills flea eggs [larvae] [pupae] for up to [3 months] [12 weeks]] 

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

Cycle] 

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

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

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

Effectively Breaks the Flea Life Cycle] 

[.Dual Action [I]: Effectively Breaks the Flea Life Cycle [ill 

[. Kills Flea Eggs & Flea Larvae for [3 months] [12 weeks]!] 

17
Sergeant's Master Label 

20 October 2010 EPA No. 2517-RGU 

Infonnation in [ ] is optional. Page 4 of 10 

FRONT PANEL DOG SQUEEZE ON 

FIPRONIL+METHOPRENE 

[. Prevents Flea Eggs From Developing Into Biting Adults] 

[. Kills all stages of the flea life cycle] 

[-Controls reinfestation [for up to 3 months]] 

[-Complete protection against all stages of the flea life cycle] 

[All Others] 

[-For Dogs and Puppies 8 weeks of age or older] 

[-Controls sarcoptic mange [infestations]] 

[·For Dogs [up to 22Ibs.], [23-44Ibs.]' [45-SSlbs.]' [S9-132Ibs.] 

[·Fast Acting] 

[-Dogs can be bathed 24 hours after treatment] 

['Long Lasting] 

[·Prevents reinfestation] 

[·Easy to use [application]] 

[-Once a month treatment recommended] 

[·A once monthly application is recommended for chewing lice.] 

[-Fast Action against [chewing] lice infestations] 

[. [Three] [3] Applications {for cartons with 3 applicators}] andlor [3 Month Supply] or 

[12 Week Supply] 

[. Best if used year round!] 

[. (lCON Showing [4 Week] [1 month] [30 day] Protection)] 

[·4 Week Dose!] 

[. 1 Month Dose!] 

[. 30 Day Dose!] 

[. Specially Formulated for Dogs and Puppies] 

[. [Free] Calendar Stickers Inside!] 

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

[. Dogs can be bathed 24 hours after Spot-on is applied] 

[·Can be used on breeding, pregnant and lactating [bitches] [female] [dogs]] 

[. [Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [clip] 

[card] [inside]] 

[. Waterproof] 

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

[-Monthly application reminder card inside] 

[. Fipronil (9.S%) +(S)-methoprene (S.S%)] 

[. Lift [here] for more information] 

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

Plus®'] 

[* [Brand Name] is not manufactured by or distributed by Merial. Frontline Plus® is a 

registered trademark of Merial.] 

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

18
Sergeant's Master Label 

20 October 2010 EPA No. 25l7-RGU 

Information in [ ] is optional. Page 5 of 10 

FRONT PANEL. . DOG SQUEEZE ON 

FIPRONll.+METHoI'RENE 

[[X) Applications) 

[For use ONLY on dogs 

[Up to 22lbs) 

[23-44 lbs) 

[45-88lbs) 

[89-l32lbs) 

[over 8 weeks of age)) 

[For Dogs & Puppies) [8 weeks or older))and))up to 22lbs.) 

[For Dogs 23-44Ibs.) 

[For Dogs 45-88lbs.) 

[For Dogs 89-132Ibs.) 

[ ] - Denotes Optional Statements and/or Images that May be Used on Front, Back 

or Side Label Panels 

[Ingredient Statement may be on front or back label] 

ACTIVE INGREDIENTS: 

Fipronil. ...................................................................... 9.80% 

(S)-methoprene .......................................................... 8.80% 

OTHER INGREDIENT**: ................................... 81.40% 

TOTAL: 100.00% 

[**diethylene glycol monoethyl ether] 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See [Back)[or)[Side) [Label Panel[s) [or) [insert) for Additional Precautionary Statements 

NET CONTENTS: 

[3) [three) [6)[six)[9)[nine) 0.023 fl oz (0.67 mL) applicators 

[3) [three) [6)[six)[9)[nine) 0.045 fl oz (1.34 mL) applicators 

[3) [three) [6) [six) [9) [nine) 0.091 fl oz (2.68 mL) applicators 

[3) [three) [6)[six)[9)[nine) 0.136 fl oz (4.02 mL) applicators 

(END - FRONT PANEL) 

19
Sergeant's Master Label 

20 October 20 1 0 EPA No. 25l7-RGU 

Infonnation in [ ] is optional. Page 6 of 10 

BACK PANEL DOG SQUEEZE ON 

FIPRONIL+METHOPRENE 

[[brand name] contains Fipronil and SwMethoprene (insect growth regulator) (lOR) to effectively 

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

[The active ingredients in [brand name] feature a sustained release formula developed to work 

with the dog's natural skin oils resulting in fast acting [and long lasting] control of fleas, ticks 

mosquitoes and chewing lice [for 30 days] on dogs.] 

[Brand Name[ 

f@'~~:OJ'1 READ ENTIRE LABEL BEFORE EACH USE. 

USE ONLY ON DOGS AND PUPPIES OVER 8 WEEKS OF AGE. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS. CAUTION. Hannful 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 puppies under 8 

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

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

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

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

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

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

medicated, debilitated or aged dogs. Call 1-800-781w4738 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. 

lfin eyes: Flush eyes with plenty of water. Call a doctor ifirritation persists. 

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 lw800-781-4738 for emergency medical treatment 

infonnation. 

20
Sergeant's Master Label 

20 October 2010 

Infonnation in [ ] is optional. 

BACK PANEL 

Page 7 of 10 

DIRECTIONS FOR USE 

EPA No. 2517-RGU 

DOG SQUEEZE ON 

FIPRONIL+METHOPRENE 

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 DOG, 

READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE. FOLLOW 

ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR 

EXTERNAL USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON 

OTHER ANIMALS. 

Do not use on puppies under 8 weeks of age. [Do not split one tube between dogs.] [Do not use 

multiple tubes on one dog.] Weigh your dog to be sure you are applying the right dose 

formulated for the weight of your dog. Consult a veterinarian before using this product on 

debilitated, aged, medicated dogs. Can be used on breeding, pregnant, or lactating dogs. 

Consult a veterinarian before using on dogs with known organ dysfunction. Dogs 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 dogs. If 

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

If signs continue, consult a veterinarian immediately. 

[{ Outer Packaging or Insert Copy} I 

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

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

the narrow end at the notches with scissors. 

How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to 

apply all of the solution to the dog's skin, as directed below. Repeat application may be made if 

necessary, but do not apply more often than once every 4 weeks. 

[Optional drawings that mayor may not appear on finished label] 

~ 

rl 

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 all stages of the flea for up to three months. 

Apply monthly if your dog 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. 

21
Sergeant's Master Label 

20 October 20 I 0 

InfOlmation in l ] is optional. 

BACK PANEL 

Page 8 oflO 

EPA No. 25 I 7-RGU 

DOG SQEEZE ON 

FIPRONIL+METHOPRENE 

For Dogs Weighing up to 221bs. [including small dogs and puppies, 8 weeks or older): 

{For cartons containing 0.67 mL (0.023 f1 oz) applicator tubes} 

Apply one tube (0.67ml)(0.023 fl oz) [from the back of the neck to a point midway between the 

neck and tail.] [as a spot on the dog's back between the shoulder blades.] 

For Dogs Weighing 23 - 44 lbs. 

{For cartons containing 1.34 mL (0.045 fl oz) applicator tubes} 

Apply one tube (1.34 ml)(0.045 fl. oz.) [from the back of the neck to a point midway between the 

neck and tail.] [as a spot on the dog's back between the shoulder blades.] 

For Dogs Weighing 45 - 881bs. 

For cartons containing 2.68 mL (0.091 fl oz) applicator tube} 

Apply one tube (2.68 mL)(0.091 fl oz) [from the back of the neck to a point midway between the 

neck and tail.] [as a spot on the dog's back between the shoulder blades.] 

For Dogs Weighing 89-132Ibs. 

{For cartons containing 4.02 mL (0.136 fl oz) applicator tube} 

Apply one tube (4.02 mL)(0.136 fl oz) [from the back of the neck to a point midway between the 

neck and tail. J [as a spot on the dog's back between the shoulder blades. J 

STORAGE AND DISPOSAL 

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

(below 77°F [2S0C]) 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.] 

22
Sergeant's Master Label 

20 October 2010 EPA No. 2517-RGU 

Information in I ] is optional. Page 9 of 10 

BACK PANEL DOG SQEEZE ON 

FIPRONIL+METHOPRENE 

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

Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.J 

In Case of Emergency, call: 1-800-781-4738 Non-Emergency call1-800-224-PETS (7387) 

[Made in USAJ 

Distributed by: 

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

P.O. Box 540399 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-XX 

EPA Est. No. XXXXX -XX-XXX 

{END - BACK / SIDE PANEL) 

[Optional Insert or package copy] 

[Coupon(s) inside or on outside of box] 

[Directions for Use} [Application Instructions[ 

[How to Apply - May contain graphics illustrating product use, e.g., dog with a drop 

falling onto its neck from a vial on front, side, or back carton label and/or applicator 

labeling. ) 

[{Outer Packaging or Insert Copy} J 

How to open 

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

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

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

How to apply: 

[Optional drawings that mayor may not appear on finished label] 

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

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

spot to the dog's back between the shoulder blades.} [or} {from the back of the 

neck to a point midway between the neck and taiL} 

23
Sergeant's Master Label 

20 October 2010 EPA No. 2517-RGU 

Information in [ ) is optional. Page 10 of 10 

[Flea life cycle diagram] [Flea Life Cycle] [SampJe coloring and layout may be different on 

final 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 Namc[ 

[Monthly reminder card] 

[3][6][9] [Month Treatment Tracker] 

[3][6][9] [Month Application Tracker][[For year round protection, apply [Brand Name] 

monthly.] 

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

[First] [1st] [Second] [2nd] [Third] [3rd] [Fourth] [4th] [Fifth][5th] [Sixth][6th] [Seventh [7'h] 

[Eighth}[S'h] [Ninth] [9"'] 

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

[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 will blink, reminding you to reapply [Brand Name]. Press the button 

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

another 30 days.] 

{END - OPTIONAL INSERT OR PACKAGE COPY} 

TUBE I VIAL LABEL Front Label 

{Brand Name}[cat graphic with line throughJ 

For dogs up to X Ibs 

Fipronil 9.8% w/w, (S)-methoprene 8.8% w/w 

0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 

mL {label code} 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

CAUTION: Read directions and precautions 

before using. Use scissors to open. 

EPA REG. No. 25 I 7-XX {label code} 

24
FIPROGUARDTM PLUS 

FrontTube Labels BackTube Labels 

KEEP OtrfOF REAcH Of [:HIUlR£N 

lJ'IUTlON' Ra.d d'roC',.ns ,nd procouno" 

b,fu", u~ng, Us. "j",,, to 'P'" 

EPAREGND,;'5ll·:O: ~ 

25
FIPROGUARD" 

PLUS for dogs 

. :!:'~:::""'---"'-'" .""""" ................ ~, ....... . """".--.. .""'''''''.,.,., ......... _ ... . "" .. -~-........ """",-",", .... -.....,...---....... "" ...... .... • e.. .. ""'''' __ ''' ....... ''''' .r ... _ 

.~-

I ---------1 

26
F";~~'·,O,," 

.'0'«"'"', 'W) , ;i'",'';U~"D'" 

fLUS""",',. 

"' "'p." ... ,"."""".,~~, ~>~",~-.",,,,.,,,,, 

D ""q~"._,.,~~,""_, 

C::::;:~ic-I 

~!c!·1 

f<!-- --.---.-----.-"-."-~ 

329~2--~ 

FIPROGUARO" 

PLUS fordogs 

..... "..,.. ........ _ ........... _ ...""".., ... ,=! ."""",.,-.... ~,­

''''''''''-''''''' ""_.,...r_"'_ 

>"",~-~ ... .,., ........ "" ....... ",," .-• """'""""--=..,-..,""'''', .... . , ",,,,,.., ""'''''''''''''_.'''''"''''''''''''"''''''' 

"~­ ""--,-"""""", ._---,,-""' - .. "", ....... ....,"'"""-..... """"""""~ -_"""~"'''''_'~'''''' ... ~-

_. ________ ._~M." _ _ . ___ "_~_ '-~'~---lJ27
f,,')""'-"'"oo """«<'''" .• """, ""f1O~UJJ"''" 

PLUS ""',,"'~_ 

FIPROGUAROPLUS fordogs 

, ..... -~"" .. -... -... -... ......... "' ...... '''''''''' ... - .... ~,-

,,, .. .,.._ ......... - ............ ~ ... ""' ........... .-- ............ - """"-"' ... -.. "" ...... . """,-,,,-,,,,,,,,,,,,,,-- .,""-

-~- .. __ 

....... . - ............ -~-...... .,.. :!.."'.::=.":,':.':;",:'~:;::".,..::" 

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

28
''''1''''''''''''' p""",,",o.,m 

FWl<OGuAAON 

eLU'_thfy. 

~"""""~.,,,,rn~,,,"~ 

=-"'.'"""~''''' n ....,._~~ .. "'~'"'_ 

ro.""'''''''''~_'~ 0""""'''''' ..... ''' __ 

k--- 32902 ---1 .. 0-11 

FIPROGUARDPLUS fordogs 

.... ,,-~ ..... -"""-....... , ... ..... ""''''.- . -.., ... -. .. "'~,-

.,-"'-.,....,-""-. ''''''''''--

.""~-,,-.... -.... ..,-..... .... ---""-~.""-""' ... "" ... . "".",""""' .............. ""'-. .... . ~~ 

.~-

... --",..,.,......,~~-"' ....... ....... ---~-.., .. """ ---""_ -"""'....", . ..,-'""""-""""~ .... "' ....... -

------------------------------>-

29
Decision stedus 

Trelcking 

Creede Resubmission 

FFS Letters 

Action Code History 

Secondary Decision 

30
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

May 4, 2010 

OPP Decision Number: D-425453 

EPA File Symbol or Registration Number: 25l7-RGU 

OFFICE OF 

PREVENDON, PESTICIDES AND 

TOXIC SUBSTA..."JCES 

Product Name: SERGEANT'S FIPRONIL + S-METHOPRENE SQUEEZE-ON FOR DOGS 

EPA Application Receipt Date: l3-Apr-20l0 

EPA Waiver Request Receipt Date: 13-Apr-20IO 

EPA Company Number: 2517 

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

KELLY R. HOSKlNS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH l58TH PLAZA 

OMAHA, NE 68l30-l703 

SUBJECT: Approval of 50% Small Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has approved your request for 50% waiver of the 

pesticide registration fee associated with the action referenced above. The decision review 

period for this action will begin on the date of this letter. 

The Action has been identified as Action Code: R310 

NEW PRODUCT;NON-F AST 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. 

Sincerely, 

Information 

f2~rJ!kc~ Technology & Resources Management Division 

Office of Pesticide Programs 

31
Revised Data Matrix: 

James Messina 

to: 

Rosarma Louie-Juzwiak 

11/04/2010 12:36 PM 

Show Details 

History: This message has been replied to. 

James Messina 

Senior Managing Regulatory Consu!tant 

Exponent 

Center for Chemical Regu!ation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

202-772-4932 

202-772-4979 fax 

301-908-1181 cell 

Page 1 of 1 

CONF!DENTIALITY NOTICE: This e!ectronic transmission (including any files attached hereto) may contain 

information that is privileged, confidential and protected from disclosure. The information is intended on!y for the 

use of the individual or entity named above and is subject to any confidentiality agreements with such party. If the 

reader of this message is not the intended recipient or any employee or agent responsib!e for delivering the 

message to the intended reCipient, you are hereby notified that any disclosure, dissemination, copying, 

distribution, or the taking of any action in reliance on the contents of this confidential information is strictly 

prohibited. If you have received this communication in error, please destroy it immediately and notify the sender 

by telephone. Thank you 

file:IIC:lDocuments and SettingslrlouielLocal SettingsITemplnotesFCBCEEI-web8782.htm 1115/2010 

32
£, 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASIIINGTON, D.C. 20460 -.-. "".,--

II review acti\ilies. j ,gthc I I ~~'6O:' burden 10 Director: UJ 

DATA MATRIX 

1,2010 

,. y, ___ .>istrant's 1 ._ .. _ ~ .• ~~.w_ 

'5 Pet Care Produtts, Inc. 2625 Soulh , ~11;1 .. _ 10ft On 

Guideline Reference 1 

830.1550,830.1600, l 

830.1650,830.1670 ' " IS30.u:m 

1:30.1 

J,830.6315, 

1,830.6317 

.iU.Ojj f, lIJU.IHlO 

{/ 

~ Data j 

Squeeze·On for Dogs 

'5 Fiproni!' 

Product chemistry of Sergeant's Fipronil + Melhoprene 

Squceze.On for Dogs 

Storage stability and corrosion characteristics 

II toxicity 

Dennal: 

Evaluation of the D Yc> -'"1----- _"" _.-

Orange Label Indicator (3){), sclssors to open -. 

-ion Package for Scrgeant's Pet Care Products, Inc. 

"~.ion oflhe Dog Squeeze On 1.34ml White Applicator with 

Green Label Indicator (3x), scissors to open - f"o>-l as a Poison . p_ for ~p.r<>p_:lnt'~ Pet Care Products, Inc. 

EPA Re No.lFile S mbol 2SI7·RGU 

Product: Sergeant's Fipronil +" 

UDNumber 

48059101 

48059102 

To "'" uEon comEietion 

44942004 

44942005 

I .. --.- ~.d Title 

KellyR." _ •. 

.-!'lH f'n. "'_~ 

Inc. 

Inc. 

Sergeant's Pcl t 

Jnc. 

I Inc~ 

I MERIALI 

Inc. 

In, . 

!t Care J 

Inc. 

. Ii Affairs 

;ef~ 

;":~~w :'Washington, DC 

I Page I of6 

Sfa"" I Note 

OWN 

OWN 

OWN 

OWN 

PAY 

PAY 

"""PAY 

PAY 

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OWN 

OWN 

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33
& 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

F .... Apl"""f<! OMB N .. l(I7(J.(IOiu 

Papenl'Ork Reductioo Act Notite: The JlIIb]j~ reponing burdenior !.his collection ofllformaiWnls estimated to average 0.25 hours per lesponsc fOr registration actIvitieS-and 025 hours per response for 

reregisuation arld special rtvicw activities, including time fOflcading the instruction and completing the necessary forms. Send wmmenls regarding !he burden estimate or My other aspect of this collection 

oflnformalion, including suggestions lOr reducing !he burden to Director: OPPElnformationManagemcnt Division (2t37) U.S. Environmental Protection Agency, 401 M Street, S.W., WlI£hington, DC 

20460. Do not send the form to this address. 

DATA MATRIX 

Date: November 3, 2010 

Applicant's!Registrant'S Name & Address 

Sergeant's Pet Care Products, Inc. 2625 Stmth 158th Plaza, Suite WO, Om;tha, NE 68130·1703 

Ingredients: Fipronil, Methoprene 

Guideline Referel1:ce Number I Guideline Study Name 

870.7200 

870.7200 

870.7200 

870.7200 

870.7200 

Signature: !/J!. EPA fOm. ~S7Q:.:1S (W\i7) EI, " 

Evaluation of the Dog Squer;:zc On 4.02ml White Applicator with 

Blue Label Indicator (3x), scissors to open" F""I as a Poison 

Prevention Package for Sergeant's Pet Care Produets, Inc. 

Powell; L.; Paffett;""R: (1995) Domestic AnimafSat"ety Study 

by Topical Administration to Dogs: Fipronil Spot Treatment (RM 

160lE): Lab Project Number: MRX 231950406. Unpublished 

study prepared by Huntingdon Research Centre, Ltd. 219 p, 

Canovas. M.; Villagcliu, J.; Lopez, S.; et al. (1994) 

Pereutaneous Absorption and Hair, Skin, and Fat Distribution of 

Radioaetivity After Spot-On Application of (Carbon 14)-RM1601 

in Beagle Dogs: Lab ProjectNumbcrs: CD·9313405F: Q.42.769. 

Unpublished study prepared by Centro de Invesligaeion y 

Desarrollo Aplieado, SAL. 68 p. 

Nolan-Smith, S. {l999Tf'lproniV(S)-Methoprenei'opical Solution: 

Target Species Safety Study in the Dog: Interim Report: Lab 

Project Number: 1686/2: 1686/2-01142: PR&D 0002101. 

UnpUblished study p)'(:pared bv Covance Laboratories Ltd. 266 p. 

Nolan-Smith, S. (1999) Fipronill(S).Methoprene Topical Solution: 

Target Speeies Safety Study in the Dog: Report Amendment: 

Amendment to Inlerim Report Lab Project Number: 168612: 

168612.01142. Unpublished study prepared by Covance Labs., 

Ltd. 6p. 

Nolan'Smith, S. (2001) To Investigate Ihe Safety of a Topical 

Formulation Containing Jl..fL-2,095,988 509T in Dogs Weighing 

Approximately 2kg (+!.1.5kg) at One, Three and Five Times the 

Maximum Label Recommended Dosage: Final Report: Lab 

Projee~ Number: 1686112: 1686112-02160: PR&D 0045801. 

U!}~JU)l\ished sludY',ll"Cpared by Covance Laboratories. 324 p,_ 

1bIL//Ji 

P'pdV''''iQ .. A;;lil,bl .. f"b~ly\t.""r_.;oo 

EPA ~~gNo.lFi\e Symbol 2517-RGU 

Product; Sergeanl's Fipronil + Methoprene 

Squeeze-Qn for Dogs 

MR.lD Number 

48059806 

43863802 

43577715 

44942104 

45143901 

45612702 

Name and TItle 

Submitter 

Sergeant's Pet Care Produels, 

Ine. 

MERIAL LIMITED 

MERIAL LIMITED 

MERIAL LIMITED 

MERIAL LIMITED 

MER1AL LIMITED 

Kelly R. Hoskins,. ManaJ,!;er ofTe::hnieal Affairs 

Pa).!e 2 of6 

Status .IJ"l"ote 

OWN 

PAY 

OLD 

PAY 

PAY 

PAY 

Dale 

11/312010 

",....filil .... ol us. Copy 

teet \d~1 WI 0 

34
1' .... A"' ..... td OMll N •. 101U-IlIlH 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ,~. 401 M Street, S.W. ,~, WASHINGTON, D.C. 20460 

PaperWork Reduction Act Notice: The public reporting burden for this collection of ilfonnalion is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for 

reregistration and special review actimies, includmg time for reading the tn3eregistrntioncompletingthe necessary fooos. Send comments regarding the burden cstimate or any other aspect of this collection 

ofinfonnation.. including suggeSlions for reducing the burden 10 Director. OPPE tnfonnationManagemcnt Division (2137) U.s. Environmemat ProteclionAgency,40t M SlIeet, S.W., Washington, OC 

20460. 00 not send the fonn to ibis address. 

DATA MATRIX 

Date: November 3, 2010 EPARe No.lFileS mbol 2517·RGU P e 3 of6 

Applicant'slRegistrant's NlIffie & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Care Produets, Inc. 2625 South I58th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs 

Illgrcdients: I:i~onil, Metho ene - Guideline Reference Number Guideline Study Name MRlD Number Submitter Status Note 

870.7200 Godin, C.; Alva, R. (2000) ML·2,095,988 45620507 MERIAL LIMITED PAY 

509TIDogiSolution/TopicaVSafelytrolerance/Reproduction, 

Reactions: Final Report: Lab Project Number: PR&D 0020201: 

WEL 99885: PR&D 00202. Unpublished study prepared by 

White Eagle Toxicology Laboratory. 123 P. 

870.3300 MeCal!:i; McTier, T. (1995) positive Referenced and Untreated 43577712 MERIAL LIMITED OLD 

Controlled, Confirmatory Laboratory Trial ofRM160lE SPOT· 

ON Formulation Applied to Dogs as 3 Weight Class Defined 

Volumes for the Control of the Cat Flea Ctenocephalides felis, the 

Brown Dog Tick Rhipicephalus sanguineus, and the American 

Dog TIck Dermacentor variabilis: Lab Project Numbers: RMlFLSTKSI94/2L: RMl VSR·249L T: PT·249LT. Unpublished study 

prepared by TRS Labs Inc. 41 p. 

870.7200 Astruc, B.; Suberville, S.; Bose, F. et a!. (1998) Evaluation of the 44487701 MERIAL LIMITED PAY 

Presence ofM&B 46513 on the Hair After a Topical 

Application (Spot·on or Spray) ofFipronii to the Dog: Final 

Report Lab Project Number. MET4I9: ROO2459. Unpublished 

sltldv oreoared by Meria!. 28 o. 

Signature: !1.,!J Ii-..J'/d Name and Title D,,, 

Kelly R. Hoskins, Manaf!er of Technical Affairs 111312010 

EI'A F""" ~57o.1S ('.91) ,"<dnlnio .. ><II' 'v,..,. ,Av.H.hl. Subm' "..Jvl' .- Au ... "'10",1111.1,., CG~V 

'led}. l d'-t /2-a( 0 

35
FOrni App ... _ Ol\lIl NO-l0711-0MO 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

.l!, 401 M Street, S.W. -~; WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting buroCll for this collection ofi:1ronnation is estimated to average 0.25 hours per responsc forreglstrationactivities and 0.25 hours per response for 

reregistration and special review activities, including time for reading thc ln4eregistratiOl1completing the necessary fonns. Sendcomments regarding the burden estimate or any other aspect of this collC{;tion 

of information, including suggestions for reducing the burden to Dircetor: OPPE 1nfonnationManagement Division (2137) U.S. Environmental Protcction Agency, 401 M Street, S.W., Wa.'ihington, DC 

20460. Do not send thc form to this address. 

DATAMATRlX 

Date: November 3. 2010 EPA Re No.lFile S bol 2517-RGU Pa e40f6 

Applicanl 'slRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Care Products,lne. 2625 South 158m Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs 

In «ilents: Fi ronil, Methoprene 

Guideline Reference Number Guideline Stud Name MRIDNumber Submitter Stalus Note 

133-3 Meo, N.; Gonzalez, C.; Mester, T. (1997) Dennal and Inhalation 44433302 :MERIAL Ll1\.1ITED PAY 

Exposure of Commercial Pet Groomers During Application of 

Frontline Spray Treatment: Final Report: Lab Project Number: 

MERIAL-445-SAFXT046: SAFX046: PDA9705. Unpublished 

study prepared by ABC Labs., California and Aanimal Appcal 

Grooming Shop & Case Veterinary Hospital. 1066 p. 

