REGISTRATION

2517-147 
:fti Data Requirements 

CJ D: Pending; 443257; 2017-RU7;I94;ACTIC>N.iNl 

:+: ~.m D: Clos~; 442432; 2517-RUT;W02;SMALL 

-;,;; e D: Pending; 442431; 2517-RU7;"31,';'''"' PI.O!; 

""' Iii! 

(OJ 

, 

•• 

DP385134;RD/IB; Complete Date: 

DP385135;RD/ /B; Complete Datt::: 

DP385137;RD/IB; Complete Date: 

DP 386764;RD/ /B; Last PossIble 

-

1
Tracking 

Create Resubmlssicn 

fFSLeiters 

Action Code Hisfory 

Secondary Oecision 

2
DP386764;RDIIB; Complete Date: 

DP385133;RDIIB; Complete Date: 

DP 385134;RDI IB; Complete OBte: 

DP 385135;RDI IB; Complete D,I', "~ 

DP385137;RDIIB; Complete Date: 

3
7~, 'iY;.( 

\(:c 

{~r Q(cfA 

3 65\:'::0:; 

DecIsion status 

Trscking 

Create Resubmission 

FFS Letters 

Action Code History 

Secondary Decision 

4
NEW APPLICATIONS 

DATE: NOV 1 9 2010 

FILE NUMBER: ')517- RuT 

PEP (OPPIN ENTRY) II) /!tn(::lO/Q 

(Initial & date) 

FILE ROOl\1: -------

(Initial & date) 

SIG: 

(InWal & date) 

F1LE ROOM: -------

(Initial & date) 

.;' ASSIGN TO PM jD (NO DATA) 

__ JACKET TO SHELF (DATA) 

5
DATA PACKAGE BEAN SHEET 

Date: 04-Apr-2011 

Page t of 3 

* * * Registration Information * * * 

Decision #: 442431 

DP #: (386764) 

PRIA 

Parent DP #: 

Submission #: 886190 

Registration: ~_~tT~RMT _-:u~_~_RG_~ANT~ __ EIJ~_R9.Ntb __ !_~TQEf;N~R9~ __ :!" __ NYJ~~·A_~ __ ~.I?_QT=()J 

Company: 2517 - SERGEANTS PET CARE PRODUCTS, INC. 

Risk Manager; f3~ ___ 1 0 - _~Jg_~~~~ ~_E!~_~~_n_ -J!Q~)_3o.~-":??P1_~_~_O_~_F'X_1 __ ~_-7?_3? ______ _ 

Risk Manager Reviewer: Rosanna louie-Juzwiak RlOUIE 

Sent Date: 

Ingredients: Sf;!~J?_~_fl.e ~ __ _ 

Expedite: 0 Yes • No 

DP Ingredient See pa.ge 3 

Calculated Due Date: 14-Jun-2011 

* * * Data Package Information * * * 

Oate Sent: 14-Feb-2011 

DP Title: #2S17-RUT CRP Self·Certification Review 

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

Date In Date Out 

Edited Due Date: 

Due Back: 

Organization: RD I TRB .~.I,d\1 last Possible Science Due Date: 1_~!:A_(3.I~?P1_1 __ _ 

Team Name: Science Due Date: 

Reviewer Name: louie-Juzwiak, Rosanna ---------------- -------------------- Sub Dala Package Due Date: 

Contractor Name: 

'" '" '" Studies Sent for Review'" '" '" 

Printed on Page 2 

'" '" '" Additional Data Package for this Decision'" '" '" 

Can be printed on its own page 

'" '" '" Data Package Instructions'" '" '" 

Complete a CRP review for the proposed product. 

Attached is the self-certification summary provided by the registrant, citing a previously submitted study (MRID 48279601). 

6
Page2 

DP#: (386764) * * * Studies Sent for Review * * * Decision#: (442431) 

i Laboratories, 

Inc. 28 p. 

7
PRIA 2 - 21 Day Content Screen Review Worksheet 

(EPA/OPP Use Only) 

J /

_ / q _ /3

0

123/09 

21 Day Screen Start Date: ---'--"-.--.::,,;{-,;,-'''-------c-c 

Experts In-Processing Signature: 15, (L- DateL 1-2 6 -I fJ Fee Paid: Yes /' 

Division management contacted on issues No, ___ Yes ____ ,Date ______ _ 

EPA Reg. Number: J,!3 /7 -If U T EPA Receipt Date: / (- 11-.20 

1 

Items for.Review 

Application Form (EPA Form 8570-l)(link to form) signed & complete 

including package type 

Yes No N/A* 

Confidential Statement of Formula all boxes completed, [ann signed, and Y--

2 

3 

a) All ioerts (link to hup://www.epa.gov/opprdOOllincrts/), 

including fragrances, approved for the proposed uses (see 

Footnote A) 

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

form) completed and signed (N! A if 100% repack) 

Certificate and data matrix consistent 

If applicant is relying on data that are compensable, is the offer 

to pay statement included. (see Footnote B) 

for 

yes 

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

no 

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

5 

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

copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% 

Selective Method (Fee use) 

b) Cite-All (Fee category experts use) 

