EPA Registration Jacket 2517‐135
/ 

21-Day Screen Completed by 

Contractor 

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

Jacket # ;?5J7-/fbL 

MRID# ___ _ 

Content Screen: Recommended to t! a s3F ail 

86-5 Review: Passed/FaiIedlB"A] 

Transfer This Jacket to: 

1
) 

To the Document Center (ITRMD) 

*Please transfer jacket jmini-jacket to Product 

Manager Team circled below: 

Minor Use Section PM-5 

Insecticide Branch PM-l0 M-13 

Herbicide Branch PM-23 PM-25 

Fungicide Branch PM-21 PM-22 

Insect /Rodent Br. PM-l PM-7 

*Reminder to PM - If applicable pick-up data 

from Screening Room. 

procesL

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

(Team Memb~r Signature) ( at ) 

2
) 

PRIA 2 - 21 Day Content Screen Review Worksheet 

(EP AlOPP Use Only) 

3/23/09 

21 Day Screen Start Date: I t - Z '2 - 0 'i 

Experts In-Processing Signature: }'V/ E ;/1!/l.d/N6/(J~ Date J .... y. -/0 Fee Paid: Yes / 

Division management contacted on issues No Yes Date ______ _ 

EPA Reg. Number: 2~n- Q&L EPA Receipt Date: I?.-z. '2-{)'i 

Items for Review Yes No N/A* 

1 Application Form (EPA Fonn 8570-1)(link to form) signed & complete X- including package type 

Confidential Statement of Formula all boxes completed, fonn signed, and X dated (EPA FOIm 8570-4) (Link to fonn) 2 a) All inerts (link to http://www.epa.gov/opprdOOl/inelis/), yes no 

including fragrances, approved for the proposed uses (see x: Footnote A) / 

3 Certification with Respect to Citation of Data (EPA Fonn 8570-34) (Link to 

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

Certificate and data matrix consistent K 

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

to pay statement included. (see Footnote B) 

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

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

4 completed and signed (N/A if source is unregistered or applicant owns the )( tecbnical) 

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

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

repack)' 

5 ves no "i,':y.Q' 

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

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

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

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

6 (Electronic labels on CD are encouraged and guidance is available)( link to )< httpJ/www .epa.gov/pesticides/regulating/reg·lstering/submisslons/index.htm#!abels 

11 

I 

3
.!. ,-

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

Notice of Filing Qink to 

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

>:- with petitions (link to 

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

9 If applicable for conventional applications, reduced risk rationale (link to X http://,,,ww.epa.gov/opprdOOllworkplanireducedrisk.html) 

Required Data (link to 

htto://'''~-w.eRa.gov/[!:esticides/regulatin2ldata reguirements.htm) and/or 

data waivers. See Footnote C. 

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

10 

2 

4
Comments: 

There Glr\C no sf r.;c/; ~1J 

r Jf I 

1 C/ C i'l ~ T I ~ 

,if (! c 

* NI A - Not Applicable 

Footnotes 

Qj'J~O c! a.f'''d 

c, ( ( c t,J f / J! , j '/ 

. j • J ! / 6 !A . ; u 

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

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

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

example, removing the inert, substituting it \Vith an approved inert, submitting 

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

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

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

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

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

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

application as described below. 

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

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

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

3 

5
) 

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

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

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

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

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

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

delays. 

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

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

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

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

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

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

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

Microbial Pesticides Branch [Link to 

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

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

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

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

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

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

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

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

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

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

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

Agency will reject the application. 

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

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

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

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

applicant with the following options: 

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

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

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

approved for the application's uses; or 

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

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

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 

6
') 

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

category estimated); or 

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

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

25% of the full fee of the category identified. 

Conventional New Product Applications 

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

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

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

following'options: 

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

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

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

approved for the application's uses; or 

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

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

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

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

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

Agency within the 21 day content review period.) 

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

category estimated); or 

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

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

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

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

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

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

options: 

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

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

approved; or 

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

unapproved inert. If an inert ingredient tolerance exemption petition is 

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

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

Agency will discuss hannonizing the timeframe for both actions. 

5 

7
) 

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

category estimated); or 

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

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

the fee. 

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

me-too or fast track (similarlidentical) new product, R300 or A530, an application 

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

AS31. The Agency reconunends that authorizations of offers to pay be submitted with 

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

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

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

should be submitted with the study waiver. 

6 

8
IFee for Servicel 

/ 

{864749ZThis package includes the following 

@New Registration 

o Amendment 

o Studies? o Fee Waiver? 

o volpay % Reduction: 

for Division . 

OAD 

oBPPD 

@RD 

Risk Mgr. [JQJ 

Receipt No. s-I 864749 

~=====::::==:== EPA File Symbol/Reg. No. 1 2517-RGL 

Pin-Punch Date: 1 12/22/2009 

This item is NOT subject to FFS action. 

I 

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

·-------fjArrc.fution-eudB: 1 j Parent/Child Decisions: 

Requested: I '¥:,'}60 

Granted: I \1.-3== 

Amount Due: $ \,31;,5. c~ I 

I" .1 J n' I c I ~--________ ...-J _vl,~ {'1l'~..y-zL..,., ';. le,,"",- J t2-i-f]JJ_-

o i4 Inert Cleared for Intended Use 

Reviewer: 

Remarks: 

tlrc be> ~ 

Uncleared Inert in Product 

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

9
10
Material to be added to an e-Jacket or Jacket 

Reg. No. ?:')Il - I 3S 

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

1. f15 Placement within the e-Jacket/Jacket r Default: (chronological, top = newest) 

o File Location: (PDF page number) 

2. W Send to Data Extraction contractors this material: 

]V Newly stamped accepted label 

o Notification 

rp New CSfS, (?,') ff)iUv\v'Ll~ 

o Other: ___________ _ 

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

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

material with this coversheet to staff in the Information Services 

Center (Room 5-4900). 

Reviewer's Name: Rosanna Louie 

Phone: 308.0037 Division: RD 

Date: "7 'rclo ""20\) 

11
U.S. ENVIRONMENTAL PROTECTION 

AGENCY 

Office of Peslicide Programs 

Regislration Division (7504P) 

1200 Pennsylvania Ave., N.W. 

Washington, D.C. 20460 

NOTICE OF PESTICIDE, 

0" Registration 

o Reregistration 

(under the Federal Insecticide, Fungicide, 

and Rodenticide Act, as amended) 

Name and Address of Registrant (include ZIP Code): 

Sergeant's Pet Care Products, Inc. 

c/o Exponent, Inc. 

2625 South 1581h Plaza 

Omaha, NE 68130 

EPA Registration No. Date of Issuance: 

2517-135 January 28, 2011 

Tenn of Issuance: 

Conditional Registration 

TimeRlimited: see conditionS below 

Name of Pesticide Product: 

Sergeant's Fipronil + Methoprene SpotR 

on for Cats 

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

Federal Insecticide, Fungicide and Rodenticide Act. 

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

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

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

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

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

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

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

for shipment. 

You must provide the Agency with a projected release for shipment date within 3 ° days of the 

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

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

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

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

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

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

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

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

at and 12 month intervals. 

P~ge 10f5 

12
4. The approval of this registration is contingent on the Agency's review to determine that the study 

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

Method, is acceptable to support the registration. 

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

you must provide the Agency the following: 

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

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

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

obtained; and 

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

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

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

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

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

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

two months after each quarter ends. 

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

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

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

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

incident: 

EPA Registration Number 

Product name (brand name) 

Lot # 

Where purchased: internet, store, veterinarian 

Active Ingredient(s) 

Weight range for product 

Date on which incident occurred. (mmldd/yyyy) 

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

Registrant case # 

Species: dog, cat, other (specifY) 

Breed: (as reported by pet owner) 

Age: months or years 

Sex: M, F, or neutered 

Weight: pounds 

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

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

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

Time to Onset: (hours, days) 

Treated by veterinarian: yes or no 

First time product used: yes or no 

Page 2 of 5 

13
Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) 

Any known precondition 

EPA Severity Code: death, major, moderate, minor 

Outcome: died, recovered, still treated, unknown 

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

include the following details: 

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

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

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

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

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

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

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

incidents of each severity code for each route of exposure. 

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

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

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

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

yr, 7 yr, 8 yr, 9 yr, 10 yr, II yr, 12 yr, 13 yr, 14 yr, IS yr, > 15 yr. 

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

weight range on the product label (if applicable). 

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

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

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

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

weight range (if applicable). 

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

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

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

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

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

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

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

Page 3 of5 

14
All labeling comments below are in reference to the proposed master label, dated January 20, 2011. 

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

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

10. On page I under Multiple Infestations, revise the claims per our discussion (delete struck-out text 

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

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

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

the development of flea pupae]]" 

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

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

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

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

flea eggs, flea eggs & larvaeH" 

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

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

read as follows: 

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

weeksJ[1 month][30 days]]" 

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

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

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

underlined words) to read as follows: 

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

six weeks]]" 

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

development of flea pupae)]" 

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

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

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

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

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

"ff3} applications]" 

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

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

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

not been submitted to the Agency for review. 

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

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

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

Page40f5 

15
assumed by the user or buyer" and "Sergeant's is committed to providing ... " so that the warranty 

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

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

instead of a separate insert to accompany the product. 

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

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

expression. 

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

lfthe Agency detennines that future mitigation measures are necessary for all pet spot~on 

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

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

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

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

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

enclosed for your records. Please contact Rosanna Louie~Juzwiak at (703) 308~0037 with any questions. 

Enclosure: Sergeant's Fipronil + Methoprene Spot~on for Cats Label, Stamped Accepted with Comments 

Si~n~_ 1\ _ ~_ -{;( uP 

Richard Gebken, Product Manager (1 0) 

Registration Division, Insecticide Branch 

EPA Form 8570·6 

Page 5 of 5 

Date: 

16
Sergeant's Master Label 

20 January 2011 Version 10.1 EPA No. 2517-RGL 

Information in [ J is optional. Page 1 of9 

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

front, back or side label panels [ 

Sergeant's Fipronil + Methoprene Spot-On for Cats 

[ABNs] 

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

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

[SentryProline (Spot On) for cats] 

[[SENTRY®] FIPROGUARDTM PLUS for cats] 

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

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

[Apply to kittens over 8 weeks old] 

[Apply to kittens 8 weeks or older] 

[Mosquitoes J 

ACCEPTED 

with COMMENTS 

In EPA Letter Dated: 

JAN 2 8 2011 

Under the Federal Insecticide, 

Fungicide, and RodenticldeAct, 

as amended, for the pesticide 

registered under EPA Reg. No. _ 21;)1 J-13 s: 

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

up to 28 days] 

[Adult Fleas] 

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

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

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

anemia] 

[Multiple Infestations] 

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

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

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

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

prevents flea pupaeJJ 

[·Breaks the Flea Life Cycle [for Ujl '0 three mOHilis]] 

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

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

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

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

eggs, flea larvae and prevents flea pupae]] 

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

flea larvae] 

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

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

Control] 

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

17
Sergeant's Master Label 

20 January 2011 Version 10.1 

Page 2 of9 

EPA No. 2517-RGL 

Information in [ J is optional. 

[Ticks] 

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

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

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

[Once A Month Flea and Tick Treatment] 

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

[0 Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to [4 Weeks] [1 month] [30 

days]] 

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

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

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

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

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

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

month] [30 days]] 

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

disease,3 [for up to [4 wecks] [1 ffioHlfl] [30 days3 [per application]]] 

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

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

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

month] [30 days]!] 

[Flea Eggs and Larvae] 

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

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

[-Kills all stages of the flea (adult fleas, flea eggs, flea larvae and prevents flea 

pupae)] 

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

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

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

Life Cyclc] 

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

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

[0 Dual Action [I]: Fipronil with (S)-methoprenc [insect growth regulator] [IGR] 

Effectively Breaks the Flea Life Cycle] 

[0 Dual Action [I]: Effectively Breaks the Flea Life Cycler!]] 

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

[- Prevents Flea Eggs From Developing Into Biting Adults] 

[0 Kills all stages of the flea lire cycle] 

18
Sergeant's Master Label 

20 January2011 Version 10.1 

Information in [ 1 is optional. Page 3 of 9 

[All Others] 

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

[-Stops and prevents infestations of listed pests] 

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

[·Past Acting] 

[-Effective even after bathing] 

[. Long Lasting] 

[-Once a month treatment] 

[-Past Action against chewing lice infestations] 

EPA No. 2517·RGL 

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

[. Best if used year round!] 

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

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

[. I Month Dose!] 

[. Easy to Use [Application]] 

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

[. [Pree] Calendar Stickers Inside!] 

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

[. Waterproof] 

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

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

[clip] [inside]] 

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

[. Monthly application reminder inside] 

[. Pipronil (9.8%) + (S)-methoprene (11.8%)] 

[. Lift [here] for more information] 

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

Frontline Plus®*] 

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

Plus® is a registered trademark of Me riaL] 

[f3t applications] 

[Rapid elimination of chewing lice infestation] 

[Effective after bathing and exposure to water and sunlight] 

19
Sergeant's Master Label 

20 January 2011 Version 10.1 

Information in [ ] is optional. Page 4 of9 

[For use ONLY on cats] 

[of ALL weights] 

[over 8 weeks of age] 

ACTIVE INGREDIENTS: 

FiproniI ............................................... 9.80% 

(S)~methoprene ............................... 11.80% 

OTHER INGREDIENT** ......... 78.40 % 

TOTAL 100.00% 

[**diethylene glycol monoethyI cther[ 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

EPA No. 25I7-RGL 

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

NET CONTENTS: 

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

{END - FRONT PANEL} 

20
Sergeant's Master Label 

20 January 2011 Version 10.1 EPA No. 2517-RGL 

1nfonnation in I 1 is optional. Page 7 of9 

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

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

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

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

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

STORAGE AND DISPOSAL 

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

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

refrigerate. Protect from direct sunlight. 

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

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

waste agency for disposal instructions. Neyer place unused product down any indoor or 

outdoor drain 

[WARRANTY 

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

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

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

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

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

{Sergeant's is committed to providing high quality products. To the extent consistent 

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

merchantability or of fitness for a particular purpose or otherwise, that extend beyond 

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

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

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

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

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

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

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

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

Distributed by: 

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

P.O. Box 540399 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-RGL 

EPA Est. No. XXXXX-XX-XXX 

{END - BACK I SIDE PANEL} 

21
20 January 20 II 

Sergeant's Master Label , Version 10.1 EPA No. 25I7-RGL 

Infonnation in [ 1 is optional. Page 8 of9 

{START - OPTIONAL INSERT OR PACKAGE COPY} 

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

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

and/or applicator labeling.1 

[Application Instructions1 [Directions for Use1 

How to Open: 

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

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

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

notches with scissors. 

How to Apply: 

[Optional diagram mayor may not appear on finished label} 

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

2. Apply contents of one [0.017 fl a'l [0.50 mL] tube [vial} of {Product Name} 

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

shoulder blades} [as a spot between the shoulder blades]. Squeeze tube 

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

[Flea life cycle diagram] [Flea Life Cycle] 

[Look at the Label (Look at the Label icon) [Easy] 6 Step [Easy] [Spot On] [SqueezeOn] [Topical] Checklist 

• Read the label completely and follow directions 

• Weigh your pet 

• Do NOT use dog products on cats 

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

• Separate animals after treatment to avoid chance of ingestion 

• Do NOT split tubes between pets} 

22
\ 

Sergeant's Master Label 

20 January 2011 

Information in ( J is optional. 

[Brand NameJ 

[Monthly reminder card] 

[3J [Month Treatment TrackerJ 

Version 10.1 

Page 90f9 

EPA No. 2517-RGL 

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

monthly.J 

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

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

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

MMlDDIYY)J 

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

reapply Jl?rand nameJ in 30 days.J 

[Monthly Application Reminder Magnet (image of reminder magnet)] 

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

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

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

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

this will reset the timer for another 30 days.] 

{END - OPTIONAL INSERT OR PACKAGE COPY} 

g~.;I!~J!;~ 

Front Label 

{Brand Name} [For use 'only on catslkittens 

8 weeks or older} 

Fipronil 9.8% w/w, (S)-methoprene 11.8% w/w 

0.50 mL {label code} 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

CAUTION: Read directions and precautions 

before using. Use scissors to open. 

EPA REG. No. 25l7-RGL {label code} 

23
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24
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2517- \ 35 

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38.1mm 

8mm 

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PRONYL OTCTM PLUS 

ART INSTRUcnON FOR THE PRINTER 

--~LACK PMS 260 

Printer/Vendor: Date sent: 

Additional Notes: 

Labels adhere to White Tubes 

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34
) 

DATA PACKAGE BEAN SHEET 

Date: 09-Nov-2010 

Page 1 of 1 

* * * Registration Information * * * 

Decision #: 425454 

DP #: (383881) 

PRIA 

Parent DP #: 

Submission #: 884815 

Registration: 2517-RGL - SERGEANTS FIPRONIL + S·METHOPRENE SPOT -ON FOR ( 

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

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

Risk Manager Reviewer: ~R~"~'~"~",~"~,":;'~R~"O~U~I~E~_~;;;;;~;;;;~~~,;;;;;;~;::.:-_ Sent Date: ~1-Nov.2010 Calculated Due Date: e4-Nov-ZU10 

~J.AN''2.01t 

Edited Due Date: ____ _ 

Type of Registration: Product Registration - Section 3 

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

Ingredients: 105402, S-Methoprene(11.8%) 

129121, Fipronil(9.8%} 

* * * Data Package Information * * * 

Expedite: 0 Yes. No 

DP Ingredient: 105402, S-Methoprene 

129121, Fipronil 

DP Title: #2517-RGl: CRP Stvdy Resubmission 

Date Sent: 09-Nov-2010 Due Back: ____ _ 

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

Assigned To Date Out 

Organization: R~D"-'.I~TR~B,,-_______ _ {zI13/{tJ last Possible Science Due Date: U5~Ct~~ 2-el0 

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

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

Contractor Name: __________ _ 

* * * Studies Sent for Review * * * 

No Studies 

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

Can be printed on its own page 

* * * Data Package Instructions * * * 

RESUBMISSION 

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

louie-Juzwiak with any questions. 