133-3 Meo, N.; Gonzalez, c.; Bclcher, T. (1997) Dermal Exposure of 44433303 MERIAL LIMITED PAY 

Commercial Pet Groomers During Application of Frontline Top 

Spot: Final Report: Lab Project Number: MERIAL-445-

SAFXT047: SAFXT047: EC-97-390. Unpublished study 

prcpared by ABC Labs., California and Aanimal Appeal 

Grooming Shop & Case VeterintUY Hospital. 925 p. 

132-1 Hughes, D. (1997) Dislodgeable Residues ofFipronil Following 44433305 MERIAL LIMITED PAY 

Application of Frontline Top Spot to Dogs: Final Report: Lab 

Project Number: COVANCE 6848-101: MERIAL METXT 166: 

METXT 166. Unpublished study prepared by Covance Labs. Inc. 

161 p. • 7_ 

Signature: ti, Ltrd...-!. '4! Name and Title Date 

Kelly R. Hoskins. Manager of Technical Affairs 1113/2010 EPA Fonn IS1(l.-J5 (9--'17) E_"i~ an perV"-';"",Availabl", Suri! '_D_ .0 .. '_- ~ •• ~ 1 ... ~., TI._r.~ 

('e( -(\ ld <; \ 2-0 ( D 

36
Fo .... "pp ...... OMS N •• le7&.OKO 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

_f!, 401 M Street, S.W. 

s- WASHlNGTON, D.C. 20460 

Paperwork Reduelion Act Notice: The publk reporting bmden for this colleclion of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for 

reregistralioo and special review aeli'oities, including time for reading the in5eregistmtioncompleting the necessary forms. Send comments regarding the burden eslimate or My other aspect of this collection 

of information, including suggestions for redUCing the burden 10 Direelor: OPPE tnformstion Management Division (2131) U.s. Environmental Prolection Agency, 401 M Street, S.W., Washington, OC 

20460. Do nol selld the fOIm 10 this address. 

DATAMATRlX 

Dale: November 3, 2010 EPARe'i'No.lFileS mbol 2517-RGU Pa e50f6 

Applicant'sfRegiskanl's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeanfs Pet Care Products, Ine. 2625 South 1581h Plaza, Strite 100, Omaha, NE 68I30~1703 Squeeze~On for Dogs 

In redients: Fi ronil, Melho rene 

Guideline Referencc Number Guidelinc Stud Name MRIDNumber Submittcr Status Note 

132~1 Hughes, D. (1997) Dislodgeable Residues ofFipronii Fotlowing 44433306 MERIALLlMlTED PAY 

Application of Frontline Spray Trealmenl to Dogs: Final Report: 

Lab Project Number: COVANCE 6848~100: 6848~100: 

MERIA1A45~METXT-165. Unpublished study prepared by 

Covance Labs. Inc. 184 p. 

132~1 de Fontenay, G.; Campagna, I.; subcrvitle, S. et al. (1997) 44531203 MERIAL LIMITED PAY 

DislodgClable Residues ofFipronii Following a Topical 

Application of Frontline Spot-On Treatment to Dogs: Final 

Report: tab Projcct Numbcr: 817/024B: MET416: 

MERJAL-480-MET-416. Unpublished study prepared by Merial 

Ltd. and Chrysalis Preclinical Services~Europe. 68 p. 

132-1 de Fonlenay, G.; Campagna, I.; Suberville, S. et al. (1997) 44531204 MERIAL LIMITED PAY 

Dislodgeable Residues ofFipronli Fottowing a Topical 

Application of Frontline Spray Treatment to Dogs: Final Study: 

Lab ProjeetNumber: 817/024A: MET414: MERIAL-480·MET~ 

414. Unpublished study prepared by Merial Ltd. and Chrysalis 

Preclinic:ai Services-Europe. 70 tI. 

N/A Irwin, I. (1997) Use Survey ofComrnerciai and Veterinary Pet 44433301 MERIAL LlMlTED PAY 

GrOOmers and Pet Owners of Frontline Top Spot and Frontline 

Spray Treatment: Lab Project Number: MERIAL-445-SURVEY. 

Unpublished study prepared by Wiese Research Associales, Inc. 

,40 p. 

Hughes, D. (1997) Validation of an Analytical Method for the 44433308 MERIAL LIMITED PAY 

DelermiJ:J.ation ofFipronil, M&B45950, and M&B46513 in DyeFree 100% Cotton Gloves: Final Report: Lab Project Number: 

COVANCE6848-104: 6848-104: MERIAL METXT 169. 

Unpubli~hed study preparcd by Covancc Labs. Inc. 41 p. 

Polakoff, B.; Youngren, S. (1997) Non-Dietary Risk Assessment 44433309 MERIAL LIMITED PAY 

Fipronil Use on Pets in a Residential Setting: Lab Projcct 

NUmy~~~:~RONIL ~~:: MERIAL~445-NDRA. Unpublished stud areq,by.Nov· en Scienccs Inc. 27 p. 

Signature: 4£ '(/ 0 J,L M' Name and Title Date 

Kelly R. Hoskins, Manager of Technical Affairs 111312010 EPA F<>Im 8571).H (9.97) 8«trQ"ic "Nfrp<r vtrsi"", Avail.bl", Sf i, , ~,rsil)fi. "'~K'l' In" .... al U .. Co"" l'-l \ 2.-01 0 

37
rx:, not ~ 

r3,2Q]( 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

,,-C; 401 M Street, S. W . 

~,-j~cludj~g ti~ for rc'~r;;g~ih-e-i 

. )ns for redu:.::ing the burden to I 

11 to this address. 

. R WASHINGTON, D.C. 

1 ofilfonnatioll is estimated to average \1.~~ n, 

. . ~ 15. Send ( 

... ,n (2131) U,S, I 

DATA 

)'/Fi 

______ "'_ .. _., __ & Address loue "r' 

'5 Pel Care Products, Inc. iL Suite IOO,(Jmaha, 

Guide! 

Polakoff, B.; Youngren. S. (l997fPet 1 

Analysis and Risk Assessment: "'-- Frontline 

;'jpray frcatment Lab Project Number: FIPRQNIL 97-11: 

MERIAIA45·PGRA. Unpublished study prepared by Novigen 

:, Inc. 17p. 

; Walls, C. ('--~'-

Spot and 

Exposure Analysis and Risk Assessment: Lab Project Number: 

FIPRONIL 98·07: MERlAI.-445-LPERA. Unpublished study 

prepared by Novigen Sciences, Inc. 21 p. 

e.; Youngren, S. (1998) Frontline on Pets in a 

.• _L'~ S.~tting: Risk Assessment of a Low Probability Event 

t'osr-f\.ppll<.:(tllvn Acute Exposure: Lab Project Number: 

FIPRONIL 98-06: MERJAL..445-PGRA. Unpublished study 

r ared b Novi en Sciences. Inc. 18 

810.3300 Em 

Signature: 

OI~"" 

Submitter 

310 MERIALJ 

I .. _ .. - _.d Tille 

Kellv R. "._L'_ LI ~airs 

.y ...... , 

,d 0.251 

any ethe, ""PC 

(,401 M Street, S.W., 

IPAY 

I PAY 

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38
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

D.C. 20460 

u.s. 

pot 

or any other 

MSl«:et,S.W., 

!"ee'O \d,IWIO 

39
& 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

burden to u.s. 

othcr 

401 MStreet, S.W., 

V"e.c'o. 1\ I", \ '""010 

40
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

.~. 401 M Street, S.W. ~ " .. ' 

. -- Agency, 40t M Street, S.W., WashingtOn, DC 

(Xc·a ld,,/2.D fO 

41
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

,l!, 401 M Street, S.W. 

,!!, ' ...... uv 

. ,.-' -_ .. _- "" 

_ '."'> ilours per response for registration activities and 0.25 hours per response for 

reading !he in4eregistrationcofl1lictingtbe necessary ronns. Send comments regarding the burden estimate or any otheT aspectoftlris collection 

burden to Director; OPPE InfonnlllionManagement Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., WaSiington, DC 

n'c'A II(q(2-0tD 

42
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

~, -.',. 

,~, 401 M Street, S. W. 

• .. v .. uu 

0.25 hours per response for registration activities and 0.25 hours per response for 

Send comments regarding the burden estimate or my other aspeetof this collection 

(2137) U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 

'~G'c\ \\1" 12010 

43
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

.O!\ 401 M Street, S.W. 

S WASHINGTON. D.C. 20460 

·OPPE (2137) u.s. 

,,--.. -_ ....... _. __ .-.. -, .. ,,_ ..... _ .. -..., -

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44
Sergeant's Pet Care Products, Inc, 

2625 South 158th Plaza • Omaha, NE 68130-1770 .. Telephone 402,938.7000 • Fax 402.938.7091 .. www.sergeants.com 

October 21, 2010 

Rosanna Louie-Juzwiak 

Document Processing Desk 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202-4501 

Subject: Submission of Product Label and Data Matrix Infonnation 

Dear Ms. Louie-Juzwiak: 

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

EPA Company Number 2517) is submitting an updated product label and data matrix in support of 

the following pending registration application: 

• Sergeant's Fipronil + S-Methoprene Squeeze-On for Dogs (EPA File Symbol 25 I 7-RGU). 

Please find enclosed mock labels and a master label for the above-referenced product. The enclosed 

mock labels (four product sizes) are for the alternate brand name FiproguardTM Plus for Dogs. In 

addition to the mock labels, Sergeant's is submitting the final master label for Sergeant's Fipronil + 

S-Methoprene Squeeze-On for Dogs, The master label contains all of the alternate brand names and 

alternate optional label language and claims. Sergeant's requests that the Agency review the mock 

labels and master label and stamp them as the EPA approved label. 

Sergeant's confirms that the label language specific to the Child Resistant Packaging (CRP) will be 

identical to the language found on the enclosed mock label and master label and that it will not 

change for any of the other alternate brand name product labels. 

Please also find enclosed an updated data matrix (EPA and Public versions). The data matrix was 

updated to reflect the MRlD numbers identified in EPA's reviews and to remove any of the MRlD 

numbers related to support of an experimental use permit (Merial Limited). The latter revision was at 

the request of EPA. 

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

Sincerely, 

Kelly 

Jt4~/1- Hoskins 

Manager of Technical Affairs 

Sergeant's Pet Care Products, Inc. 

Enclosures 

cc: Richard Gebken, EPA 

45
Form App,o .. d OMB No. 2U70..(lO~U 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

" ,"!C!"! 401 M Street, S.W. ~""'. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of l1formalion is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for 

ren:gistration and special review activities, including time for reading the instruction and completing the necessary forms. Send comments regarding thc burden estimate or any other aspect of this collection 

of infonuation, including suggestions for reducing the burden 10 Director. OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 40 I M Street, S.W., Washington, DC 

20460. Do not send the form to this address. 

DATA MATRIX 

Dale: October 20, 2010 EPA Reg No.lFile Symbol 2517-RGU Page Iof9 

Applicant'slRegistrant's Name & Address Product: Sergcant's Fipronil + Methoprene 

SCf£eant'S Pet Carc Products, Inc. 2625 South 158th Plaza, Suile 100, Omaha, NE 68130-1703 Squeeze-On for Dogs 

Ingredients: Fipronil, Methoprcnc 

Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note 

830.1550,830.1600,830.1620, Product Propcrties Data for Sergcant's FiproniJ + Methoprene 48059101 Sergeant's Pet Care Products, OWN 

830.1650, 830. 1670, 830. I 700. Squeeze-On tor Dogs Inc. I 

830.1750 I 

830.1800 Enforcement analytical method 48122601 Sergeant's Pct Care Products, OWN 

'[---1 Inc. 

830.6302,830.6303,830.6304, Product chcmistry of Sergcant's FiproniJ + Melhoprene 48059102 Sergeant's Pet Carc Products, OWN 

830.7300, 830.7000, 830.6315, Squeeze-On for Dogs Inc, I . 830.7100,830.6320,830.6317 _ J 

830.6317,830.6320 Storage stability alld corrosion characterislics To be submittcd Sergeant's Pet Carc Products, OWN , 

, UDOn complelion Inc. 

870.1100 Acute oral toxicity 44942004 MERIAL LIMITED PAY 

870.1200 Acute dcnnal toxicity 44942005 MERIAL LIMITED PAY 

870.1400 Primary eyc irritation 44942006 MERIAL LIMITED PAY 

870.1500 Primary dennaJ irritation 44942007 Iv1ERIAL LIMITED PAY 

870.1600 Dermal scnsitization 44942008 MERIAL LIMITED PAY 

Evalualion of the Dog Squecze On 0.67ml White Applicalor with 48059803 Sergeanl's Pct Care Products, OWN 

Orange Label Indicator (3x), scissors to open - F=l as a Poison Inc. 

Prevenlion Package for Sergeant's Pet Care Producls, Inc. 

Evaluation of tile Dog Squeeze On 1.34ml White Applicator with 48059804 Sergcallt's Pet Care Products, OWN 

Green Label Indicator (3x), scissors to open - F=I as a Poison Inc. 

Prevention Package for Sergeant's Pel Care Products, Inc. 

Evaluation of the Dog Squeeze On 2.68ml White Applicator with 48059805 Scrgcant's Pet Care Products, OWN 

Red Label Indicator (3x), scissors to open - F=l as a Poison Inc. 

Prev;;ntion Paekal!C for Sergealit's Pet Care Products, Inc. 

Signature: ihjl/.' fiLpI;m Name and Title Date 

Kclly R. Hoskins, Mana.ger ofTeclmicaJ Affairs 1012012010 

EPA Form 8571)..35 (9.971 EI«"oo,rA'nd P"OJ VcrsiOll' A .... h~ Subm" onl. P,.er .e!Sioo A~.",y 1""",.1 U .. COpy 

," \ ,d 

tJC-' 

Cf"f 

46
Fn .. App.-.,-.d OMB No. 26'16·0\'160 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

~~ .},.,," 401 M Street, S.W • 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection ofmfOimation is estimated to average 0.25 hours pcr response for registration activities aud 0.25 hours per response for 

reregistration and special review activities, including time fur reading the instruction and completi11g the necessary fonns. Send comments regarding the burden estimate or any other lISped ofthis collection 

of information, including suggestions for reducing the burden to Director: QPPE Information MiIIlagement Division (2137) U.S. Ellvironmcntal Protection Agency, 401 M Street, S. W., Wasllinglon, DC 

20460. Do nOl send the form to this address. 

DATA MATRIX 

Date: October 20, 2010 EPA Re No.lFileS mbol 2517-RGU Pa e20f9 

Applicant'slRegistrant's Name & Addrcss Product: Sergeant's Fipronil + Methoprene 

Ser,geant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs 

Ingredients: Pi ronil, Metho rene 

Guideline Reference Number Guideline Study Name MRlD Number Submitter Status I },;{,t .... 

Evaluation ofthe Dog Squeeze On 4.02ml White Applicator with 48059806 Sergeant's Pet Care Products, OWN 

Blue Label Indicator (3x), scissors to open - F=I as a Poison Inc. : 

Prevention Package for Sergeant's Pet Care Producl~, Inc. I 

870.7200 Powell, 1.; Pafictt, R. (1995) Domestic Animal Safety Study 43863802 MERIAL LIMITED PAY i I 

by Topical Administration to Dogs: Pipronil Spot Treal.ment (RM 

160IE): Lab Project Number: MRX 23/950406. Unpublished 

study prepared by HUlltingdon Research Centre, Ltd. 219 p. 

870.7200 Canovas, M.; Villageliu, 1.; Lopez, S.; et ai. (1994) 43577715 MERlAL LIMITED OLD I 

Percutaneous Absorption and Hair, Skin, and Fat Distribution of 

Radioactivity After Spot-On Application of (Carbon 14)-RMI601 

I in Beagle Dogs: Lab Project Numbers: CD-93!3405F: Q-42.769. 

Unpublished study prepared by Centro de Investigacion y 

Desarrollo ApJicado, S.A.L. 68 o. I 

870.7200 Nolan-Smith, S. (1999) Fipronill{S)~Methoprene Topical Solulion: 44942104 MERIAL LIMITED PAY 

Target Species Safety Study in the Dog: Intcrim Report: Lab 

Project Number: 168612: 168612-01142: PR&D 0002101. 

Unpublished study prepared bv Covance Laboratoties Ltd. 266 v. 

870.7200 Nolan~Smith, S. (1999) FiproniU(S)-Methoprene T{lpical Solution: 45143901 MERIAL LIMITED PAY 

Targct Specics Safety Study in the Dog: Report Amendment: 

Amendment to Interim Repurt: Lab Project Numbcr: 1686/2: 

168612~DI 142. Unpublished study prepared by Covanre Labs., 

Ltd. 6 o. 

870.7200 Nolan-Smith, S. (2001) To Investigate the Safety of a Topical 45612702 MERlAL LIMITED PAY 

Formulation Containing ML-2,095,988 509T in Dogs Wcighing 

Approximately 2kg (+!-1.5kg) at One, Three and Five Times the 

Maximum Label Recommcndcd Dosage: Final Report: Lab 

Project Number: 1686112: 1686112-D2160: PR&D 0045801. 

Unpu}llished study prepared by Covance Labomtories. 324 p. 

Signature: Z-JlJ. r/£'Az·h EPA f""" S510·J5 (9.9'1) EIO<.1r""r J ""~<t ",,,,,,,,,Av.il'f' ~i'''" y Pap.,-ver.ion. 

Name and Titlc 

KcIl R. Hoskins, Manae:er of Technical Affairs 

Ag<H<j' lnlorn.l U .. Cupy 

Date 

10/20/2010 ~)­

s-;Jf' 

47
Fo,m APl,r<wod OMB No. 2070-11060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401 M Street, S.W . 

• WASHINGTON, D.C. 20460 

PapelWork Rcdnction Act Notice: The public reporting burden for this COlleelion ofinfonnation is eSlimmed to average 0.25 hours per response for registration activities and 0.25 hours per response for 

reregistration and special review activities, including time for reading the in3eregistra!ioncompleting the necessary fonus. Send comments regarding the burden estimate or any other aspeet of this collection 

ofinformation, including suggestions for reducing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 

20460. Do not send the fom to this address. 

DATA MATRIX 

Date: October 20, 20 I 0 EPA Reg No./File Symbol 2517-RGU Page 3 of9 

Applicant'slRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs 

Ingredients: Fipronil, Methoprene 

Guideline Refereuee Number Guideline Stud' Name MRlD Number Submitter Status Note 

870.7200 Godin, c.; Alva, R. (2000) ML-2,095,988 45620507 MERlAL LIMITED PAY 

509T /DoglSolutionff opicallSafetyff olerancelReproduetion, 

Reactions: Final Report: Lab Project Number: PR&D 0020201: 

WEL 99885: PR&D 00202. Unpublished study prepared by 

White Eagle Toxicology Laboratory. 123 p. 

810.3300 McCall, J. (1999) Dose Titration Study of (S)-Methoprene by 44942105 MERIAL LIMITED PAY 

Topical Administration to Dogs: Final Report: Lab Project 

Number: PR&D 0009901. Unpublished study prepared by TRS 

Labs, Inc. 51 o. 

810.3300 Young, D. (1999) Dose Confinnation Study of Topically 44942106 MERlAL LIMITED PAY 

Administered Fipronil/(S)-Methoprcne Against Adult 

Ctenocephalides felis(Cat Fleas) iu Dogs: Final Report: Lab 

Project Number: PR&D 0013501. Unpublished study prepared by 

Young Veterinary Research Services. 59 D. 

810.3300 McCall, J.; Alva, R.; Irwin, J.; ct al. (2002) A Study to 45866902 MERIAL LIMITED PAY 

Evaluate the Efficacy of Frontline Plus for Control of 

Mosquitoes, Aedes aegypti, on Dogs: Final Report: Lab Project 

Number: PR&D 0055201. Unpublished study prepared by TRS 

Labs, Inc. 24 p. 

Signature: Il/L /~fh Name and Title Date , 

Kelly R. Hoskins, Manager of Technical Affairs 10/20/2010 ,o1 EPA F¢nn ~~7o.J5 ( .97) Eloclmnil'"" d Paper eniOll' Avail'lljl ,il\Jb .. " ¢"Iy r,pe' """i¢" A~.n<y In",,,.1 U •• C¢py '" liL U 

48
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W. 

C WASHINGTON, D.C. 20460 

For", App,."d OIllB i'le.1070·llQiO 

Paperwork ReductiOll Act Notice: The public reporting burtlen fOf this collection of infonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for 

reregistration and special review activilies, including time for reading the in4crcgislralioncompleling the necessary fonus. Send comments regarding the burden estimate or any oIlier aspect oflhis collection 

of infonnation, including suggestions for reducing the burden to Direclor: OPPE InformatiOll Management Division (2137) U.S. Environmental Protection Agency, 40[ M Street, S.W., Washington, DC 

20460. Do nO! send tile form to this address. 

DATA MATRIX 

Date: October 20, 2010 EPA Re No.lFile Symbol 2517-RGU Pa e 4 of9 

Applieant'sJRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 SQuecze-On for Dogs 

Ingredients: Fipronil Methoprcne 

Guidelinc Refercnee Number Guideline Study Name MRID Number Submitter Status Notc 

810.3300 Pcngo, G.; Pollmeier, M.; Barrick, R. (2000) An Efficacy Study of 45620501 MERIAL LIMITED PAY 

Frontline Spray, Frontline Top Spot, and ML-2,095,988 509T, for 

the Treatment and Control of Trichodectes canis in the Dog: Final 

Report: Lab Projcct Number: PR&D 0022101, PR&D 00221. 

Unpublished study prcpared by Centro Vcterinario Oriolo. 24 p. 

810.3300 Alva, R.; Barrick, R. (1999) A Study to Detcrminc the Effect of 45620502 MERIAL LIMITED PAY 

Treatment with Frontline Top Spot on the Prevalence and Scverity 

of Flea Allcrgy Dermatitis in Dogs: Final Rcport: Lab Project 

Number: PR & D 0010201: PR & D 0010202: PR&D 00102. 

Unpublished study prepared by VCA S1. Petcrsburg Animal 

Hospital. 45 o. 

810.3300 Postal, J.; Lc Nain, S. (1998) Evaluation of the Efficacy of 45620503 MERIAL LIMITED PAY 

RM:J 601 C/35, in the Treatment of Flea-Allergy Dermatitis in the 

Dog, Compared with a Referenec Product: Final Report: Lab 

Project Number: ASR 19083: CLl276. Unpublished study 

prepared by MeriaL 92 p. 

810.3300 Marchiondo, A. (2001) PR & D 0024101: Frontline 45620504 MERIAL LIMITED FAY 

SprayfFrontline Spot-OnlML-2, 095, 988 509TlDogs 

ISolution/Topical: Final Report: Lab Projcet Number: PR&D 

0024101: PR&D 00241. Unpublished study prepared by 

Stillmeadow, Inc. 29 D. 

810.3300 Gaxiola, S.; Alva, R.; Irwin, 1. (2001) PR& D 0052301: 45620505 MERIAL LlMrrED PAY 

Frontline Spray/Frontline Spot-OnIML-2, 095, 988 

509TlDogs/Solution/Topieal: Final Report: Lab Project Number: 

PR&D 0052301, PR&D 00523. Unpublished study prcpared by 

UniVersity of Sinaloa. 40 p. 

810.3300 Pengo, G.; Pollmeicr, M. (2000) Frontline Spray & Top Spot! 45620506 MERIAL LIMITED PAY 

DogsiSolutionfropical CliniallDose Confirmation/ Ectoparasitcs, 

Mites, Sarcoptes Scabiei var canis: Final Report: Lab Project 

Number: PR&D 00I2901: PR&D 00129. Unpublishcd study 

prcpar,cd by Cenjro Vctcrinario Oriolo. 23 p. 

Signaturc: // /111 // 1/" L...i Name and Titlc Datc A/ f jl. L.Jmj{ _ IJf Kclly R. Hoskins, Manager ofTcchnieal Affairs 10/20/2010 

EPA Form 8'7(I.)S t9 7) Ele<ttooi< P'l"'rV."ioo. Av,"lf~"'S"bmit ooly P,pcrvof5lon A&<ncy l"tem.l Use Copy ~s '51')!l1'-ct 

49
Form Appro,'ed OMP No. 2070·0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

:,:~:::L " 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: TIle public reporting burden for this collection of infonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for 

reregistration and speeial review activities, including time for reading the instruction!.lI1d completing the necessary fonns. Send comments regarding the burden estimate or any other aspect ofthi; collection 

of infonnation, including suggestions for reducing the burden to Dircctor: OPPE !nfonnation Mallagement Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 

20460, Do not semi the fonn to this address. 

DATA MATRIX 

Date: October 20, 2010 EPA Reg No.lFile Symbol 2517-RGU Page 5 of9 

Applicant'sfRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Care Products, Inc. 2625 South I 58th Plaza, Suite 100, Omaha, NE 68130- 1703 Squeeze-On for Dogs 

Ingredients: Fipronil, Methoprene 

Guideline Reference Number Guideline Study Name MRlD Number Submitter Status Note 

870.3300 McCall, J.; McTier, T. (1995) Positive Referenced and Untreated 43577712 MERIAL LIMITED OLD 

Controlled, Confirmatory Laboratory Trial ofRMI60lE SPOTON Fonnulation Applied to Dogs as 3 Weight Class Defined 

Volumes for the Control of the Cat Flea Ctenocephalides felis, the 

Brown Dog Tick Rhipicephalus sanguineus, and the American 

Dog Tick Dermacentor variabilis: Lab Project Numbers: RMIFLSTKS!94!2L: IU\11 VSR-249LT: PT-249LT. Unpublishcd study 

prepared by TRS Labs, Inc. 41 P. 

870.7200 Astruc, B.; Suberville, S.; Bosc, F. et al. (1998) Evaluation ofthc 44487701 MERIAL LIMITED PAY 

Presencc ofM&B 46513 on the Hair After a Topical 

Application (Spot-on or Spray) ofFipronil to the Dog: Final 

Report: Lab Project Number: MET419: R002459. Unpublished 

study prepared by Meria!' 28 p. 

810.3300 Everett, R.; Cunningham, J. (1993) An htvestigation Study to 43121118 MERIAL LIMITED OLD 

Evaluate the Ellect of Bathing ofLaboratOlY Dogs on the 

Efficacy ofRM:I601 Spray: Revised: Lab Project Number: RMD 

592: P/220LT. Unpublished study prepared by Agresearch 

Consultants, Inc. 43 p. 

810.3300 CrutherS, L. (1993) Efficacy ofRMI60lC at 3 mllkg and 6 mllkg 43121 !22 MERIAL LIMITED OLD 

Against Ixodes scapularis/dammini Nymphs, Dermaccntor 

variabilis Nymphs, Amblyomma americanum Nymphs, 

Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides 

Adults Using Treated Dog Hair as the Tel>1ing Substrate: Revised: 

Lab Project Number: 9320: P!225LT. Unpublished study 

I prepared by Professional Lab and Research Services, Inc. 28 o. 

Signature: £/LI.I,,[11 Name and Title Date 

KeJJy R. l'loskins, Manager of Technical AlTairs 1012012010 

EPA Fonn 857()'151?971 .... • •• n" I>.n •• \I •• ~ 'v",""" '"h~" M'" n._,.~~:"" A.,ncv 1""."eI U,. Cony . , <>f J-<~ 

Y\ 

50
"o,m App,oved 01'>111 No. 2070·00.0 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401 M Street, S.W. 

0 WASHINGTON, D.C. 20460 

Papcnvork Reduction Aet Notice: The public reporting burden for this collectiou ofinfonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for 

reregistration and spccial review activities, induding timc for reading the in6eregistrationcompletingthe necessary fonns. Send comments regarding the burden estimate or any other aspect of this collectiou 

ofinfonnation, including suggestions for reducillg thc burden to Director: QPPE Infomlation Management Division (2137) U.S. Environmental Protection Agency, 40 I M Street, S.w., Washington, DC 

20460. Do not send the Ibnn to this address. 

DATA MATRIX 

Date: October 20, 2010 EPA Re No.lFileS mbol 2517-RGU Pa e60f9 

ApplicanCslRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Care Products, Inc. 2625 Soutll I 58th Plaza, Suite 100, Omaha, NE 68130·1703 Squeeze-On for Dogs 

In redients: Fi ronil, Metho rene 

Guidel ine Reference Number Guideline Stud Name MRIDNumber Submitter Status Note 

810.3300 Pengo, G.; Poll meier, M. (2002) Study to Confinn the Efficacy of 45628201 MERIAL LIMITED PAY 

FiproniJ Against Lice in Dogs Under Field Conditions: Final 

Report: Lab Project Number: PR&D 0037401. Unpublished 

study prepared b Centro Veterinario Oriolo. 21 o. 

133-3 Meo, N.; Gonzalez, C.; Mester, T. (1997) Dermal and Inhalation 44433302 MERIAL LIMITED PAY 

Exposure of Commercial Pet Groomers During Application of 

Frontline Spray Treatment: Final Report: Lab Project Number: 

MERIAL-445-SAFXT046: SAfX046: PDA9705. Unpublished 

study prepared by ABC Labs., California and Aanimal Appeal 

Grooming Shop & Case Veterinary Hospital. 1066 P. 

133-3 Meo, N.; GOllZalez, c.; Bclcher, T. (1997) Dennal Exposure of 44433303 MERIAL LIMITED PAY 

Commercial Pet Groomers During Application of Frontline Top 

Spot: Final Report: Lab Project Number: MERIAL-445-

SAFXT047: SAFXT047: EC_97_390. Unpublished study 

prepared by ABC Labs., California and Aanimal Appeal 

Groomin):!, ShQl) & Case Veterinary Hospital. 925 p. 

132-1 Hughes, D. (1997) Dislodgeable Residues ofFiproniJ Following 44433305 MERlAL LIMITED PAY 

Application ofFrolltJine Top Spot to Dogs: Final Report: Lab 

Project Number: COV ANCE 6848-10 1: MERlAL METXT 166: 

METXT 166. Unpublished study prepared by Covance Labs. Inc. 

161 p. /' 

Signature: L,R /kf/J Name alld Title Date 

KeJJy R. Hoskins, Manager of Technical Affairs 1012012010 " •• ~"._ .,,"" <G 0' ~_ A "_" ... _ ,,_,:~, ••• " ~"'~-;, "", .... ~ .. ~~;~" A~.n." In ...... ' lI .. Cnn" 

, .£ ~~d& 

51
Form App", .. d 01\113 No. 2070·0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W. 

" WASHINGTON, D.C. 20460 

Papenvork Reduction Act Nonce: The public reporting burden for this collection of information is estimated 10 averagc 0.25 hours per response for registration activities and 0.25 hours pcr response for 

reregistration and special review activities, including time for reading the in7eregistrationcompleting the nccessary forms. Send comments regarding thc burden estimate or any othcr aspeclOfthis collection 

of information, including suggestions for reducing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protectioll Agency, 40t M Street, S.W., Washington, DC 

20460. Do not selJd the form to this address. 

DATAMATRlX 

Date: October 20, 20 I 0 

Applicant'sIRegistrant's Name & Address 

Sergeant's Pet Care Product~ htc. 2625 Soutb 158th Plaza, Suite 100, Omaha, NE 68130-1703 

Ingredients: FiproniJ, Methoprcne 

Guideline Reference Number Guideline Stud Name 

132-1 H\lghcs, D. (1997) Dislodgeable Residues ofFipronil Following 

Application ofFronUine Spray Treatment to Dogs: Final Report: 

Lab Project Number: COVANCE 6848-100: 6848-100: 

MERlAL-445-METXT-165. Unpublished study prepared by 

Covance Labs. Inc. 184 p. 

132-1 ! de Fontenay, G.; Campagna, J.; Suberville, S. et al. (1997) 

Dislodgeable Residues ofFipronil Following a Topical 

Application of Frontline Spot-On Treatment to Dogs: Final 

Report: Lab Project Number: 817/0248: MET41 6: 

MERIAL-480-MET-416. Unpublished study prepared by Merial 

Ltd. and Cbrysa,lis Preclinical Services-Eu~?pe. ~ 

132-1 ! de Fontenay, G.; Campagna, J.; Suberville, S. et a!. (1997) 

Dislodgeable Residues of Fipronil Following a Topical 

ApplicationofFrontJine Spray Treatment to Dogs: Final Study: 

Lab Project Number: 817/024A: MET414: MERlAL-480-MET414. Unpublished study prepared by Merial Ltd. and Chrysalis 

Preclinical Services-Europe. 70...£:.. 

NlA Irwin, 1. (1997) Use Survey of Commercial and Vetcrinary Pct 

Groomers and Pet Owners of Frontline Top Spot and Frontlinc 

Spray Treatment: Lab Project Number: MERlAL-445-SURVEY. 

Unpublished study prepared by Wiese Research Associatcs, Inc. 

340 p. 

Hughes, D. (1997) Validation of an Analytical Method for the 

Determination ofFiproniJ, M&B45950, and M&B46513 in DyeFree 100% Cotton Gloves: Final Report Lab Project Numbcr: 

COVANCE 6848-104: 6848·104: MERlAL METXT 169. 

Unpublished stuqyprepared by <::;o'lance Labs. Ine. 41 p. 

Polakoff, B.; Youngren, S. (1997) N on-Dictary Risk Assessment 

Fipronil Use on Pets in a Residential Setting: Lab Project 

Number: FIPRONIL 97-09: MERtAL-445-NDRA. Unpublished 

EPA Reg No'/Fil.e:Symbol 2517·RGU 

Product: Scrgeant's FiproniJ + Methoprene 

Squeeze-On fl?~ Dogs 

MRlDNumber 

44433306 

44531203 

44531204 

44433301 

44433308 

44433309 

Submitter 

MERIAL LIMITED 

MERlAL LIMITED 

MERlAL LIMITED 

MERlAL LIMITED 

MERIAL LIMITED 

MERIAL LIMITED 

Status 

PAY 

PAY 

PAY 

PAY 

PAY 

PAY 

Page 7 of9 

Note 

stud re ed b Novi en Sciences, Inc. 27 r 

Signature: Name and Title Date . ~ 

KeJJ R. Hoskius, Mana crofTechnical Affairs 101201201O~J.;; Agonor rn1«n.1 u .. C~py 

'-:Y'\ 

52
Foem Approv<d OMB N&. 2070-\la60 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W. 

o WASHINGTON, D.C. 20460 

Paperwork Redllction Act Notice: The public reporting bmden for this collection ofinfonnation is estimated 10 average 0.25 hours per response for registration lICtivities alld 0.25 hours per response for 

reregistration and special review activities, inclllding time for reading the in8crcgistfationcolllplctingthe necessary fomts. Send comments regarding the bllrden estimate or any other aspect oftJlis 

collection ofinfonnation, including sllgge~tions for rcdocillg the burden 10 Director: OPPE lnfonnaliOil Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., 

Washington, OC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: October 20, 20 I 0 

Applicant'sfRegislranl's Name & Address 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 

Ingredients: Fipronil, Methoprene 

Guidclillc Reference Number I Guideline Study Name 

Polakoff; 8.; Youngren, S. (1997) Pet Groomer Exposurc 

Analysis and Risk Assessment: Frontline Top Spot and Frontlinc 

Spray Treatment: Lab Project Number: FIPRONIL 97-11: 

MERIAL-445-PGRA. Unpublished study prepared by Novigen 

Sciences, hlc. 17 p. 

Polakoff, B.; Youngren, S.; Walls, C. (1998) Frontline 

Top-Spot and Frontline Spmy Treatmcnt: Defillitive Short-Term 

and Intennediate-Tenn Residential Non-Dietary Risk 

assessment: Lab Project Number: FlPRONIL 98-04: MERIAL445-NDRA. Unpublished study prepared by Novigen Sciences, 

Inc. 3~ 

Polakoff, 8.; Youngren, S.; Walls, C. (1998) Frontline Top 

Spot and Frontlinc Spray Treatment: Definitive Pet Groomer 

Exposure Analysis and Risk Assessmcnt: Lab Project Number: 

FIPRONIL 98-07·. MERIAL-445-LPERA. Unpubli&1ed &udy 

prepared by Novigen Sciences, Inc. 21 p. 

Polakoff, B.; Youngren, S. (1998) Frontline on Pets ill a 

Resident ial Setting: Risk Assessment of a Low Probability Event 

Post-Application Acute Exposure: Lab Project Number: 

EPA Reg No.lFile Symbol 2517-RGU 

Product: Sergeant's Fipronil + Methoprene 

Squeeze-On for Dogs 

MRIDNumber 

44433310 

44531206 

44531207 

44531208 

Submitter 

MERIAL LIMITED 

MERlAL LIMITED 

MERIAL LIMITED 

MERIAL LIMITED 

Status 

PAY 

PAY 

PAY 

PAY 

PaRe 8 of9 

Note 

, Signature: 

FIPRONIL 98-06: MERIAL-445-PGRA. Unpublished study 

prepared b,· Novigen Sciences, Inc. 18p. 

JI,,/L,{J,Lb EPA Fo,m 8S7oJ.J) t9-97) Eleclro""at"il P.~VeI'ioru Avail.blr¥m'lt'Only Paper "'''00 

Name and Title 

Kelly R. Hoskins, Manager ofTcchnical Affairs 

Atoney 1"10"",1 U~Copy 

, \ ~v\Y~ ~\ 

Date 

1012012010 

---

53
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Form A.ppr ... d OMB No. ~O;O·OO60 I 

0 401 M Street; S. W. 

0 WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting hurden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for 

reregistration and special review activities, including time for reading the in9cregislrationcomp!cting the necessary Coons. Scnd comments regarding the burden estimate or any other aspect of til is 

collection ofinformation, including suggestions for redociog the burden to Director: QPPE InformatiOll Management Division (2137) U.S. Environmental Protection Agcm:y, 401 M Street, S.W., 

WashingtOll, DC 20460. Do not send the fonn to this address. 

DATAMATRlX 

Date; October 20, 2010 EPA Rc NoJFile Symbol 2517-RGU Pa e90f9 

Applicant'slRegi~trant's Name & Address Product: Sergeant's Fiproni! + Methoprene 

Se~geant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 ~.queeze-On for D(}gs 

In redients: Fi roni!, Metho rene 

Guideline Refcrcnce Number Guideline Study Name MRlDNumbcr Submitter Status Note 

810.3300 Everett, R.; Cunningham, 1. (1993) A Dose Titration Study to 43121114 MERIAL LIMITED OLD 

Detennine Ihe Optimal Spray Concentration ofRM 1601 for 

Long Tenn Control of the Cat Flea Ctenocephalides fdis and 

the Brown Dog Tick Rhipicephalus sanguineus in the Dog: 

Reviscd: Lab Project Number: RMD 292: P/214LT. 

Unpublished study prepared by A.t!,research Consultants. 53 p. 

810.3300 Cruthers, L. (1993) Product Perfonnance: A Dose Confinnation 43121115 MERlAL LIMITED OLD 

Study to Verify the Optimal Spray Concentration of RM 1601 

rm Long Residual Control of the Cat Fica (Ctenocephalides 

felis) and the Brown Dog Tick (Rhipicephalus sanguineus) in 

thc Dog: Revised: Lab Project Number: 9251: P/215LT. 

Unpublished study prepared by Professional Labs and Research 

Services, Inc. 51 p. 

810.3300 Everett, R.; Cunningham, 1. (1993) A Comparative Evaluation 43121116 MERIAL LIMITED OLD 

of Two Treatmcnt Regimes Using RM 1601 Spray for 

Control of the Cal Flea Ctenocephalides felis on the Dog: 

Reviscd: Lab Project Number: RMD 692: P/222LT. 

Unpublished study preparcd by Agresearch Consultants, luc. 

4Or· 

810.3300 McCall, J.; McTier, T. (1993) Laboratory Evaluation ofRM 43121117 MERIAL LIMITED OLD 

1601 Spray for Control Dennaeentor variabilis and 

Rhipecephalus sanguineus on the Dog: Lab Project Number: 

RMffKSl93flL: PS/229LT. Unpublished study prepared by 

TRS Labs, Inc. 18p. 

Signature: kA ;I /£/0 Name and Title Date 

Kelly R. Hoskins, Manager ofTcchuical Affairs 1012012010 

EPA. Fmm S57()"1> t9.97) EJ<woo'. '"' ,per Yo,.,io", A.all7'0 /' ~ """Iy Vape' v.,.,;o" A.grn<y IR!<rn.ll1 •• Copy jJb 

"x,!\.LV 

C'lli'l 

54
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Sergeant's Pet Care, Inc. 

cia Mr. James Messina, Exponent, Inc. 

1150 Connecticut Avenue, NW 

Suite 1100 

Washington, D.C. 20036 

OCT 1 3 2010 

OFFICE OF 

CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Follow-up to EPA's Request for Additional Information to Support Pending 

Fipronil-containing Product Applications, EPA File Symbol Nos.: 2517-RGA, 

2517-RGL, 2517-RGT, and 25 I 7-RGU, dated September 10, 2010. 

Mr. Messina: 

This letter is to follow-up on the phone conference with Sergeant's and Ms. Deborah 

Chadbourne, held on September 30, 2010, where the Agency provided additional clarification 

information concerning EPA's request for additional information to demonstrate the acquisition 

of the Fipronil source used to conduct the product studies that accompanied the above-referenced 

applications. The Agency determined that at thi s time, no additional information in response to 

EPA's original request is needed prior to the Agency's completion of the review of the abovereferenced applications. Furthermore, no additional response to this request is needed at this 

time. However, please note that if the Agency determines that this information is still needed, 

that this may be added as a condition of registration. If you have any questions regarding this 

action, you 'may contact Rosanna Louie-Juzwiak at !ouh':iuz\\ iJk,ro~:Jnnll ('I epa,!2()~, 

Regards, 

&~_~ c.LLRichard Gebken, Product Manager 10 

Insecticides Branch 

Office of Pesticide Programs (7504P) 

55
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

September 10, 2010 

OFFICE OF 

CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

CERTIFIED MAIL: Article Number 7006 2150 0002 6305 7545 

Sergeant's Pet Care Products, Inc. 

clo Mr. Kelly Hoskins 

2625 South 1581h Plaza 

Omaha, NE 68130-1770 

Subject: 

Mr. Hoskins: 

Request for Additional Infonnation to Support Pending Fipronil-containing 

Product Applications 

EPA File Symbol Nos.: 

2517-RGA, Sergeant's Fipronil Squeeze-on [or Dogs 

2517-RGL, Sergeant's Fipronil + S-methoprene Spot-on for Cats 

2517-RGT. Sergeant's Fipronil Spot-on for Cats 

2517-RGU. Sergeant's Fipronil + S-methoprene Squeeze-on for Dogs 

The Agency is in process of reviewing the above-referenced applications for the proposed 

fipronil-containing spot-on products for use on pets. In order to proceed with these applications, 

additional infonnation needed regarding your listed sources of the two fipronil technical products 

identified in the Fonnulator's Exemption Statement dated December 21, 2009: 

Within fifteen (15) days Jrom the date of this letter ((iRbr¢t a copy of the bill of sale 

showing the purchase of the fipronil technical product(s) used---to conduct the submitted studies 

(e.g. product chemistry, acute toxicity, and companion animal safety studies to support the 

above-referenced proposed products). Your response must identify the fipronil technical product 

used for each study submitted to the Agency. Please supply the following infonnation: 

1. The EPA registration number and establishment number of the technical product from 

which the proposed product is derived, 

2. The name and address of the entity from which the manufacturing product was 

obtained,and 

3. A copy of the Bill of Sale for the purchase of the source technical product used in the 

testing. 

56
If the Agency does not receive the requested documentation by September 28, 2010, the 

Agency may not be able to grant registrations fur these products by the current PRIA date of 

November 4,2010. 

If you have any questions concerning this matter, you may contact Rosanna LouieJuzwiak at (703) 308-0037, or email her at Louie-Juzwiak.Rosanna@epa.Qov. 

Sincerely, 

;(?J,ccd C.~L 

Ri chard Gebken 

Product Manager 10, Insecticides Branch 

Registration Division 

SENDER: COMPLETE THIS SECTION COMPLET~ THIS SECTION ON O£UVERY 

• ~omplete items 1, 2, and 3. Also complete 

item 4 if Restricted Delivery Is desired 

• Print your name and address on the ~verse so that we can return the card to you. 

• Attach this card to the back of the maiJpiece 

or on the front if space permits. ' 

1. Article Addressed to: 

~N'\S 1'f;:f ('In'tE,: 9Q.c\)\J..c, , , 

C/o \,AR. \(.(;LLI.( !-\05'i-INS 

24 L IS 3Cv .. :rH [58\}! PLA 2j"\ 

pAgent 

o Addressee 

D. Is delivery address_dIfferqni frofrr.iteTn 11 0 Yes 

If YES, enter delivery addr&sn-beJ;o%' _, 0 No 

_ c--'- -J) , 

- -.! 

3. Service Type """'," 

,..tr Certified Mail 0 ~ Mail 

o Registered 0 Return ReceIpt for Merchandise 

o Insured Mall 0 C.O.D. -

4. Restricted Delivery? fExtm Fee) ,0 'res 

2. Article Number 

(fransfer from service fabal) 7006 2150 0002 6305 7545 

! PS Form 3811, February 2004 

! 

Demestic RetUrn Receipt 

57
DATA PACKAGE BEAN SHEET 

Date: 11-May-2010 

Page 1 of 1 

'* * * Registration Information * * '* 

Decision #: 425453 

DP #: (377600) 

PRIA 

Parent DP #: 

Submission #: 873354 

Registration: 2517-RGU - SERGEANT'S FIPRONIL + S,METHOPRENE SQUEEZE-ON I 

Company: 2517 - SERGEANT'S PET CARE PRODUCTS, crN~Cc' ___ _ 

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

Risk Manager Reviewer: Bonaventure Akinlosotu BAKrNLO~S~ ____________ _ 

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

Type of Registration: Product Registration - Section 3 

Adion Desc: (R310) NEW PRODUCT;NDN-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl 

Ingredients: 105402, S-Methoprene(B,8%j 

129121, Fipronil(9.8%) 

'* * * Data Package Information * * * 

Expedite: 0 Yes • No Dale Sent: 11-May-2010 

DP Ingredient: 105402, S-Methoprene 

129121, Fipronj_. ____ _ 

DP Title: E~ffi~'~oa~'~y _____ _ 

CSF Included: • Yes 0 No Label Included: • Yes 0 No Parent DP #: 

Assigned To Date In Date Out 

Due Back: 

Organization: cR~D~/~rB~ _____ _ Last Possible Science Due Date: 05-Dct-2010 

Team Name: Efficacy (18) 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 fipronlV3-methoprene EP, presumably me-too of Menal's Frontline 65331-5 

Thx, baa 

58
Efficacy Review 

Date: October 27, 2010 

Efficacy Reviewer: Clayton Myers, Ph.D., Entomolo 

mvers.claytonUD,epa.gov 

703-347-8874 

Risk Manager Rev.: Rosanna Louie 

Products: 

EPA Reg. #: 

A.I.'s: 

Decision #s: 

DP#s: 

Submissions: 

MRIDs: 

Sergeants Fipronil + S-Methoprene Squeeze-On for Dogs 

2517-RGU 

Fipronil, S-methoprene 

425453 

377600 

R310, New Products, RD Science Review 

Cited: 43121116, 43121117, 43121122, 44942105, 44942106,45620501, 

45620502,45620503,45620504,45620505,45620506,45628201, 

45866902 

Overall Review of Label Claims and Directions: 

Based upon the cited efficacy data for fipronil, claims are supported on dogs for fleas, flea larvae 

and eggs, breaking of the flea life cycle, ticks, sarcoptic mange, mosquitoes, and chewing lice. 

Waterproof claims, or statements indicating that the product will work after bathing the animal 

are not acceptable, as no data was submitted to support the efficacy of the product after wetting 

or bathing the animal. These claims must be removed from the label as listed below: 

Line by Line Review of Unacceptable Efficacy Claims: 

The following claims must be deleted from the label: 

[Dogs can be bathed 24 hours after treatmeR't] 

[Dogs can be bathed 24 hours after Spot on is applied] 

[\Vaterprool] 

59
DATA PACKAGE BEAN SHEET 

Date: 22~Jun~2010 

Page 1 of 1 

* * * Registration Information * * * 

Decision #: 425453 

DP #: (379384) 

PRIA 

Parent DP #: 

Submission #: 873354 

Registration: 2517-RGU - SERGEANT'S FIPRONIL + S~METHOPRENE SQUf;EZE~ON pO ~ 

Company: 2517 - SERGEANTS PET CARE PRODUCTS~,~IN~C~_~ _______ _ 

Risk Manager; RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 S.::723~ _____ _ 

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS 

Sent Date: ___ _ Calculated Due Date: 04-Nov-2010 Edited Due Date: ____ _ 

Type of Registration: !:.roduct Reg~1ra1ion - Sec1ion 3 

Action Desc: (R310) NEW PRODUCT;NS'.N-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl 

Ingredients: 105402, S-Methoprene(S.S%) 

129121. Fipronil(9.S%) 

* * * Data Package Information * * * 

Expedite: 0 Yes" No Date Sent 22-Jun-2010 Due Back: 

DP Ingredient 105402, S-Me1hoprene ----------

.129121, Fip!~_~~ __ _ -------------------------

DP Title: CRP 

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

Assigned To Date In Da1e Ou1 

-~ Lu.lio Organization: RD -1)zi/I_t7- last Possible Science Due Date: 05-0ct-20 to I TRB 

Team Name: Child Resistant Packagi!1L ____ _ 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 * * * IFor your review: Application for a fipronill3-methoprene EP, presumably me-too of Merial's 65331-5 ~. V'/}t~ 

Thx, baa 

60
l'N1TED STATES ENVIRONMEt'iT-\L PROTECTIOi"" A-GE\iCY 

\VASHlNGTO!\, D.C 2H-!(,U 

NOTE TO RM 10 Bonaventure Akinlosotu 

'HFlCIi U]' Cllf\JK.\.L S UTfl 

,,,u POll i :Tlo,," I-REVr\TlO, 

September 28,2010 

SUBJECT: Documents To Use With Data for Child-Resistant Packaging EPA FILE NO: 

2517-RGT, 2517-RGA, 2517-RGL, & 2517-RGU, DP 377739, 377717, 

379385, & 379384 Decision # 425437, 425455, 425454, & 425453 

Please note that for EPA FILE NO: 2517-RGT, 2517-RGA, 2517-RGL, & 2517-

RGU the following documents were used for the CRP review: 

• CSF's used for calculation of the amount of Fipronil per package were dated April 

9, 2010 and MRID 48059501, 48059801,48059401, & 48059101; 

• CRP Certifications dated May 27, 2010; 

• Labels to be used for Final stamping should be dated June 29, 2010 as these are 

the labels with the acceptable language regarding the opening of the CRP. [If you 

need copies of these labels I can email them to you.] 

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

contact me at (703)-308-7368. 

Rosalind L. Gross 

61
tiNnED STATES ENVIRONMENTAL PROTECTION -\GENCY 

WASHINGTON, D.C. 2U,.f(,ij 

NOTE TO RM 10 Richard Gebken 

'ilT1Cl' OF\:m:~'lW'\l,,\/\l'Fl\ 

\,1) 1'01 ,1J-TjU'>: rl{UT\'IIO:;-

September 28, 2010 

SUBJECT: Resubmission of Data for Child-Resistant Packaging EPA FILE NO: 

2517-RGT and 2517-RGL, DP 377739 and 379385 Decision # 425437 and 

425454 

Please note that for EPA FILE NO: 2517-RGT and 2517-RGL the Senior Adult 

Use Effectiveness (SAUE) data are unacceptable. The data exceeded the maximum 

percentage of subjects per test site per 16 CFR 1700.20(a)(3)(i). Additionally, the data 

had the maximum number of failures (10 failures) for a pass of the SAUE. The registrant 

will need to submit a revised SAUE study replacing the last nine test subjects from site 

902. The report should indicate: which packages were replaced, why, the age, sex, 

tester, and test site for the replacement subjects. The new report and a new electronic 

CD for the study must meet age distribution criteria, sex distribution criteria, maximum 

percentage of subjects per test site, and maximum percentage of subjects per tester per 

16 CFR 1700.20. Alternatively, a complete new SAUE study may be submitted for review. 

It will require review of the hard copy and electronic version of the data. This new/revised 

study will require the same resource intensive activity of approximately 30 days once the 

reviewer receives the aforementioned submission. Please advise registrant accordingly. 

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

contact me at (703)-308-7368. 

Rosalind L. Gross 

62
Sergeant's Pet Care Products, Inc, 

2625 South 158th Plaza .. Omaha, NE 681311-1770 .. Telephone 402.938.7000 .. Fax 402,938.7091 • w;vw,sergeants.com 

June 30, 2010 

Rosalind Gross 

clo Bonaventure Akinlosotu 

Registration Division 

Office of Pesticide Programs (7504P) 

U.s. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Infonnation 

EPA File Symbols 2517·RGT, 2517-RGA, 2517-RGL & 2517-RGU 

Dear Ms. Gross: 

Sergeant's Pet Care Products, Inc, (EPA Company Number 2517) is submitting additional infonnation 

in response to the Agency's questions regarding Sergeant's Child Resistant Packaging (CRP) studies 

submitted to EPA on April 12,2010 in support of the pending registration applications under EPA File 

Symbols: 2517-RGT, 2517-RGA, 25l7-RGL, and 2517-RGU (all of which contain Fipronil at 9,7-

9.8%). 