Attachments: 

Cover letter MRID 48279600 

CRP Resubmission (1746-001) MRID 48279601 

CD of the Study 

35
) 

CHILD-RESISTANT PACKAGING REVIEW 

Technical Review Branch 

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

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

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

DP Barcode 383875 & 383881 

Decision # 425437 & 425454 

EPA Petition or EUP No. ___ _ 

Date Division Received -'1,,01"'2"'9'-/1[.>0'-__ _ 

Type Product(s) Insecticide (flea product) 

Data Accession No(s). 48279600 48279601 

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

Division "R",D,-__ 

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

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

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

support CRP certification for 2517-RGT & Review of CRP 

studies EPA Reg. No. 2517-RGT to determine if they are 

adeguate to support CRP certification for 2517-RGL 

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

Fipronil 9.8% 

S-Methoprene 11.8% 

Summary of Findings 

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

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

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

during testing, 

Should any human experience/epidemiological evidence indicate a 

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

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

package involved. 

36
2 

Package 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

narrow end at the notches with scissors." 

Toxicity 

The toxicity of the product is based on the toxicity of Fiproni!. The toxic or 

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

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

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

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

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

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

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

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

37
3 

Toxicity, Child Failure, and Package 

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

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

2517-RGT 0.5 0.017 1.030 9.7 49.96 1 

2517-RGL 0.5 0.017 1.025 9.8 50.23 1 

Failure 

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

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

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

complete access to the placebo (water). 

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

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

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

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

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

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

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

second and third applicator. 

Analysis of Data and Conclusion 

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

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

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

used in the CRP testing. 

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

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

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

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

38
failures. This study was a pass according to the child sequential test in 16 CFR 

1700.20. 

4 

Senior Adult Use Effectiveness Study 3 white applicators with purple stripe 

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

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

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

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

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

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

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

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

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

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

subjects in accordance with 16 CFR 1700.20. 

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

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

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

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

RGT meets the CRP test requirements. 

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

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

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

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

establish that they are CRP. 

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

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

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

during testing. 

Should any human experience/epidemiological evidence indicate a 

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

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

package involved. 

39
December 13, 2010 

Sergeant's Fipronil Spot On For Cats 

nt's Pet Care Products, Inc. 

Chemical- Fipronil9.7% 

ectiveness failure is failure to access the applicator in the prescribed test time of 5 min. for the first package 

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

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

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

and cutting open a second or second and third applicator. 

s to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

g the applicator or any partial or complete access to the placebo (water). 

mful amt = 28.5mg = 28.5mg divided by [1 030mg/ml x 0.097 Fipronil] = 0.285 ml = 0,29 ml for Fipronil only 

RGT 

mful amt = 28,5mg = 28.5mg divided by [1025 mg/ml x 0.098 Fipronil] = 0.284 ml = 0.28 ml for Fipronil & S

REG # 2517-RGL 

cator is the child-resistant feature, 

cators are filled in ml, 

1 

udies were submitted by the Company to cover the 5 sizes (0.5, 0,67,1.34,2,68,4.02 ml) for the Fipronil 

he Fipronil and S·Methoprene products. This is based on the registrant's submission of: samples of 

cator as tested and proposed to be marketed for the Fipronil only and the Fipronil and S·Methoprene 

 which appeared to be identical; and a June 30, 2010 letter indicating the same applicator color (white) 

eight colors will be used for both the Fipronil only and the Fipronil and S·Methoprene products as was 

e CRP testing. 

40
2 

PKG Description Include # Pkges Com pany Data Data Conclusion . 

ml per Pkg 

# unitfpkg, child fail = # Child Get CRE SAUE Compreh Only include eRE & SAUE via computer analysis 

units, color, toxfharm = # at Begin ens'lve Camp 

units Test Review uter 

& why Analy 

sis 

3 white applicators with 1 setof3 o child XCRE CRP Certification 5/27/10 is acceptable. 

purple stripe on label applicators failures = associat Label dated 6/29/10 same CRP directions as 

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

Each applicator@ O.Sml to each child test lowest Oata Analysis showed no child failures. 

water as placebo. other. SAUE Study Is a pass of the child test according 

ToX/harm = 1 applicator, to the sequential test chart in 16 CFR 

child fail = 1 applicator 1700.20. 

3 white applicators with 1 set of 3 90% X lowest CRP Certification 5/27/10 is acceptable. 

purple stripe on label applicators SAUE SAUE Label dated 6/29/10 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 = 1 applicator, B, which is the maximum number of failures 

child fail = 1 applicator for a passed SAUE. The SAUE is 90%. The 

study is a pass of the senior adult test in 

16 CFR 1700.20 and the effectiveness 

specifications In 16 CFR1700.15(b). The 

number of subjects per test site was corrected 

such that 9 subjects (90-98) were coded as 

being tested at site H980 rather than site 

H902 (a different location within a mall, a 

distinction not previously made). Site H902 

now is 24% of test subjects in accordance with 

16 CFR 1700.20. 

41
Sergeant's Fipronil + S-Methoprene Spot On For Cats 

nt's Pet Care Products, Inc. 

Chemical - Fipronil 9,8% 

S-Methoprene 11.8% 

3 

December 13, 2010 

ectiveness failure is failure to access the applicator in the prescribed test time of 5 min. for the first package or 

ckage, not opening the applicator with scissors along the needle application tip, cutting the applicator between 

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

or at other locations, cutting off the bottom of the main chamber of the applicator, or not separating a single 

g open a second or second and third applicator. 

 to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for ali sizes. 

 the applicator or any partial or complete access to the placebo (water). 

mful amt = 28.5mg = 28.5mg divided by [1030mg/ml x 0.097 Fipronil] = 0.285 ml = 0.29 ml for Fipronil only 

RGT 

mful amt = 28.5mg = 28.5mg div'lded by [1025 mglm x 0.098 Fipronil]: 0.284 ml = 0.28 ml for Fipronil & S

EG # 2517-RGL 

.8% 

cator is the child-resistant feature, 

ators are filled in mi. 

udies were submitted by the Company to cover the 5 sizes (0.5, 0.67,1.34, 2.68, 4.02 ml) for the Fipronil 

he Fipronil and S-Methoprene products, This is based on the registrant's submission of: samples of 

ator as tested and proposed to be marketed for the Fipronil only and the Fipronil and S-Methoprene 

which appeared to be identical; and a June 30, 2010 letter indicating the same applicator color (white) 

ight colors will be used for both the Fipronil only and the Fipronil and S-Methoprene products as was 

e CRP testing. 

42
4 

PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# uniUpkg, child fail ::: # Child Get at CRE SAUE compreh Only include eRE & SAUE via computer 

units, color, tox/harm ::: # Begin Test ensive Computer analysis 

units Review Analysis 

& why 

 3 white applicators with 1 setof3 CRP Certification 5/27/10 is 

3 purple stripe on label applicators acceptable. Label dated 6/29/10 

 connected to each other. connected same CRP directions as in study 

Each applicator@ 0.5ml to each mentioned below. Size accepted 

water as placebo. other. based on: 

ToX/harm ::: 1 applicator, MRID 48279601 (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 CF-R 

1700,20. The SAUE is 90%. The 

study is a pass of the senior adult 

test in 16 CFR 1700.20 and the 

effectiveness specifications In 16 

CFR1700.1S(b). 

Bridging Letter 6/30/10 indicating 

same size and color package as 

package tested is okay. 

43
) 3> 

DATA PACKAGE BEAN SHEET 

Date: 22-Jun-2010 

Page! of 1 

* '* * Registration Information * * * 

Decision #: 425454 

DP #: (379385) 

PRJA 

Parent DP #: 

Submission #: 873355 

Registration: 2517-RGL - SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FORL4T 

Company: 2517· SERGEANTS PET CARE PRODUCTS, INC. 

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

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS 

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

Type of Registration: Product Registration _ Section 3 

Edited Due Date: 

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

Ingredients: 105402, S-Methoprene(11.8%) 

129121, Fipronil(9.8%) 

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

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

DP Ingredient: 105402, S-Melhoprene 

12912 I, Fipronil 

Due Back: 

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

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

Assigned To Date In 

_~ I ~-z-I\O ~~ 

:d'~1'1A Organization: "R~D~I~T"R~B ______ _ last Possible Science Due Date: 05-0cl-2010 

Team Name: Child Resistanl Packaging Science Due Dale: ___ _ 

Reviewer Name: _____ _ Sub Data Package Due Date: 

Contraclor Name: 

* * * Studies Sent for Review * * * 

No Studies 

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

Can be printed on its own page 

* * * Data Package Instructions * * * 1 .. 

For your review: Application for a fipronilf3-melhoprene EP. presumably me-too of Merial's 65331-4 / kJ ~ Thx, baa I . ______________ _ 

44
CHILD-RESISTANT PACKAGING REVIEW 

Technical Review Branch 

IN 6/22/2010 OUT 9/28/2010 

RD, TRB, Reviewed by RO~~10 

EPA Reg. No. or File Symbol 2517-RGL 

DP Baroode DP379385 

Decision # 425454 

EPA Petition or EUP No. ___ _ 

Date Division Received 4/12/2010 

Type Product(s) Insecticide (flea product) 

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

Product Mgr.lChemical Review Mgr/Contact Person RM 10 Bonaventure Akinlosotu 

Division roR",D,-__ 

Product Name(s) Sergeant's Fipronil + S-Methoprene Spot-On for Cats 

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

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

determine if they are adequate to support CRP certification 

for this product 

Active Ingredient(s), PC oode, & % Fipronil 9.8% 

S-Methoprene 11.8% 

Summary of Findings 

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

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

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

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

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

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

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

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

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

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

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

45
per test site and per tester. The corrected/new study and a new electronic CD for 

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

section below. 

Should any human experience/epidemiological evidence indicate a 

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

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

package involved. 

Package 

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

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

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

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

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

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

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

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

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

placebo, comes in 5 different sizes (0.5.0.67, 1.34,2.68,4.02 ml). 

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

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

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

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

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

narrow end at the notches with scissors." 

Toxicity 

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

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

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

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

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

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

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

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

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

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

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

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

46
3 

Toxicity, Child Failure, and Package 

EPA Reg# ml (1ml :z FI. Oz. (29.6ml Produc1 % Fipronil mg Flpronll # uni1 "'tox 

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

2517-RGT 0.5 0.017 1.030 9.7 49.96 1 

2517-RGA 0.67 0.023 1.020 9.7 66.29 1 

2517-RGA 1.34 0.045 1.020 9.7 132.58 1 

2S17-RGA 2.68 0.091 1.020 9.7 265.16 1 

2517-RGA 4.02 0.136 1.020 9.7 397.74 1 

2517-RGL 0.5 0.017 1.025 9.8 50.23 1 

2517-RGU 0.67 0.023 1.020 9.8 66.97 1 

2S17-RGU 1.34 0.045 1.020 9.8 133.95 1 

47
4 

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

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

2517·RGU 2.68 0.091 1.020 9.8 267.89 1 

2517-RGU 4.02 0.136 1.020 9.8 401.84 1 

Failure 

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

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

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

complete access to the placebo (water). 

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

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

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

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

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

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

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

second and third applicator. 

Analysis of Data and Conclusion 

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

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

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

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

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

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

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

direelions as were used in the CRP testing. 

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

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

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

48
MRID number 48059805. A comprehensive review was done for the lowest SAUE 

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

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

Child Study 3 white applicators with purple stripe on label size O.S ml size 

(MRID 480S9S03) involved giving each child 1 set of 3 applicators connected to each 

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

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

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

5 

Senior Adult Use Effectiveness Study 3 white applicators with purple stripe 

on label size O.S ml size (MRID 480S9S03 which is the lowest SAUE) involved 

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

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

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

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

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

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

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

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

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

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

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

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

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

(MRID 480S980S which is the lowest CRE) involved giving each child 1 set of 3 

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

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

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

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

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

CFR 1700.20. 

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

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

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

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

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

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

CFR 1700.1S(b). 

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

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

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

49
requirements in 16 CFR 1700.20 and the effectiveness specifications in 16 CFR 

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

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

6 

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

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

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

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

of that information: 

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

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

requirements. 

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

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

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

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

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

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

establish that they are CRP. 

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

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

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

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

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

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

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

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

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

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

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

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

it will need to be subm ilted. 

Should any human experience/epidemiological evidence indicate a 

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

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

package involved. 

50
 Sergeant's Fipronil Spot On For Cats 

 Sergeant's Fipronil Squeeze On For Dogs 

ant's Pet Care Products, Inc. 

Chemical- FiproniI9.7% 

September 28, 2010 

fectiveness failure is failure to access the applicator in the prescribed test time of 5 min. for the first package 

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

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

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

 and cutting open a second or second and third applicator. 

ss to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

g the applicator or any partial or complete access to the placebo (water). 

mful amt; 28.5mg; 28.5mg divided by [1030mg/ml x 0.097 FipronilJ; 0.285 ml; 0.29 ml for Fipronil only 

RGT 

rmful amt; 28.5mg ; 28.5mg divided by [1020mg/ml x 0.097 FipronilJ; 0.288 ml ; 0.29 ml for Fipronil only 

-RGA 

nnful amt; 28.5mg ; 28.5mg divided by [1025 mg/ml x 0.098 FipronilJ; 0.284 ml ; 0,28 ml for Fipronil & S

REG # 2517-RGL 

rmful amt; 28.5mg; 28.5mg divided by [1020mg/ml x 0.098 FipronilJ; 0.285 ml; 0.29 ml for Fipronil & S

 REG # 2517-RGU 

cator is the child-resistant feature. 

cators are filled in mi. 

1 

tudies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1,34, 2.68, 4,02 ml) for the Fipronil 

the Fipronil and S-Methoprene products, This is based on the registrant's submission of: samples of 

cator as tested and proposed to be marketed for the Fipronil only and the Fipronil and S-Methoprene 

, which appeared to be identical; and a June 30, 2010 leiter indicating the same applicator color (white) 

eight colors will be used for both the Fipronil only and the Fipronil and S-Methoprene products as was 

he CRP testing. 

51
2 

PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unitfpkg, child fail = # Child Get CRE SAUE Compreh Only include eRE & SAUE via computer analysis 

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

units Test Review uter 

& why Analy 

sis 

3 white applicators with 1 setof3 o child XCRE CRP Certification 5/27/10 is acceptable. 

purple stripe on label applicators failures = assQciat Label dated 6/29/10 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 = 1 applicator, the sequential test chart in 16 CFR 1700.20. 

child fail = 1 applicator 

3 white applicators with 1 setof3 90% X lowest CRP Certification 5/27/10 is acceptable. 

purple stripe on label applicators SAUE SAUE Label dated 6/29/10 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 = 1 applicator, B, which is the maximum number of failures 

child fail = 1 applicator for a passed SAUE. The SAUE is 90%. 

However, one test sHe (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)(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 subjec1s 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. 

52
3 

PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unitfpkg, child fail = # Child Get CRE SAUE Compreh Only include eRE & SAUE via computer analysis 

units, color, toxfharm = # at Begin ensive Camp 

units Test Review uter 

&why Analy 

sis 

3 white applicators with 1 setof3 a child X CRP Certification 5/27/ to is acceptable. 

orange stripe on label applicators failures = Label dated 6/291 to same CRP directions as 

connected to each other. connected Pass 50 in study. 

Each applicator@ to each child test Data Analysis showed no child failures, 

O.67m] water as placebo. other. Study is a pass of the child test according to 

ToX/harm = t applicator, the sequential test chart in t6 CFR t700.20. 

child fail = t applicator 

3 white applicators with 1 setof3 98% X CRP Certification 5/27/tO is acceptable. 

orange stripe on label applicators SAUE Label dated 6/29/tO same CRP directions as 

connected to each other. connected in study. 

Each applicator @ 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 = t applicator, a pass of the senior adult test in 16 CFR 

child fail = t applicator 1700.20 and the effectiveness specifications 

in t6 CFR t700.15(b). 

3 white applicators with tsetof3 o child X CRP Certification 5/27/tO is acceptable. 

green stripe on label applicators failures = Label dated 6/291 to same CRP directions as 

connected to each other. connected Pass 50 in study. 

Each applicator@ to each child test Data Analysis showed no child failures. 

1.34ml water as placebo. other. Study is a pass of the child test according to 

Tox/harm = 1 applicator, the sequential test chart in 16 CFR t700.20. 

child fail = t applicator 

3 white applicators with tsetof3 95% X CRP Certification 5/27/tO is acceptable. 

green stripe on label applicators SAUE Label dated 6/29/tO same CRP directions as 

connected to each other. connected in stUdy. 

Each applicator @ to each Data Analysis showed 4seniors failed to open 

t.34ml water as placebo. other. package A and t senior failed to open 

ToX/harm = 1 applicator, package 8. SAUE is 95%. The study is a 

child fall = 1 applicator pass of the senior adult test in 16 CFR 

1700.20 and the effectiveness specifications 

in t6 CFR1700. t5(b). 

53
4 

PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unitlpkg, child fail ;;;; # Child 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 

3 white applicators with 1 setof3 2 child X lowest CRP Certification 5127/10 is acceptable. 

red stripe on label applicators failures ;;;; CRE Label dated 6/29f10 same CRP directions as 

connected to each other. connected Pass 50 in study. 