Sergeant's generated CRP data on a standard white applicator in sizes 0.5, 0.67,1.34,2.68, and 4.02 

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

CRPdata: 

Use Applicator Base Color Fill Weight Color FiU Weight (mL 

Do. Un to 22 Ib, White Oran2e 0.67 

Dog 23-44 Ib, White Green 134 

00045-88 Ib, White Red 2.68 

Dog 89-1321b, White Blue 4.02 I 

Cats All Weights White Purple 0.50 

The CRP data are required because of the inclusion of the active ingredient fipronil in the pet squeeze~ 

on products. The CRP testing was conducted on a standard package size and color configuration that is 

identical for the fipronil only products and the fipronil + s~methoprene products; therefore, the 

submitted CRP data support all four pending products regardless of the active ingredient content. Based 

on this Sergeant's is relying on MRlD's: 48059503, 48059803, 48059804, 48059805, and 48059806 to 

fulfill the CRP data requirements for the pending registration applications listed above. 

63
Once approved and Sergeant's begins to market the pesticide products (now pending under EPA File 

Symbols: 2517-RGT, 25 I 7-RGA, 2517-RGL, and 2517-RGU), it will utilize the same applicator color 

(white) and fill weight colors per mL fill weight as was used in the submitted and referenced CRP 

testing. Based on available information, the density range of the pending products on which the CRP 

data were generated is the same or similar. Therefore, Sergeant's believes the CRP data can be used to 

support aU four pending registration applications. 

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

Sincerely, /14 /)£i9z- Kelly R. Hoskins 

Manager of Technical Affairs 

cc: Larry Nouvel 

64
Sergealil's Pet Care Products, Inc. 

2625 Soulh 15BlIl Plala Q Onmlm, NE 681311-1770 ~ TelcITllone 402.938.7000 ~ Fox 402.9.')8.7091 0 wI'lw.sergcanls.com 

May 27. 2010 

Richard Gebken, PM 1 0 

Office of Pesticide Programs (7504P) 

C S. Environillental Protec1lon Agcncy 

Document Proces5ing Desk 

Room S-4900, One Potomac Y nrd 

2777 South Crystal Dlive 

Arlington, VA 22202 

Sllbject· Child Resistant Packaging Certification 

Sergeant's Fiprollil + S-methoprcnc Squcc%c-On for Dngs 

EPA File Symbol 15 I 7. R(ll 

D~ar Mr. Gcbkcn: 

I certifY'lhat the packaging used for Ihe following product meets the slandards (If 40 CFR 157.32. 

including tbe revised standnrds in 16 CFR 1700.15(b), \vhen testcd by the revised teslll1g 

procedUl"es in 16 CFR 1700.20, us publisbed in 60 fR 37710 (July 21, 1995): 

.. Sergeant's Fipronil + S~l11elhoprclle Squeezc-Oll for Dogs (EPLI.,. F'lle Symbol 2517-

RGU). 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 15SII, Plna. Omaha. NJ: 

68130-1703. EPA CompallY NUTIlber 2517) IS submilling thIS child resist<lllt packaglllg 

certlrlcatloll to :iUpport Lhe pending product registration for Sergeant's Fipronil + S-\l1cthoprene 

Squ~eze-()n for Dogs O:.PA File Symbol 2517-RGU}. All product labels have language 

specifying the lise of scissors to open the product clllHalner and lubellanguage stating tile 

product is noL to bc ilpplied by children. 

If you have any queslions, please contact me aI402-938-7079. 

Sincerely. 

/// :1 II / / tcJ{!.f / / ~'";1~7f-"-nJJ , Kelly R.&HoskillS 

ManagerofTcdlllical Affairs 

ce' I.arry '\)uuvel 

65
CHILD-RESISTANT PACKAGING REVIEW 

Technical Review Branch 

IN 6/22/~UT 9/28/2010 

. - .x:~ 

RD, TRB, Reviewed by Rosalind L Gross 9128/2010 

EPA Reg. No. or File Symbol 2517-RGU 

DP Barcode DP379384 

Decision # 425453 

EPA Petition or EUP No. ___ _ 

Date Division Received 4/12/2010 

Type Product(s) Insecticide (flea product) 

Data Accession No(s). 48059503.48059803,48059804.48059805,48059806 

Product MgrJChemical Review Mgr/Contact Person RM 10 Bonaventure Akinlosotu 

Division ",R",D,-__ 

Product Name(s) Sergeant's Fipronil + S-Methoprene Squeeze-On for Dogs 

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

Submission Purpose Reviewof CRP studies EPA Req. No. 2517-RGA to 

determine if they are adequate to support CRP certification 

for this product 

Active Ingredient(s), PC code, & % Fipronil 9_8% 

S-Methoprene 8.8% 

Summary of Findings 

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

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

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

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

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

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

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

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

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

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

66
1700.20(a)(3)(i) regarding age and sex distribution, the number of test subjects 

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

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

section below. 

Should any human experience/epidemiological evidence indicate a 

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

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

package involved. 

Package 

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

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

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

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

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

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

narrow tip area at the notches with scissors. There are three applicators 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 5 different sizes (0.5, 0.67, 1.34, 2.68, 4.02 ml). 

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

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

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

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

tube [vial] with notched end pointing up and away from 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 amt = 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 amt = 28.5mg = 28.5mg divided by [1020mg/ml 

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

2517-RGA Access to a toxic or harmful am! = 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 am! = 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. 

67
3 

Toxicity, Child Failure, and Package 

EPA Reg #I- m! (1m! ... Fr. Oz. (29.6ml Product % FipronH mg FipronH #- unit'" tox 

0.033811. oz.) =1 fl. oz.) Density gfml /harm1ul amt 

2517-RGT 0.5 0.017 1.030 9.7 49.96 1 

2517-RGA 0.67 0.023 1.020 9.7 66.29 1 

2517-RGA 1.34 0.045 1.020 9.7 132.58 1 

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 

2S17-RGU 0.67 0.023 1.020 9.8 66.97 1 

2S17-RGU 1.34 0.045 1.020 9.8 133.95 1 

68
4 

EPA Reg # ml (1ml= FI. Oz. (29.6ml Product %Flpronll mg Flpronil # unit= tox 

0.0338 fl. oz.) =1 fl. oz.) Density g/ml Iharmful amt 

2517·RGU 2.68 0.091 1.020 9.8 267.89 1 

2517·RGU 4.02 O. t36 1.020 9.8 401.84 1 

Failure 

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

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

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

complete access to the placebo (water). 

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

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

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

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

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

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

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

second and third applicator. 

Analysis of Data and Conclusion 

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

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

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

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

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

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

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

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 

69
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 S, 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 

70
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 -134,135,136,13 7 .doc). 

6 

A bridging leiter was submilted 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 of subjects per test site (24%) per 16 CFR 

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

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

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

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

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

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

it will need to be submitted. 

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. 

71
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% 

September 28, 2010 

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

or 1 min. 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 

~f 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. 

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 ml for Fipronil only 

Cat EPA REG # 2517-RGT 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1 020mg/ml x 0.097 Fipronil] = 0.288 ml = 0.29 ml for Fipronil only 

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 ml for Fipronil & SMethoprene Cat EPA REG # 2517-RGL 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1 020mg/ml x 0.098 Fipronil] = 0.285 ml = 0.29 ml for Fipronil & SMethoprene Dog EPA REG # 2517-RGU 

% AI - Fipronil 9.7% 

Note: 

The applicator is the child-resistant feature. 

The applicators are filled in mi. 

1 

1. 

2. 

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

only and the Fipronil and S-Methoprene products. This is based on the registrant's submission of: samples of 

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

products, which appeared to be identical; and a June 30, 2010 letter indicating the same applicator color (white) 

and fill weight colors will be used for both the Fipronil only and the Fipronil and S·Methoprene products as was 

used in the CRP testing. 

72
2 

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

ml per Pkg 

# unitlpkg, child fail ;; # Child Get eRE SAUE Compreh Only include eRE & SAUE via computer analysis 

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

units Test Review uter 

& why Analy 

sis 

2517-RGT 48059503 3 white applicators with t set of 3 a child XCRE CRP Certification 5/271 to is acceptable. 

Cat Fipronil only 1746-001 purple stripe on label applicators failures = associat Label dated 6/291 to same CRP directions as 

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

Each applicator @ O.5ml to each child test lowest Data Analysis showed no child failures. 

water as placebo. other. SAUE Study is a pass of the child test according to 

ToX/harm ;;: t applicator, the sequential test chart in t6 CFR 1700.20. 

child fail:::: t applicator 

2517-RGT 48059503 3 white applicators with tsetof3 90% X lowest CRP Certification 5/27/tO is acceptable. 

Cat Fipronil only 1746-001 purple stripe on label applicators SAUE SAUE Label dated 6/29/tO same CRP directions as 

connected to each other. connected in study. 

Each applicator@ 0.5ml to each Data Analysis showed 9 seniors failures with 

water as placebo. other. package A and 1 senior failure with package 

Tox/harm:::: t applicator, B, which is the maximum number of failures 

child fail :::: 1 applicator 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 t6 CFR 

1700.20(a)(3)(i) regarding age and sex 

distribution, the number of test subjects per 

test site and per tester. 

73
3 

~PA REG# MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# uniUpkg, child fail = # Child Gel CRE SAUE Compreh Only include eRE & SAVE via computer analysis 

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

units Test Review uler 

& why Analy 

sis 

2517-RGA 48059803 3 white applica10rs with 1Se1of3 o child X CRP CertifiCa1ion 5/27/10 is acceptable. 

Dog Fipronil 1746-002 orange stripe on label applicators failures = Label dated 6/29/10 same CRP directions as 

only connec1ed to each O1her. connected Pass 50 in study. 

Each applica10r @ to each child test Data Analysis showed no child failures. 

a.67ml wa1er as placebo. other. S1udy is a pass of the child test accord'mg to 

ToX/harm = 1 applica1or, the sequential1est chart in 16 CFR 1700.20. 

child fail = 1 appUca10r 

2517-RGA 48059803 3 white applicators with 1se1of3 98% X CRP Certification 5/27/10 is acceptable. 

Dog Fipronil 1746-002 orange stripe on label applicators SAUE Label dated 6/29/10 same CRP direc1ions as 

only connected 10 each o1her. connected in study. 

Each applica10r @ to each Data Analysis showed 2 seniors failed to 

0.67ml water as placebo. other. open package A SAUE is 98%. The study is 

ToX/harm = 1 applica1or, a pass of1he senior adult test in 16 CFR 

child fail = 1 applica10r 1700.20 and the effectiveness specifica1ions 

in 16 CFR1700.15(b). 

2517-RGA 48059804 3 white applicators with 1 setof3 o child X CRP CertifiCa1ion 5/27/10 is acceptable. 

Dog Fipronil 1746-003 green stripe on label applica10rs failures = Label dated 6/29/10 same CRP directions as 

only connec1ed 10 each other. connected Pass 50 in study. 

Each applica1or@ to each child tes1 Data Analysis showed no child failures. 

1.34ml wa1er as placebo. other. Study is a pass of the child 1es1 according to 

ToX/harm = 1 applicator, 1he sequential test chart in 16 CFR 1700.20. 

chlld fail = 1 applicator 

2517-RGA 48059804 3 white applica10rs wi1h 1 setof3 95% X CRP Certifica1ion 5/27/10 is acceptable. 

Dog FipronH 1746-003 green s1ripe on label appliCa10rs SAUE Label dated 6/29/10 same CRP directions as 

only connected 10 each other. connected in study. 

Each applicator @ to each Data Analysis showed 4seniors failed to open 

1.34ml water as placebo. other. package A and 1 senior failed to open 

Tox/harm = 1 applicator, package B. SAUE is 95%. The study is a 

child fail = 1 applicator pass of1he senior adult test in 16 CFR 

1700.20 and the effec1iveness specifications 

in 16 CFR1700.15(b). -------

74
4 

I;PA REG # MRID PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg , 

# uniVpkg, chlfd fail = # Chifd Get CRE SAUE Compreh Only include eRE & SAUE via computer analysis 

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

units Test Review uter 

& why Analy 

sis 

2517-RGA 48059805 3 white applicators with tsetof3 2 child X lowest CRP Certification 5/27/tO is acceptable. 

Dog Fipronil t746-004 red stripe on label applicators failures = CRE Label dated 6/29/10 same CRP directions as 

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

Each applicator@ to each child test Oata Analysis showed 2 child falfures, a 43 

2.68mf water as placebo. otheL month old male accessed 2 applicators before 

Toxlhann = t applicator, the demonstration and a 51 month old female 

child fail = t applicator accessed one applicator after the 

demonstration. Study is a pass of the child 

test according to the sequential test chart in 

t6 CFR t700.20. 

25t7-RGA 48059805 3 white applicators with t setof3 98% XSAUE CRP Certification 5/27/tO is acceptable. 

Dog Fipronil t746-004 red stripe on label applicators SAUE associat Label dated 6/29/10 same CRP directions as 

ol1ly connected to each other. connected ed with in study. 

Each applicator @ to each lowest Data Analysis showed 2eniors failed to open 

2.68ml water as placebo. other. CRE package A SAUE is 98%. The study is a 

T ox/harm = t applicator, pass of the senior adult test in t6 CFR 

child fail = t applicator 1700.20 and the effectiveness specifications 

in 16 CFRt700.15(b). 

'17-RGA 48059806 3 white applicators with 1 setof3 t child X CRP Certification 5/271 to is acceptable. ~,og Fipronif t746-005 blue stripe on label applicators faifure = Label dated 6/291 to same CRP directions as 

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

Each applicator@ to each chifd test Data Analysis showed one age calculation 

4.02ml water as placebo. other. error, a 44 month old male was reported as 45 

T ox/harm = t applicator, months old. The age distribution is not in 

child fail = 1 applicator accordance with 16 CFR 1700.20. The 

study results are not affected. There was t 

chifd faHure, a 44 month old male accessed t 

applicator after demonstration. Study is a 

pass of the chifd test according to the 

sequential test chart in t6 CFR t700.20. 

75
5 

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

ml per Pkg 

# unitlpkg, child fail = # Child Get eRE SAUE Compreh Only include eRE & SAUE via computer analysis 

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

units Test Review uter 

& why Analy 

sis 

2517-RGA 48059808 3 white applicators with 1 setof3 97% X eRP Certification 5/27/10 is acceptable. 

Dog Fipronil 1748-005 blue stripe on label applicators SAUE Label dated 6/29/10 same CRP directions as 

only connected to each other. connected in study. 

Each applicator @ to each Data Analysis showed 1 birth date was 

4.02ml water as placebo. other. missing, Upon finding it in the hard copy of 

Tox/harm ::: 1 applicator, data the age calculation was okay. The study 

child fail ::: 1 applicator results are not affected. There was one age 

calculation error, but the test subject remained 

in the same age group. The study results are 

not affected. The results showed 3 seniors 

failed to open package A. SAUE is 97%. The 

study is a pass of the senior adult teSl in 16 

CFR 1700.20 and the effectiveness 

specifications in 16 CFR1700.15(b). 

76
6 

September 28, 2010 

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-Methop,ene 11.8% 

A Senior Adult Use Effectiveness failure is failure to access the applicator in the prescribed test time of 5 min. for the· first package or 

1 min. 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 

:hamber 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. 

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 Fipronilj = 0.285 ml = 0.29 ml for Fipronil only 

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 ml for Fipronil only 

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 ml for Fipronil & 5-

Methoprene Cat EPA REG # 2517-RGL 

Access to a toxic or harmful amt = 28.5mg = 28.5mg divided by [1020mg/ml x 0.098 Fipronilj = 0.285 ml = 0.29 ml for Fipronil & 5-

Methoprene Dog EPA REG # 2517-RGU 

Y. 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, 4.02 ml) for the Fipronil 

only and the Fipronil and S-Methoprene products. This is based on the registrant's submission of: samples of 

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

products, which appeared to be identical; and a June 30, 2010 letter indicating the same applicator color (white) 

and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methoprene products as was 

used in the CRP testing. 

77
7 

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

ml per Pkg 

# unitlpkg, child fail = # Child Get at eRE SAUE Compreh Only include eRE & SAUE via computer , 

units, color, tox/harm = # Begin Test ensive Computer analysis I 

units Review Analysis 

& why 

2517-RGL 3 white applicators with 1 setof3 CRP Certification 5/27/10 is 

Cat Fipronil + S~ purple stripe on label applicators acceptable. Laber dated 6/29/10 

Methoprene connected to each other. connected same CRP directions as in study 

Each applicator@ O.5ml to each mentioned below. Size not accepted i 

water as placebo. other. based on: 

Tox/harm = 1 applicator, MRID 48059503 (1746-001), EPA 

child fail = 1 applicator Reg No. 2517-RGT. Study is a pass 

of the child test according to the 

sequential test chart in 16 eFR 

1700.20. 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(0)(3)(1). Therefore, 

this CRP test data is unacceptable. 

Bridging Letter 6/30/1 0 indicating 

same size and color package as 

package tested is okay. 

78
8 

September 28,2010 

CRPdatasummarycht 

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 in the prescribed test time of 5 min. for the first package or 

1 min. 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 

hamber 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. 

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 Fipronilj = 0.285 ml = 0.29 ml for Fipronil only 

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 ml for Fipronil only 

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 ml for Fipronil & SMethoprene Cat EPA REG # 2517-RGL 

Access to a toxic or harmful am! = 28.5mg = 28.5mg divided by [1020mg/ml x 0.098 Fipronilj = 0.285 ml = 0.29 ml for Fipronil & SMethoprene Dog EPA REG # 2517-RGU 

10 AI - Fipronil 9.8% 

S-Methoprene 8.8% 

Note: 

1. 

2. 

3. 

The applicator is the child-resistant feature. 

The applicators are filled in ml, 

10 CRP studies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1.34, 2.68, 4.02 ml) for the Fipronil 

only and the Fipronil and S-Methoprene products. This is based on the registrant's submission of: samples of 

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

products, which appeared to be identical; and a June 30, 2010 leiter indicating the same applicator color (white) 

and fill weight colors will be used for both the Fipronil only and the Fipronil and S-Methoprene products as was 

used in the CRP testing. 

79
9 

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 & SAUE via computer 

units, color, tax/harm = # at Begin ensive Computer analysis 

units Test Review Analysis 

& why 

2517-RGU 3 white applicators with 1setof3 CRP Certification 5/27/10 is 

Dog Fipronil + S- orange stripe on label applicators acceptable. Label dated 6/29/10 

Methoprene connected to each other. connected same CRP directions as in study 

Each applicator@ a.87ml to each mentioned below. Size accepted 

water as placebo. other. based on: Bridging Letter 6/30/10 

ToX/harm = 1 applicator, indicating same size and color 

child fail = 1 applicator package as package tested; and 

passing eRE & SAUE values per 16 

CFR 1700 for MRID 48059803 (1746-

002) EPA Reg No. 2517-RGA. 

2517-RGU 3 white applicators with 1 set of 3 CRP Certification 5/27/10 is 

Dog Fipronil + S· green stripe on label applicators acceptable. Label dated 6/29/10 

Methoprene connected to each other. connected same CRP directions as in study 

Each applicator@ 1.34ml to each mentioned below. Size accepted 

water as placebo. other. based on: Bridging Letter 6/30/10 

Toxlhann = 1 applicator, indicating same size and color 

child fail = 1 applicator package as package tested; and 

passing CRE & SAUE values per 16 

CFR 1700 for MRID 48059804 (1746-

003) EPA Reg No. 2517-RGA. 

,J17·RGU 3 white applicators with 1 setof3 CRP Certification 5/27/10 is 

Dog Fipronil + S· red stripe on label applicators acceptable. Label dated 6129/10 

Methoprene connected to each other. connected same CRP directions as in study 

Each applicator@2.68ml to each mentioned below. Size accepted 

water as placebo. other. based on: Bridging Letter 6/30/10 

Toxlharm = 1 applicator, indicating same size and color 

child fail = 1 applicator package as package tested; and 

passing CRE & SAUE values per 16 

CFR 1700 for MRID 48059805 (1746-

004) EPA Reg No. 2517-RGA 

80
10 

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

ml per Pkg 

# unftlpkg, child fail = # Child Get CRE SAUE Compreh Only include eRE & SAUE via computer 

units, color, tox/harm = # at Begin ensive Computer analysis 

uni1s Test Review Analysis 

& why 

2517-RGU 3 white applicators with 1setof3 CRP Certification 5/27/10 is 

Dog Fipronil + 8- blue stripe on label applicators acceptable. Label dated 6/29/10 

Methoprene connected to each other. connected same CRP directions as in study 

Each applicator@ 4.02ml to each mentioned below. Size accepted 

water as placebo. other. based on: Bridging Letter 6/30/10 

Tax/harm = 1 applicator, indicating same size and color 

child fail = 1 applicator package as package tested; and 

passing eRE & SAUE values per 16 

CFR 1700 for MRID 48059806 (1746-

005) EPA Reg No. 2517-RGA. 

81
Product Toxicity based on Flpronil Toxicity 

Access to a toxic or harmful am! = 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 ml for Fipronil only 

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 ml for Fipronil only 

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 ml for Fipronil & 5-

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 ml for Fipronil & 5-

"ethoprene Dog EPA REG # 2517-RGU 

11 

EPA Reg # ml (ml = fl. oz. (fl. oz. :: Product % FipronU mg Fipronil # unit = tax Iharmful amt 

0.0338 fl. 29.6ml) Density g/ml 

oz.) 

2517-RGT 0.5 0.017 1.030 9.7 49.96 1 

2517-RGA 0.67 0.023 1.020 9.7 66.29 1 

2517-RGA 1.34 0.045 1.020 9.7 132.58 1 

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 

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 

82
DATA PACKAGE BEAN SHEET 

Date: 11-May-2010 

Page 1 of 1 

* * * Registration Information * * '" 

Decision #: 425453 

DP #: (377598) 

PRIA 

Parent DP #: 

Submission #: 873354 

Registration: 2517-RGU - SERGEANT'S FIPRONIL + S-METHOPRENE SQUEEZE.:ON F 

Company: 2517 - SERGEANTS PET CARE PRODUCTS, INC. 

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

Risk Manager Reviewer: Bonaventure Akinlosotu BAKJNLOS 

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

Type of Registration: Product Registratfon - Section 3 

Edited Due Date: ____ _ 

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

Ingredients: 105402, S.Methoprene(8.8%) 

129121, Fipronil(9,8%) 

* * * Data Package Information * * * 

Expedite: 0 Yes. No 

DP Ingredient: 105402, S-Methoprene 

129121, Fipronfi 

DP Title: TOX: Similarity 

Date Sent: 11-May-2010 Due Back: ___ _ 

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

Assigned To Date In O"eO", / 

Organization: cR~O~I~T~R~B~ _____ -="",,,,,- Last Possible Science Due Date: OS·Oct-2010 _ 

Team Name: TDX 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 prlnted on ~s own page 

* * * Data Package Instructions * * * 

For Your Review: An R310 action, a new fipronilJ3-methoprene EP; presumably me-too of Merial's Frontline 65331-5. 

Thx, baa 

83
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

September 13,2010 

MEMORANDUM 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Name of Pesticide Product: SERGEANT'S FIPRONIL + S-METHOPRENE 

SQUEEZE-ON FOR DOGS 

EPA Reg. No. IFi1e Symbol: 2517-RGU 

DP Barcodes: DP 377598 

Decision No.: 425453 

Action Code: R310 

PC Codes: 129121 (Fiproni1: 9.8%); 105402 (S-Methoprene: 

8.8%) 

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

Technical Review Branch 

Registration Division (7505P) 

To: Bonaventure Akinlosotu/Richard Gebken RM 10 

Insecticide Branch 

Registration Division (7505P) 

Registrant: SERGEANT'S PET CARE PRODUCTS, INC. 

FORJvruLATION FROM LABEL: 

Active Ingredient(s): 

129121 Fiproni1 

105402 (S)-methoprene 

Other Ingredient(s): 

TOTAL 

ACTION REQUESTED: The llisk Manager requests: 

Bywt. 

9.8% 

8.8% 

81.4% 

100.0% 

• 

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

Merial's Frontline 65331-5." 

Page 1 of3 

84
\ , c~ 

\,-lL >'" .; 

,',0-

v 

BACKGROUND: 

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

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

animal and other studies (MRIDS 43577711, 43863802, 43577715, 44942104, 45143901, 

45612702 and 45620507). The material received for review also includes a proposed label, a 

CSF dated 1212112009, and a copy of a cover letter dated April 12, 2010. 

COMMENTS AND RECOMMENDATIONS: 

1. After a comparison of the CSFs, TRB concludes that 2517~RGU is toxicologically similar to 

65331 ~5, and that the toxicity studies that supported the registration of 65331 ~5 will also 

support the registration of2517-RGU. 

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

December 12, 1999 from M. Hashim to A. Sibold; the formulation (10% Fipronil and 12% 

Methoprene) was assigned to EPA Toxicity Category 111 for oral toxicity, and to Category IV 

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

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

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

dennal sensitization. 

3. The companion animal safety study in beagle puppies (MRID 44942104), conducted on a 

formulation containing 10% Fiproni1 and 9% S-Methoprene, was submitted as an interim 

report and classified as supplementary/guideline in a TRB review (B. Backus to A. Sibo1d) 

dated May 5, 2000. Subsequently, additional information (in MR1D 45143901) was 

submitted to the Agency and reviewed and the study was reclassified to acceptable in a TRB 

review (B. Backus to A. Sibold) dated July 11,2000. 

4. In a TRB memorandum (M. Hashim & B. Backus to A. Sibo1d) dated October 21, 2002, it 

was stated that the study in MR1D 45612702 was acceptable, and that it adequately supported 

the proposed use of a 10% Fipronil-9% (S)-Methoprene fonnulation at the label-specified 

dosage rate of 0.67 mLiapplication on dogs weighing less than 10 Ibs at no less than 30-day 

intervals. 

5. The memorandmn of October 21,2002 also stated that the study in MRID 45620507 was 

acceptable, and that the findings of this study were adequate to support the use of EPA Reg. 

Nos. 65331-3 and 65331~5 at the specified label use rates (varying according to the weight of 

dog) at 28-day intervals on breeding, pregnant and lactating bitches. 

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

MRlD 43577711 is a 6-page docmnent titled "Discussion in Support of Bridging Domestic 

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

submitted in suppott of 65331-EUP-E. 

Page2of3 

85
7. The study in MRID 43863802 titled: "Domestic Animal Safety Study by Topical 

Administration to Dogs" was reviewed (sign-off date 04/03/96) by V. Dobozy in HED. 

From the review: "The study demonstrated that RM160lE/62 (9.7% fipronil) has at least a 

5X margin of safety in dogs greater than 10 weeks of age. The product label should state that 

there may be temporary irritation after application." The review of 04/03/96 also notes the 

follmving: "The spot-on label states "Fipronil is not absorbed into the body, but rather 

collects in the oils of the skin and hair follicles. Fipronil continues to be released from hair 

follicles onto the skin and fur, resulting in long residual activity." A previously submitted 

study (MRID #43577715) in which radiolabeled fipronil was administered to dogs at a high 

dose (10 mg/kg) demonstrated that the chemical is absorbed systemically. Plasma levels of 

radioactivity were detected from day 2 to day 30 post-treatment. These statements should be 

deleted from the label for dogs. A similar study in cats determined that systemic absorption 

was insignificant." 

The proposed label for 2517-RGU includes the following claim: "The active ingredients in 

[brand name} work by collecting in the hair follicles and skin oils. This product features a 

sustained-release formula that discharges from the animal's hair follicles using the natural 

skin oils ... " This should be deleted from 2517-RGU, and the similar claim for 65331-5 

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

registration of 2517-RGU. 

9. The proposed precautionary labeling and first aid statements for 2517-RGU are acceptable. 

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

11. The CSF (dated 12/2112009) for 2517-RGU shquld also be reviewed and accepted by the 

TRB Chemistry Team. 

Page 3 of3 

86
DATA PACKAGE BEAN SHEET 

Date: 11 w MaYw 2010 

Page t of2 

* * * Registration Information * * * 

Decision #: 425453 

DP #: (377596) 

PRIA 

Parent DP#: 

Submission #: 873354 

Registration: 25H,RGU - SERGEAfliT'S FIPRONIL + S-METHOPR_ENE SQUEEZE-ON F ~"--0 

Company 2512- SERG~~T'S PE.:r CA'3E ~RSlDU~!S, ~---- - ~-- - ------------. r1 1J;Y ~ Risk Manager RM 10 - Richard Gebken - (703) 305_-6I.2.1 Ro£m# ~~!§-7237 _ _______ ~~ l 

Risk Manager Reviewer B~mavent~ ~klnlosotu-.!3~~INLOS __ __ __ _ __ _ ___ _ ______ 11 v 

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

Type of Registration: ~ro~~ct Registration -_ Section.L 

Actfon Desc: (~~_1 0) N~yv P~.9:~l:'CT;N2N-FAST TRACK (INC,~!:JPES_REVIEWS OF ~B9P~~T_~!:i~MIS~ 

Ingredients: 105402,_S-=Met~.9E.~e:~!:(!~~L __ 

* * * Data Package Information * * * 

Expedite: 0 Yes" No Due Back: 

DP Ingredient: !_~~~~~_,_~MethJ_~!_e_n~ _______________________________ _ 

!?JJ21, Fi~?.!1!! __ 

DP Title: Prod Chem 

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

Date In Date Out 

Organization: !3:Q_~_TR§ _______ ,, ________________________ _ 

Team Name: CHEM Science Due Date: 

Reviewer Name: Sub Data Package Due Date: _____________ _ 

Contractor Name: 

* * * Studies Sent for Review * * * 

Printed on Page 2 

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

No Additional Data Packages 

* * * Data Package Instructions * * * 

For Your Review: MRID 480591 -01 & 02 for an R310 action, a fipronilf3-methoprene EP; presumably me-too of Merial's Frontline 65331-5. 

Thx, baa 

87
DP BARCODE No.: 377596 FILE SYMBOL No.:2517-RGU DECISION No.: 425453 

PC Coders): 105402,129121 ACTION CODE: R 310 

FOOD Use: NO NON-FOOD Use: YES 

DATE OUT: August 31, 2010 

SUBJECT: End Use Product Chemistry Review 

FROM: r~ . ~.,y\~ I

duct N~e: SERGEANT'S FIPRONIL+S-METHOPRENE SQUEEZE-ON 

\r;;,st a i'tairola (" ~ " 1 ~ll 0 

Product Chemistry Team )(\ ',{vv' -\.' . 

Technical Review Branch / 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#s 480591-0 I and -02). TRB has been asked to determine the acceptability of the product 

chemistry data and the proposed basic and 2 alternate CSF's. 

SUMMARY OF FINDINGS: 

1. Name of Active lngredient(s); Fipronil and Methoprene. 

2. All of the source materials of the active ingredient are derived from registered sources. 

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

labeled uses. 

4. Confidential Statement of Fonnula(s); 

[Xl Basic - 12121109 

[X] Alternate # I &# 2 

Dated: 

both -

resubmitted (email) - Dated: 08/3111 0 

Dated: 08/31110 

Alternate CSF(s) complies with 40CFR§152.43: [Xl Yes [l No 

5. Product label 

88
DP BARCODE No.: 

PC Coders): 

FOOD Use: Yes 

5. Product label 

FILE SYMBOL No.: 

Action Code: R 310, R 340, 345 

NON-FOOD Use: Yes 

DECISION No.: 

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

lNA; 

1 NA 

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 

1 Yes [Xl No [ 1 NA 

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 [XlNA 

Is the sub statement in compliance with PR Notice 97~6? [ ] Yes, if not, 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 and methoprene. 

2 

89
DP BARCODE No.: FILE SYMBOL No.: DECISION No.: 

PC Coders): 

FOOD Use: Yes 

Action Code: R 310, R 340, 345 

NON-FOOD Use: Yes 

6. Group A: Product Chemistry Data 

TRE'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 480591-01 

Description of materials used 

830.1600 to produce the product X A 480591-01 

Description of fonnulation 

830.1650 I process X A 480591-01 

Discussion on the formation 

830.1670 of impurities X A 480591-01 

830.1700 Preliminary analysis 

Standard 

certified 

Certified limits 

limits 

(158.350) Proposed Limits 

Justification for 

830.1750 wider limits 

Enforcement analytical 

830.1800 method G 

A = Acceptance, N = Not Acceptable, G = Data Gap, 

W = Waiver Request, I = In Progress, NA = Not Applicable 

3 

90
DP BARCODE No.: FILE SYMBOL No.: DECISION No.: 

PC Code(s): 

FOOD Use: Yes 

7. GroupB: 

Guideline Study Title 

No. 

830.6303 Physical State 

830.6315 Flammability 

830.6316 Explodability 

830.7000 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 

Insoluble in water NA 

1.00-1. 04g/mL A 

A = Acceptance, N = Not Acceptable, G = Data Gap, W = Waiver request, 

NA = Not applicable, 1 = In progress 

CONCLUSIONS: 

MRIDNos. 

480591·02 

480591-02 

480591-02 

480591-02 

480591-02 

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

has concluded: 

1. Basic CSF Dated: 08/31110 is Acceptable and attached. 

2. Alternate CSF(s) #1  Dated: 08/31110 are Acceptable and attached 

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

Enforcement Analytical Method for Fipronil and Methoprene. 

4. All required Group B data were reviewed and determined to be Acceptable; exceptguidelines 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 

91
UNI t c::D STATES ENVIRONMENTAL PROTEC11vN AGENCY 

WASHINGTON, D.C. 20460 

April19,2010 

OPP Decision Number: D-425453 

EPA File Symbol or Registration Number: 2517-RGU 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + S-METIIOPRENE SQUEEZE-ON FOR DOGS 

EPA Receipt Date: 22-Dec-2009 

EPA Company Number: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. EPA File Symbol or 

Registration Nwnber: 

KELLY R HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTII 158TH PLAZA 

OMAHA, NE 68130-1703 

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

Dear Registrant: 

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

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

results of the PRN-86-5 screen will be communicated separately. During the administrative 

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

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

The Action has been identified as Action Code: R31 0 

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

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); 

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

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

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

overpayment. 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, c:J 

Front 

/~~ End Processing Staff 

Infonnation Technology & Resources Management Division 

92
change PRIA code 

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

Cc: Bonaventure Akinlosotu, Teresa Downs 

Hi JJ and Teresa, 

Please change the following from R30D to R310. Company has submitted the difference in fee already_ 

2517~~RGU 

2517-RGL 

2517-RGA 

2517~RGT 

Linda Arrington 

Registration Division 

7033056249 

703 305 6920 (fax) 

93
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Apri115,2010 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

Report of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

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

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

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

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

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

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

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

to whom the data have been released. 

94
480591·00 

Sergeant's Pet Care Products, Inc. 

2625 South 1S8th Plaza • Omaha, NE 68130-1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www,sergean1s,com 

April 12, 2010 

Richard Gebken, PMIO 

Office of Pesticide Programs (7504P) 

u.s. Envirorunental Protection Agency 

Document Processing Desk 

Room S·4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs 

EPA File Symbol 2517·RGU 

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

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158'" 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 + S-methoprene 

Squeeze-On for Dogs (EPA File Symbol 2517-RGU). 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 MRIDls (where applicable) and study title names 

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

form 8570-35 data matrix cOlTectly 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 Sergeant1s 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 + S-methoprene Squeeze-On for Dogs (EPA File 

Symbol 2517-RGU). The new studies are being submitted in accordance with PR 

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

95
Sergeant's Pet Care Products, Inc. 

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

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

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

the referenced products listed on your 8570~1 fonn (block #6) are also not citable for 

purposes of satisfying the data requirements outlined in 40 CFR § 152.34. These eRP 

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

Sergeants submitted a new Child Resistant Packaging study for review as part of 

this package (an MRID number has not been assigned). Sergeants listed this new 

study in the new enclosed data matrix. 

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

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

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

Please find enclosed the following documentation in support of our response: 

1. Administrative materials: 

• Transmittal document; 

• EPA Fonn 8570-1: Application for Pesticide Ponn ; 

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

• EPA Fonn 8570-35: Data Matrix Ponn - EPA and Public Versions; and 

• Additional PRIA Payment ConfIrmation Receipt. 

2. Product-specific product chemistry data. 

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

Sincerely, 

~.H!~S ~~ Ie-AT 

Manager of Technical Affairs 

Sergeant's Pet Care Products, mc. 

Enclosures 

96
Sergeant's Pet Care ProdUcts, Inc. 

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

Data Transmittal Document: 

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

2625 South 158'" Plaza 

Suite 100 

Omaha, NE 68130-1703 

Submittal Date: April 12, 2010 

Volume Study Title MRID 

I Group A Product Chemistry for Sergeant's Fipronil 48059101 Dog Spot-On II (2517-RGU) 

2 Group B Product Chemistry for Sergeant's Fipronil 48059102 Dog Spot-On II (2517-RGU) 

97
Please read instructions on reverse before 'p/eting form Form Approv' JMB No 20700060 - Approval expires 05-31 -98 

United States L:LRegistration OPP Identifiel Number 

EPA Environmental Protection Agency D_Amendment 

Washington, DC 20460 o Other 

Application for Pesticide - Section I 

1. Company/Product Numbel 2. EPA Product Manager 3. Proposed Classificalion 

2517-RGU Richard Gebken 

4. Company/Product (Name) PM#10 C8JNone DRestricted Sergeant's Fiproni I + S-methoprene Squeeze-On For Dogs 

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

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

2625 South 158<11 Plaza 

Omaha, NE 68130 EPA Reg. No. 65331-5 

Product Name FRONTLINE PLUS FOR DOGS 

D Check ffthls is a new address 

Section II 

o Amendment - Explain below. o Final printed labels in response to Agency letter daled XX-XX-XX 

~ Resubmission in response to Agency letler dated 01_27_2010 o "Me Too" Application 

o Notification - Explain below. o Other - Explain below. 

Explanation: Use additional page(s) if necessary. (For section I and Section 11.) 

Section III 

1. Material This Product Will Be Packaqed In: 

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

[gJ Yes* fZJ Yes DYes o Metal 

DNO D No [gJ No ~ Plastic 

If "Yes" No. per If "Yes" No. per DGlass 

*Certification must Unit Packaging wgt. Container Package wgt. Container 

DPaper be submitted 0.023 fl oz (0.50 ml) 3,4,6 vials 

0.045 fl oz (1.34 ml) I I DOther (Specify) Plastic Bag 0.09t fl oz (2.68 ml) 

0.136 t1 oz (4.02 ml) 

3. Location of Net Contents Infolmarlon 4. Size(s) Retail Containel 5 Location of Label Direclions 

[2JLabel D Container 0.023 fl oz (0.50 ml). 0.045 fl oz (1.34 ml), 0.091 fl DOn Can 

oz(2.68 ml), 0.t36 fl oz(4.02 ml) [SIan Labeling accompanying product 

6. Manner in Which Label is Affixed to Product DLithograph ~Other 

DPapel glued 

DStenciled 

Section IV 

1. Contact Point (Complete ilems direct/ be/ow for fdentificatlon of individual to be contacted, if necessarY, to process this application.) 

Name Title Telephone No. (Include Area Code) 

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

Certification 6. Date Application 

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

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

under applicable law. 

2. Signiyr,e 3, Title 

BY • OJ .... ~ I-bw.~ !~T Manager of Technical Affairs 

4. Typed Name: Kelly R. Hoskins 5. Date: 4//2-/7-0 I'D 

98
Form Approved OMB Nos, 207(}0060: 2070'{)057; 2070.{)107; 2070-0t22; 2070-0164 

","">. 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (St) 

.... -~ 1200 Pennsylvania Avenue, N.W • 

WASHINGTON, D.C. 20460 

Papel\vo!k Redoction ACI NOlice: The public reporting burden for Ihis collcction ofinforrnation is estimated to averagc t 25 hours per response for registralion 

and 025 hours per response for reregistration and special review activities, including time for reading thc inslructions and completing the necessary forms. Send 

commerts regarding burden estimate or any other aspeclofthis collection of information, mcluding suggestions for reducing the burden to: Director, Collcction 

Strategies Division (2822T), U.S. EnvironmemaJ Protection Agcocy, tWO Pennsylvania Avenue, N,W., Washington, DC 20460, Do not sefid the compleledfmm 

10 this address. 

Certification with Respect to Citation of Data 

ApplicanfsiRe!listranfs Name, Address, and Telephone Number EPA ReQislration Number/File Symbol 

Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha, NE 68 t30 25t7·RGT 

Active Inoredien1(s) and/or representative test compound/s) Date 

Fipronil 0411212010 

General Use Pat~m(s) (list ai those claimed for this product usm!l 40 CFR Part t58) Prodld Name 

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

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

submit this form. You must subm~ the Formulator's ExelTfltion Statement (EPA Form 8570-27). 

D I am responding to a Data-Call-In Notk;e, and have induded with this form a list of companies sent offers of compensation (the Dala Malrix form should 

be used fur this purpose). 

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

D I am using the dte-all method of support, and have induded with this form [2] I am using the selective method of support (or dte-all option 

a lisl of companies sent offers of compensation (the Data Matrix furm under the selecHve method), and have included with this (orm a 

should be used furthis purpose), completed rlst of data requirements (Ihe Data Matrix furm must be 

used), 

SECTtONtI: GENERAL OFFER TO PAY 

[Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements] 

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

SECTION III: CERTIFICATION 

I certify that this app~cation for registralion, this fonn for reregistration, 0; this Data-Call-In response is supported by all data submitted or dted in the 

application for registration, the lbrm for reregistration, or the Data-Call-In response. In addition, if the cile--all option or cite-all option under the se!ectjve method is 

'Ind'lcated'tTl Section I, th'lS appftcation is supported by ail data in the Agency's files that (1) concern 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 would be required to be submitted under the data 

requirements in effect on lhe date of approval of this application if the application sought the inillal registration of a product of identical or similar composition and 

uses. 

I certify that for each exdusive use study cited n support of this registration or reregistration, that I am the Original data submitter or that I have obtained 

the wr~ten permission of the original data submitter to cHe thai study. 

I certify that for each study cHed in support of this registrallon or reregistration that is not an exdusive use study, eHher: (a) I am the original data 

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

compensation have expired for the sludy; (d) the sludy is in the public literature; or (e) I have notified in wilting the company that submttted the study and have 

Offered (I) to pay compensation to the exlent required by sections 3(c){1){F) and/or 3{c)[2){B) of FIFRA; and ~i) to commence negotiations to determine the 

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

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

accordance with sections 3{c){1)(F) ami/or 3(c){2){B) of FIFRA are available and will be submitted to the Agency upon request. Sholld I fail to produce such 

evidence \0 the Agency upon request, t undersland that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with 

FIFRA. 

I certify that the statements I have made on this form and all attachments to it are vue, accuraB, and complete. I acknolliedge that any 

knowingly false Of misteadirg statement may be punishable bJ fine or imprisonment or both under applicable law. 

Signalure 14&rt f.. Hos/""~ / ::C-A-'t 4;17.-/10 

Typed or Prinled Name and Title 

Kelly R. Hoskins, Manager of Technical Affairs 

_ 0 E roni " EPA Form 8570-34 (12 2 03) lect cad Paper versions a a e v ilabl Submit only P aper versIOn. 

99
Pay.gov - Online Payment 

Online Payment 

Step 3: Confirm Payment 

Thank you. 

Your transaction has been successfully completed. 

Pay.gov Tracking Information 

Application Nama: PRIA Service Fees 

Pay,gov Tracking ID: 250LG67N 

Agency Tracking 10: 74110736632 

Transaction Date and Time: 04/12/2010 14:32 EDT 

Payment Summary 

Account Holder Name: Sergeants Pet Care Products 

Payment Amount: $3,213.00 

Payment Date: 04113/2010 

Decision Number: 

Registration Number: 2517-RGU 

Page I of I 

11213 

Account Type: Business Checking 

Routing Number: 

Account Number: *"''''5483 

Company Name: Sergeants Pet Care Produc 

Company Number: 2517 

Acllon Code: R310 

httos:l/www.nav.lZov/oavR:ov/navments/authorizeACHPavment.htmI 4/1212010 

100

*Commercial/financial information may be entitled to confidential treatment*
\ 

\} 1 in ~treet! S. W. 

j' 'I~' "~~., \\1i,)lll,'-. wAlSHINGTON, D.C. 20460 ~~;\ !'t" \' , he rrpllrt~g burde!\ for (his c,o!tectlo![ of infunHatiol~ is estimated to average 0.25 hOtJrs per respo!lse for registratio!l a.::iv!tics and (I.2S hours per respouse for 

; \~ '~)1) '1' ~\i!l ~ttl~llt'CS, mdudmg hme for rt<ldJ!1~ the J!lS!ruCllOl1 amI eOll'1ple!lIJg!ln' l1eces~ar)' form5. Send comments regmdmg the burden eS1lma!e Dr My o!lH!r aspecl of1his collee!)on , 2t1:t60 ., 10, urltng ~J.ggeiliQ(lsf'lt reriw:ing tite burden In Oi.ro;l(y;: QPPE !!lfum1.(lJiJ:m1).t:.uw.gt:~ut Dj)<l~im (2t17) U.s. Enviv.mme!!l.n..t Pro/t'.,ctW(\ A?."ew.:y, <ll)t M Street .. S.W., W'!s!o.j,!lgto~~ DC ., . Do no! send the fonn w iliis address. 

I DATA MATRIX n.\l..t~~ A Ii i2., 2CljIJ EPAR' "(\fuJPikS mooi Z5i7"RGU Pa e, l'Jf7 

: Al1rECJ,Ul..t'sJR..zgl~J.nw.l'£ N-.w,c & Address hQ,;koc.t Sergeant's fi?r-;mit + M'ViP4?fw.e 

i Sergeant's?cl Care Pwdue'c;, Inc. 2625 South l58th P1aza, Suite 100, Omaha, NE 63DO"l?!)3 Squeeze-On for Dogs 

In edients: Fi raniJ, MelllO rene 

I Guideline Reference Number Guidelilte Stu~)' Name MRIDNumbcr Submltter StaIns Note 

IlBO.1550, l)30.1600, 831}, 1 621}, PWOuo Properties Dam fuz Serge:afJi's PipwIli) +- M{.1)lOpreflC N~""> submissiou Sergeant's ?et Care Pwduo::ts, O\VN 

830.1650, 830.J670, 830. 1700, Squeeze-On for Dogs Jnc. 

830.1750 

&30.l8OO £\'.fofc~meru "wii\.iy~K?1 rnethoo 1'kw S'tIJvmissioo Sl:lgi,"ri',' s Pct C':Uc Pmrl"Utls, OWN 

hl."-. 

%30.6302, S3D.6303, 830.6304, Product chemistI)' of Sergeant's Fipronll + Melhoprct1.e New SJlbm)sslon Sergeant's Pet Care Products, mVN 

830.7300, 8.1!l?0(}O, 8.30J1.115, Sq!lt~eze-Oo. for Dogs lac. 

830,7JOO, 830,6320, 830.63J7 

83'i}:63\7,83'i}.1S320 gt07age S'iabi\it)' rmQI::0)703Wn d"ru:rltne'iiSlics To oc whrolwc.J Serge?,~~'s Pe£ em\', P~oo'U"t\S, OWN 

UpOIl completion hic. 

1S70.J1OD Acme cral toxiclty 44~42004 MBRIAL LlM1TED PAY .' 

31D.l?:ml ACllle dwmttl to:,idty 44942005 MERIAL UMITED PAY 

870.1400 Primal)' eye irritation 449420{16 MERlAL LIMITED PAY 

1 

RiG. i 5(jfJ Primary demllll irrittttion 449420Q? MERIAL UM!TED PA.Y 

\ .d~ 

870.!fiDO Dermal sensitization 44942008 IvIDJUALLlMITED I 

E'I1,\..w..~j,o!"\ Qf the Dog Squeeze On O.67ml Wilile Applicator !villi Nell's!.wmts£!<m Serle?"' .. ·· O\¥'J:~ 

\ O{;l.ng~ l:Jbd rnJic;J1or (3x}, scissors to open" F I as a Poison '/.." '(:'d Care rroduc\S, 

Prevenlirm \'m;m"(l 1m Sl!n't('.I"',t's, Pd Care Products.. Inc. --,v,! \ StlttW, ~ + • 

Evaluation of {he Dog Sqllceze On I.}~ml Whitt Appiit:alvl Nial )-.'". \ lnc, 

Green Label lndicator(3x), scissors!() open - F ,las a"Poison ,I Pcl rare Products, OWN 

Pre,'iet\-\iott p~c for Serg,canl's Pet Care Proauets, lnc. . , }kw 5!!Q(Ui:i:iiofl SergcrJl"o' s .. 

Enluat"lon of the Dog SqacCJt: (h Z.61h>:>.t Whlt~ A\1\11(~l!lor Wltll lac, 

Red Labd In6it<>ltIi {3,,>, 0,ssorstIJ open - F I as a POISiln I Dale 

[)41l2f2{\\O 

PrC"vtlllion Package for Scrgea1l1s ret Caet: ?wt\urtJ, !\~. ~ar.U<" and TWe fT~ea\ Aff;itrs 

I Signalure: V" PiLl e Hosf.u...1 /d': T 

'Kcl\;f R, "Ho'ikin$, Managel i) A{c#0' 1"l<r~"(ili,I:"i'J 

I 

--, ~ "'-.-'''~,~, ., ". __ ".~,~~. h"bblo Su'bm1! "")y,!",,'<''''-'''''''' 

101
Form APlrfov.d OMn N~.1070·UMO 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ~ 

- 401 M Street, S.W. 

WASHINGTON. D.C. 20460 

l'lIpcnvork Reduction Act Notice: The public reporting burden for ~lis collcclion of infonJlalion is estimated to average 0.25 hours per response for registration activilies and 0.25 hours per response tor 

reregistration :llId special revielV aclivities, including time for rcadi:lg the instmction and completing tbe necessill)' forms. Send cumments regarding the burd~n estimate or any otllcr aspect oftbis colleclion 

of information, including suggestions for reducing the burden to Director: QPpf: inlormation Mrumgement Divisioll (2137) U.S. Environmental Protection AgCIICY, 40 I M Street, SW" Washington, DC 

20460. Do not send the form to this address. 

DATA MATRIX 

Date: April 12,2010 EPA Reg No.lFile Symbol 2517-RGU Pae20f7 

Applicant'siRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Can: Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs 

In redients: Fi ronil, lvletho rene 

Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note 

Evaluation of the Dog Squeeze On 4.02ml White Applicator witll New sublnission Sergemlt's Pet Care Products, OWN 

Blue Label Indicator (3x), scissors to open - F=I as a Poison Inc. 

Prevention Package for Sergeant's Pet Care Products, Inc. 

870.7200 Walker, K. (1995) Discussion il\ Support of Bridging DOlllestie 435777Il MERIAL LIMITED OLD 

Animal Safety Data on Frontline Spray Treatment to Frontline 

Spot Treatment Datu Package. Unpublished study prepared by 

Rhone Merieux, Inc. 6 p. 

870.7200 Powell, L.; PaffeU, R. (1995) Domestic Animal Safety Study 43863802 MERIAL LIMITED PAY 

by Topical Administration to Dogs: Fipronil Spot Treatment 

(RM 1601 E): Lab Project Number: MRX 23/950406. 

Unpublished study prepared by Huntingdon Researeb Centre, 

Ltd.219p. 

870.7200 Canovas, M.; VilJageliu, J.; Lopez, S.; et al. (1994) 43577715 MERIAL LIMITED OLD 

Percutaneous Absorptioll and I-lair, Skin, and Fat Distribution of 

Radioactivity After Spot-On Application of(Carbol\ 14).RMI601 

in Beagle Dogs: Lab Project Numbers: CD-93/3405F: Q-42.769. 

Unpublished study prepared by Centro de Investigacion y 

DcsarroUo Aplieado, SAL. 68 P. 

870.7200 Nolan-Smith, S. (I999) Fiprollil/(S)-Methoprelle Topical Solution: 44942104 MERIAL LIMITED PAY 

Target Species Safety Study in the Dog: Interim Report: Lab 

Project Number: 168612: 1686/2-0 Il42: PR&D 0002 I 0 L 

Unpublished study prepared bv Covunee Laboratories Ltd. 266 p. 