Each applicator @ to each child test Data Analysis showed 2 child failures, a 43 

2.68ml water as placebo. other. month old male accessed 2 applicators before 

Tax/harm;;;; 1 applicator, the demonstration and a 51 month old female 

child fail = 1 applicator accessed one applicator after the 

demonstration. Study 'IS a pass of the child 

test according to the sequential test chart in 

16 CFR 1700.20. 

3 white applicators with 1setof3 98% XSAUE CRP Certification 5/27/10 is acceptable. 

red stripe on label applicators SAUE associat Label dated 6/29/10 same CRP directions as 

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 

ToX/harm = 1 applicator, pass of the senior adult test in 16 CFR 

child fail = 1 applicator 1700.20 and the effectiveness specifications 

in 16 CFR1700.15(b). 

3 white applicators with 1setof3 1 child X CRP Certification 5f27/10 is acceptable. 

blue stripe on label applicators failure = Label dated 6/29/10 same CRP directions as 

connected to each other. connected Pass 50 in study. 

Each applicator @ to each child 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. = 1 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 1 

child failure, a 44 month old male accessed 1 

applicator after demonstration. Study is a 

pass of the child test according to the 

sequential test chart in 16 CFR 1700.20. 

54
5 

PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unitfpkg, 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 

3 white applicators with 1 setof3 97% X CRP Certification 51271to is acceptable. 

blue stripe on label applicators SAUE Label dated 61291 to same CRP directions as 

connected to each other. connected in study. 

Each applicator @ to each Data Analysis showed t birth date was 

4.02ml water as placebo. other. missing. Upon finding it in the hard copy of 

Tox/harm = t applicator, data the age calculation was okay. The study 

child fail = t 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 test in 16 

CFR t700.20 and the effectiveness 

specifications in 16 CFR t700.15{b). 

55
6 

September 28, 2010 

Sergeant's Fipronil + S·Methoprene Spot On For Cats 

nt's Pet Care Products, Inc. 

Chemical· Fipronil 9.8% 

S·Methoprene 11.8% 

ectiveness failure is failure to access the applicator in the prescribed test time of 5 min. for the first package or 

ckage, not opening the applicator with scissors along the needle application tip, cutting the applicator between 

 the main chamber, cutting into the body of the main chamber of the applicator, cutting into the body of the ma',n 

or at other locations, cutting off the bottom of the main chamber of the applicator, or not separating a single 

ng open a second or second and third applicator. 

s to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

g the applicator or any partial or complete access to the placebo (water). 

mful am! = 28.5mg = 28.5mg divided by [1030mg/ml x 0.097 Fipronil] = 0.285 ml = 0.29 ml for Fipronil only 

RGT 

mful amt = 28,5mg = 28.5mg divided by [1020mg/ml x 0.097 Fipronil] = 0.288 ml = 0.29 ml for Fipronil only 

RGA 

mful amt = 28.5mg = 28.5mg divided by [1025 mg/ml x 0.098 Fipronil] = 0.284 ml = 0.28 ml for Fipronil & S· 

REG # 2517 ·RGL 

mful am! = 28,5mg = 28.5mg divided by [1020mg/ml x 0.098 Fipronil] = 0.285 ml = 0.29 ml for Fipronil & S· 

REG # 2517·RGU 

.8% 

cator is the child·resistant feature. 

cators are filled in ml. 

udies were submitted by the Company to cover the 5 sizes (0,5, 0.67, 1,34, 2.68, 4,02 ml) for the Fipronil 

he Fipronil and S·Methoprene products, This is based on the registrant's submission of: samples of 

cator as tested and proposed to be marketed for the Fipronil only and the Flpronil and S·Methoprene 

 which appeared to be identical; and a June 30, 2010 letter indicating the same applicator color (white) 

eight colors will be used for both the Flpronil only and the Fipronil and S·Methoprene products as was 

e CRP testing. 

56
7 

PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# uniUpkg, child fail = # Child Get at eRE SAUE Compreh Only include eRE & SAUE via computer 

units, color, tox/harm :: # Begin Test ensive Computer analysis 

units Review Analysis 

& why 

3 white applicators with 1setof3 CRP Certification 5/27/10 is 

purple stripe on label applicators acceptable. Label dated 6/29/10 

connected to each other. connected same CRP directions as in study 

Each applicator @ O.5ml to each mentioned below. Size not accepted 

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 CFR 

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(8)(3)(1). Therefore, 

this CRP test data is unacceptable. 

Bridging LeUer 6/30/10 indicating 

same size and color package as 

package tested is okay. 

57
8 

September 28,2010 

Sergeant's Fipronil + S-Methoprene Squeeze On For Dogs 

nt's Pet Care Products, Inc. 

Chemical - Fipronil 9.8% 

S-Methoprene 8,8% 

ectiveness failure is failure to access the applicator in the prescribed test time of 5 min. for the first package or 

ckage, not opening the applicator with scissors along the needle application tip, cutting the applicator between 

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

or at other locations, cutting off the bottom of the main chamber of the applicator, or not separating a single 

ng open a second or second and third applicator. 

s to 1 unit. Access to 1 unit is more than 28.5mg of Fipronil for all sizes. 

 the applicator or any partial or complete acoess to the placebo (water). 

mful amt = 28.5mg = 28.5mg divided by [1 030mg/ml x 0.097 Fipronil] = 0.285 ml = 0.29 ml for Fipronil only 

RGT 

mful amt = 28.5mg = 28.5mg divided by [1020mg/ml x 0.097 Fipronil] = 0.288 ml = 0.29 ml for Fipronil only 

RGA 

mful amt = 28.5mg = 28.5mg divided by [1025 mg/ml x 0.098 Fipronil] = 0.284 ml = 0.28 ml for Fipronil & S

EG # 2517-RGL 

mful amt = 28.5mg = 28.5mg divided by [1020mg/ml x 0.098 Fipronil] = 0.285 ml = 0.29 ml for Fipronil & S

REG # 2517-RGU 

8% 

cator is the child-resistant feature. 

cators are filled in mi. 

udies were submitted by the Company to cover the 5 sizes (0.5, 0.67, 1.34, 2.68, 4.02 ml) for the Fipronil 

he Fipronil and S-Methoprene products. This is based on the registrant's submission of: samples of 

ator as tested and proposed to be marketed for the Fipronil only and the Fipronil and S-Methoprene 

which appeared to be identical; and a June 30, 2010 letter Indicating the same applicator color (white) 

ight colors will be used for both the Fipronil only and the Fipronil and S-Methoprene products as was 

e CRP testing. 

58
9 

PKG Description Include # Pkges Company Data Data Conclusion 

ml per Pkg 

# unit/pkg, 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 

3 white applicators with 15etof3 CRP Certification 5/27/10 is 

orange stripe on label applicators acceptable. Label dated 6/29/10 

connected to each other. connected same CRP directions as in study 

Each applicator @ O.67ml 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 

3 white applicators with 1 setof3 CRP Certification 5/27/10 is 

green stripe on label applicators acceptable. Label dated 6/29/10 

connected to each other. connected same CRP directions as in study 

Each applicator@ 1.34m1 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 CRE & SAUE values per 16 

CFR 1700 for MRID 48059804 (1746-

003) EPA Re9 No. 2517-RGA . 

3 white applicators with 1 setof3 CRP Certification 5/27/10 is 

red stripe on label applicators acceptable. Label dated 6/29/10 

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 

Tax/harm -= 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 

59
10 

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, tox/harm = # at Begin ensive Computer analysis 

units Test Review Analysis 

&why 

3 white applicators with 1setof3 CRP Certification 5/27/10 is 

blue stripe on label applicators acceptable. Label dated 6/29/10 

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 

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 48059806 (1746-

005) EPA Reg No. 2517-RGA. 

60
Product Toxicity based on Fipronil Toxicity 

mful amt = 28.5mg Fipronil mful amt = 28.5mg = 28.5mg divided by [1030mg/ml x 0.097 Fipronil] = 0.285 ml = 0.29 ml for Fipronil only 

RGT 

mful amt = 28.5mg = 28.5mg divided by [1020mg/ml x 0.097 Fipronil] = 0.288 ml = 0.29 ml for Fipronil only 

RGA 

mful amt = 28.5mg = 28.5mg divided by (1025 mg/ml x 0.098 Fipronil] = 0.284 ml = 0.28 ml for Fipronil & 5-

REG # 2517-RGL 

mful am! = 28.5mg = 28.5mg divided by [1020mg/ml x 0.098 Fipronil] = 0.285 ml = 0.29 ml for Fipronil & 5-

REG # 2517-RGU 

11 

ml (ml = f1. oz. (f1. oz. ::::: Product % Fipronil mg Fipronil # unit = tox Ihannful amt 

0.0338 fl. 29.6ml) Density g/m 1 oz.) 

0.5 0.017 1.030 9.7 49.96 1 

0.67 0.023 1.020 9.7 66.29 1 

1.34 0.045 1.020 9.7 132.58 1 

2.68 0.091 1.020 9.7 265.16 1 

4.02 0.136 1.020 9.7 397.74 1 

0.5 0.017 1.025 9.8 50.23 1 

0.67 0.023 1.020 9.8 66.97 1 

1.34 0.045 1.020 9.8 133.95 1 

2.68 0.091 1.020 9.8 267.89 1 

4.02 0.136 1.020 9.8 401.84 1 I 

61
DATA PACKAGE BEAN SHEET 

Date: 12-May~201 0 

Page 1 of 1 

* * * Registration Information * * * 

Decision #: 425454 

DP #: (377644) 

PRIA 

Parent DP #: 

Submission #: 873355 

Registration: 2517-RGL - SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FOR ( 

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

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

Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS -; \

Sent Date: _____ Calculated Due Dale: ~ ~..,.-r Edijed Due Date: ____ _ 

Type of Registration: Product Registration - Section 3 

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

Ingredients: 105402, S-Methoprene(11.8%) 

129121, Fipronil(9.8%) 

* * * Data Package Information * * * 

Expedite: 0 Yes. No Dale Sent: 12-May-2010 Due Back: ___ _ 

DP Ingredient: 105402, S-Methoprene 

t29121, Fipronil 

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

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

Assigned To Date In Date Out 

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

Team Name: ,E~ffi~,,~oy,,-,(I~B~) ____ _ Science Due Date: ____ _ 

Reviewer Name: ~-----~ 

Sub Data Package Due Date: _____ _ 

Contractor Name: ___________ ~ 

* * * Studies Sent for Review * * * 

No Studies 

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

Can be printed on its own page 

* * * Data Package Instructions * * * 

For Your ReView: An R310 action, a new fipronilJ3-methoprene EP: presumably me-too of Medal's Frontline 65331-4. 

Thx, baa 

62
Efficacy Review 

Date: December 27, 2010 

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

myers.clayton@epa·gT~ --1: ~\~ 

703-347-8874 ~ \'1-1-

Risk Manager Rev.: Rosanna Louie 

Products: 

EPA Reg, #: 

A.I.'s: 

Decision #s: 

DP#s: 

Submissions: 

MRIDs: 

Sergeants Fipronil + S-methoprene Spot-on for Cats 

2517-RGL 

Fipronil, S-methoprene 

425454 

377644 

R310, New Products, RD Science Review 

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

45628105,46019202 

Overall Review of Label Claims and Directions: 

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

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

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

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

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

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

supported and must also be removed from the label. 

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

-All 'repels' claims must be removed 

-All claims against flea pupae must be removed 

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

ReviewerlPM 

63
~"[brand name J contains Fipronil and S~Methoprene (insect growth regulator) (IGR) to 

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

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

skin oils. This product features a sustained~release fonnula that discharges from the animal's 

hair follicles using the natural skin oils, resulting in fast~actingl and long~lastingJ control of fleas, 

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

being released from hair follicle J": 'repel' claim must be deleted. The statement regarding 

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

deferred to the RM Reviewer/PM. 

64
DATA PACKAGE BEAN SHEET 

Date: 12-May-2010 

Page 1 of2 

* * * Registration Information * * * 

Decision #: 425454 

DP #: (377642) 

PRIA 

Parent DP#: 

Submission #: 873355 

Registration: 2517-RGL - SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FOR ( 

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

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

Risk Manager Reviewer: Booaveolure Akinlosotu BAKINLOS 

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

Type of Registration: Product Registration - Semion 3 

Edited Due Dale: ~~~~~ 

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

tngredients: 105402, S-Methoprene(11.8%) 

129121, Fipronil(9.8%) 

* * * Data Package Information * * * 

Expedite: 0 Yes. No 

DP Ingredient: 105402, S-Methoprene 

129121, Fipronil 

DP Tme: Prod Chem 

CSF tncluded: • Yes 0 No 

Date Sent: 12-May-2010 

label Included: • Yes 0 No Parent DP #: 

Due Back: ~~~~~ 

Assigned To Date tn D.teO,' / 

Organization: cR~D~I~TcR~B~~~~~~~_ ~~~~~ last Possible Science Due Da1e: 05-Dct-2010 

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

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

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

* * * Studies Sent for Review * * * 

Prinled on Page 2 

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

No Additional Data Packages 

* * * Data Package Instructions * * * 

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

Thx, baa 

65
4805940t 

48059402 

48059402 

48059402 

4805940t 

48059402 

4805940t 

48059402 

48059402 

4805940t 

48059402 

4805940t 

48059402 

48059402 

48059402 

Page 2 

Spot-On 

Unpublished study ,<e,"'" by 

Inc. 40 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 40 p. 

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

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

U~published study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unplblished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 40 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 40 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 40 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 40 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

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

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

Unpublished study prepared by Sergeant's Pet Care Products, 

Inc. 6 p. 

830. t670/Discussion of formation of 

impurities 

830.63 t3/Stability to sunlight, 

normal and elevated temperatures, 

metals, and metal ions 

830.7 t OONiscosity 

830.6303/Physical state 

830. tSSO/Product Identity and 

composition 

830.6304/0dor 

830. t7S0/Certified limits 

830.6314/0xidizing or reducing 

action 

830.63 t 6/Explodability 

830. t620/Description of production 

process 

830.6302/Color 

830.1600/Description of materials 

used to produce the product 

830.631S/Flammability 

830.63 t9/Miscibility 

830. 730010ensitylrelative density 

66
FEE 

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

PC Coders): 129121 ACTION CODE: R 310 

FOOD Use: NO NON-FOOD Use: YES 

DATE OUT: August 31, 2010 

SUBJECT: 

FROM: 

TO: 

End Use Product Chemistry Review 

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

\~\ b~h\O , [::aira Gairola . ~ q! -v.l ) U 

Pra8uct Chemistry Team 

Technical Review Branch I Registration Division (7505P) 

Richard Gebken !Bonaventure Akinosotu PM 10 

Insecticide Branch I Registration Division (7505P) 

Company Name: SERGEANT'S PET CARE PRODUCTS INC. 

Formulation Type: LIQUID 

INTRODUCTION: 

The applicant requested a new non food use) end use product. In support of the application, the 

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

B.( MRlD#s480594-0l and -02). TRB has been asked to detennine the acceptability of the product 

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

SUMMARY OF FINDINGS: 

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

2. All of the source materials of the active ingredient are derived from registered sources. 

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

labeled uses. 

4. Confidential Statement ofFormula(s): 

[X] Basic - 12/21109 Dated: 

[X] Alternate # 1 &# 2 - Dated: 

resubmitted (email) - Dated 08/31110: 

submitted (email) - Dated 08/31110 

Alternate CSF(s) complies with 40CFR§152.43: [X] Yes [] No 

67
DP BARCODE No.: 

PC Coders): 

FOOD Use: Yes 

5. Product label 

FILE SYMBOL No.: DECISION No.: 

Action Code: R 310, R 340,345 

NON-FOOD Use: Yes 

a. Ingredient statement: Nominal concentration of AI listed on CSF(s) concur with product label 

(PR Notice 91-2) 

[ ] Yes, if not, explain below: 

Metallic equivalent: [ 

Soluble arsenic: [ 

Isomeric ratios: 

Acid equivalent: 

[ 

[ 

1 Yes 

1 Yes 

1 Yes 

lYes 

[ 1 NA; 

[ 1 NA 

[ 1 NA 

[ ] NA; {name} acid equivalent = xx % 

b. Health related sub statements: Product contains? 

Petroleum distillate at > 10%: 

Methanol at> 4%: 

[ lYes [ lNo [ lNA 

[ lYes [ lNo [ lNA 

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

for: flammability, explosive potential or electric insulator breakdown? 

[lYes [lNo 

Is the sub statement in compliance with PR Notice 97 M 6? [ ] Yes, if not, explain below: 

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

below: 

2 

68
DP BARCODE No.: FILE SYMBOL No.: DECISION No.: 

PC Coders): 

FOOD Use: Yes 

Action Code: R 310, R 340, 345 

NON-FOOD Use: Yes 

6. Group A: Product Chemistry Data 

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

tables below. 

Data TRB's 

Guideline submitted Assessment 

No. Study Title Yes No of Data MRlDNos. 

Product Identity & 

830.1550 Composition X A 480594-01 

Description of materials used 

830.1600 to produce the product X A 480594-01 

Description of formulation 

830.1650 process X A 480594-01 

Discussion on the formation 

830.1670 of impurities X A 480594-01 

830.1700 Preliminary analysis 

Standard 

certified 

Certified limits 

limits 

(158.350) Proposed Limits 

Justification for 

830.1750 wider limits 

Enforcement analytical 

830.1800 method G 

A = Acceptance, N = Not Acceptable, G = Data Gap, 

W = Waiver Request, I = In Progress, NA = Not Applicable 

3 

69
DP BARCODE No.: FILE SYMBOL No.: DECISION No.: 

PC Code(s): 

FOOD Use: Yes 

7. GroupB: 

Guideline Study Title 

No. 

830.6303 Physical State 

830.6315 Flammability 

830.6316 Explodability 

830.7000 IpH 

830.7300 Density (units) 

Action Code: R 310, R 340,345 

NON-FOOD Use: Yes 

Value or Qualitative TRB's 

Description Assessment 

of Data 

Clear yellow liquid A 

, >90°C A 

Not explosive A 

roduct insoluble in water NA 

1.00-1.05g/mL A 

A = Acceptance, N = Not Acceptable, G = Data Gap, W = Waiver request, 

NA = Not applicable, I = In progress 

CONCLUSIONS: 

MRIDNos. 

480594-02 

480594-02 

480594-02 

480594-02 

480594-02 

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

has concluded: 

1. Basic CSF resubmitted (email) ~ Dated 08/31110 is acceptable and attached 

2. Alternate CSF(s) #1  Dated 08/31110 are Acceptable and attached .. 

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

Enforcement analytical method. 

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

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

registrant is required to generate one year storage stability & corrosion characteristics study. 

The recommended observations periods are 0,1,3,6,9, & 12 months intervals. 

5. The proposed label was screened as it pertains to the product chemistry requirements. The 

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

4 

70
DATA PACKAGE BEAN SHEET 

Date: 12~May~201 0 

Pagelof1 

* * * Registration Information * * * 

Decision #: 425454 

DP #: (377643) 

PRIA 

Parent DP #: 

Submission #: 873355 

Registration: 2517-RGL - SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FORCJi(S (\}1. \.0 

Company 2517 - SERGEANT'S PET CARE PRODUCTS, INC (, ~ \ 

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

Risk Manager Reviewer Bonaventure Aklnlosotu BAKINLOS / 0-

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

Type of Registration: Product Registration - Section 3 

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

Ingredients: 105402, S-Methoprene(11.8%) 

129121, Fipronil{9.8%) 

* * * Data Package Information * * * 

Expedite: 0 Yes. No 

DP Ingredient: 105402, S-Methoprene 

129121, Fipronil 

DP Title: Tox: Similarity 

Date Sent: 12-May-2010 Due Back: ____ _ 

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

Assigned To Date In Date Out /' 

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

Team Name: ~TO~X,,-________ _ Science Due Date: ____ _ 

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

Contractor Name: ~-~~~~-

* * * Studies Sent for Review * * * 

No Studies 

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

Can be printed on its own page 

* * * Data Package Instructions * * * 

For Your Review: An R310 action, a new fipronil/3-methoprene EP; presumably me-too of Merial's Frontline 65331-4. 

Thx, baa 

71
UNITED STATES ENVIRONMENTAL PROTECTlON AGENCY 

WASHINGTON, D.C. 20460 

September 15,2010 

MEMORANDUM 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Name of Pesticide Product: SERGEANT'S FIPRONIL + S-METHOPRENE 

SPOT-ON FOR CATS 

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

DP Barcodes: DP 377643 

Decision No.: 425454 

Action Code: R310 

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

11.8%) 

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

Teclrnical Review Branch 

Registration Division (7505P) 

(7 ~ n ..-J.--..-, 

5~V+ - lS- _~'l-O\O . 

1'1 

To: Bonaventure Akinlosotu/Richard Gebken RM 10 ____ ---

Insecticide Branch 

Registration Division (7505P) 

Registrant: SERGEANT'S PET CARE PRODUCTS, INC. 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

129121 Fipronil 

105402 (S)-methoprene 

Other Ingredient(s): 

TOTAL 

ACTION REQUESTED: The Risk Manager requests: 

Bywt. 

9.8% 

11.8% 

78.4% 

100.0% 

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

Medal's Frontline 65331-4." 

Page 1 of3 

72
BACKGROUND: 

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

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

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

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

12/2112009, and a copy of a cover letter dated April 12, 2010. 

COMMENTS AND RECOMMENDATIONS: 

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

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

support the registration of 2517-RGL. 

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

December 12, 1999 from M. Hashim to A. Sibold; the fonnulation (10% Fipronil and 12% 

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

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

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

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

dermal sensitization. 

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

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

1996) and classified as supplementary. 

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

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

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

animal's hair follicles using the natural skin oils ... " This should be deleted from 25l7-RGL, 

and the similar claim for 65331-4 ("Fipronil collects in the oils of the skin and hair follicles, 

and continues to be released from hair follicles onto the skin and coat. .. ") should be deleted 

from the label of that product. 

4. In a IRB memorandum (M. Hashim & B. Backus to A. Sib old) dated April 12, 2000, it 

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

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

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

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

5. In a TRB memorandum (B. Backus to A. Sibold/A. Layne) of September 23, 2002 it was 

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

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

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

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

Page 2 of3 

73
MRID 43577711 is a 6-page document titled "Discussion in Support of Bridging Domestic 

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

submitted in support of 65331-EUP-E. 

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

registration of2517-RGL. 

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

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

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

TRB Chemistry Team. 

Page 3 of3 

74
UNITED ST ATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

April 19, 2010 

OPP Decision Number: D-425454 

EPA File Symbol or Registration Number: J517-RGL 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FOR CATS 

EPA Receipt Date: 22-Dec-2009 

EPA Company Number: 2517 

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

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH I58TH PLAZA 

OMAHA,NE 68130-1703 

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

Dear Registrant: 

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

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

results of the PRN~86-5 screen will be communicated separately. During the administrative 

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

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

The Action has been identified as Action Code: R310 

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

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACy); 

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

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

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

overpaymen as soon as is practicable. If your waiver request is denied, you will receive an 

invoice for the outstanding balance. 

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

Ombudsman al (703) 305-6249. 

Sincerely, ~ 

'/.i/WUt 

Front End Processing 

~ 

Staff 

Infonnation Technology & Resources Management Division 

75
change PRIA code 

Linda Arrington to: John Jamula 

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

HOI JJ and Teresa, 

04/16/201011:38 AM 

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

2517--RGU 

2517-RGL 

2517-RGA 

2517-RGT 

Linda Arrington 

RegiS1ration Division 

7033056249 

7033056920 (fax) 

76
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

April 15, 2010 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

Report of Analysis for Compliance with PR Notice 86-5 

OFFICEQF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

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

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

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

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

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

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

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

Manager, to whom the data have been released. 

77
480594-00 

Pet Care Products, Inc. 

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

April 12, 2010 

Richard Gebken, PMl 0 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Sergeant's Fipronil + S-methoprene Squeeze-On for Cats 

EPA File Symbol 25l7-RGL 

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

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South l58ili Plaza, Suite 100, Omaha, 

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

pending product registration for Sergeant's Fipronil + S-methoprene Squeeze-On for Cats 

(EPA File Symbol 25l7-RGL). The data are being submitted to EPA in response to the 

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

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

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

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

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

that are used to support each applicable guideline. Instructionsfor completing the EPA 

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

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

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

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

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

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

data in accordance with PR Notice 86-5. In addition, you must revise the data matrix as 

outlined in #1 above to reflect this change. 

Sergeants is submitting new prodnct chemistry data specific to Sergeants' spot on 

product Sergeant's Fipronil + S-methoprene Squeeze-On for Cats (EPA File 

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

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

78
Sergeant's Pet Care Products, Inc. 

2625 South 168th Fraza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

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

self-certification is unacceptable/or each product. The currently approved CRP data/or 

the referenced products listed on your 8570-1 form (block #6) are also not citable for 

purposes 0/ satisfying the data requirements outlined in 40 CFR § 152.34. These CRP 

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

Sergeants submitted a new Child Resistant Packaging study for review as part of 

this package (an :MRID number has not been assigned). Sergeants listed this new 

study in the new enclosed data matrix. 

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

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

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

Please find enclosed the following documentation in support of our response: 

1. Administrative materials: 

• Transmittal document; 

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

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

• EPA Fonn 8570-35: Data Matrix Fonn - EPA and Public Versions; and 

• Additional PRIA Payment Confirmation Receipt. 

2. Product-specific product chemistry data. 

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

Sincerely, 

~ 2. f.ksfLH I z-i\ I 

Kelly R. Hoskins 

Manager of Technical Affairs 

Sergeant's Pet Care Products, Inc. 

Enclosures 

79
Sergeant's Pet Care Products, Inc. 

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

Data Transmittal Document: 

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

2625 South 158th Plaza 

Suite 100 

Omaba, NE 68130-1703 

Submittal Date: April 12, 2010 

Volume Study Title MRID 

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

_(2517-RGL) 48059401 

2 Group B Product Chemistry for Fipronil Cat Spot-On I 48059402 (2517-RGL) 

80
Please read Instructions on reverse before comp/etfng form. Form Approveu. OMB No. 2070-0060. Approval expi/es 05-31-98 

United States ~_Registration OPP Identifier Number 

EPA Environmental Protection Agency D.Amendment 

Washington, DC 20460 o Other 

Application for Pesticide - Section I 

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

2517-RGL Richard Gebken 

4. Company/Product (Name) 5.PM# 10 ~None DResl/icted Semeants Fipronil + S-methoprene Spot-On For Cals 

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

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

2625 South 158th Plaza 

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

Product Name FRONTLINE PLUS FOR CATS 

D Check ifthis is a new address 

Section II 

o Amendment - Explain below. o Final printed labels in response to Agency leiter dated XX-XX-XX 

[Xl Resubmission in response to Agency letter dated Ot·27-201 0 o "Me Too" Application 

o Notification - Explain below. o Other - Explain below. 

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

Section III 

t. Material This Product Will Be Packaged In: 

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

cg] Yes· cg] Yes DYes DMetal 

DNO D No I2J No cg] Plastic 

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

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

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

I DOther (Specify) Plastic Bag 

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

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

DOn Labeling accompanying product 

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

DPaper glved 

DSlenciled 

Section IV 

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

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

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

Certification 6. Date Application 

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

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

under applicable law. 

2. Signature 

tf.-l~ /?::1tT 

3. Title 

BY Jlolw t· Manager of Technical Affai/s 

4. Typed Name: 5. Date: 

Kelly R. Hoskins 41 n/lo 

81
Form Approved OMS Nos. 2070-0060; 207{)'''()057; 2070-0107: 2070-Ot22; 2070-0164 

.-"""- UN/TEO STATES ENVIRONMENTAL PROTECTION AGENCY (t) SIirl, 1200 Pennsylvania Avenue, N_W_ -' WASHINGTON, D_C_ 20460 

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

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

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

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

to rhis address. 

Certrfication with Respect to Citation of Data 

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

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

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

Fiproni! and S-methoprene 04/1212010 

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

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

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

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

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

be used for this purpose). 

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

D I am using the cile-all method of support, and have Included with this form 0 I am using the selectrve method of support lor cile-all oplion 

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

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

used). 

SECTION II: GENERAL OFFER TO PAY 

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

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

SECTION III: CERTIFICATION 

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

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

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

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

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

lIses 

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

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

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

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

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

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

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

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

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

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

FIFRA. 

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

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

Signature J./ ,/,-,-, ~. f/.,s~ /t:It r 

Date Typed or Printed Name and Title 

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

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

82
Pay.gov - Online Payment 

Online Payment 

Step 3: Confirm Payment 

Thank you. 

Page 1 of! 

11 2 13 

Your transaction has been successfully completed. 

Pay.gov Tracking Information 

Application Name: PRIA Service Fees 

Pay.gov Tracking ID: 250LG6HI 

Agency Tracking 10: 74110736947 

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

Payment Summary 

Account Holder Name: Sergeants Pet Care Products 

Payment Amount: $3,213.00 

Account Type: Business Checking 

Routing Number: 

ACcount Number: **-*5483 

Payment Date: 0411312010 

Decision Number: 

Registration Number: 2517-RGL 

Company Name: Sergeants Pet Care Produc 

Company Number: 2517 

Action Code: R310 

httvs:llwww,oav,eov/oave:ov/oavments/authorizeACHPavment.html 4/12/2010 

83

*Commercial/financial information may be entitled to confidential treatment*
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

- 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: Tile public reporting burden for this colleclion of infonnation is cslimatcd 10 average 0.25ltours per response for registration activities an

reregistration and special review activities, including lime for reading the instruction and completing the necessary forms. Send comments regarding the burden estimate or a

of infonnation, including suggestions for reducing the burden 10 Director: OPPE Infonl13lion Management Division (2137) U.S. Environmental Protection Agency, 40 I M St

20460, Do not send the form to this address. 

DATAMATRlX 

Date: A ri112, 2010 EPA Reg No.lFile Symbol 2517-RGL 

Applieant'slRegistrant's Name & Address Product: Scrgeant's FipronE + Methopr

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

Ingrcdients: Fiproni!, Methoprene 

Guideline Reference Number Guideline Study Name MRlDNumber Submitter 

830.1550, 830.1600, 830.1620, Product Properties Data for Sergcant's Fipronil + New submission Scrgeant's Pet Care Products, In830.1650, 830.1670, 830.1700, Methoprene Spot-On for Cats 

830.1750,830.1800 

830.1800 Enforcement analytieal method New submission Se eant's Pet Care Products, In

830.6302,830.6303,830.6304, Product chemislry of Scrgcant's Fipronil + Methoprcne New submission Scrgeant's Pet Care Products, In830.7300,830.7000,830.6315, Spot-On for Cats 

830.7100, 830.6320, 830.6317 

830.6317,830.6320 Storage stability and corrosion characteristics To be submitted Sergcant's Pet Carc Products, In

upon completioll 

870.1100 Acute oral toxieity 44942004 MERIAL LIMITED 

870.1200 Acute dcrmal toxie"!ty 44942005 MERIAL LIMITED 

870.1400 Primary eye irritation 44942006 MERIAL LIMITED 

870.1500 Primary dennal irritation 44942007 MERlAL LIMITED 870.1600 Dermal sensitizalion 44942008 MERlAL LIMITED 

Evaluation ofthc Cat Squeeze On O.5ml Whitc Applieator with New submission Sergeant's Pct Care Products, In

Purple Labellndieator (3x), scissors to open - F=I as a Poison 

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

870.7200 Walker, K. (1995) Discussion in Support of Bridging Domeslic 43577711 MERIAL LIMITED 

Animal Safety Data on Frontline Spray Treatment to Frontlinc 

Spot Treatment Data Package. Unpublished study prepared by 

Rhone Merieux, Ine. 6 p. 

Signature: Vth.u bfostuA. IrAI Name and Title 

Kelly R. Hoskins, Manager ofTeclmieal Affairs 

EPAFQrm gS;CCJS (9-97) ,nd Pap.r Version, AvaH.hle Submil <mly P'l"', .. ,.,ion. Ag,n.y [n"rn
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W. 

o W ASHlNGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registralion activities an

reregistration and special review activities, including time for rcading the in2crcgistrationcompleting the necessary forms. Scnd comments regarding the burden estimate or a

of information, including suggestions for reducing the burden to Director: OPPE Infonnation Management Division (2137) U.S. Environmenlal Protection Agency, 401 M St

20460. Do not send the fonn to this address. 

DATAMATRlX 

Date: A ril 12,2010 EPA Reg No.lFile Symbol 2517-RGL 

Applicant'sIRegistrant's Name & Address Product: Sergeant's Fipronil + Methop

Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Spot-On for Cats 

In redients: Fi ronil, Metho rene 

Guideline Reference Number Guideline Study Name MruD Number Submitter 

870.7200 VlIIage!iu, J.; Lopez, S.; Germa, M.; et al. (1994) 43577716 MERlAL LJMITED 

Percutaneous Absorption and Distribution of Radioactivity in 

Hair, Skill, and Fat After Spot-On Application of (Carbon 14)-RM1601 in Cats: Lab Project Numbers: CD-9313748F. 

Unpublished study prepared by Centro de Investigacion y 

Desarroilo Aplicado, S.A.L. 42 p. 

870.7200 Clery, D. (1999) Fipronil/(S)-Methopreneffopicai/Solution/ 44942009 MERIAL LiMITED 

Target Species Safety Study in the Cat: Interim Final Report: 

Lab Project Number: GBOl1199-00 I: PR&D 002330 1. 

Unpublished study prepared by Biological Labs. Europe Ltd. 

127 p. 

870.7200 Godin, C.; Alva, R. (2000) ML-2,095,988 508Q/CatiSolution/ 45618502 MERJAL LIMITED 

T opicallSafetyfr oIerancelReproduction, React ions: Final 

Report: Lab Project Number: PR&D 0020301: WEL 99886. 

Unpublished study prepared by White Eagle Toxicology 

Laboratory. 88 p. 

810.3300 Voung, D. (1999) Dose Titration Study of(S)-Methoprene by 44942010 MERIAL LIMITED 

Topical Administration to Cats: Final Report: Lab Project 

Number: PR&D 0010001. Unpublished study prepared by 

Voung Veterinary Research Services. 42 o. 

810.3300 Marchiondo, A. (1999) Dose Continnation Study ofTopically 44942011 MERIAL LIMITED 

Administered Fipronil/(S)-Methoprene Against Adult 

(Ctenocephalides felis) in Cats: Final Report: Lab Project 

Number: PR&D 0023201. Unpublished study prepared by 

Sillelair Research Center, J nco 46 p. 

810.3300 Pollmeier, M. (1999) An Efficacy Study of Frontline Top Spot 45628101 MERlAL LIMITED 

for the Treatment and Control of Felicola subrostratus in the 

Cat: Final Report: Lab Project Number: PR&D 0022201. 

Unpublished study prepared by Centro Veterinario Oriolo. 18 p. 

Signature: VI L L LJ... .1. I , / "2 _ Name and Title 

rN J Kelly R. Hoskins, Manager of Technical Affairs 

EPA FOLm 857(1.)5 (9.97) EI, tjnio ."d Paper Version, M.il,ble. Suomit only P'p<r veL>"Jfl Age"oy lnl<r
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

• 401 M Street, S.W . 