870.7200 Nolan-Smith, S. (1999) Fiprolli!l(S)-Methoprene Topical Solution: 45143901 MERIAL IJMlTED PAY 

Targel Species Safety Study in the Dog: Report Amendment: 

Aillendment to Interim Report: Lab Project Number: 168612: 

1686/2·Dl 142. Unpublished study prepared by Covancc Labs., 

Ltd. 6 p. 

870.7200 Nolan-Smith, S. (200I) To Investigate the Safety of a Topical 45612702 MERIAL LIMITED PAY 

Formulation Containing ML-2,095,988 509T itl Dogs Weighing 

Approximately 2kg (+I-I.5kg) at Olle, Three and Five Tillles the 

Maximulll Labe! Recommended Dosage: Final Report: Lab 

Project Nllmber: 1686/12: 1686112-D2160: PR&D 004580 I. 

Unpllblished study prepared by Covanee Laboratories. 324 p. 

Signature: lt/fL.-t ~. ti9l~ IHr, Naille and Title Da(e 

Kelly R. Hoskins, Manager of Technical Affairs 04112/2010 

EPA Form 8570-35 (9·97) Electrollle ""d P.'I'er Ver~o", Av,;I,ble submit ~nlv Paper ver~,," , ge,«y I ""m.1 u,< COpy 

102
~ 

~b'm '\I~n-"v<d olr[n No. lO70-0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

" 401 M Street, S.W. 

" WASHINGTON, D.C. 20460 

Papenvork Reduction Act Notice; The public reporting burdcli lor tllis collectioa of infonnalion is eSlimated 10 average 0.25 hours Iler response for registration activities and 0.25 ltours per response for 

reregistration and special review activities, including limll for reading the in3ercgislralioncomplcling the necessary forms. Send (XlmmenlS regarding the burden estimate or any other aspect oflhis collection 

ufinformalion, including suggestions IOf reducing the burden [0 Director: OPPE Information Management Divisioll (2\37) U,S. Environmental Protection Agency, 40 I M Street, S W., Washington, DC 

20460. Do liD! sentllhe form 10 tllis ~Iddress. 

DATA MATRIX 

Dale: A rilll, 2010 EPARe No.lFileS mbol 2517~RGU Pae30f7 

Applieant'sJRegistrant's Name & Address Pruduet: Sergeant's Fiproni! + Me!hoprene 

Sergeant's Pet Care Products, Inc. 2625 South I58tll Plaza, Suite 100, Omaha, NE 68130- I 703 Squeeze-On for Dogs 

In redients: Fi ronil, Metho relic 

Guideline Reference Number Guideline Study Name MRlD Number Submitter Status Note 

870.7200 Godin, c.; Alva, R. (2000) ML-2,095,988 45620507 MERIAL LIMITED PAY 

509T /Dog/Sol utionff op ieal/Safety rr oleranee/Reprod uetioll, 

Reactions: Final Report: Lab Project Number: PR&D 0020201: 

WEL 99885: PR&D 00202. UnpUblished shldy prepared by 

White Eagle Toxicology Laboratory. 123 o. 

810.3300 Evere!!, R.; Cunningham, J. (1993) A Comparative Evaluation of 43121116 MERIAL LlM[TED OLD 

Twu Treatment Regimes Using RM 1601 Spray for Control or 

the Cat Flea Ctenocephalides [elis on the Dog: Revised: Lab 

Project Number: RMD 692: PI222LT. Unpublished study 

prepared by Agresearch Consultants, Inc. 40 p. 

810.3300 McCall, 1.; McTier, T. (1993) Laboratory Evaluation ofRIvI 43121117 MERIAL LIMITED OLD 

160 t Spray for Control Dermacentor variabilis and Rilipecephalus 

sanguilleus on tile Dug: Lab Project Number: RMrrKS/93IlL: 

PS/22!JLT. Unpublished study prepared by TRS Labs, Inc. 18 p. 

810.3300 Cruthers, L. (1993) Efficacy ofRlvll60 IC at 3 ml/kg and 6 ml/kg 43121122 MERIAL LIMITED OLD 

Against Ixodes seapularis!danunilli Nymphs, Dermaeeillor 

variabilis Nymphs, Amblyomma amerieanum Nymphs, 

Rllipieephalus sanguineus Nymphs, and CtellOcephalides [elides 

Adults Usillg Trei!!cd Dog Hair as the Testing Substrate: Revised: 

Lab Project Number: 9320: PI225LT. Unpublished study 

prepared bv Professional Lab and Research Services, Inc. 28 p. 

8\0.3300 McCall, 1. (1999) Dose Titration Study of (S)-Methoprene by 44942105 MER1AL LIMITED PAY 

Topical Admillistration to Dogs: Final Report: Lab Project 

Number: i'R&D 000990 t. Unpublished study prepared by TRS 

Labs, Inc. 51 D. 

810.3300 Young, D. (! 999) Dose Confirmation Study of Topically 44942106 MERIAL LIMITED PAY 

Administered Fipronil/(S)-Metiloprene Against Adul! 

Ctenoeephal ides felis(C[u Fleas) in Dogs: Fin\ll Rcport: Lab 

Project Number: PR&D 0013501. Unpublished study prepared by 

Young Veterinary Research Services. 59 p. 

Signature: JL. (/;../ 12-. Hosu.,.v.. !, 12:-A-T Name and Title Date 

Kelly R. Hoskins, Manager ofTcehllieal Affairs 0411212010 ~"A C·M_ '<7~" mom, ~,._.. ,_ ."~ " ••••• " ••• , ___ •.. _.,.", .. <".,"_,. __ ,., ,, __ •. vm;,," Iy 1"1"" Ageo",y 1"'.mallJ" COI'r 

103
t'om, Apr,",· .. 1 0).111 No. 1070_110('0 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

" 401 M Street, S.W. 

e WASHINGTON, D.C. 20460 

Papcnvork Reduction Act Notice: Thc public reporting burden for this eollcetion of information is estimated to averagc 0.25 hours per response for registratio!! activities and 0.25 hours per response for 

reregistration and special revicw aetivilics, including timc tor reading the in4cregistrationcomplcting the ncccssary forms. Send COll1mcnts regarding the borden estimate or any other aspect of this collection 

of in for mati 011, including suggestions for reducing the burden to Director: OPPE Infommtlon Managemcnt Division (2137) U.S. Environmcntal Protcction Agency, 401 M Street, S.W., Washington, DC 

20460. Do not send the fonn to dlis address. 

DATA MATRIX 

Date:A ri112,2010 EPA Re No'/File S mbol 2517-RGU Pae40f7 

Applicant'siRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Ser!!eant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs 

In redients: Fi ronil, Metho rene 

Guidcliue Reference Number Guideline StudY Name MRID Number Submitter Status Note 

810.3300 Pengo, G.; Pollmeier, M.; Barrick, R. (2000) All Efficacy Study of 45620501 MERIAL LIMITED PAY 

Frontline Spray, Frontline Top Spot, and ML-2,095,988 509T, for 

the Treatment and Control of Trichodectes canis in the Dog: Final 

Report: Lab Project Number: PR&D 0022101, PR&D 00221. 

Unpublished stu~yprep',ued by Centro Veterinario Oriolo. 24 p. 

810.3300 Alva, R; Barrick, R. (1999) A Study to Determine the Effect of 45620502 MERIAL LIMITED PAY 

Treatment with Frolltline Top Spot on the Prevalence and Severity 

of Flea Allergy Dermatitis in Dogs: Final Report: Lab Project 

Number: PR & D 0010201: PR & D 0010202: PR&D 00102. 

Unpublished study prepared by VCA SI. Petersburg Animal 

HosPital. 45 p. 

810.3300 Postal, 1.; Le Nain, S. (1998) Evaluatioll of the Efficacy of 45620503 MERIAL LIMITED PAY 

RM160 I C/35, in tite Treatment of Flea-Allergy Dermatitis in the 

Dog, Compared with a Referellee Product: Final Report: Lab 

I'roject NUlllber: ASR 19083: CLl276. Unpublished study 

repared by Merial. 92 p. 

& 1(1.3300 Marchiondo, A. (2001) PR & D 002410 I: Frontline 45620504 MERIAL I,lMITED PAY 

Spray/Frontline Spot-OnIML-2, 095, 988 509T/Dugs 

ISolutionITopical: Final Report: Lab Project Number: PR&D 

002410 I: PR&D 00241. Unpublished study prepared by 

Stillmeadow, Inc. 2? p. 

810.3300 Gaxiola, S.; Alva, R.; Irwin, 1. (2001) PR& D 0052301: 45620505 MERIAL LIMITED PAY 

Frontline Spray/Frontline Spot-On/ML-2, 095, 988 

509T/Dogs/SolutionfTopieal: Final Report: Lab Project Number: 

PR&D 0052301, PR&D 00523. Unpublished stody prepared by 

University of Sinaloa. 40 P. 

810.3300 Pengo, G.; Pollmeier, M, (2000) Frolltline Spray & Top Spot! 45620506 MERIAL LIMITED PAY 

Dogs/Solution(fopieal Clinial/Dose Confirmation! Eetoparasites, 

Mites, Sarcoptes Scabiei val' canis: FInal Report: Lab Project 

NUlllber: PR&D 0012901: PR&D 00129. Ulipublishcd study 

prepared by Centro Veterinario Oriolo. 23 p. 

Signalllre: JLp.flJ...\ t.. tfow..: I'. ~ I '9:-/IT Name ami Title Date 

Kelly It Hoskins, Mallager of Technical Affairs 04112/2010 

EPA Fo,," 8570-)5 (9.97) f.1'«T~ and Paper Ver~M' Avail,blc S"bmll o"ly Pa~"v.,..io" A.,n,v 1",,,,,,, 'I" ,onv ;ency "' 

104
Form Approy,d OMB No. !070_00M 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401 M Street, S.W. 

e WASHINGTON, D.C. 20460 

Paperwork Reduetinn Act Notice: The public reporting burden for this collection ofmfornration is estimatcd tn average 0.25 bours per rcsponse for registralion activities and 0.25 bours per response lor 

rercgistration and special review activities, including timc lor reading tbe in5cregistmtioncompleting the necessary lorms. Send commcnts regarding the burden estimate or any other aspect of tbis collection 

of information, including suggestions lor tedueing the burtlen to Directnr: OPPE InformatiouManagement Division (2137) U.S. Environmental Protection Agency, 40 I M Street, S.W., Washington, DC 

20460. Do not send the form to this address. 

DATA MATRIX 

Date: April 12, 2010 EPA Re No.lFile S mbol 2517-RGU Pa e50f7 

Applicant'siRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Care Products, Inc. 2625 Sonth 158th Plaza, Suite 100, Omaha, NE 68130-1703 Soueeze-On for Dogs 

In redients: Fi roni!, Metho rene 

Guideline Reference Number Guideline SCud Namc MRIDNumber Submitler Slatus Note 

810.3300 Pengo, G.; Pollmeier, M. (2002) Study to Confinn the Efficacy of 45628201 ME RIAL LIMITED PAY 

Fipronil Against Lice in Dogs Under Field Conditions: Final 

Report: Lab Project Number: PR&D 003740L Unpublished 

study prepared by Centro Veterinario Oriolo. 21 p. 

810.3300 McCall, 1.; Alva, R.; Irwin, 1.; etaL (2002) A Study to 45866902 MERIAL LIMITED PAY 

Evaluate the Efficacy of Frontl inc Plus for Conlrol of 

Mosquitoes, Aedes aegypti, on Dogs: Final Report: Lab Project 

Number: PR&D 0055201. Unpublished sludy prepared by TRS 

Labs, Ine. 24p. 

133-3 Meo, N.; Gonzalez, c.; Mester, T. (1997) Demml and Inhalation 44433302 MERIAL LIMITED PAY 

Exposure of Commercial Pet Groomers During Application of 

Fronlline Spray Trcatmenl: Final Report: Lab Project Number: 

MERIAL-445-SAFXT046: SAFX046: PDA9705. Unpublished 

study prepared by ABC Labs., California and Aanimal Appeal 

Grooming Sh9P& Case Veterinary HospilaL 1066 p. 

133-3 Meo, N.; Gonzalez, c.; Belcher, T. (I997) Dermal Exposure of 44433303 MERIAL LIMITED PAY 

Commercial Pet Groomcrs During Appl ication of Frontline Top 

Spot: Final Report: Lab Project Number: MERIAL-445-

SAFXT047: SAFXT047: EC-97-390. Unpublished study 

prepared by ABC Labs., California and Aanimal Appeal 

Grooming Shop & Case Veterinary Hospital. 925p. 

132-1 Hughes, D. (1997) Dislodgeable Residues ofFipronil Following 44433305 MERIAL LIMITED PAY 

Application of Frontline Top Spot to Dogs: Final Report: Lab 

Projeel Number: COVANCE 6848-101: MERIAL METXT 166: 

METXT 166. Unpublished study prepared by Covance Labs. Inc. 

161 p. 

132-1 Hughes, D. (1997) Dislodgeable Residues ofFipronii Following 44433306 MERIAL LIMITED PAY 

Application of Frontline Spray Treatment to Dogs: Final Report: 

Lab Project Number: COVANCE 6848-100: 6848-100: 

MERIAL-445-METXT-165. Unpublished study prepared by 

Covance Labs. Inc. 184 

Signature: ~OJ<1 'L H.,~1.w1....J ?#tr Name and Title Date 

Kelly R. Hoskins, Manager of Technical Affairs 0411212010 EPA Form gS7()'3S (9-97) Ele<;"@ioand raper V."io", Av"l.ble. Submit only P'PO! versioLL A.,n.V In',,n,' 11," r~,w 

105
reregistration and ~ 

of informal ion, 

20460. Do I 

Date: April 

A nn Ii('~nt' siR cgistra 

s Pct Care I 

132·1 

132-1 

I N/A 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

• 401 M Street, S.W. 

• WASHINGTON. D.C . . The public Icporting burden I 

;"t''''· ;n~I",I;n" to",,. f", '''~dill~ tlle 

__ ions for redllcing the bUrdcll to Dirc"'Ul u,.-t'c J 

o ~lis address. 

the necessary rorms. 

Division (2137) 

DATA MATRIX 

,,~ ~ ,>uu. w~~ 

:, Inc. 2625 SQuill 158th Plaza, Suite ]00, Omaha, NE 68130-1703 

de Foutenay, G.; Campagna, J.; Subcrvlllc, S. ct al. (1997) 

Dislodgcablc Residues ofFipronil Following a Topical 

Application of Frontline Spot-On Treatmenllu Dogs: Final 

Reporl: Lab Project Number: 817/0248: MET416: 

:MERIAL-480-MET -416. Unpublished study prepared by Merial 

Ltd. and Chrvsalis Preclinical Services-Europe. 68 p. 

de Fontenay, G.; Campagna, J.; Suberville, S. ct al. (1997) 

Dislodgeable Residues ufFipronil Followiug a Topical 

Applicalion of Frontline Spray Treatment to Dogs: Final Study: 

Lab Project Number: 817/024A: MET414: MERIAL-480-MET414. Unpublished study prepared by Merial Lid. and Chrysulis 

70 p. 

Irwin, 1. (1997) Usc SlIrvey of CommercialandV eterinary Pet 

Groomers and Pet Owners of Frontllne Top Spot and Frontline 

Spray Treatmenl: Lab Project Number: MERIAL-445·SlJRVEY. 

Unpublished study prepared by Wiese Research Associates, Inc. 

~ ------

Hughes, D. (1997) Validaliun of an Analytical Method for the 

lJelermmauon 01 ['Ipronll, 1VI&l:I4.'l~5U, and M&l:I46.'l lJ m DyeFree 100% Cotton Gloves: Final Report: Lab Project NUfllber: 

COVANCE 6848·104: 6848-104: MERIAL METXT 169. 

I fnn"hli"h"il "Inriv nr"n~r"ri hv r(lV~n"e Labs. Inc. 41 D. 

Polakoff, n.; Y01lngren, S. (1997) Non-Dietary Risk. 

Fipronil Use on Pets in a Residential Setling: Lab Project 

Nllmber: FIPRONIL 97·09: MERIAL-445·NDRA Unpublished 

study prepared by Novigen Sciences, Inc. 27 D. 

.-.- f, B.;' 

and R, .• .v""",,, 'VI' '-'1'01 an J r ___ ..... -. __ ";----;-

Treatment: Lub Project Number: FIPRONIL 97-11: MERIAL· 

445-PGRA. Unpublished study prepared by NOl'igen Sciences, 

Inc. 17 p. 

MRIDNUI 

44531203 

44531204 

44433301 

44433308 

I "-p, 

" .~".~ ...... ~n activities and 0.25 hours per response for 

g the burden estimate or any other aspectofthis collccuon 

Agency, 401 M Street, S_W., Washington, DC 

./File Symbol 251",-

ant's Fipronil + r 

,r Dogs 

Submitler 

MGRIAL LIMITED PAY 

I MERIAL LIMITED PAY 

MERIAL LIMITED PAY 

LIMITED PAY 

I PAY 

I PAY 

~ 

1/ Il/' "T- Name alld Title 

(Kelly R. Hoskins, Mana er ufTechnieal Affairs 

""r~o" Ag'"")' Inter".1 Usc eop1 

106
Form "I'ILrO".d OMI! :.10. 2070·0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401 M Street, S.W. 

0 WASHINGTON, D.C. 20460 

Paperwork Reduction Act NOliec: The public reporting burden for this colteclion of information is estimated to average 0.25 hours per response for regislration aClivilies and 0,25 hours per response fur 

reregistration and special review activities, including tinle for reading the in7eregistralioncompleting the necessary fonns. Selld eommenlS regarding the burden estimate or any other aspect of this 

collect"lon ofinformalion, including suggestions for redlCing the burden to Direclor·. OPPE I n1ormation Managemellt Division (2137) U.S, Environmenlal Protection Agency, 401 M Slreel, S.W., 

Washington, DC 20460. Do not send lhe form to this address, 

DATA MATRIX 

Date: April 12,2010 EPA Reg No.lFile Symbol 2517-RGU Page 70f7 

Applicant'slRegistrant's Name & Address Product: Sergeant's Fipronil + Methoprene 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Squeeze-On for Dogs 

Ingredients: Fipronil, Methoprene 

Guideline Reference NlImber Guideline Study Name MR[DNumber Submitl.cr Status Note 

Wall, H. (1998) Frontline Products Reports of Suspected 44531205 MERIAL LIMITED PAY 

Adverse Events Analysis of Breed, Age and Sex Distribution of 

Dogs and Cats, Unp~blished stlldy prepared by Medal Ltd. 8 p. 

Polakoff; B.; Youngren, S.; Walls, C. (1998) Frontline 44531206 MERIAL LIMITED PAY 

Top-Spot and Frontline Spray Treatment: Definitive Short-Term 

and Intermediate-Term Residential Non-Dietary Risk assessment: 

Lab Project Number: FIPRONIL 98-04: MERIAL-445-NDRA. 

Unpublished studv prepared by Novigen Sciences, Inc. 35 P. 

Polakoff; B.; Youngren, S.; Walls, C. (1998) Frontline Top 44531207 MERIAL LIMITED PAY 

Spot and Frontline Spray Treatment: Definitive Pet Groomer 

Exposure Analysis and Risk Assessment: Lab Project Number: 

FlPRONIL 98-07: MERIAL-445·LPERA. Unpublished stlldy 

prepared by Novigen Sciences, Inc. 21 p. 

Polakoff, 8.; Youngren, S. (1998) Frontline on Pets in a 44531208 MERIAL LIMITED PAY 

Residential Setting: Risk Assessmem ora Low Probability Event 

Post-Application Acute Exposure: Lab Projeet Number: 

FIPRONIL 98-06: MERlAL-445-PGRA. Unpublished study 

I prepared by Novigen Sciences, Inc. 18p. 

Signature: 1/ ,P,.l (Z.. Hc~ / 2::-A-1 

Name and Title Date 

Kelly R. Hoskins, Manager of Technical A1Tairs 04112/2010 EPA Fonn &57().l5 (9_97) EI<'\'1nLC ""d raper v,,,,o,,, Available Sub"Li!" Iy Pap"'" ¥er~o" Ag.noy In"m.1 U,. Copy 

107
~ 

~. 

" ,~0 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

I\.Tr'Tl\l\J 

to average 

the instnletion and cOlllplcling the IIcccssmy forms. 

burden to Director: OPPE Informa1ion Management Division (2137) U.S. 

estimate or any other aspect 

Agency, 401 M Street, S.W, Washington, DC 

Sergeant's Pet Care 

Inc. 

108
n 

,~-

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

average 

review activities, 

suggestions for reducing 

the instruction and completing the necessary forms. Send comments regarding the burden estimate or any other aspect 

to Director: OPPE Information Management Division (2137) U.s. Environmental Protection Agency, 40 I M Street, S.W., Washington, DC 

Inc. 

OLD 

PAY 

109
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

• 401 M Street, S.W . 

• D.C. 20460 

average U.25 huurs per rcsponse _ ~ _ _ ________ • ___ r 

the in3cn:gistrationcompleting the necessary forms. Send comments regarding the burden estimate or any other aspect Oflhis collection 

burden to Director: OPPE information Management Division (2137) U.S. EnviwIllllc1llni Protection Agency, 401 M Street, S.W., WaoJJington, DC 

. Fipronil 

PAY 

PAY 

110
reregistration and special 

ofinfoflu3tion, including 

tl" 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S. W. 

o D.C. 20460 

response 

the in4ercgistrationcompleting the necessary forms. Send comments regarding the burden estimate or any other 

burden to Director: OPPE Information Management Division (2137) U,S. EnvirOllmental Protection Agency, 401 M Street, S,W" 

PAY 

111
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W . 

• W D.C. 20460 

per response lor registration activities and U.25 hours per response 

reading the in5cregistrationcompleting the necessary forms. Send commentS regarding the bmdcn eStimate or any other aspect of this collection 

to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., Washillgton, DC 

PAY 

PAY 

PAY 

112
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W . 

• 

reading Ole in6eregislralioncomplcling lhe necessary forms. Send commCnls regarding lhe burden eSlimale or any olher aspectoflhis collection 

10 DireClor: OPPE information Managemenl Division (2137) U.S. Environmenlal Proteclion Agency, 40 I M Slreel, S.W., Washington, DC 

DATAMATRlX 

PAY 

113
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W. 

o 

reading the in7ercgistratiOllcompleting the necessary forms. SClid comments rcgalliing the burden estimate or any other 

die burden to Director: OPPE Information Mallagement Division (2137) u.s. EnvirollmclItal Protection Agency, 401 M Street, S.W., 

114
FW: Response to EPA Letter 

James Messina 

to: 

Bonaventure Akinlosotu 

03/31/201001:15 PM 

Show Details 

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

Regards, 

Jim 

From: James Messina 

sent: Wednesday, March 31, 2010 1:11 PM 

To: akinlostotu.bonaventure@epa.gov 

Cc: Gebken.Richard@epamail.epa.govi KHoskins@SERGEANTS.com; Rick Tinsworth; Larry Nouvel 

Subject: Response to EPA Letter 

Mr. Akinlosotu, 

Page 1 of 1 

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

dated January 27, 2010 regarding the following registration applications: 

1. Sergeant's Fipronil + 5-methoprene Squeeze-On for Dogs (2517-RGUj 

2. Sergeant's Fipronil + S-methoprene Squeeze-On for Cats (2517·RGl) 

3. Sergeant's Fipronil Squeeze-On for Dogs (2517·RGA) 

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

Sergeant's intends to continue the support of the above·referenced registrations and will submit supporting CRP 

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

If you have any questions, please contact me. 

Best Regards, 

James Messina 

Senior Managing Regulatory Consultant 

Exponent 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

202-772-4932 

202.772·4979 fax 

301-908-1181 cell 

file:IIC:\Documents and SettingslBAkinloslLocal SettingsITemplnotesFCBCEEI-web4575 ... 1153/31/2010 
$, .... Eosrof~ 

f~~ ~ ~ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

~~ ~,t Washington, D.C. 20460 '<>",-<$0< 

Wednesday, January 27, 2010 

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

opp Decision Number: D·425453, D425454, D425455, D425437 

Registrant Name: Sergeant's Pet Care Products 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

Registrant Address: James Messina, Senior Managing Regulatory Consultant 

Exponent 

Subject: 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

Data Deficiency 

Product Name: Sergeant's Fipronil + Methoprene Squeeze-on for Dogs, 

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

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

EPA File Symbol: 2517-RGU, 25 I 7-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 

determined 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 (PRIA 2). Your options underAO CFR 

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

timeframe and set 0f 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, 2010 to provide a response concerning the deficiencies listed in this letter. Your response 

116
may include making corrections or additions to complete the application, or notifying the 

Agency of the date on which you expect to complete the application, or withdrawing your 

application. If you do not respond to this letter within 75 days or if you respond with a date on 

which you expect to complete the application but fail to meet that scheduled date, the Agency 

will treat the application as if you had withdrawn it. Withdrawal concludes the Agency's review 

of your application. Any subsequent submission of the same application must then be submitted 

as a new application with a new deadline for EPA to make a determination on your application 

and subject to a new registration service fee. 

The deficiencies identified in the Agency's review at this time are as follows: 

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

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

used to support each applicable guideline. Instructions for completing the EPA form 8570-35 

data matrix correctly can be found withip 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 CPR § 152.34. These CRP tests are product 

package design specific and unrelated to your proposed package, 

Further review of your application and your response to the deficiencies may identify 

additional deficiencies and you will be so infonned. 

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 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. 

117
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 \vill administratively withdraw your application. 

3. Correct application deficiencies: All acceptable data and data matrix as outlined 

above must be submitted to the Agency on or before April 12, 2010. At that time, The 

Agency will re-classify your applications from a R300 new product; me-too fast track, to 

a R31 0 new product; non-fast track The Agency will then request additional PRlA fees 

accordingly, and processing will not proceed until all the deficiencies are satisfied and 

applicable PRlA 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.govduringthe hours of 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. 

)P,LoI/UL 

Richard J. Gebken 

Product Manager (I 0) 

Insecticide Branch 

Registration Division (7505P) 

118
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 SqueezeMon for Dogs, 

Sergeant's Fipronil + Mehoprene SqueezeMOn for Cats, Sergeant's Fipronil 

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

EPA File Symbol: 2517-RGU, 2517-RGL, 2517-RGA, 2517·RGT 

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 

determined 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 (PRIA 2). Your options under 40 CFR 

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

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

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

40 CFR 152.105: 

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

12,2010 to provide a response concerning the deficiencies listed in this letter. Your response 

119
may include making corrections or additions to complete the application, or notifying the 

Agency of the date on which you expect to complete the application, or withdrawing your 

application. If you do not respond to this letter within 75 days or if you respond with a date on 

which you expect to complete the application but fail to meet that scheduled date, the Agency 

will treat the application as if you had withdrawn it. Withdrawal concludes the Agency's review 

of your application. Any subsequent submission of the same application must then be submitted 

as a new application with a new deadline for EPA to make a determination on your application 

and subject to a new registration service fee. 

The deficiencies identified in the Agency's review at this time are as follows: 

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

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

used to support each applicable guideline. Instructions for completing the EPA form 8570~35 

data matrix correctly can be found within PR Notice 98-5. An electronic copy of this PR Notice 

can be obtained at the following Agency web site: 

http://www.epa.gov/opppmsd1/PR Notices/pr98-5.pdf. 

2. The "Cite-all" option for product chemistry is inadequate. You carmot 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 accoroance with 40 CFR § 152.34, the submitted Child Resistant Packaging (eRP) 

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 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 detennination 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. 

120
2. Not respond: If you do not respond or fail to provide (a revised data matrix, 

acceptable product-specific chemistry data, and acceptable (CRP) data), on or before 

April 12, 2010, the Agency will administratively withdraw your application. 

3. Correct application deficiencies: All acceptable data and data matrix as outlined 

above must be submitted to the Agency on or before April 12, 2010. At that time, The 

Agency will re-classify your applications from a R300 new product; me-too fast track, to 

a R31 0 new product; non-fast track. The Agency will then request additional PRIA fees 

accordingly, and processing will not proceed until all the deficiencies are satisfied and 

applicable PRIA fees are paid. 

Please respond to this letter by March 31, 2010 by contacting Mr. Bonaventure Akinlosotu at 

(703) 605-0653, or bye-mail at akinJostotu.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. 

~UL Richard J. Gebken 

Product Manager (10) 

Insecticide Branch 

Registration Division (7505P) 

121
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

December 31, 2009 

opp Decision Number: D~425453 

EPA File Symbol or Registration Number: 2517-RGU 

OH!CEOF 

PREVEI\'l10N, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + S-METHOPRENE SQUEEZE-ON FOR DOGS 

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 158THPLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

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

payment. If you submitted data with this application, the results of the PRJ""\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: 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. 

Resources Management Division 

122
Pay.gov ~ Online Payment 

.Onlin_e p~Y.!f1~.'"!.t ... 

Step 3: Confirm Payment 

Thank you. 

Your transaction has been successfully completed. 

Pay.gov Tracking Information 

Application Name: PRIA SeNice Fees 

Pay,gov Tracking 10: 2505HOIN 

Agency Tracking 10: 74094010968 

Transaction Date and Time: 12121/200911:52 EST 

Payment Summary 

Account Holder Name: Sergeants Pel Care Producls 

Payment Amount $1,365.00 

Payment Date: t2122/2009 

Decision Number: 

Registration Number: 

Page 1 of I 

Account Type: Business Checking 

Routing Number: 

Account Number: .. • .. 5483 

Company Name: Sergeants Pet Care Produc 

Company Number: 25t7 

ActiOn Code: R300 

h1 tp s:1 Iwww.pay.gov/paygov/paymems/authorizeACHPayment.html 12/21/2009 

123

*Commercial/financial information may be entitled to confidential treatment*
Please read instructions on reverse bmore comp/etinQ form. Fo!m Approved. OMB No. 2070·0060. Approval expires 05·31·98 

I Uniled States ~ Registration OPP tdentilier Numbe! 

EPA Environmental Protection Agency o Amendment 

Washinglon, DC 20460 o Other 

Application for Pesticide - Section I 

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

2517-""" /?Ct tL Richard Gebken 

4. CompanylProduCl (Name) 

Sergeam's Fipronil + S·melhoprene Squeeze-On For Dogs 

PM# to ~None DRestricted 

5. Name and Address ot Applicant (Include ZIP Code) 6. Expedfted Review. In accordance with FIFRA Section 3(C)(3)(b)(I), my 

Sergeam's Pel Crue Producls, Inc. product is similar or (Jentical in composition and labeling to: 

2625 South 158'" Plaza 

Omaha, NE 68 t 30 EPA Reg. No. 6533t-5 

Product Name FRON1UNE PLUS FOR DOGS 

D Check f! Ihis is a flew address 

Section II 

D Amendment - Explain betow. o Flnat printed labels in !esPOnSe to Agency tetter dated XX·XX·XX 

o Resubmission in response to Agency teller daled XX-XX-XX ~ "Me Too" Applical"lon 

o Notilication' Explain below. o Other - Explain below. 

Explanation: Use add'~'lonal pagers) if necassary. (For section I and Seclion II.) 

Submission of a Hew end-llse registration applicalion. 

Section III 

Aaterial This Product Will Be Packaoed In: 

l.-nild-Resistant Packaging Unil Packaging Water Soluble Packaging 2. Type ot Container 

[SJ Yes' !ZJ Yes DYes o Metat 

ONO o No IZl No [S] Plastic 

It ''Yes" No. per It 'Yes" No. per OGIaSs 

'Certification must unit Packaging wgL Container Package wgt. Container 

OPaper be submitted 0023 fl 02 (0.50 mil ),4,6 viats 

0.045floz(I.34mtJ i I OOther (Specify) Plastic Bag 0091 floz(2.68 mil 

0.136 fl oz (4.02 ml) 

3. Localion ot Net Conlenls Inlo!mation 4. Size(s) Retail Container 5. Localion ot label Oirections 

[ZJLabel o Container 0.023 fl oz (O~O mt). 0.04~ fl 02 (t 34 mil, 0.091 fl 

oz (2.68 mt), 0. t36 fl oz (4.02 mt) 

DOn Can 

[glOn Labelino accompanying product 

6. Manne! in Which label is Altlxed to Product DUthograph IZJOther 

DPaper glued 

DSlenCiled 

Section IV --- L Conlact PoinU90mpiele ilems direc/l below lor idenli/iclllion 0/ indIVidual 10 be conlacted, if flecessaf1l, 10 orocess Ihis aaolica/ion 

Name Tille Telephore I>K>. \1, 'Clude Area Code) 

Ketty R Hoskins Manager of Technical Affairs '<02·':138·707-1 

~---

Certification f. Date Appllcalion 

I cer1ify thai the statemenls I have made on this torm and all attachmenls thereto are true, accurate and complete, , Receivc.d 

acknowledge Ihat any knOWingly talse or misleading statement may be punishable by fine or Imprisonment or bolh (Stamped) 

under aoolicable law. 

2. Signature 3. Title 

t, A :&/t ,(1- f Manager of Technical Affairs 

Typed Name/ Kelly tl. Hoskins 5. Date: 12/2 t/2009 

124
Sergeant's Pet Care Products, Inc. 

2625 South t58th Plaza • Omaha, NE 68 t30-1770 • Telephone 402.938.7000 • Fax 402.938.7099 • www.sergeants.com 

December 21,2009 

Richard Gebken,PMIO 

Office of Pesticide Programs (7504P) (REGFEE) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room SA900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Sergeant's Fipronil + S-methoprene Squeeze~On for Dogs 

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 + S-methoprene 

Squeeze-On for Dogs (containing the EPA registered active ingredients Fipronil (9.8%) and Smethoprene (8.8%)). Please find enclosed the following documentation in support ofthis 

registration'. 

(I) Application for Pesticide Fonn (8570-1); 

(2) Certification with Respect to Citation of Data Foml (8570-34); 

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

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

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

(6) Product Label (five copies); 

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

(8) Letter of Authorization. 

Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs is substantially similar to Medal 

Limited's EPA registered product FrontLine Plus for Dogs (EPA Registration # 65331-5). 

Sergeant's has sent offer to pay letters to all data submitters listed on the enclosed data matrix. 

We look forward to working with the Agency to register this "me-too" product. If you have any 

questions, please cOnlaet me at 402-938-7079. 

Sincerely, 

/~/'L/bL 

Kelly R. Hoskins 

Manager of Technical Affairs 

Enclosures 

125
Rll'h:Il'd lH"hkcll 

jlriH!Ilcl \1:llldgC[ .~.2 

DOC:llifleIl! Pnh:cssiIIc!, Ih>sk 

Ort'i,,'(' ur Pesticide lir\)J:;rnm~ 

l .S. Emirnllm<~nlal I'rn[..:cli<lll Agl'l1cy 

I\Olll11 S-,49(lO. ()Il~: Pntolll;\C )':Jrd 

::"77 Soulh CrysI,:1 Drive 

:\rlinglOll. VA 2211)2--1::;0 I 

Serg,cant's Pet Care Products, Inc, 

:-,('r~l>:ill(S pI:'[ ('an: ]lruJlIl'h. Illc iSl'rllcnI11·'.1('l:!:'i S\llllh j)R'I' Pleva. Ol1lah:l. l\cbI'IISk:1 

6;'; 1':;0- I 771). LPA (\)lllP~ll1\' i\I1lllbcr 25 I 71, ~llllh(ln/CS Fxp()llcllt. Inc. (I I SO C()lllll'cliclH 

.'\n:nlle, !\\\'. :-lIllie I Ino. \\'iISlllllgh'1l DC 20(J3h) In ,lei on Ull[ bdHlIL as (1111" 

;\I1tl]()rii'cd RCprL':!clllilll\''''. Ihr clJ1m;ceSsal"Y interaclloll.\: regardlllg oil oronr prndw:t 

rc.:gistrati,m ;lpplic;lllllll,s :lIld rcgi:'lmliulls. PIt::lse nule lhis do('s lwt chnng.c tht: currCnl 

Cikd ;\ulhorizcd A~L'nl It)r Scr;;c<lll!'s . 

.I;IlllCS )\"l(,:-;'>ln:1 ,md·()r Rid, TiIIS\l'(lrlll 

Exponent. hlC, 

11511 CUIlIIl:l'liclil i\\ l.'.. ;-.JW 

Sui(l' I 100 

WJsl1illglun. DC 20U:J!) 

(202) 772-4!Jn 

(201) T'2-4<j7\) t~IX 

j n J(:'>",i n(l(a c \ 11' llIC,lJI.,;OIlI n i il~\Xl(n h:1I l:;\ I l\)1 ~clll.,'()) n 

" ./5} 

/ 

" 1>.<:11: R. 11,)skIIlS 

\'Llll:I~cr 01"1 cc]IIlI"',il Atf~lir:, 

126
Sergeant's Pet Care Products, Inc. 

2625 South t581h Plaza • Omaha, NE 68130-1770 • Telephone 402,938.7000 • Fax 402.938.7091 • www.sergeants.com 

December 21. 2009 

Richard Gebken, PMIO 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Certification 

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. certifies that the packaging used in the manufacture of the 

following products: 

• Sergeant's Fipronil Spot-On for Dogs; 

• Sergeant's Fipronil Spot-On for Cats: 

• Sergeant's Fipronil + S-methoprene Spot-On for Dogs; and 

• Sergeant's Fipronil + S-methoprene Spot-On for Cats. 

meets the standards of 40 CFR 157.32, including the revised standards in 16 CFR 1700.15(b). 

All product labels have language specifying the use of scissors to open the product container and 

label language stating the product is not to be applied by children. In addition, Sergeant's is in 

discussion with approved CRP testing labs to develop a protocol per the revised testing 

procedures in 16 CFR 1700.20. 

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

Smcerely, 

;f~/C/~ Kelly R. Hoskins 

Manager of Technical Affairs 

cc: Larry Nouvel 

127
Form approved. OMB No. 2070-0060, 2070·0057. 2070·0 t07. 2070-0122, 2070·0 t64. 

&EPA ~ , 

United States 

Environmental Protection Agency 

Washington, DC 20460 

Formulator's Exemption Statement 

(40 CFR 152,85) 

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

Sergeant's Pet Care Products, Inc. 

25 I 7-NEW 

2625 South 158th Plaza Product Name 

Omaha, NE 681 30 Fipronil + S-methoprene Squeeze-On for Dogs 

Date of Confidential Statement of Formula (EPA Form 8570-4) 

12/21/2009 

As an authorized representalive of the applicant for registration of the producl idenUfied above. I certity that: 

(t) This product conlains Ihe tollowing aclive ingredient{s): 

Fipronil (9.8%) 

S-methoprene (8.8%) 

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result 0/ the use of that active ingredient in the manulacluring, 

formula lion or repackaging another product which contains that acti"" ingredient which is registered under FIFRA Section 3, is purchased by 

us from anolher person and meets the lequiremenls ot 40 CFR section t58.50(e}(2) or (3). 

(3) Indicate by checking (A) or (B) below which paragraph applies: 

71 {A} An accurate Conndenlial Statement of Formula (EPA FORM 8570.4) tor the above identified product is attached to this stalemenL 

That formula statement indicates. by company name, registration number, and product name, the source of the active ingredient{s} listed in 

paragraph {1}. 

OR 

, (6) The Confidential Statemont of Formula (CSF}(EPA Form 8570-4) referenced above and on tile with the EPA is complete, current. an 

accurate and contains the information required on the current CSF. 

(4) The following aclive ingredienls in this product qualify for Ihe formulator's exemption. 

Source 

Active Ingredient Product Name Registration Number 

Fipronil Technical 

S-methoprene 

S-methoprene , 

Signature Name and Title Date 

/~,f'I /~ , Kelly R. Hoskins, Manager of Technrcal Affairs 12/2112009 

EPA For" 8570·27 {Rev. 06-2004} Copy 1 EPA ---~ 

Copy 2 - App'ic~'11 cOl)y 

128

*Product ingredient source information may be entitled to confidential treatment*
II 

Form AOPfoved OMS Nos, 2070·0060; 2070·0057; 2070·0 to7. 2070·0122: 2070·0t64 

UN!TED STATES ENV!RONMENTAL PROTECTION AGENCY 

1200 Pennsylvania Avenue, N.w. 

WASHINGTON, D,C. 20460 

Paperwork Reduclion Act NOlicc: The p.!blic reparting burd:n for Ihis collect ian ofinfanmlion is eSlim~ted to average t.25 haurs per rcsponse for rcgimatian 

and 0.25 houl"S per response for rcregistration and speciat review IICtivitie&, inc!uJing lime for reading the imtnlctions and completing the necessary fo'm~. Send 

oommer,ts regardmg burden eSlirnatc Or any other aspect of this callwion ofinfOll'l1alion, including suggesflons far reducing Ihe burden to: Direclor, Callectian 

Strategies Divi!ion (2822T), U.S, Environmental PrOlecrion Agency, t200 Pennsytvania Avenue, N.W" W"shln~ton, DC 20460, Do nat send Ihe comptered fonn 

to this address. 

Certification with Respect to Citation of Data 

Applicanl's/Registrant's Name, Address, and Telephone Number 

Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha. NE 68 t30 

Active InoredienVsl andlor represenlative test compoundfs) 

Fipronil, S·methoprene 

General Use PaUern(s! (f'st al those cla'imed for this product usin~ 40 CFR Part (58) 

tndoor non·food 

EPA Re~lstration Number/File Symbol 

2517·NEW 

Data 

t212112009 

Product Name 

Sergeanl·s Fipron~ ~ S-m~IMp,ene Squeeze-On lorOogs 

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

submit this form, You must subm~ the Formulator's EXCffipi"lon Statemenl (EPA Form 8570·27). 

o 

IZl 

I am responding to a Data-Call·ln Notice, and have included with this form a list of companies sent offers of compensation (the Oata Matrix form should 

be used for this purpose)_ 

SECT tON t: METHOD OF DATASUPPORT (Check one method only) 

tam US'lng Ihe c·,te-all method of support. and have included with this form 

a list of compames sent offers of compensalion (the Oala MatriX form 

should be used for this purpose). 

o I am using Ihe selective melhod of support (or cite·all option 

under the seleclive method). and have included wilh this form a 

completed list of data requirements (the Deta Matrix form must be 

used). 

SECTION U: GENERAL OFFER TO PAY 

IRequired If using the cite-all method or when using Ihe cite-all oplion under the selective method to satisfy one or more data requirementsl 

[2] I hereby offer and agree to pay compensation. to othar persons. with regard 10 the approval of this applcation, to the extent required by FIFRA, 

SECTION!fI: CERTIFtCATION 

I certify thai this applicabon for regislrat,on, this form for reregistration, or this Data-CalHn response is supported by all data submilled or cited in the 

application for regisuahon, the form for reregislration, or Ihe Data·Call-ln response. In addition, if the cite-all option or cite-aU option under the selec!"lve method is 

lndicated in Section I. this application is supported by all data in the Agency·s files that (1) concern the propertles or effects of this product or an identical or 

substantiatly sim~ar PIO~uct, or one or more of the ingredienls in this product: and (2) is a Iype of data that would be required to be subm~ted under the data 

requirements in effect on Ihe dale 01 approval of this applicalion if Ihe application sought the initial registration of a producl of identical or sim~ar composition and 

uses. 

I certify thel for each exclusive use sludy cited in support of this registralion or reregis!ralion, that I am the original data submiUer or that I have obtained 

the wrillen permission 01 the original dala submitter to cite thai study. 

I certify thai for each study cHad in support of this registration or reregistration Ihat is not an exclusive use study, either: (a) I am the original dl'ta 

submiller: (b) I hava oblained the permission of the onginat data submiUer to use the study in support of this application: (c) all periods of eligibility for 

compensation have exp,red for Ihe study; (d) the sludy is in the public litelature: or (e) I have notified in wriUng tha company that submiUed the study and have 

offered (I) to pay compensation to the extenl required by sections 3(c)(1)(F) andlor 3(c)(2)(8) of FIFRA; and (ii) 10 commence nego!"iaOons todeterm'lna 'he 

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

I certify that I~ all Instances where an offer of compensation is lequired. cop,es of all offers to pay compensalion end eviden~.e of Ihe" deliverv in 

accordance with sectIOns 3(c)( t}(F) andlor 3(c)(2)(8) of FIFRJ'\ are ava~at:4e and will be subm~ted to the Agency upon request. ShooJd I fa~ to produce. s~::h 

ev·dence to Ihe Agency "pon requesl, I understand Ihat Ihe Agency may initiate aclion to deny, cancel or suspend Ihe registration of my ~:odu4. in conlormily wilh 

FIFRA. 

I certify that the statements t have made on this form and aU attachments to it are true, accurate, and complete. '. ;":{"~·,..wi!edge that any 

knowlngty false or misleading statement may be punishable by fine or impri!ionment or both under applicable law. 

I~----------------------------.------.--------------------- Date TyPed or Printed Name and nle 

f212 !l2009 Kelly R. Hoskins. Manager of Technical A:r"i!.; 

EPA Form 8~0-34 (t2-2003) Electronic and Paper versions available Submit only Paper version. 

129
~ FonnApprore<i OM5 No. illIfl.OO6/l 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

e ;;:<;.y. 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: Tnt public rcportillg burd~n ror Inis collcClioll of info'mation is eSlinoJICO to average 0.25 nour~ pet tcsponse for ,'cgislrmion JClivilies and 0.25 hours pcr response 

for rcrcgislr1Ihon and special review ncr;vilic:s. including lime for rending Ille insauction and completing lhe nece.s.<;';lJ"y fo(ms. Send comment, reg.aming the burden estimate or any Oilier ""peel of Ih" 

collection ofillfonnnlio". 'mcluding ,uggC:SI'lOns forred"cing !lIe burden to Dircc!Dr: OPPE Jnfonnalion Manngcment U.visio" (21 )7) U.S. Env"'.>nmcnt.1.l PrOiection Agency, 401 M Sl=l. $. W" 

Wasni'l !Qn. DC 20460. Do not send Ihe fonn to lhisaddrcss. 

DATA MATRIX 

Dale: 12/21/2009 EPARe No./File 5 mbol: 2517-NEW Pa e1of3 

Applicanl's/Regisfranl's Name & Address: 

Sergeant's Pet Care Producls, Inc 

2625 South 1581Jl Plaza, Omaha, NE 68130-1703 

Producl: Sergeant's Fipronil + S-melhoprene Squeeze-On for Dogs 

Ingredient: Fipronil 

Guideline Reference Guideline Study Name MRID Number Submiller Stalus NOle 

Number 

Cile-all Syngenta Crop Protection, Inc (#100) 

PO Box t8300 

Greensboro, NC 27419 

Cite-all Bayer CropScience lP (#264) 

2 T.W .Alexander Drive 

Research Triangle Park, NC 27709 

Cite-all Bayer Environmental Science (#432) 

PO Box 12014 

Research TrianQls Park, NC 27709 

Cite-aU Aeckill Benckiser Inc (#3282) 

Morris Corporate Center IV 

399 :\~~;~~~e Parkway Parsi an, NJ 07054 

Cile-all J,J. Mauget Co. (#7946) 

12733 D~~~lor's Loop 

Woodbrid e, VA 22192 

Cite-all BASF Corporalion (#7969) 

Agricultural Products 

PO Box 13528 

Research Trianale Park, NO 27709 

Sjgnal/~ // /' 

Name and Tille Dale 

Jl. 12121/2009 A ;~! Kelly R. Hoskins, Manager 01 TeChnical Affairs 

EPA Fo'm 8.17t ~Sl9 " (~. ,,;, '"~ r>",~ Vm",o, A""tl,h~ Submit oo/r P.,,,,,, >\.~,joo. A~.,,<:y lo"mol U" COjly 

130
fonnAppro,'"," OMS No, IOJ~,lItI(.o 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

w:z ~ 401 M Street, S.W. 

WASmNGTON, D.C. 20460 l'~pcrwork Rcdllclion Act NOliee: The public reponing humcn for Ihis eolteelion of infnnnation is estimaled 10 n~emge 0.25 houn; pt:l respunse for regislrntion neli~itie" and 0,25 hours jlCJ response 

for rercgismllion and special re~iew aClivilics, including time for reading the instrUelion and eompteting Ihe nceessal)' foolns. Send eommenls rcgnming the hurdc" csri"m\<: or any olher aspect of rhis 

cotJeelion ofinfornlation. inetudi"B suggeslions for reducing the burde" \0 DirccloL OPPB Informalion Manngemcnr Di~isio" (2137) U,S. En~ironmenml P>"O\e{:lion Agency> 401 M Strect, S.W .. 

Washin IOn. DC 20460, Do nOI sc"d Ihe fonn to this address. 

DATA MATRIX 

Dale: 12121/2009 EPA Re No./File S mbol: 2517-NEW Pa 2013 

Applican1'slRegis1ranfs Name & Address: 

Sergeanl's Pet Care produc1s, Inc Product: Sergeanl's Fiptonil + &methoprene Squeeze-On lOt Dogs 

2625 Soulh 1581h Plaza, Omaha, NE 68130-1703 

In redient Fi ronil 

Guideline Relerence Guideline Study Name MRID Number Submitter SlaWs Note 

Number 

C~e-all Chemsico (#9688) 

Division 01 United Induslries Corp 

PO Box 142642 

SI. Louis, MO 63114 

C~e-all Conlrol Solulions, Inc (#53883) 

5903 Genoa-Red Blull 

Pasadena, TX 77507 

Cne-all Virbac (#54022) 

POBox 16598 

Fort Worth, TX 76162 

Cite-all Combal Insec1 Con1rol Sys1ems (#64240) 

CIO Henkel Consumer Goods Inc. 

122 ClI;~~et, NW, Sui1e 740 

Washln on, DC 20001 

Cite-all Merial Limited (#65331) 

3239 Salellile Blvd, Bldg 500, LOC 106B 

DulU1h, GA 30096 

Cite-all Spray Drill Task Force (#66607) 

McKenna, Long & Aldridge LLP , 

1900 K Slreel, NW I 

Washi~;;;~n, DC 20006 

Signah/ Name and nle Dale 

; /;/? H / / " 12/21/2009 

Kelly R. Hoskins, Manager of Technical Aftairs <D.' r __ <I'm. ""-0.,' " .. c.~"," '"" "'~"V"'~"' A,~,I.h" <,,""' .. ""'" "'~'~"'"" A.",,",' r",,,,,,, ",. ,DO" 

I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY f<mnApprnw:<lOMDN<>.2U10.00c;U I 

131
n 

:{i1;(' 401 M Street, S.W. 

WASHINGTON, D.C. 20460 l'~pc,.wo~k Rcduclion Act Notice: The publie reporting burden for If,;, collection of information is estimated to average 0.25 nours per response for registration activities and 0.25 hours per [e~ponse for 

reregistration and specinl ,eview activiti"" including lime for feuding llIe instruclion und eomplcting!he necessary forms_ Send comments regarding llIe burden cstimmt: or any other lISpeel of this cOllttl;on 

of in(ormarion, inCluding suggestions ror Icclueing the burden !O Diree'or: OPPE Informalinn M"nngenl~"l Division (2137) U.S. Environmemal Protection Agency, 401 M Street, S,W" Washington, DC 

20460. 00 not ,end lhe form to Ihis "ddrcs" 

DATA MATRIX 

Dale: 12/21/2009 EPA Re No.lFile S mbol: 2517-NEW Pa e 3013 

Applicanl's/Registrant's Name & Address: 

Sergeant's Pet Care Produc1s, Inc Product: Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs 

2625 South 1581n Plaza, Omaha, NE 68130-1703 

In redient: Fi ronil 

Guideline Reference Guideline Study Name MAID Number Submitter Status Note 

Number 

Cite-all Outdoor Residential Exposure Task Force 

(#71754) 

1350 t Street, NW. 

Washinoton, DC 20005 

Cite-all Agricultural Reenlry Task Force (1171755) 

1350 t Street, N.W. 

Washinoton, DC 20005 

Cite-all Ambrands (#73342) 

t18 Y2 East Main Street, Suite 1 

Salem, VA 24153 -- Cite-ali Innovative Pest Control Products (#73766) 

PO Box 880216 

Boca Raton, FL 33488 

Cile-all FtFRA Endangered Species Task Force 

(#73989) 

C/O Harold Himmelman (Beveridge & 

Diamond) 

1350 I Streel, NW , Washinoton, DC 20005 

Cite-all Residentiat Exposure Joint Vemure (#74888) 

900 17!1l Street, NW, Suite 300, 

Washington, DC 20006 

Cite-all Agricultural Handlers Exposure Task Force 

(#75234) 

, PO Box 509 , Macon, MO 63552 L -.-

Si

g

'2 Name and Title Date 

y // / Ketty R. Hoskins, Manager of Technical Alfairs 12/21/2009 

f.rA 1'",", K~10_Jj I 18w,""~ ,"d i"I'" Vco,,,,", M',iLttk ~"~'"" ""'y r,f'C' "",,,," AI;<'''<Y inltm.1 0,. Copy 

132
FonnAI'P""'cd OMI} No. 21l'10·00r.o 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

SLl ~ 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Redaelion Ad Nolice: The public reponing b~nlcn for lhis eo!1ection of information is eSlimated In a~erage 0_25 hours per responsc for registration aetivilic.<; and 0.25 hours per lesponse 

for rcrcgislrmioo and specinl review aCli~itiCl;. inell1ding rimc far reading Ihe instruction nnd eonlpleling Ihe ncce.lsary form,. Semi eommenls legarding Ihe burden estimolc or "ny olber aspect of Ihis 

eolleclion of informnlion. inetuding svgge.~lion' for red~eing Ibe burden 10 Dircclor: OPPE Infoflnalion Man"gemcnt Divl.ion (2137) U.S. En"lfonmcntnl Proleelion Agcllcy, 401 M 'slrCCI, S.W .. 