• WASHINGTON, D.C. 20460 

Papenvork Reduction Act Notice: The public reporting burdcn fbr dlis collection of information is cstimated to avcragc 0.25 hours per responsc for registration activities an

reregistration and special review activities, including timc for reading the in3eregistrationcompleting the necessary forms. Send comments regarding the burden estimate or a

of information, including suggestions for reducing the burden to Director; OPPE Information Management Division (2137) U.S. Environmental PrOleetion Agency, 40t M St

20460. Do not send the form to this address. 

DATAMATRlX 

Date: April 12, 2010 EPA Reg No.lFile Symbol 2517-RGL 

Applicant'sJRegistrant's Name & Address Product: Sergeant's FiproniJ + Methop

Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Spot-On for Cats 

Ingredients: Fipronil, Methoprcne 

Guideline Reference Number Guideline Study Name MRID Number Submitter 

810.3300 POllmeier, M.; Pengo, G.; Barrick, R. (2000) An Efficacy Study 45628102 MERIAL LIMITED 

of Frontline Spray, Frontline Top Spot and ML-2,095,988 508Q 

for the Treatment and Control ofFelicola subrostratus in (he Cat: 

Pinal Report". Lab Project Number: PR&D 0037201. 

Unpublished study prepared by Centro Vctcrinario Oriolo. 22 p. 

810.3300 Pollmcier, M.; Pengo, G. (2001) Studies to Confinn the Efficacy 45628103 MERIAL LIMITED 

ofFipronii Against Lice in Cats Under Field Conditions: Final 

Report: Lab Project Number: PR&D 0037501. Unpublished 

study prepared by Centro Veterinario Oriolo. 20 p. 

810.3300 Pos(al, 1.; Le Nain, S.; Gonzalez, C.; e( a1. (1999) Studies to 45628104 MERlAL LIMITED 

Asess (lic Efficacy of Frontline Spot-On (10% w/v Fipronil) in 

thc Treatment of Feline Flea Allergy Dennatitis (FAD) Under 

Field Conditions: Final Report: Lab Project Number: ASH. 

19012: CLl277. Unpublished study prepared by MedaL 64 p. 

{OPPTS 810.3300) 

810.3300 Alva, R.; Barrick, R. (1999) A Study to Detennine the Effect of 45628105 MERlAL LIMITED 

Treatment with Frontline TopSpot on (he Prevalence and 

Sevcrity of Flea Allergy Dcrmatitis in Cats: Final Report: Lab 

Project Number: PR&D 0012701-04: PR&D 0012701: PR&D 

0012702. Unpublished study prepared by VCA St Petersburg 

Animal Hospital and Altamaha Animal Clinc. 41 P. 

810.3300 McCall, 1. (2003) A Study to Evaluate the Efficacy of Frontline 46019202 MERlAL LIMITED 

Plus for Control of Mosquitoes, Aedes aegypti, on Cats: Final 

Report. Project Number: PR!DI00951O I, 009510 L Unpublished 

study prepared by TRS Laboratories, luc. 26 p. 

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

Exposure of Commercial Pet Groomers During Application of 

FrOntline Spray Treatment: Final Report: Lab Project Number: 

MERlAL-445-SAFXT046: SAFX046: PDA9705. Unpublished 

study preparcd by ABC Labs., California and Aanimal Appeal 

& Case Veterinary HospitaL 1066 P. 

Sign"oe, Y tiL 'E-. f{QSb..I'-S L <:J =J Namc and Title 

Kelly R. Hoskins, Managcr ofTcchnical Affairs 

EPA Form 85'10.35 (9.97) Elc'f/'nic .. Paper V."ion, Availablo. Subrni! only Paper v "ion Ag.ncy 1"!ff"
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

0 401 M Street, 

0 WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden fur this collection of infurmation is estimated to avcrage 0.25 hours per rcsponse for registration activilies an

reregistration and special review activities, including timc for reading the in4eregistrationcompleting the neccssary forms. Send comments regarding the burden estimale or an

of infunnation, including suggestions for reducing the burden to Direclo7: OPPE Information Management Division (2137) U,S. Environmental Protection Agency, 401 M Str

20460. Do not send the fom) to this address. 

DATAMATRlX 

Date: April I2,2010 EPA Reg No.IFHe Symbol 2517-RGL 

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

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Suite 100, Omaba, NE 68130-1703 Spot-On for Cats 

Ingredients: Fipronil, Methoprcne 

Guideline Reference Number Guideline Study Name MRID Number Submitter 

133-3 Meo, N.; Gonzalez, c.; Belcher, T. (1997) Dermal Exposure or 44433303 MERIAL LIMITED 

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 

Grooming Shop & Case Veterinary Hospital. 925 P. 

132-1 Hughes, D. (I997) Dislodgeable Residues ofFipronii Following 44433304 MERIAL LMITED 

Application of Frontline Top Spot to Cats; Final Report: Lab 

Project Number: COVANCE 6848·103: MERIAL METXT 

168: 90066D. Unpublished study prepared by Covance Labs. 

Inc. 118 p. 

132-1 Hughes, D. (1997) Dislodgeable Residues ofFipronil Following 44433307 MERIAL LIMITED 

Application of Frontline Spray Treatment to Cats: Final Report: 

Lab Project Number: COVANCE 6848·102: MERIAL METXT 

167: 6848· I02. Unpublished study prepared by Covance Labs. 

Inc. 129 p. 

132·1 de Fontenay, G.; Magloire, B.; Suberville, S. et al. (1997) 44531201 MERIAL LIMITED 

Dislodgeable Residues ofFipronil Following a Topical 

Application of Frontline Spot·On Treatment to Cats: Final 

Study: Lab Project Number: MET417: 817/023B. 

Unpublished study prepared by Merial Ltd. and Chrysalis. 69p. 

132-1 de Fontenay, G.; Magloire, 8.; Suberville, S. et al. (I997) 44531202 MERIAL LiMITED 

Dislodgeable Residues ofFipronii Following a Topical 

Application of Frontline Spray Treatment to Cats: Final 

Report: Lab Project Number: MET415: MERIAL-480·MET415: 817f023A. Unpublished study prepared by Merial Ltd. 

and Chrysalis Preclinical Services-Europe. 7I p. 

N/A Irwin, 1. (1997) Use Survey of Commercial and Veterinary Pet 4443330 I MERIAL LIMITED 

Groomers and Pet Owners of FrOntline Top Spot and Frontline 

Spray Treatment: Lab Project Number: MERIAL·445· 

SURVEY. Unpublished study prepared by Wiese Research 

Associates, Inc. 340 p. 

Signature: 1/,11.... f... f!& s Iti-:1 Name and Title 

Kelly R Hoskins, Manager of Technical Affairs 

EPA Form 8570-35 19·971 ElecU- < ""d P'ne, V"'''O"' A .. ,lable. Submit onl, P,o"" ,e1,iOll, In .. 'n.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

• 401 M Street, S.W . 

• WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this coliection ofinfonnation is estimated to average 0.25 hours per response for registration aclivities an

reregistration and special review activities, including time for reading the in5ercgislratiollcomplcting the necessary foms. Send comments regarding the burden estimate or a

of infimnation, including suggestions for reducing the burden to Director: OPPE lnfonna!ion Management Division (2137) U.S. Envimnmental Protection Agency, 4Qt M St

20460. Do not send the form to this address. 

DATA MATRIX 

Date: A ril 12,2010 EPA Reg NoJFile Symbol 2517-RGL 

Applieant's/Registrant's Name & Address Produet: Sergeant's Fiproni! + Methop

Sergeant's Pet Care Produets, Ine. 2625 South 158th Plaza, Suite 100, Omaha, NE 68130-1703 Soot-On for Cats 

Ingredients: Fipronil, Metho rene 

Guideline Reference Number Guideline Study Name MRIDNumber Submitter 

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

Determination of Fiproni!, M&B45950, and M&B46513 in Dye-Free 100% Cotton Gloves: Final Report: Lab Projeet 

Number: COVANCE 6848-104: 6848-104: MERIAL METXT 

169. Unoublished study prepared by Covanee Labs. Inc. 41 o. 

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

Assessment Fipronil Use on Pets in a Residential Setting: Lab 

Project Number: FIPRONIL 97-09: MERlAL-445-NDRA. 

Unpublished study prepared by Novigen Seienees, Inc. 27 P. 

Polakoff, 8.; Youngren, S. (1997) Pet Groomer Exposure 44433310 MERIAL LIMITED 

Analysis and Risk Assessment: Frontline Top Spot and 

Frontline Spray Treatment: Lab Projeet Number: FIPRONIL 

97-11: MERIAL-445-PGRA. Unpublished study prepared by 

Novigen Sciences, Ine. 17 D. 

Wall, H. (1998) Frontline Produets Reports of Suspected 44531205 MERIAL LIMITED 

Adverse Events Analysis of Breed, Age and Sex Distribution of 

Dogs and Cats. Unpublhihed study prepared by Meria! Ltd. 8 p. 

Polakoff, 8.; Youngren, S.; Walls, C. (1998) Frontline 44531206 MERIAL LIMITED 

Top-Spot and Frontline Spray Treatment: Definitive ShortTerm and Intermediate-Term Residential Non-Dietary Risk 

Assessment: Lab Projeet Number: FIPRONIL 98-04: 

MERlAL-445-NDRA. Unpublished study prepared by Novigen 

Scienees,lne. 35 p. 

Polakoff, B.; Youngren, S.; Walls, C. (1998) Frontline Top 44531207 MERIAL LIMITED 

Spot and Frontline Spray Treatment: Definitive Pet Groomer 

EXposure Analysis and Risk Assessment: Lab Project Number: 

FIPRONIL 98-07: MERIAL-445-LPERA. Unpublished study 

prepared by Novigen Scienees, Inc. 21 p. 

Polakoff, B.; Youngreu, S. (1998) Frontline on Pets in a 44531208 MERIAL LIMITED Residential Setting: Risk Assessmeut of a Low Probability 

Event Post-Application Acute Exposure: Lab Projeet Number: 

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

, prepared by Novigen Seienees, Ine. 18 p. 

Signature: VAil. {L /'7"-( Name and Title 

Kelly R. Hoskins, Manager of Technical Affairs 

EPA Form S,7G-l, (9-97) Elec,"1#< ""d P'pe, A.v.il.ble. Submit only p.t><'r v<rSio" In",,,
'--

\'!'foi 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

for reading the instruction and completing the necessary [oms. Send estimate 

burden to Director: OPPE lnfonnation Management Division (2137) U.s. Agency, 401 M Str

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

Sergeant's 

On for Cats 
'. .. 

. 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

• 401 M Street, S.W . 

• 

necessary forms. ili, . 

to Director: Division (2t37) U.S. Agency, 401 M Str

+ Methop
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 401 M Street, S.W. 

o HNGTON,D.' 

ion is estimated to avera 

reregistration and special IOf reatllng lhe mJereglstralioncompJeling me necessary forms. Send comments regarding the burden estimate or a

of information, including burden to Director: OPPE Informalioll Management Division (2137) U.S. Environmental Protection Agency, 40\ M St
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

o 

o 

burden to Director: 

401 M Street, S.W. 

per response tor reglstrallon activities an

Send commenlS regarding the burden estimate or a

(2137) U.S. Environmental Prolection Agency, 40 I M St
'-

.. 

reregistration 

of infonnation, 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

the' 

to Director: 

• 

• 401 M Street, S.W . 

D.C. 

estimate or a

. Environmental Protection Agency, 40 t M St
FW: Response to EPA Letter 

James Messina 

to: 

Bonaventure Akinlosotu 

03/311201001:15 PM 

Show Details 

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

Regards, 

Jim 

From; James Messina 

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

To: akin]ostotu.bonaventure@epa.gov 

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

Subject: Response to EPA Letter 

Mr. Akinlosotu, 

Page 1 of! 

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

dated January 27, 2010 regarding the following registration applications: 

1. Sergeant's Fipronil + S~methoprene Squeeze-On for Dogs (2S17-RGU) 

2. Sergeant's Fipronil + S-methoprene Squeeze-On for Cats (2S17-RGl) 

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

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

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

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

If you have any questions, please contact me. 

Best Regards, 

James Messina 

Senior Managing Regulatory Consultant 

Exponent 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

202-772-4932 

202-772-4979 fax 

301-90B-11B1 cell 

94
\ 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Washington, D.C. 20460 

Wednesday, January 27, 2010 

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

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

Registrant Name: Sergeant's Pet Care Products 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

Registrant Address: James Messina, Senior Managing Regulatory Consultant 

Exponent 

Subject: 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

Data Deficiency 

Product Name: Sergeant's Fipronil + Methoprene Squeeze~on for Dogs, 

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

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

EPA File Symbol: 2517-RGU, 2517-RGL, 2517-RGA, 2517-RGT 

Application Date: 

EPA Receipt Date: 

respectively_ 

December 21, 2009 

December 22, 2009 

Dear Mr. Messina: 

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

determined that it is incomplete or that further infonnation is needed. TIlls letter is a Mitten 

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

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

Pesticide Registration Improvement Renewal Act (PRIA 2). Your options under.40 CFR 

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

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

ofthe sections below in determining how and when you respond to this letter. 

40 CFR 152.105: 

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

12,2010 to provide a response concerning the deficiencies listed in this letter. Your response· 

95
may include making corrections or additions to complete the application, or notifying the 

Agency of the date on which you expect to complete the application, or withdrawing your 

application. If you do not respond to this letter within 75 days or if you respond with a date on 

which you expect to complete the application but fail to meet that scheduled date, the Agency 

will treat the application as if you had withdrawn it. Withdrawal concludes the Agency's review 

of your application. Any subsequent submission of the same application must then be submitted 

as a new application with a new deadline for EPA to make a determination on your application 

and subject to a new registration service fee. 

The deficiencies identified in the Agency's review at this time are as follows: 

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

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

used to support each applicable guideline. Instructions for completing the EPA form 8570~35 

data matrix correctly can be found within PR Notice 98-5. An electronic copy of this PR Notice 

can be obtained at the following Agency web site: 

http://www.epa.gov/opppmsdlIPR Noticeslpr98-5.pdf. 

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

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

products. As a result, you must submit acceptable end use product chemistry data in accordance 

with PR Notice 86-5. In addition, you must revise the data matrix as outlined in #1 above to 

reflect this change. 

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

self~certification is unacceptable for each product. The ctuTently approved CRP data for the 

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

satisfying the data requirements outlined in 40 CPR § 152.34. These CRP tests are product 

package design specific and unrelated to your proposed package. 

Further review of your application and your response to the deficiencies may identify 

additional deficiencies and you will be so informed. 

FIFRA Section 331PRIA: 

This application is also subject to a deadline for making a determination on the application 

under FIFRA Section 33, Pesticide Registration Service Fees, established under PRIA. The time 

frame for,the Agency to make a determination on this application ends on April 12, 2010 and 

you have the following three options: 

1. Withdraw the application: You may notify us not later than March 31, 2010 that 

you are withdrawing your application. As noted above, withdrawal concludes the 

Agency's review of your application; however, you may resubmit your application 

after the deficiencies have been addressed. Should you choose to resubmit your 

application, it would be subject to a new deadline for making a determination on your 

application and a new registration service fee. - Since a fee was paid with this 

application, the Agency will provide any applicable refund as soon as practicable. 

96
2. Not respond: If you do not respond or fail to provide (a revised data matrix, 

acceptable product-specific chemistry data, and acceptable (CRP) data), on or before 

April 12, 2010, the Agency will administratively withdraw your application. 

3. Correct application deficiencies: All acceptable data and data matrix as outlined 

above must be submitted to the Agency on or before April 12,2010. At that time, The 

Agency will re-classify your applications from a R300 new product; me-too fast track, to 

a R31 0 new product; non-fast track. The Agency will then request additional PRlA fees 

accordingly, and processing will not proceed until all the deficiencies are satisfied and 

applicable PRIA fees are paid. 

Please respond to this letter by March 31. 2010 by contacting Mr. Bonaventure Akinlosotu at 

(703) 605-0653, or bye-mail at akinlostotu.bonaventure@epa.govduringthehours of 7:00 am 

to 4:00 pm EST with a response and for any questions concerning this letter. When submitting 

information or data in response to this letter, a copy of this letter should accompany the 

submission to facilitate processing. 

Snrely, p/Ld/UL 

Richard J. Gebken 

Product Manager (I 0) 

Insecticide Branch 

Registration Division (7505P) 

97
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Washington, D.C. 20460 

Wednesday, January 27, 2010 

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

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

Registrant Name: Sergeant's Pet Care Products 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

Registrant Address: James Messina, Senior Managing Regulatory Consultant 

Exp:ment 

Subject: 

Center for Chemical Regulation and. Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

Data Deficiency 

Product Name: Sergeant's Fipronil + Methoprene Squeeze-on for Dogs, 

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

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

EPA File Symbol: 2517-RGU, 2517-RGL, 2517-RGA, 2517-RGT 

Application Date: 

EPA Receipt Date: 

respectively. 

December 21, 2009 

December 22, 2009 

Dear Mr. Messina: 

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

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

notification of those deficiencies and identifies your options under 40 CFR 152.105 and Section 

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

Pesticide Registration Improvement Renewal Act (PRIA 2). Your options under 40 CFR 

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

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

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

40 CFR 152.105: 

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

12,2010 to provide a response concerning the deficiencies listed in this letter. Your response 

98
may include making corrections or additions to complete the application, or notifying the 

Agency of the date on which you expect to complete the application, or withdrawing your 

application. If you do not respond to this letter within 75 days or if you respond with a date on 

which you expect to complete the application but fail to meet that scheduled date, the Agency 

will treat the application as if you had withdrawn it. Withdrawal concludes the Agency's review 

of your application. Any subsequent submission of the same application must then be submitted 

as a new application with a new deadline for EPA to make a determination on your application 

and subject to a new registration service fee. 