W~sllln"lon, DC 2(l460. Do nOI ~end the form 10 Ihis a.ddre.Is. 

DATA MATRIX 

Date: 12121/2009 EPA ReoNo.lFile SYmbol: 2517-NEW Pa e10f3 

Appticant'siRegistrant's Name & Address: 

Sergeant's Pet Care Ploducts, tnc Product: Sergeant's Fipronil + S-methoprene Squeeze·On tor Dogs 

2625 South 1581~ Plaza, Omaha, NE 68130-1703 

Ingredient: S-methoprene 

Guideline Reference Guidetine Study Name MRID Number Submitter Status Note 

Number 

Cile-att ADM Alliance Nutrition, Inc, (#1157) 

tOO~~Orlh 30'h Street, Box C1 

Quine, tL 62305 

Cite-all The Hartz Mountain Corp. (-#2596) 

Attn: Robert Rosenwasser 

400 Ptaza Drive 

Secaucus. NJ 07094 

Cite-all Wellmark tnternationat (#2724) 

1501 E. Woodfietd Road, Sulte 200 Wesl 

Schaumbum, IL 60173 

Cite-all Chattem, tnc. (#40086) 

Attn: David Schitting 

t715 West 38'~ St 

Chattanoooa, TN 37409 

Cite-all Enforcer Products (#40849) 

A Division of Acuity Specialty Products 

1420 Seaboard Industrial Boutevard 

Atlanta, GA30318 

Cite-all Control Solutions, tnc. (#53883) 

5903 Genoa-Red Bluft 

Pasadena. TX 77507 

'- Dale 

S,g",,"~..&:' // Name and Tille 

,Y" 12/21/2009 

/J 4" "'.;-' Kelly R. Hoskins, Manager ot Technical Alfairs 

"I'A , no", ""n." IQ '!h,","" ,,>oJ I'M''''' V,"m'" "YoIil.lbl" Suti<"" ,,"Iv r,,,,, ,~,,,no. Agon<y I~"m'>ll! .. Copy 

133
rom, I\pproYl!(l OMIl riQ.. '(I7o·rn'w 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ~ 

~iZ 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwurk Rcduclion Ad Notice: The public rcporting burden fOI ,his colleclion of information is cslil1'alCd to avcragc 0_25 hours per response fOllcgisllalion aClivilies and 0.25 hOUIS per lesponse 

fOI reregi<lralion amI special revicw aClivili",., including lime rOI re.'\ding 'he inslruction and COn'p1cling lhe nccessnry forn"'_ Scnd commen'S regarding 'he bUI~cn cslin~'le or any olher ,,-~pec, or ,hi, 

COlicclion of infonflntion, including suggc,lions for reducing lhe bUlden to Dileclo!: OPl'E In[Olmntion Management Division (2137) U.S. Environmental PIOlcclion Agcncy, 401 M Streel. S.W., 

Washin lon, OC 20460. Do nOl seud lhe form '0 this address. 

DATA MATRIX 

Date: 12/21/2009 EPARe No.lRle S mbol: 25f7-NEW Pa e 20f3 

Applicant's/Registranl's Name & Address: Product: Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs 

Sergeant's Pet Care Products, Inc 

2625 South 158'M Plaza, Omaha, NE 68130-1703 

In redient S-metho rene 

Guideline Reference Guideline Study Name MRID Number Submiller Status Note 

Number 

Cite-all Management Contracl Services, Inc. 

(#63823) 

PO Box 5209 

Valdosta, GA 31603 

Cite-all Merial Limited (#65331) 

3239 Satellite Blvd, Bldg 500, LOC 106B 

Duluth, GA 30096 

Cite-all Spray Drift Task Force (#66607) 

McKenna, Long & Aldridge, LLP 

1900 K Street, NW 

Washi~~ton, DC 20006 

Cite-all B2E Corporalion (#69554) 

1501 East Woodfield Road 

Suite 200 West 

Schaumbu'r~: IL60173 

Cite-all Babolna Bioenvkonmental Centre Ltd 

(n-?0062) 

PO Box 5126 

Valdosta, GA 31603 

Cite-all EGIS Pharmaceuticals Public Limited Co. , 

, {#72947~ , 1150 t8 Street, NW, Suite fOOD : Washinoton, DC 20036 

Signature Name and Title Date 

~L,t/,h,e_ 12121/2009 

Keillt R. Hoskins, Manager 01 Technical Affairs 

r.M "onll ~ -:.'i 9-97 ::k:<: 0"" '"~ P' "Vc"'>",l\v.lliAl>]o .'"bm"'''''1 P'1",,,,,,,,OO "&,ncy 'n"m>l ,-",Com 

134
for", "l'pmYC<) OMD No.107!',<>Mn 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

'" "'" 401 M Street, S. W. 

WASHINGTON, D.c' 20460 P~perwork Reduclion Act Notice: The public reponillg burden for lhis collection of infomlaJinn is CSlimateil to ~vcrage 0.25 hours per re~po[)se for registration activities and 0.25 hours pcr rcsponse f[)r 

reregislmt'on nnd spcci~t review activities, including thDC fur fe<,ding the inslruction ~nd cornplet'mg Ihe necess~ry forms. Send colnmems regarding the burden estimlltc or any otlEcraspec1 oFlhis collection 

of informntion. including suggestions for reducing the burden 10 Director: OPPE lnform~tion Manngement Division (2137) U.S, Environmenmt Prmeclion Agency. 401 M Strrel, S.W., Wasl'inglon, DC 

20460. O[) not semt Ihc form to this address. 

DATA MATRIX 

Dale: 1212112009 EPA R!39 No/File §yrnbol: 2517-NEW Pa e 30t3 

Applicant'sfRegislrant's Name & Address: 

Sergeant's Pet Care Products, Inc 

2625 South 1581

" Plaza, Omaha, NE 68130-1703 

Product: Sergeant's Fipronil + S-melhoprene Squeeze-On for Dogs 

Ingredient: S-melho eoe 

Guideline Reterence Guideline Study Name MRID Number Submitter Status Note 

Number 

Cite-aU Valent Bio5Ciences Corporation (#73049) 

870 Technology Way, Suite 1000 

libertyville, Jl60048 

Cite-all AM BRANDS (#73342) 

t t8 \'2 East Main Street, Suile 1 

Salem, VA 24153 

Cite-all Marketquest, Inc., (#73510) 

t 18 Y2 East Main Street. Suite 1 

Salem, VA 24153 

Cite"all AMZO Corporation (#74032) i 

3330 Noyac Roed, Building D 

SaQ Harbor, NY 11963 

Cite-all Residential Exposure Joint Venture (#74888) 

gOO 1 ylM Street, NW, Suite 300 , Wash'lnoton, DC 20006 

Cite-all B2E Bio1ech, LLC (#75318) 

1501 East Woodfield Road, Su~e 200 West , Schaumburg, IL 60173 

Cite-alt ZaCOR Incorporated (#82122) I 

1001 G Street NW, Suite 500 West 

WashinQton, DC 2000t ; 

Signalure Name and Tille Dale I /UA' /L /,i;'.;~,~ Kelly R. Hoskins, Manager at Technical AUairs 12/2112009 

EPA Fern' $\ ~,- '''Y91) 1)10<''''"''"00 r,!,," v,·,S;;;;;, A'~",I»:. S"~m" ""iy I'"!",, ",',,,". Agency In .. ,",1 Uso ("ory 

135
ft 

- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. 

D.C. 

average 0.25 hours per response for registration activities alld 0.25 hours per response 

completing the necessary fOrms. Send commems regarding the burden estimate or any other a.>pect OflhlS 

lnfonnaliOfl Mallagement Division (2\37) U.S. Environmental Protection Agency, 401 M Street, S, W .. 

"" .......... ' ...... "- ........ ~,. 

Date: 12/21/2009 EPA Re No.lFfle S mbo!: 2517-NEW Pa e 1 of 3 

Applicant's/Regislrant's Name & Address: 

Sergeant's Pet Care Products, Inc Product: Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs 

,. NE 68130-1703 

136
~ 

- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

~d 

20460 

per response for registration activities and 025 hours per [eSpOllse 

instruction and completing the necessary foms. Send comments regarding the burden estimate or any other aspect of this 

to Director: OPPE Infonnation Management Division (2137) U.S. EnvirOnmental Protection Agency, 401 M Street, S.W., 

UrI..I..M. 

112009 EPA Re No.lF 

IRegistrant's Name & Address: 

Pet ___ Care Products, Inc Product: Sergeant's FipronH + S-methoprene Squeeze-On for Dogs 'h_. " ___ 0 __ 

Corp 

500, LOC 1068 

137
~ 

-

reregistratioJl and spec"ial review activities, i 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

average 0.25 hours per response for registration activities and 0.25 hours pef response for 

of infonnatioJl, including suggestions for reducing 

the instruction and completing the necessary fonns. Send comments regarding the burden estimate or any other aspeci of this collectIOn 

to Director: OPPE Information Management Division (2137) U.s. ErlVHonmental Protection Agency, 401 M Street, S.W" Washington, DC 

Product Sergeant's Fipronil + S-methoprene Squeeze-On for Dogs 

300, 

Kelly R Hoskins, Manager of Technical Affairs 12/21/2009 

138
~ 

-

loe 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

0,25 hours per response for registration activities and 0.25 hours per response for 

reading the instruction illld completing the necessary fomts. Send comments regarding the burden estimate or any other aspect of this 

the burden to Director: OPPE Information Management Division (2137) U,S. ElivironmcntaI Protection Agency, 401 M Street, S,W" 

DATA 

Product Sergeant's Fipronil + S·methoprene Squeeze-On for Dogs 

Attn: Robert Rosenwasser 

400 Plaza Drive 

Secaucus, NJ 07094 

1501 E. Suite 200 West 

Pasadena, TX 

of Technical Affairs 

139
n 

- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S. W. 

SHINGTON, D.C. : 

information is estimated 10 a 'cragc U . .D hours per respollse lOr reglsrratlon ijCllvltles ana U,L) hours per respouse 

IhSlruCllun ana completing the necessary forms_ Send comments regarding the burden estimate or any other aspect oflhis 

to Director: OPPE Information Managcmcnl Divisioll (2137) U.s. EnvironmclUal Protection Agency, 401 M Strcet, S.W., 

500, LOC t068 

LLP 

12121/2009 

.,..,,,,"" 

140
n 

-

reregistration and special review activities, i: 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON. D.C. 20460 to average 0.25 hours per response 

for reading the instruction and completing the necessary forms. Send comments regarding Ihe burden estimate or any other aspect 

of information, including suggestions for reducing 

Do not 

burdell to Director: QPPE Inronnation Management Division (2137) U.S. Environmental Proteclion Agency, 40) M Street, S.W., Washington, DC 

'"e Product: Sergeant's Fipronil + S-melhoprene Squeeze-On for Dogs 

NE 

Suite 200 West 

Kelly R. Hoskins, Manager of Technical Affairs 12/2112009 

141
Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in I ] is optional. Page I of9 

EPA No. 25 I 7-XX 

21 December 2009 

FRONT PANEL DOG SQUEEZE ON 

FIPRONI.l<+METHOPRENE 

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

text on front, back or side label panels] 

Sergeant's Fipronil + Methoprene Squeeze-On for Dogs 

[ABNs:[ 

[(Sergeant's) (Sentry) Frontspot Plus (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) Firstline Plus (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) Frontedge Plus (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) VetSpot Plus (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) Frontguard Plus (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) Frontier Gold (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) Frontpronil Plus (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) Fiproline Plus (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) Ectoadvance (Spot On) for dogs (and puppies)[ 

[(Sergeant's) (Sentry) Gold FrontSpot (Spot On) for dogs (and puppies)[ 

[SentryProline (Spot On) for dogs (and puppies)[ 

[SentryVet (Spot On) for dogs (and puppies)[ 

[Mosquitoes] 

[- Kills mosquitoes] [within 24 hours] 

[-Kills [and] [repels] mosquitoes that may transmit heartworm] 

[Adult Fleas [ 

[-Kills adult fleas [for up to three months.] 

[-Kills newly emerged adult Fleas before they Jay eggs] 

[-Kills [and repels] Fleas, source of [flea allergy dermatitis] [, flea bit anemia] [and 

tapework infestations]] 

[- Kills [&] [and[ [Repels] Fleas Up to [4 weeks] [1 month[ [30 days]'] 

[. If dog is at high risk for flea reinfestation a once a month application may be need-::J} 

Multiple Infestations 

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

[- Flea [&[ [and[ Tick Control for Dogs [&] [and[ Puppies 8 weeks old [&[ [and[ older[ 

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

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

[and [ pupae] 

[-Kills [&[ [and[ [Repels[ Fleas, Ticks [&[ [and[ Mosquitoes[ 

[-Breaks the Flea Life Cycle [for up to three monthsJl 

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

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

142
Sergeant's Master Label 

21 December 2009 EPA Submission EPA No. 2517,XX 

Information in [ ] is optional. Page 2 of9 21 December 2009 

FRONT PANEL DOG SQUEEZE ON 

I'IPRONIL+METHOPRENll 

[Ticks] 

[oKills fleas, ticks, mosquitoes, flea eggs, and lice] 

[ • [Seven] [7J Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea larvae 

[&] [and] flea pupae]] 

[06 [Six] Way Protection! Kills fleas, ticks, mosquitoes, lice, flea eggs [&] [and] flea 

larvae] 

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

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

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

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

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

[Once A Month Flea and Tick Treatment] 

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

[. Kills [&] [and] Repels Fleas, [and] Ticks [and mosquitoes] for up to [4 weeks] [I 

month] [30 days]'.] 

[. Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to [4 Weeks] [I month] [30 days]] 

[·[Images of the different kinds of bugs killed with a line drawn through each bug]] 

[oKills [and] [&] repels] Ticks including those that may transmit Lyme disease] 

[. Kills [and] [&] repels] Ticks for Up to [4 weeks] [I month] [30 days]!] 

[. [Kills [and Repels] [all stages of] (Deer) Ticks [before they can] [that] [transmit Lyme 

Disease,] for up to [4 weeks] [I month] [30 days] [per application]] 

[. Kills [and] [&] repels ]Ticks (Including Deer Ticks) for up to [4 weeks] [I monthj [30 

days]] 

[. Kills [and] [& ] repels] [Brown Dog ticks,] [American Dog ticks,] [and ',ope Star ticks J 

[and deer ticks] ( [(Rhipicephalus sanguineus)] for up to [4 weeks] [I month] ~30 d,~'s]] 

[0 Kills [&] [and] Repels] American Dog Ticks [(Dermacentor variabilis)] f(n up to [4 

weeks] [I month] [30 days]'] 

[Flea Eggs and Larvae] 

['Controls [flea] reinfestation [for up to [12 weeks] [3 months]]] 

[oKills adult fleas, flea eggs, flea larvae and pupae for up to [three months] [12 weekslJ 

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

[. If dog is a high risk for flea reinfestation a once month application may be needed] 

[·Kills flea eggs [larvae] [pupae] for up to [3 months] [12 weeks]] 

[0 With (S)-methoprene Insect Gro\Vth Regulator [IGR] which Breaks the Flea Life 

Cycle] 

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

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

[0 Dual Action [!]:Fipronil with (S)-methoprene IGR [insect gro\Vth regulator] 

Effectively Breaks the Flea Life Cycle] 

[·Dual Action [']; Effectively Breaks the Flea Life Cycle [']] 

[0 Kills Flea Eggs & Flea Larvae for [3 months] [12 weeks]!] 

143
Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in [ ] is optional. Page 3 of9 

EPA No. 2517-XX 

21 Decem ber 2009 

l 

FRONT PANEL DOG SQUE&ZE ON 

FIPRONIL+METlfQPRENE 

[. Prevents Flea Eggs From Developing Into Biting Adults] 

[. Kills all stages of the flea life cycle] 

[-Controls reinfestation [for up to 3 months]] 

[-Complete protection against all stages of the flea life cycle] 

[ All Others] 

[oPor Dogs and Puppies 8 weeks of age or older] 

[·Controls Sarcoptic Mange [infestations]] 

[·For Dogs [up to 22lbs], [23-44Ibs], [45-88Ibs], [89-132Ibs.] 

[·Past Acting] 

[-Dogs can be bathed 24 hours after treatmentl 

[·Long Lasting] 

[·Prevents reinfestation] 

[oEasy to use [application]] 

[-Once a month treatment recommended} 

roA once monthly application is recommended for chewing lice.] 

[oFast Action against [chewing] lice infestations] 

[. Three Applications {for cartons with 3 applicators}] andlor [3 Month Supply] or [12 

Week Supply] 

[. Four Applications {for cartons with 4 applicators} J and/or [4 Month Supply] or [16 

Week Supply] 

[0 Six Applications {for cartons with 6 applicators}] and/or [6 Month Supply] or [24 

Week Supply] 

[0 Best if used year round!] 

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

[. 4 Week Dose!] 

[. I Month Dose!] 

[. 30 Day Dose!] 

[0 Specially Formulated for Dogs and Puppies] 

[0 [Free] Calendar Stickers Inside!] 

[0 [Free] Brochure Inside!] 

[. [Free] Brochure and Calendar Stickers Inside J 

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

[. Dogs can be bathed 24 hams after Spot~on is applied] 

[-Can be used on breeding, pregnant and lactating [bitches] [female dogs]] 

[0 [Free with purchase] [Free inside] Monthly Application Reminder [Magnet} [clip] 

[card] [inside]] 

[0 Waterproof] 

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

["Monthly application reminder card inside] 

[For Dogs & Puppies] [8 weeks or older] [and] [up to 22Ibs.] 

[For Dogs 23-44 Ibs.] 

144
Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in I J is optional. Page 4 of9 

EPA No. 25 I 7-XX 

21 December 2009 

FRONT PANEL pOG SQUEEZE ON 

FIPRONIL+METHOPRENE 

]For Dogs 45-88Ibs.] 

]For Dogs 89-132 Ibs.] 

I J - Denotes Optional Statements and/or Images that May be Used on Front, Back 

or Side Label Panels 

[Ingredient Statement may be on front or back label] 

ACTIVE INGREDIENTS: 

Fipronil H ••••••••••••••••••••••• ,. ••••••••••••••••••••••••••••••••••••••••••••••• 9.8% 

(S)-methoprene .............................................................. 8.80/0 

OTHER INGREDIENTS: ........................................ 81.4% 

TOTAL: 100.0% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See [Back][or][Side] [Label Panel[sJ [or) [insert] for Additional Precautionary Statements 

NET CONTENTS: 

Contains (3) (4) (6)-0.023 fl oz (0.67 ml) applicators 

Contains (3) (4) (6)-0.045 fl oz (1.34 ml) applicators 

Contains (3) (4) (6)-0.091 fl oz (2.68 ml) applicators 

Contains (3) (4) (6)-0.136 fl 02 (4.02 ml) applicators 

{END - FRONT PANEL} 

145
Sergeant's Master Label 

2 I December 2009 EPA Submission EPA No. 2517-XX 

Information in [ ] is optional. Page 5 of9 21 December 2009 

BACK PANEL O'{)G SQUEEZE ON 

FI!'IlPNIL+MllT@!,RENE 

[brand name] cOll.tains Fipronil and S-Methoprene (insect growth regulator) (lOR) to effectively 

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

The active ingredients in [brand name] work by collecting in the hair follicles and skin oils. This 

product features a sustained-release formula that discharges from the animal's hair follicles using 

the natural skin oils, resulting in fast-acting [and long-lasting] control of fleas, ticks, mosquitoes 

and chewing lice [for 30 days]. 

[Diagram with visual of Fipronil collecting and being released from hair follicle] 

READ ENTIRE LABEL BEFORE EACH USE. 

USE ONLY ON DOGS AND PUPPIES OVER 8 WEEKS OF AGE. 

PRECAUTIONARY STATEMENTS 

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

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 puppies 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 application. If signs persist, 

or become more severe within a few days of application, consult a veterinarian immediately. If 

your pet has an unusual reaction to the initial application, consult a veterinarian before repeating 

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

on medicated, debilitated or aged animals. Call 1-800-224-PETS [7387] for 24-hour assistance. 

PHYSICAL OR CHEMICAL HAZARDS 

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

FIRST AID 

If swallowed Call a poison control center for 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 anY1hing by mouth to an unconscious person. 

Ifin eyes Flush eyes with plenty of water. Call a doctor if irritation persists. 

If on skin Wash with plenty of soap and water. Get medical attentioii if 

irritation persists. -

HOTLINE NUMBER 

-

Have the product container or label with you when calling a poison control cer.t~r cr doctor, or 

going for treatment. You may also contact 1-800-224-PETS [7387J for emergency medic'li 

treatment infonnation. 

146
Sergeant's Master Label 

21 December 2009 EPA Submission EPA No. 2517-XX 

Information in [ ] is optional. Page 6 0[9 

BACK PANEL 

DIRECTIONS FOR USE 

21 December 2009 

DOG SQUE.EZE ON 

FIPRO~IL+METHQPRENE 

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 DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON 

OTHER ANIMALS. 

Do not use on puppies under 8 weeks of age. Weigh your dog to be sure you are applying the 

right dose formulated for the weight of your pet. Best ifused year round. Consult a veterinarian 

before using this product on debilitated, aged, medicated dogs. Can be used on breeding, 

pregnant, or nursing dogs. Consult a veterinarian before using on dogs 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 dog with a mild soap and rinse 

with large amounts of water. If signs continue, consult a veterinarian immediately. 

HOW TO APPLY AND OPEN CHILD RESISTANT PACKAGING: Remove product tube 

from package. Holding tube with top end pointing up and away from face and body, cut off top 

end with scissors. Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly 

to apply all of the solution to the dog's skin, as directed below. Repeat application may be made 

ifnecessary, but do not apply more often than once every 4 weeks. 

FREQUENCY OF APPLICA nON 

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

infestations. (Studies show that] (brand name] kills all stages of the flea for up to three months. 

If your pet is at high risk for flea reinfestation[, or in a highly infested environment], apply 

monthly. Apply monthly to control ticks, mosquitoes and chewing lice. (Brand name] remains 

effective even after bathing, water immersion, or exposure to sunlight. Allow treated area to dry 

thoroughly. Do not reapply for 30 days. 

For Dogs Weighing up to 221bs. (including small dogs and puppies, 8 weeks or older}: 

{For cartons containing .67 ml (0.023 fl. oz.) applicator tubes} 

Apply one tube (.67ml)(0.023 fl. 02.) from the back of the neck to a point midway betweer: t!1e 

neck and tail. 

For Dogs Weighing 23 - 441bs. 

{For cartons containing 1.34 ml (0.045 fl. oz.) applicator tubes} 

Apply one tube (1.34 ml)(0.04S fl. oz.) from the back of the neck to a point mi(h'v3Y uetween the 

neck and tail. 

For Dogs Weighing 45 - 88 lbs. 

For cartons containing 2.68 ml (0.091 fl. oz.) applicator tube} 

Apply one tube (2.68 ml )(0.091 fl. oz.) from the back of the neck to a point midway between the 

neck and tail. 

147
Sergeant's Master Label 

21 December 2009 EPA Submission EPA No. 25 1 7-XX 

Information in [ 1 is optional. Page 7 of9 

BACK PANEL 

For Dogs Weighing 89-132 Ibs. 

{For cartons containing 4.02ml (0.136 fl. oz.) applicator tube} 

21 December 2009 

DOG SQEEZE ON 

FIPRONIL+METHOIlRENE 

Apply one tube (4.02 ml)(O.136 fl. oz.) from the back of the neck to a point midway between the 

neck and taiL 

STORAGE AND DISPOSAL 

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

(below 77°F [25°C)) dry place inaccessible to children and pets. Do not refrigerate. Protect 

from direct sunlight. 

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

container. Offer for recycling if available. If partly filled: Call yOUf 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 ofthe 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 681 54-0399.J 

In Case of Emergency, call: 1-800-781-4738 [For more infonnation) [Visit us at:] 

[www.sergeants.comJ 

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

Distributed by: 

Sergeant's Pet Care Products, Inc. 

P.O. Box 540399 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-XX 

EPA Est. No. XXXXX -XX -XXX 

[BAR CODE t.:<EAJ 

148
Sergeant's Master Label 

21 December 2009 EPA Submission 

1nformation in [ ] is optional. Page 80f9 

EPA No. 2517-XX 

21 December 2009 

BACK PANEL DOG SQEEZE ON 

FIPRONIL.+METHQp.RENE 

{END - BACK I SIDE PANEL) 

{START - OPTIONAL INSERT OR PACKAGE COPY) 

(. How to Apply and Open Child Resistant Packaging - May contain graphics 

illustrating product usc, e.g., dog 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] 

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

3. Squeeze tube firmly to apply all of the solution to the dog's skin from the back of the 

lleck to a point midway between the neck and tail.] 

[Flea life cyc1e 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 fill in name)] 

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

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

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

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

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

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

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

[brand name] in 30 days.] 

[Monthly Application Reminder Magnet (image ofreminder magnet) 

Enclosed for your convenience is an application reminder magnet. Push the (reset) button, allti 

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

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

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

another 30 days.] 

{END - OPTlONAL INSERT OR PACKAGE COPY) 

149
Sergeant's Master Label 

21 December 2009 EPA Submission EPA No. 25 I 7-XX 

Information in [ 1 is optional. Page 9 of9 21 December 2009 

rUBE I VIAL LABEL 

Front Label 

{Brand Name} 

Fipronil 9.8% W/W, (S)-methoprene 8.8% 

W/W 

0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 

mL {label code} 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

CAUTION: Read directions and precautions 

before using. Open with scissors. 

EPA REG. No. 2517-XX 

{label code} 

150
Pages 151 through 155 contain the product confidential statement of formula and is not included in this copy.