The deficiencies identified in the Agency's review at this time are as follows: 

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

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

used to support each applicable guideline. Instructions for completing the EPA form 8570~35 

data matrix correctly can be found within PR Notice 98~5. An electronic copy of this PR Notice 

can be obtained at the following Agency web site: 

http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf. 

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

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

products. As a result, you must submit acceptable end use product chemistry data in accordance 

with PR Notice 86~5. In addition, you must revise the data matrix as outlined in #1 above to 

reflect this change. 

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

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

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

satisfying the data requirements outlined in 40 CFR § 152.34. These CRP tests are product 

package design specific and unrelated to your proposed package. 

Further review of your application and your response to the deficiencies may identify 

additional deficiencies and you will be so informed. 

FIFRA Section 331PRIA: 

This application is also subject to a deadline for making a determination on the application 

under FIFRA Section 33, Pesticide Registration Service Fees, established under PRIA. The time 

frame for the Agency to make a determination on this application ends on April 12, 2010 and 

you have the following three options: 

1. Withdraw the application: You may notify us not later than March 31, 2010 that 

you are withdrawing your application. As noted above, withdrawal concludes the 

Agency's review of your application; however, you may resubmit your application 

after the deficiencies have been addressed. Should you choose to resubmit your 

application, it would be subject to a new deadline for making a determination on your 

application and a new registration service fee. - Since a fee was paid with this 

application, the Agency will provide any applicable refund as soon as practicable. 

99
) 

2. Not respond: If you do not respond or fail to provide (a revised data matrix, 

acceptable product-specific chemistry data, and acceptable (CRP) data), on or before 

April 12, 2010, the Agency will administratively withdraw your application. 

3. Correct application deficiencies: All acceptable data and data matrix as outlined 

above must be submitted to the Agency on or before April 12, 2010. At that time, The 

Agency will re-classify your applications from a R300 new product; me-too fast track, to 

a R31 0 new product; non-fast track. The Agency will then request additional PRIA fees 

accordingly, and processing will not proceed until all the deficiencies are satisfied and 

applicable PRIA fees are paid. 

Please respond to this letter by March 31. 2010 by contacting Mr. Bonaventure Akinlosotu at 

(703) 605-0653, or bye-mail at akinlostotu.bonaventure@epa.govduringthehours of 7:00 am 

to 4:00 pm EST with a response and for any questions concerning this letter. When submitting 

information or data in response to this letter, a copy of this letter should accompany the 

submission to facilitate processing. 

~UL Richard J. Gebken 

Product Manager (10) 

Insecticide Branch 

Registration Division (7505P) 

100
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

December 31, 2009 

OPP Decision Number: D-425454 

EPA File Symbol or Registration Number: 2517-RGL 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANTS FIPRONIL + S-METHOPRENE SPOT-ON FOR CATS 

EPA Receipt Date: 22-Dec-2009 

EPA Company Number: 2517 

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

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

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

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

communicated separately. During the administrative screen, the Office of Pesticide Programs 

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

the Pesticide Registration hnprovement Act. 

The Action has been identified as Action Code: R300 

NEW PRODUCT;ME-TOO PRODUCT FAST TRACK; 

No additional payment is due at this time. 

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

Ombudsman at (703) 305-6249. 

Sincerely, 

Front End ~c~ m~~ 

~ ~ ~ ----

Infonn i'6n'P chnolo esources Management Division 

101
Pay.gov - Online Payment 

Onlil!~ P~Xf!:l~nt 

Step 3: Confirm Payment 

Thank you. 

Your transaction has been successfully completed. 

Pay.gov Tracking Information 

Application Name: PRIA SeNice Fees 

Pay.gov Tracking 10: 2505H008 

Agency Tracking 10: 74094011145 

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

Payment Summary 

Payment Date: 12/2212009 

Decision Number: Account Holder Name: Sergeants Pel Care Products 

Payment Amount: $1,365.00 Registration Number: 

Page 1 of I 

1 1213 

Account Type: Business Checking 

Routing Number: 

Account Number. ~"'··5483 

Company Name: Sergeants Pet Care Produc 

Company Number: 2517 

Action Code: R30Q 

h ttps:1 /www.pay.gov/paygoY/paymen1s/authorizeACHPayment.htm I 12/2112009 

102

*Commercial/financial information may be entitled to confidential treatment*
PI ease rea d Insl{lJclions on reverse before completing form. FOlm Approved. OMB No. 2070-0060. Approval a~pires 05·31-98 

Uniled Stales ~ Registration opp identitier Number 

'EPA Environmental Protection Agency o Amendment 

Washinglon, DC 20460 D Other 

Application for Pesticide - Section I 

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

2517-r:teA1'" Richard Gebken 

4, CompanyfProdUCI (Name) 5.PM# 10 ~Nona DRestfic'ed Selqeants Flpronil + S"methoorene Spot- On For Cats 

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

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

2625 South 1SSIh Plaza 

Omaha, NE 68130 EPA Reg. No. 65331·4 

Producl Name FRONTLINE PLUS FOR CATS 

o Check II Ihis IS a new address 

Section II 

D Amendmenl- Explain below. o Final printed labels in response to Agency letter dated XX-XX·XX 

o ResubmiSSion in response 10 Agency leller dated XX-XX-XX ~ "Me Too' Application 

o NOliticalion - Explain below. o Olher - Explain betow. 

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

Submission 01 a new end· use regislralion applicalion. 

Section III 

,iAaterial This Product Will Be Packaoed tn: 

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

IZJ Yes' !Zl Yes DYes o Metal 

ONo o No is;] No [2J Plastic 

II "Yes" No. per It "Yes" No. per DGlass 

'Certification must Unil packaging wgl. Conlalner Package wg1. Conlainel 

DPaper be submitted 0.017 fl on (O.5Omll 2,3,4,6 

I OOlher (Specity) Plaslic Bag 

3. Location 01 Net Conlenls Intormation 4. Size(s) Releil Conlainer 5. Localion 01 Label Direclions 

IX!Labet o Container 0.017 n oz (O.SOmt) Don Cen 

Don Label"lng accompanying prOduct 

6. Manner in WhiCh lebel is Atlixed 10 ProduCI Duthograph [Z]Olher 

DPaper glued 

DSlenclled 

SectIon IV , , 3 , , , > 3 

, 

,. Contact Poinl (Com lele ilems direcll below tor idrmlificalion of individual to be conlac/ed. if necess_ary, 10 prpcess Ihis "pplicalion.) , , 

Name I Tille I Telephone No. (Includi} '" Are~ Code) 

Kelly R. Hoskins Manager 01 TeChnical Allairs • , ,)~.o"l:·938-7079 , 

Certification -' J: 15. Dale ~ppldHun I certily Ihallhe statemenls I have made on Ihis torm and all aUachmenlS thereto arelrue, accurale and complete. I """ Rece,~ed" 

ackno\\lledge Ihal arr; knowingly talse or misleading stalemenl may be punishable by line or Imprisonmenl or bolh ' , " (St',lr'l1pe'cD 

under eoolicable law. ,~ , J , , " , 

:yS~~ /L /j_ /. 

3. TItle "" , , 

", , Manager 01 Technical Affeirs , , , , 3 , , 

Nped f\!.;'l"ffie: 5. Dale: I2I21/2009 " 

I , , , '" , Kell R. Hoskins 

103
Sergeant's Pet Care PrOfiocts, Inc, ........ _ .. _._-_ ... _ .. _- -.~----.~.-.-.. -.-~-.-~--. 

15 D~cciliber 10U9 

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Prodlici rVlnn:lgcr:?:~ 

D()!.:UIlICI1! [lrnct~~sil'lg De"k 

Off-jet' II!' Pesticide I'rograms 

l .S. En\-lronmo::ni31 Prclicciioll Agency 

Rnom S-4l)()(i. On..; PlllOnl,ll' Y,ml 

2777 Somil Crystal DriV<.: 

Arlington. V A 22202-450 I 

DCll1" \11'. Gebken: 

SerC-'l'()n(s Pet Cue Products. Jne. (S~r~c;:1I1i's; 261:' Sl)llill \SWh Plaza. Olllah:l. t\CbrilSb - . ~ 

6){ 130- 1770. I":PA COl llj1any N umher 25 11), ;111 i Imri leS r,x pOllenl. I lie. () ) 50 en IlIleetic1 II 

Alenll..:. 1\'W. $(Iit.: 1100, Wllshingloll DC, 1()0361wl1Ci Oil Ullr bellilll: ,IS (Iur 

Alllhorized Representai i \'e, fell' (II] neccssa r')! IIlicructiol1:o.: rega rei i ng ,III 1I r lllir prod\lcl 

regisif<1tinll applications mid rcgislrlliiolls, PlcclSC nuie thi~ dtles not change iilc CUITCn! 

Iilcd Authorizo:.:d Ageni fl)r Scrgcrmt"s. 

The Exponl'nl, file. eon(ae! is as fullows: 

Jmlles Messina <lnc]iclY Rick Tins\v(1nll 

Exponl:nt. Inc. 

1150 Conned!Cu( Ave., N\V 

~lJilt: 1100 

\Vashingtl)11. DC 20036 

(202) 772-4932 

(202) 772-4979 tin 

jnl~ss!nJ(i:j'expoIle!ll.Golll/nins\Vlmh(u:(;XpnlleJll.com 

Slnc(:l'el~" 

/?::~;/ .'//cn,"t.~f~ - .:/ 

;' 

Kclly R. II(lskill~ 

ManClg.cr orleeilnic'-II Affair;.: 

CC: ,lames Messiilll 

104
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com 

December 21, 2009 

Richard Gebken, PMI0 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Certification 

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. certifies that the packaging used in the manufacture of the 

following products: 

• Sergeant's Fipronil Spot-On for Dogs; 

• Sergeant's Fipronil Spot-On for Cats: 

• Sergeant's Fipronil + S-methoprene Spot-On for Dogs; and 

• Sergeant's Fipronil + S-methoprene Spot-On for Cats. 

meets the standards of 40 CFR 157.32, including the revised standards in 16 CFR 1700.15(b). 

All product labels have language specifying the use of scissors to open the product container and 

label language stating the product is not to be applied by children. In addition, Sergeant's is in 

discussion with approved CRP testing labs to develop a protocol per the revised testing 

procedures in 16 CFR 1700.20. 

If you have any questions, please contact me at 402-938-7079. 

Sincerely, 

IU:f;A'dL.. 

Kelly R. Hoskins 

Manager of Technical Affairs 

cc: Larry Nouvel 

105
Sergeant's Pet Care Products, Inc. 

2625 South 15Bth Plaza • Omaha, NE 68130~ 1770 • Telephone 402.938.7000 • Fax 402.938.7099 • www.sergeanis.com 

December 21,2009 

Richard Gebken, PMl 0 

Office of Pesticide Programs (7504P) (REGFEE) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S~4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, V A 22202 

SUbject: Sergeant's Fipronil + S~methoprene Spot-On for Cats 

EPA File Symbol 2517-NEW 

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. (Sergeants, EPA Company Number 2517) is submitting a 

"me~too" EPA registration applica1ion for the new product Sergeant's Fipronil + S-methoprene 

Spot-On for Cats (containing the EPA registered active ingredients Fipronil (9.8%) and S~ 

methoprene (11.8%)). Please find enclosed the following documentation in support of this 

registration: 

(1) Application for Pesticide Form (8570~1); 

(2) Certification with Respect to Citation of Data Fonn (8570·34); 

(3) Formulator's Exemption Statement Form (8570-27); 

(4) Data Matrix Form (8570~35) - EPA and Public Versions; 

(5) Confidential S1atement of Formula (two copies); 

(6) Product Label (five copies); 

(7) PRIA category R300, Payment Confimwtion Receipt; and 

(8) Letter of Authorization. 

Sergeant's Fipronil + S-methoprene Spot-On for Cats is substantially similar to Merial Limited's 

EPA registered product FrontLine Plus for Cats (EPA Registration # 65331-4). Sergeant's has 

sent offer to pay letters to all data submitters listed on the enclosed data matrix. 

We look forward to working with the Agency to register this "me-too" product. 

questions, please contact me at 402~938-7079. 

Sincerely, 

!~i~/~ Manager of Technical Affairs 

Enclosures 

, , 

, , > > , , 

" , If you have anY, ',,' 

" , , " 

, -, 

" , , , 

, , , " 

" , , 

, 

, , 

" 

," , ,J" 

, 

, , 

" " 

106
Form approved. OMS No. 2070·0060, 2070-0057. 2070-0107, 2070-0122, 2070-0164. 

&EPA , Uniled States 

Environmental Protection Agency 

Washinglon, DC 20460 

Formulator's Exemption Statement 

(40 CFR 152.85) 

Applicant's Name and Address EPA File Symbol/Registration Number 

Sergeant's Pet Care Products,Inc. 2517-NEW 

2625 South 158th Plaza Produci Name 

Omaha, NE 68130 Sergeant's Fipronil + S-methoprene Spot-On for Cats 

Dale of Confldenlial Sialemeni of Formula (EPA Porm 8570·4) 

12/2112009 

As an aulhorized representalive 01 Ihe applicant for regislration of Ihe producl idenlified above, I certify Ihal: 

(1) This product contains Ihe following active ingredlent(s}: 

Fipronil (9,8%) 

S-methoprene (11.8%) 

(2) 01 Ihese, each aclive ingredientlisled in paragaph (4) is present solely as Ihe resull of the use of Ihat aclive 'Ingredient in Ihe manufacturing, 

10rmulalion or repackaging anolher producl which conlains that aClive ingredienl which is regislered under FIFRA Seclion 3, is purcha~d by 

us from another person and meels Ihe requiremenls of 40 CFR section 158_50(e)(2) or (3), 

j 

(3) Indicale by checking (A) or {8} below which paragraph applias: 

71 (A) An accurale ConOdential Sialemeni of Formula (EPA FORM 8570·4) for the above idenlified product is allached fo Ihis slatement. 

Thai formula slalemenl indicates. by company name, registrallon number, and product name, the source of the aClive ingredienl(s) lisled in 

paragraph (1). 

OR 

, (8) The Confidential Stalement of Formula (CSF}(EPA Form 8570·4) referenced above and on fila wilh Ihe EPA is complele, currenl. an 

accurale and contains the information required on the currenl CSF. 

(4) The fonowing active ingredients in this producl qualify for Ihe formutator's exemption. 

Source 

Aclive Ingredienl Product Name Regislralion Number 

Fipronil Teclmical , , " , , , , , 

" , , , , 

, " S-methoprene , , , ) " , , , , S-methoprene " , , , , , , " 

" " , ,, , " " . , , , " 

Signalure Name and Tille Dale " , , . , 

~L/l/!-AJ . > , , > 

Kelty R. Hoskins, Manager of Tecbnical Affairs 12/2112009 , , 

'" ' 

! EPA FormUS70-27 (Rev. 06-2004) Copy 1 - EPJ< " , , Copy 2 - Appllc3~LCDPY 

107

*Product ingredient source information may be entitled to confidential treatment*
Form Approued OMB Nos. 2070·0060' 2070-0057; 2070-0t07; 2070-0t22; 2070..()t54 

/1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

1200 Pennsylvania Avenue, N.W. 

WASHINGTON, D.C, 20460 

paperwork Reduction ACl Notice: The pub(ic reporting rurdcn for this colleclion ofinfotDlBlion is eslim~led 10 aUerage t.25 hours p::r response for regisl,"lion 

and 0.25 hours per respCflse for fercgistralian and speciat review activities, including lime for reading the instruclions and compleling Ihe necessary farms. Send 

commCniS regarding burden estimate or allY olher as~ct of this collection of • Information, incll)(flng suggestions for reducing Ihe burden 10: DirCclOI, ColleClion 

Stralegies Division (2S2ZT"), U.S. Environmcnlat Protection Agency, t200 Penn5ylvani~ Avenue, N.W., Washing'on, DC 20460. Do nOI send Ihe cOlilpleted form 

10 lhis address. 

Certification with Respect to Citation of Data 

Appllcant's/Ref)istrant's Name, Address, and Telephone Number 

Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha, NE 68130 

Actiue Inoredient(s) and/or representatiue test compoundtsl 

Fipronil and S-methoprene 

EPA Registretion Number/File Symbot 

2517-NEW 

"''' t212112oo9 

General Use Pallern(s) (list all those claimed for this product usinQ 40 CFR Pert 158) Product Name 

Indoor non-foOd Sergeant's Fipronit +S-methoprene Spot-On tOi Cats 

NOTE: If your product is a 100% repackaging of enother purchesed EPA-registered produellabeted for ell the same uses on your label, you do not need to 

submit this form. You must submit the Formuletor's Exemption Statement (EPA Form 8570-27). 

o 

[2] 

I am responding to a Data-Call_In Notice, and have included with this form a lost of companies sent oilers of compensation (Ihe Data Matrix form should 

be used for this purpose). 

SECTION I; METHOD OF DATA SUPPORT (Check one method only) 

I am using the Cite-all method of support, and have included wilh this form 

a list of companies sent offers of compensation (the Data Matrix form 

Should be used for this purpose), o I am using Ihe selective method of support (or cite-all oplion 

under the selectiue method), and have included with this form a 

completed list of data requirements (the Data Malrix form must be 

used). 

SECTION tt: GENERAL OFFER TO PAY 

[Required it using the cite-all methOd or when using the cite-ell option under the selective method 10 satisfy one or more deta requirements] 

12] I hereby oller end agree to pay compensation, to other persons, with regard to the approval of this applica~on, to the extent required by FIFRA. 

SECTION III: CERTtFtCATION 

I certity that this application for registretion, Ihs form for reregistration, or this Data-Call-In response is supported by all data submilled or ciled in Ihe 

epplication for re{lis(ration, the form for reregislration, or the Data-GaU-ln responSe. In addllion, jf the cite-all option or cile-all option under the selectiUe method is 

indicated in Section t, this applicalion is supported by all data in tha Agency's roles that (1) ooncarn Ihe properties or eN'ects otthis product or an identical or 

substantially Similar product, or orte or more ot the ingr6{lients in this product; and (2) Is a type of date that would be required to be submitted under the deta 

requirements in etfee! on the date of epproual of th·os appr,ca~on if the appf,cai'lon sooghtthe -In',lial registralion of a product of identical or srmilar composition and 

uses 

I cartify that for each eXclusiue use study cited in supporl of this registraljon or reregistration, that t em the original data submiller or thet I haue obtained 

the written permission otthe original data submitter 10 cite that study. 

I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, eilher: (a) I am the originJI data, 

submiller; (b) I haue obtained the permission of the onginal deta submller to use the study in support otthis applicelion; (c) all periods of eligibility fOJ} , J , } 

compensation haue expired for Ihe study; (d) the study is in Ihe public literature; or (e) I haue nptifled in wriling the company that submilled Ihe study and ha.ve 

offered (I) to pay compensa~on to the extent requirod by sections 3(c)( tXF) and/or 3(c)(2)(8) of FIFRA; and (Ii) to commenca negotianons to detemfn'e!he , 

emount and terms of compensation. it any, to t::e paid for the use of the study. ' , • 

, } } " > 

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evio,llnce'of 'peir deli',E'JY In, 

accordance with sections 3(c)(t)(F) and/or 3(c)(2){8) of FIFRA are auailabla and will be submitted to the Agency upon roquesL Should I fail 10 prod~ce'sys.h' 

evidence to the Agencyupon rG'lJest, t understand that the Agency may inH'late ecflon to deny, cancel or suspend Ihe reg',slration 01 my prryjuci in conformity with 

FIFRA. " ", " 

" " , t certify that the stetements t have made on thts form and all allachmentsto it are true, accurala, ilnd compt8le, I ~{'}<(16wtedge that,any 

knOWingly false or mistoading statement may bo punishable by 1ine or imprisonment or both under applicilble law. • , } , 

, , Kelly R. Hoskins, Manager of TeChnical Aflllrrs' 

" lure Dale Typed or Printed Name and Title 

};;:Pd. /t. /L ~, 12/21/2009 

EPA FOfl~~~5~~~h-2003) Electronic end ~eper verSions available. Submit only Paper version. 

108
.W 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

nr 

'."1' 

forr 

n Act Notice: The I n for Ihis ( __ V.L.') hours per for registrarion aClivilies and 0.25 

and completing thc necessary fo=. Send commeniS regarding the burden eslimalc 07 any o

. OPPE InformallOn Managemenl Division (2137) U.S. Environmenlall:'mleellon Agency. 4U! M 

n to I 

Applicant'siAegistrant's Name & ! 

Sergeant's Pet Care Products, Inc 

2625 South 1S81h Plaza, Omaha, NE ! 

.... , 

Number 

Cite-all 

j"eile-ali 

I Cile-all 

I: Fipronil 

DATA MATRIX 

[ EPA ReQ NolFile Svmbol; 

Product: Sergeant's Fipronil + S-methoprene Spot-On tor Cats 

I MRIDI 

I tiyngenta Crop Protection, Inc {N100} PO Box 18300 

l. NC 27419 

I _._ ... __ ._ •• _a lP (#264) 2 rw .Alexander Drive 

Research Triangle Park, NC 27709 

r·Status 

Bayer I::nvironmental (#432) 

PO Box 12014 

Research Trianqle Park, NC 27709 I 

I Cite-all Reckitt Benckiser Inc 

Morris Corporate Center IV 

399 I.nterpace Parkway I 

Parsiooaiw, NJ 07054 

Cile-all J.J. Mauget Co. (#7946) 

12733 Loop I 

Woodbridqe, VA 22192 

Cite-all BASF Corporalion (#7969) 

Agricultural Products 

PO Box 13528 

Research Triannla Park, NC 27709 

Signature, _ , Name and Tille 

J..::J..o---" <A Kellv R. Hoskins. ManaQer of Technical Allairs 

• • 

""IOn . 

"g'''''yl 
"'-' 

FOhn Apr"

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

!:l S'H2 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Nolice: The public reporting burden for this colleclion of informalion is eSlimaled 10 avemgc 0.25 hour,; per response fOl registralion aClivities and 0.25 

ror reregislmllOl1 Dad special review aClivilie>;, includillg lime for fC.lding Ihe inslOlclion and oompleling Ihe necessary forms. Send commCniS regarding the burden e'linme or any 

collection of infOlmalion. including sugge>;l;ons for reducing lhe burden In Direclor: OPPE Infol7nnlion Mnnagc=nl Division (2137) U,S. Environmcnlal Proleclion Agency, 40 I M 

Wasllin lon, DC 20460. Do nOI send lhe form to Ihis address. 

DATA MATRIX 

Dale: 12121/2009 EPA Re No.lFile S mbol; 2517-NEW Pa 

Applicant's/Registrant'S Name & Address: 

Sergean('s Pet Care Products, tnc 

2625 South t58lh Plaza, Omaha, NE 68130-1703 Product: Sergeant's Fipronil + S-methoprene Spot-On for Cats 

In redient: Fi roni! 

Guideline Reference Guideline Study Name MRID Number Submitter Status 

Number 

Cite-all Chemsico (#9688) 

Division of United Industries Corp 

PO Box t42642 

St.louis, MO 63114 

Cite-all Control Solutions, tnc (#53883) 

5903 Genoa-Red Bluff 

Pasadena, TX 77507 

Cite-all Virbac (#54022) 

PO.Box 16598 

Fort Worth, TX 76162 

Cite-all Combat Insect Control Systems (#64240) 

C/O Henkel Consumer Goods Inc. 

122 C NW, Suite 740 

Washin ton, DC 2000t 

Cite-all Merial Limited (#6533t) 

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 

- - - Washinaton, DC 20006 

-- 8'9/2' p; -J, :y/ /' c Name and Title 

Kelly R. Hoskins, Manager at Technical Aflails 

"0,'<10. ,n,' ... ,hM" <.,"mu_"'. •. __ ."" 

1---- F" .. 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
401 M Street, S. W. 

reregislralion 

10 Director: u,. Agency, 401 

EPARe No.lFiteS !!;!ot: 2517·NEW Pa 

AppUcanl's/Registrant's Name & Address: 

Pel Products, Inc ProdUct Sergeant's Fipronit + S-meJhoprene Spot-On lor Cats 

(#71754) 

1350 I Street, N-W. 

Suite 1 

(#73989) 

ClO Harold Himmelman (Beveridge & 

NW 

Kelly R. Hoskins, Manager 01 Technical Allairs 
FO,m App.o 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

& 401 M Street, S.W. 

WASHINGTON D.C. 20460 

Paperwork Rcduction Act Notice: The public reponing burden for lhiscoilec(ion ofinformntion is esli'lUUed (0 average 0.25 hours per response for regislralion activities and 0.25 

for reregistra(ion and .Ipecial reviow aelivilies. including time for reading Ihe inslrucrion and oompleling the necessary forms. Send comments regarding the burden esdmrue Or any o

collec,inn of infnrma(ion, including suggestions for reducing (he burden 1.0 Direc'or: OPPE Management Division (2137) U.S. Environmenlal PrOlec(ion Agency, 401 M 

Washilll1Jon, OC 20460. Do nOl send the form 10 Ihis-address. 

DATA MATRIX 

Date: 12/21/2009 EPA Ae No.lFile svmbol: 2517-NEW Pa

Applicanl'slRegistranl's Name & Address: 

Sergeant's Pel Care Prooucts, Inc 

2625 Soulh 158'h Plaza, Omaha, NE 68130-1703 

Product Sergeant's + S'methoprene Spot·On lorCals 

Ingredient: S-methoprene 

Guideline Reference Guideline Study Name MAID Number Submitter Sialus 

Number 

Cite-all ADM Alliance Nutrition, Inc. (#1157) 

1000 North 30'h Street, Box C I 

Quincv, Il 62305 

Cile-all The Hartz Mounlain Corp. (-#2596) 

Alln: Robert Rosenwasser 

400 Plaza Drive 

Secaucus, NJ 07094 

Cile·all Wellmark International (#2724) 

1501 E. Woodfield Road, Suite 200 West 

Schaumburn, Il60173 

Cite-all Chal1em, Inc. (#40086) 

Attn: David Schilling 

1715 West 38th St 

TN 37409 

Clle-all Enlorcer Products (#40849) 

A Division 01 Acuity Specialty Products 

1420 Seaboard Industrial Boulevard 

Atlanta, GA 30318 

Cite-all Control Solutions, Inc. (#53883) 

5903 Genoa-Red Bluff 

Pasadena, TX 77507 Name and Tide 

Kell R. Hoskins, Manaaer of Technical Alfalrs 

Ei'A r;;·nn ,no 1»"" Yo·","", ",",",hie. ""'O"PI" 1"0,";00. In"'""! U", 
FonnAvpn;Jv

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

&, 401 M Street, S,W. 

WASHINGTON D.C. 20460 

l'ilpcrwork ReduClion Acl NOlice: The public reporting butden for this collection of information is estimated 10 average 0.25 hour.; pcr response for registrntion activities MId 0,25 h

for re.regi,tr..tion ana special review activities, ;nchKling ti"", for reading the in,!ruction and completing the forms. Send comments regarding the burdcn estimme or any o

coltection of information, including suggestions for reducing Ihe burden to Director: OPPE Information Management Division t2137) U.S. Environmental Protection Agency, 401 M 

Wnshin ton, DC 20460, Do not send ,he form to this address. 

DATA MATRIX 

Date: 12/2 1/2009 EPAAe No./Fite S mbol; 2517-NEW Pa 

Apptican!'SfAegistrant'$ Name & Address: 

Sergeant's Pet Care Products, Inc Product: Sergeant's Fipronil + S-methoprene Spot-On tor Cats 

2625 South 158th Plaza, Omaha, NE 68130-1703 

In redient: S-metho rene 

Guideline Reference Guidetine Study Name MAID Number Submitter Status 

Number 

Cite-aU Management Contract Services, Inc. 

(#63823) 

PO Box 5209 

Valdosta, GA 3t603 

Cile-all Meriat (#65331) 

3239 Satellile Blvd, Btdg 500, lOC 106B 

Duluth, GA 30096 

Cite-all Spray Drift Task Force (#66607) 

McKenna, Long & Aldridge, LLP 

1900 K Street, NW 

Washinoton, DC 20006 

Cite-all B2E Corporation {#69554} 

150t East Woodfietd Aoad 

Suite 200 West 

IL 60173 

Cite-all Babolna Bioenvironmentat Centre Ltd 

(#70062) 

PO Box 5126 

Valdosta, GA 31603 

Cite·all " " " ,. " EGtS Pharmaceuticals Public Limited Co. , " " , ." . " , (#72947l " 

. , . , ''', t150 18 Street, NW, Suite 1000 . " . , , . . "'" Washinoton, DC 20036 

Signature Name and Tille 

/[If/' 

00 , .. " , . . , ." . Kelly A. Hoskins, Manager ot Technical Allairs " " , 

EPA F"ml P-lS '"'" P."".,- Vo,,;o«< ",""",,"', 2"1)' . " " At\<"<l' In""'.' 

" 
'-

Fom

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street) S.W. 

WASHINGTON D.C. 20460 

Paperwork Act Notice: The pubtic reporting humen for this CDilecl;on of infO!1ll8lion is estimated (0 average 0,25 hom:5 per for reglstratioll activities and 025 

reregiSIOllion and special review activities, including time for I'elIdillg (he instruction nnd cOlllplcling (he necessary forms. Send eommenlS regarding the hUlden e.<;limalc or any Olhe

of informotion, including suggestions for reducing the burden (0 Director; OPPE lnfmrlllllion Mnllugement Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.

20460. Do nol the form (0 Ihis address. 

DATA MATRIX 

Date: 12/21/2009 EPA ReaNo.lFile SYmbol: 2517-NEW Pa 

Applicant'sfRegislrant's Name & Address: 

Sergeanl's Pel Care Products, Inc Product Sergeanl's Fipronil + S-melhoprene Spol-On for Cals 

2625 Soulh lS8lh Plaza, Omaha, NE 68130-1703 

In redient S-melho rene 

Guideline Reference Guideline Siudy Nama MAID Number Submiller St

Number 

Clle-all Valent Biosciences Corporation (#73049) 

870 Technology Way, Suile 1000 

IL 60048 

Cite-all AMBRANDS (-#73342) 

118 J-2. East Main Sireet, Suite 1 

Salem, VA 24153 

Cile-aU Markelquest, Inc., (#73510) 

118'h East Main Sireet, Sulle 1 

Salem, VA 24153 

Cite-all AMza Corporalion (#74032) 

3330 Noyac Road, Building D 

SanHarbor, NY 11963 

Cile-all Residential Exposure Joinl Venlure (#74888) 

gOO 1 ih ?treet, NW, Suite 300 

Washinqlon, DC 20006 

Cile-all B2E Biolech, LLC (#75318) 

150 I East Wood1ield Road, Suite 200 West 

IL 60173 

Cile-all ZaCOA Incorporated (#82122) 

1001 G Sireet, NW, Suile 500 West 

Washinqlon, DC 20001 

Signature w v v Name and nte 

..4'" // / ' _ KeUyA. Hoskins, Managelof Technical Alfairs 

EI'A F""" .. P;1jl<"r V."ion,,,-.d,lo1o. S,1mi, ,,: v w: u .. 

" • 

• 
2 

f" Md 

of 

Inc 

NE 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

to average 0.25 hours pcr response for registration activities and 0

for reading the instruclion and completing rile necessary fonns. Send comnlcnts regarding the burden estimate or a

the burden to Director: OPPE lnfonnarion Managemcnr Division (2137) U.S. Envirollmenral Protection Agency. 40

DATA MATRIX 

lie Symbol: 

Product: Sergeant's Fipronil + S-methoprene Spot-On for Cats 

Park, NC 27709 

IV 
-

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S. W. 

W 

reporting burden for this collection 01 mtom13tion IS estimated 10 average 0.25 hours per response for registration activities and 

including lime for reading the instruction and completing the necessary fonns. Send commerns regarding the burden estimate or 

reducing the burden to Director: OPPE Illfonnalioll Management Division (2137) U.S. Environmental Protection Agency, 4

JJr:lI..I..n. .... .,. ..... .. 

Date: 12/21/2009 EPA Re No./File S mbol: 2S17-NEW Pa 

Applicant's/Registrant's Name & Address: 

Sergeant's Pet Care Products, Inc Product: Sergeant's Fipronil + S-methoprene Spot-On for Cats 

,," __ . -

Industries Corp 

PO.Box 16598 

Fort Worth, TX 76162 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

reregistration and special review activities, including tilne for reading the instruction and completjug the necessary forms_ Send comments regarding the burden estimate or any 

of information, including suggestions for reducing the burden 10 D'irector: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Stree

Product: sergeant's Fipronil + S-methoprene Spot-On for Cats 

• Kelly R. Hoskins, Manager of Technical Affairs 
n 

-

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

average 0.25 hours per response for registration activities and 0

the instruction and completing the necessary forms. Send comments regarding the burden estimate or any 

to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 40

DATAMATRlX 

Date: 12/21/2009 EPA Re No.lFile S mbal: 25' 

Applicant'siRegistrant's Name & Address: 

Sergeant's Pet Care Products, Inc Product: Sergeant's Fipronil + S-melhoprene Spot-On for Cats 

---- - . _. -. NE 68130-1703 

. . 

• • 

SU'lte 200 West 

Products 
() 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

10 average 

instruction and completing the necessary forms_ 

to Direclor: OPPE Iliforrnation Management Division (2137) U.S. 

estimate m any 

Protection Agency, 4

Product: Sergeant's Fipronil + S-methoprene Spot-On for Cats 
n 

-

review 

'00 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S. W. 

to average 

the instruction and completing the necessary fonns. 

to Director: OPPE Information Management Division (2137) U.S. 

estimate or any 

Agency, 401 M Stree

Product: Sergeant's Fipronil + S-melhoprene Spot-On for Cats 

. . . 

East Woodfield Road, Suite 200 West 

Kelly R. Hoskins, Manager ofTechnicaJ Affairs 
Sergeant's Master Label 

21 December 2009 EPA Submission 

InformaIion in I 1 is optional. Page 1 of8 

U:,LEPA No. 2517-XX 

2\ December 2009 

FRONT PANEL ,.... •. c:~T Sp()'rQN 

FlpRONIL+Wi:TI!QpRli'NE 

[Optional text appears in brackels ~ the final label may include some or all of the optional text on 

front, back or side label panelsi 

Sergeant's Fipronil + Methoprene Spot-On for Cats 

[ABNs] 

[(Sergeant's) (Sentry) Frontspot Plus (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) Firstline Plus (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) Frontedge Plus (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) VetSpot Plus (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) Frontguard Plus (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) Frontier Gold (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) Frontpronil Plus (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) Fiproline Plus (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) Ectoadvance (Spot On) for cats (and kittens)] 

[(Sergeant's) (Sentry) Gold FrontSpot (Spot On) for cats (and kittens)] 

[SentryProline (Spot On) for cats (and kittens)] 

[SentryVet (Spot On) for cats (and kittens)] 

[Mosquitoes] , , ; :: : 

[. [Kills [and] [&] [repels] mosquitoes] [within 24 hours] , "" 

[. Kills [and] [& J [repels] mosquitoes that may transmit heartworm:;'" : " , 

[Adult Fleas] 

[. [Kills adult fleas [for up to six weeks]] 

[. Kills [&] [and] [repels] Fleas [Up to [4] [6] weeks]!] 

, , , ".". 

" , " , , " 

" , 

. " 

" , " , , " 

, , .. , . , . , . , " , , > > > 

[. Kills [and] [&] [repels] fleas source of flea allergy dennatitis, flea bite anemia, 

and tapeworm infestation] 

[Multiple Infestations] 

[-Kills [chewing] lice and controls sarcoptic mange] 

[. Flea [&] [and] Tick Control for Cats [&] [and] Kittens 8 weeks old and older] 

[-Kills fleas, flea eggs, ticks, chewing lice [&] [and] mosquitoes] 

[·Kills [and] [&] [Repels] fleas, ticks, chewing lice [&] [and] mosquitoes] 

[-Kills fleas, ticks, mosquitoes, (chewing) lice, flea eggs, larvae and pupae] 

[·Breaks the Flea Life Cycle [for up to three months]] 

[-Monthly flea, tick, mosquito, lice, and flea egg protection] 

[-Monthly flea, tick, mosquito and lice protection] 

[-Kills fleas, ticks, mosquitoes, flea eggs, and lice] 

[- [Seven] [7] Way Protection [Kills fleas, ticks, mosquitoes, lice, flea eggs, flea 

larvae and flea pupae]] 

[- 6 [Six] Way Protection! Kills fleas, ticks, mosquitoes, lice, flea eggs & flea 

larvae] 

[. [4 Week] [I month] [30 day] [Flea and Tick [&] [and] Treatment] 

121
Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in I I is opl ionaJ. Page 2 of8 

EPA No. 2517·XX 

21 December 2009 

FRONT PANEL ••. • ..... CA:T.SPO.:r ON 

FjpRO~ILtMEfII:OPRENE [. [Four (4) Week] [I month] [30 day] [Flea Tick, Mosquito and Lice Control] 

[oUse [brand name] monthly to break the flea life cycle.] 

[oUse [brand name] monthly to control ticks and chewing lice] 

[oMonthly flea, tick, mosquito, flea egg, flea larvae and chewing lice protection.] 

[. [4 week] [I month] [30 day] Flea and Tick Treatment!] 

[Once A Month Flea and Tick Treatment] 

[. Kills [&] [and] Repels Fleas and Ticks for up to [4 weeks] [I month] [30 

days]!] 

[. Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to [4 Weeks] [I month] [30 

days]] 

[0 (Brand Name) provides convenient and effective flea, tick, chewing lice and 

mosquito control for cats and kittens.] 

[0 Controls reinfestation [for up to six weeks]] , , , > • > •• , 

[Ticks] " , 

[oKills [and] [&] [repels] ticks including those that may transmit Lyme diseasei .... 

[. Kills [and] [&] [repels] Ticks for Up to [4 weeks]!] :"; ", ' 

[. Kills [and] [&] [repels] [all stages of] Deer Ticks (vector ofLym~Jli",,~se) fur',:' 

up to [4 weeks][1 month][30 days]] ',.' :',', 

[. [Kills [and Repels] [all stages of] (Deer) Ticks [before they can] [thlltj (translnit" 

Lyme Disease,] for up to [4 weeks] [1 month] [30 days] [per applicarl6hl] " :, 

[. Kills [and] [&] [repels] [Brown], [American,] [and Lone Star Dog Ticks] "., 

[(Rhipicephalus sanguineus)] for up to [4 weeks] [I month] [30 days]] : ,", 

[. Kills [&] [and] [Repels] American Dog Ticks [(Dermacentor variabilis)] for liP' ' 

to [4 weeks] [I month] [30 days]!] 

[Flea Eggs and Larvae] 

[oControls [flea] reinfestation [for up to six weeks]] 

[0 Kills adult fleas, flea eggs, flea larvae and pupae [for up to six weeks]] 

[oKills all stages of the flea (adult fleas, flea eggs, flea pupae and flea larvae)] 

[0 If cat is a high risk for flea reinfestation a once a month application may be 

needed] 

[·Kills flea eggs [larvae] [pupae] for up to six weeks] 

[. With (S)-methoprene [Insect Growth Regulator] [IGR] which Breaks the Flea 

Life Cycle] 

[. With (S)-methoprene to Break Flea Life Cycle] 

[. With [Insect Growth Regulator] [IGR] to Break Flea Life Cycle] 

[. Dual Action [!]. Fipronil with (S)-methoprene [insect growth regulator] [IGR] 

Effectively Breaks the Flea Life Cycle] 

[. Dual Action [!]. Effectively Breaks the Flea Life Cycle[!]] 

[. Kills Flea Eggs & Flea Larvae for [(six weeks)]'] 

[0 Prevents Flea Eggs From Developing Into Biting Adults] 

[0 Kills all stages of the flea life cycle] 

122
Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in [ J is optional. Page 3 of8 

EPA No. 2517-XX 

21 December 2009 

FRONT PANEL ...CATSPOTON 

F.IPI{ONIL-jiMEjI'HOPI{ENE 

[All Others] 

[-Controls Sarcoptic Mange [infestations] 

[·Stops and prevents infestations] 

[·For Cats and Kittens 8 weeks of age or older] 

[. Fast Acting] 

[·Cats can be bathed 24 hours after treatment] 

[. Long Lasting] 

[·Once a month treatment recommended] 

[·A once monthly application is recommended for chewing lice.] 

[·Fast Action against [chewing] lice infestations] 

[. Three Applications {for cartons with 3 applicators}] and/or [3 Month Supply] 

or [12 Week Supply] 

[. Four Applications {for cartons with 4 applicators}] and/or [4 Month Supply], or • 

[16 Week Supply] :'"'' 

[. Six Applications {for cartons with 6 applicators}] and/or [6 Month Supply] ~', '. 

[24 Week Supply] , " , , , ) , , [. Best if used year round!] ; '; 

[. (ICON Showing [4 Week] (! month] (30 day] Protection)] .,., ,. • [. [4 Week] [I month] [30 day] Dose!] " 

[. I Month Dose'] 

[. Easy to Use [Application]] 

[. Specially Formulated for Cats and Kittens] 

[. [Free] Calendar Stickers Inside!] 

[. [Free] Brochure Insidet] 

[. [Free] Brochure and Calendar Stickers Inside] 

[. Apply once every [4 weeks] [month] [30 days]!] 

[. Cats can be bathed 24 hours after squeeze-on is applied] 

[. Waterproof] 

"" , , , " " , 

[·Can be used on breeding, pregnant and lactating [queens], [female cats]] 

[. [Free with purchase] [Free inside] Monthly Application Reminder [Magnet] 

[clip] [insert](inside] 

[·Can be used on puppies 8 weeks of age and older 

(·Monthly application reminder card inside] 

[ingredient statement may appear on front label or back label] 

ACTIVE INGREDIENTS: 

Fipronil .................................................. 9.8% 

(S)-methoprene ................................... 11.8% 

INERT INGREDIENTS,,,,,,,,,,,,,,,,.,,78A % 

TOTAL 100.00% 

" , ,. , , " 

" , " , . " 

, , , . ", , 

. " '" > , , , . 

123
Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in [ [is optional. Page 4 of8 

EPA No. 2517-XX 

21 December2009 

FRONT PANEL '. '. . ,.CATSPC)TON 

FIPRONIL+i\i!!,,'l'HOPRENE 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

See [Side] [Back] Panel For Additional Precautionary Statement 

NET CONTENTS: 

One [TwoJ[Three] [Four] [Six] 0.017 fl oz (O.SOml) applicators 

{END - FRONT PANEL} 

" , ) " ) ), 

• 

) , , , )j 

• • 

" , , , " , , ) 

" . •• • · .. , , > 

· . · " " . •• • · " 

, > , , 

· .. • • • , , , . 

124
Sergeant's Master Label 

21 December 2009 EPA Submission 

lnfonnalion in [ [is 0Plional. PageS of8 

EPA No. 2S17-XX 

21 December2009 

BACK PANEL '" "," "CATSPOTON 

F!l'll,!'llTIU+MEmOPl,l.ENE 

[brand name] contains Fipronil and S-Methoprene (insect growth regulator) (IGR) to 

effectively kill [and repel] fleas (all stages) and ticks [(including those that may transmit 

Lyme Disease)]. The active ingredients in [brand name] work by collecting in the hair 

follicles and skin oils. This product features a sustained-release formula that discharges 

from the animal's hair follicles using the natural skin oils, resulting in fast-acting [and 

long-lasting] control of fleas, ticks, mosquitoes and chewing lice [for 30 days]. 

(diagram with visual of fipronil collecting and being released from hair follicle] 

READ ENTIRE LABEL BEFORE EACH USE 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS. CAUTION. HannfuI if 

swallowed. Causes eye irritation. Avoid contact with skin, eyes or clothing. Wash 

· . thoroughly with soap and water after handling. 

PHYSICAL OR CHEMICAL HAZARDS , , • > , • 

• COMBUSTABLE: Do not use or store near heat or open flame. " • • · .. " , > , , , FIRST AID • , , , , .. 

~ • 

If swallowed Call a poison control center for a doctor inunediately fOl'lreatmeni adVice. 

Have person sip a glass of water if able to swallow. D<;N1q( induc~ > •• : ' 

vomiting unless told to do so by a poison control center ,dr,doctor. Do not 

give anything by mouth to an unconscious person. ' . , . • , >-,..,-

If in 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 attention if 

irritation persists. 

HOTLINE NUMBER 

Have the product container or label with you when calling a poison control center or doctor, or 

going for treatment. You may also contact 1-800-224-PETS [7387] for emergency medical 

treatment information. 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner inconsistent with its 

labeling. 

Do not allow children to apply product. TO PREVENT HARM TO YOU AND YOUR 

PET, READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH 

USE, FOLLOW ALL DIRECTIONS AND PRECAUTIONAR Y STATEMENTS 

CAREFULLY, FOR EXTERNAL USE ON CATS ONLY DO NOT USE ON 

RABBITS. DO NOT USE ON OTHER ANIMALS. 

Do not use on kittens under 8 weeks of age. Best if used year round. Consult a 

veterinarian before using this product on debilitated, aged, medicated cats. Can be used 

on breeding, pregnant, or nursing (female cats) (queens). Consult a veterinarian before 

using on cats with known organ dysfunction. Pets may experience some 

125
Sergeant's Master Label 

21 December 2009 EPA Submission 

Informal ion in I I is optional. Page 6 of 8 

EPA No.2517-XX 

21 December 2009 

BACK P Al'/EL >,' CAT SPOT ON 

!lmii!:>:NiIJ+MJi;TJIOFRENE 

temporary irritation at the site of product application. Certain medications can interact 

with pesticides. Sensitivities may occur after using ANY pesticide product on pets. If 

signs of sensitivity occur bathe your cat with a mild soap and rinse with large amounts of 

water. If signs continue, consult a veterinarian immediately. 

(INSERT DIAGRAM THAT DEPICTS APPLICATION OF PRODUCT ON THE 

CAT) 

HOW TO APPLY AND OPEN CHILD RESISTANT PACKAGE: 

Remove product tube [vial] from the package. Holding tube [via!J with notched end 

pointing up and away from the face and body, cut off the narrow end at the notches with 

scissors. While holding the cat with one hand, use the other hand to apply the solution. 

Invert the tube [vial] and use the narrow end to part the cat's hair. Apply contents of one 

(0.017 fl oz) tube [via!J of {Product Name} as a stripe, starting high on the back of the; • ,. :. 

cat's neck to in front of the shoulder blades. Hold the cat for a few seconds to give the,. • 

solution time to be absorbed imo the cat's coat. When finished, vvrap the tube [vial] in! •••• 

paper and put into the trash. Only one applicator per treatment is needed. : ' , ~ , : • , , > , . , "",> '" FREQUENCY OF APPLICATION . " ' " , . Use [brand name] monthly for complete control of flea, tick [and] chewing lie'i ld11d ' ,~ 

mosquito] infestations. [Studies show that] [brand name] kills all stages ofthe'iH::a for ul?,: , 

to three months. If your pet is at high risk for flea reinfestation[, or in a highly infested ~ , ,~~ • 

environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing, • * 

lice. [Brand name] remains effective, even after bathing, water immersion, or exposure' >; •• ' 

to sunlight. Allow treated area to dry thoroughly. Do not reapply for 30 days. 

(Brand Name) can be used on breeding, pregnant and lactating (queens) (female cats). 

STORAGE AND DISPOSAL 

PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in 

a cool (below 77°F [2soCJ) dry place inaccessible to children and pets. Do not 

refrigerate. Protect from direct sunlight. 

CONTAINER DISPOSAL: If empty: Non-refillable container. Do not reuse or refill 

this container. Offer for recycling if available. If partly filled: Call your local solid 

waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain 

[WARRANTY 

Read the entire Directions for Use and Warranty before using this Product. By using this 

product, user or buyer accepts the following warranty. [[The directions for use of this 

product are believed to adequate and must be followed carefully. It is impossible to 

eliminate all risks associated with the use of this product. Unintended consequences may 

result because of unknown factors. All such risks shall be assumed by the user or buyeLj 

126
Sergeant's Master Label 

21 December 2009 EPA Submission 

Information in I I is optionaL Page 7 of8 

BACK PANEL 

EPA No. 2517~XX 

21 December 2009 

.' CAT SPOT ON 

I,]PRPN!L+)V!jl(1'JlOJilU:NE 

[Sergeant's is committed to providing high quality products. To the extent consistent 

with applicable law, Sergeant's makes no warranties, express or implied, of 

merchantability or of fitness for a particular purpose or otherwise, that extend beyond 

statements on this labeL To the extent consistent with applicable law, Sergeant's, the 

manufacturer, or the Seller shall not be Hable for indirect, special, incidental or 

consequential damages. To the extent consistent with applicable law, the exclusive 

remedy of the user or buyer shall not exceed the purchase price paid.J 

[If you have questions or comments about this product, please write: Sergeant's 

Consumer Response, P.O. Box 540399, Omaha, NE 68154-0399.J 

In Case of Emergency, call: 1~800~781~4738 [For more tnformationJ [Visit us atJ 

[www .sergeants.com J , , Non-Emergency call1-800-224-PETS (7387) [Made in USAJ , , > ) , , 

, 

Distributed by: 

Sergeant's Pet Care Products, Inc. 

P.O. Box 540399 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-XX 

, , , , , -' > , , > , 

, " '-' , , 

, 

, > 

, 

, 

> > 

EPA Est. No. XXXXX-XX-XXX ", , 

{END - BACK/ SIDE PANEL} 

{START - OPTIONAL INSERT OR PACKAGE COPY} 

, , , , 

> » , , 

", , 

[e How to Apply and Open Child Resistant Package - May contain graphics 

illustrating product use, e.g., cat with a drop falling onto its neck from a vial 

on front, side, or back carton label and/or applicator labeling.J 

[How to Apply 

1. Remove product tube from package. Holding tube with top end pointing up 

and away from face and body, cut off top end with scissors. [image of tube 

and end being cut off] 

2. Invert tube over cat and use open end to part cat's hair. 

3. Apply contents of one (0.017 fl oz) tube [vialJ of {Product Name} as a stripe, 

starting high on the back of the cat's neck to in front of the shoulder blades. 

Squeeze tube firmly to apply all of the solution to the cat's skin 

[Flea life cycle diagram J 

127
Sergeant's Master Label 

21 December 2009 EPA Submission 

Informalion in [ [is optional. Page80fB 

EPA No. 2517-XX 

2 I December 2009 

BArK P Al\IEL 

[Look at the Label (Look at the Label icon) 6 Step [Spot On] [Squeeze-On] [Topical] 

Checklist 

• Read the label completely and follow directions 

• Weigh your pet 

• Do NOT use Dog products on Cats 

• Do NOT treat with more than one pesticide product at a time 

• Separate animals after treatment to avoid chance of ingestion 

• Do NOT split tubes between pets] 

[Brand Name] 

[Monthly reminder card] 

[For year round protection apply [Brand Name] monthly.] 

[Pet's Name (Empty blank for owner to fill in name)] 

[First [dose] [Treatment] (Empty blank for owner to fill in date)] 

[Second [dose] [Treatment] (Empty blank for owner to fill in date)] 

[Third [dose] [Treatment] (Empty blank for owner to fill in date)] '" :" 

[Fourth [dose] [Treatment] (Empty blank for owner to fill in date)] """ , [Fifih [dose] [Treatment] (Empty blank for owner to fill in date)] " 

[Sixth [dose] [Treatment] (Empty blank for owner to fill in date)] ":", 

[calendar stickers with brand name] [Place stickers on your calendar as a re~i~a~r to 

reapply [brand name] in 30 days. 

[Monthly Application Reminder Magnet (image of reminder magnet) 

, , " , .. , 

, , , " 

" , " , , " 

" , , , .. 

, , , , , 1 , • 

, .- " , , , . ,

Enclosed for your convenience is an application reminder magnet. Push the (reset) 

button, and the reminder light will blink twice. The reminder tag is now set for 30 days. 

At the end of 30 days the reminder light will blink, reminding you to reapply [Brand 

Name]. Press the button once and the blinking light will stop. Press the button again and 

this will reset the timer for another 30 days. 

{END - OPTIONAL INSERT OR PACKAGE COPY} 

TUBE / VIAL LABEL 

Front Label 

{Brand Name} 

Fipronil9.8% w/w, (S)-methoprene 11.8% w/w 

0.50 mL 

Back Labe! 

KEEP OUT OF REACH OF CHILDREN I 

CAUTION: Read directions and precautions I 

before using. Open with scissors. 

EPA REG .. No. 2517-XX 

{label code} 

128
129
Page 130 through 132 contain the product confidential statement of formula and is n