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

5 Copies of Label (link to http://www.epa.gov/oppfeadl/labelingllrmD 

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

hUp:!!www.epa.gov/pesticideslregulating/registering/submissionslindex.htm#labels 

1 

8
7 Is the data package consistent with PR Notice 86~S (link to PRN 86-5) A 

Notice of Filing (link to 

8 htt[!:lIwww.eQa.gov/Qesticides/reguiatim!ltoierance I!etitions.htm) included 

with petitions (link to 

http://www.eva.uov/pesticides/reguIatillgltolerances.htm) ~ 

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

http://www.epa.gov/opprdOOl/workpian/reducedrisk.htmI) YRequired Data (link to 

httl2 ://www .ena.gov iQesti ci des/reguIatin e1data reguirements.htm) and/or 

data waivers. See Footnote C. 

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

10 

2 

9
Comments: 

For ~E~rlr\ :J"" ,\cl; ACe, -\ ,,"- (r:.:y:',j i,;nt y"J )h? 

""e \i\,t rnl,'rblOJ Thcs<c ;",kJe '1530 ,('31"'\) &31~(,31,;; 

G31,/ G:>d\) or1 /bOO, "'j::h ~dd;\lcA" -\1"7 YP<'\jv,csl"A ~ UJ",'vrr,,,-

"37°,13 0 • Abo) ~-;,( f"-\,,,,,,,,,,4,A""\jt,,r\ Mct",oJ \hQ.; c;'k "'~ 

old 5),,"4'7 OM\ >-'( ("'"e erM, \) \ ",01- '\M~ ",-"th,.] ; <'\ 1",1 o.leel7 

Ie> 0n\<'ccbL \0 \,,+h \'" old ~iI\J, ","" f,,'\kOts, W"- leew ,t 

to \~ \' k h o,e II ~e \,,,vV \0 ~/O c, eel ' 

1:'1"10(;,5 0 ~\'O~') '\0/ Y\M_+~oJ uSe 

-S- a,cket ('~:\,,~ jC\,,- \0 Co",\.r",';"s, 

'5-1 ~c\ie5 pqs,seA, 

'" N/A - Not Applicable 

Footnotes 

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

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

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

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

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

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

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

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

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

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

application as described below. 

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

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

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

3 

10
site [link to http://www.epa.20v/opprd001/inerts/lists.html] and if the inert is not 

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

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

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

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

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

delays. 

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

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

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

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

new inerts except PIP inerts are reviewed by nAB. The nAB 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 fLink to 

http://www .epa.gov /oppbppd Ilbiopesticides/contacts bppd.htlTI]. 

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

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

information [link to http://www.cpa.gov/opprdOOllinerls/lips.pdOmustalso be included 

to enable the Agency to determine if it ha-; been approved. Each component of an illelt 

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

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

Agency's receipt of au application, applicants must an'ange 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. 

During the 21 day content review, applicants should submit infonnation 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 

11
3. Withdraw the application (the Agency retains 25% of 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 (R311, R312 or R313), it will contact the applicant with the 

following options: 

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

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

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

approved for the application's uses; or 

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

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

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

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

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

Agency within the 21 day content review period.) 

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

category estimated); or 

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

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

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

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

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

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

options: 

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

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

approved; or 

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

unapproved inert. If an inert ingredient tolerance exemption petition is 

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

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

Agency will discuss harmonizing the timeframe for both actions. 

5 

12
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

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

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

the fee. 

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

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

without the necessary authorizations of offers to pay will be placed into either R30 I or 

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

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

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

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

should be submitted with the study waiver. 

6 

13
IFee for Servicel 

1~~ThiS package includes the fOIlO~~;;-~-l 

~ New Registration 

° Amendment 

for Division 

OAD 

oBPPD 

~RD 

y( 

(886190/~ 

yj Studies? :"'l Fee Waiver? 

../ Risk Mgr. [JQJ vol pay % Reduct."io~n,~: ==--~ ; L ____________________________ ~ __ ~______ L _______________ ~_____________ _ __ J ~=====::::.:.; 

Receipt No. s-I 886190 

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

Pin-Punch Date: I 11/19/2010 

-~~----------. 

~~--~----~-~--~--~---~-~-~~~-~-~~ --~ ------------------------~~-----------j 

_I iThis item is NOT subject to FFS action. ,----------------

i~~-~~~~;A;ctton-em:le_:­ --, Parent/Child Decisions: i 

Requested: IE-s I 6 

Granted: I 12') i () 

LAmount~ue: $ L( 1(-0 1 (0 

1;:"''''0 "il,,",r:;r¥ 11/#, /10 

~ .Inert clea~\ef for IntEln:d~~ Use 

ReViewer: oj \ /\ \ ( : \ L_) 

Uncleared Inert in Product 

Date: r i I Z'f /; L: o • 

Remarks: 

14
3 

< , 

7 

X 

<, 

~ -----. 

ISB'S Front-end PRlA Completeness Screen 

Draft 3; 10/25/07 

Rcc.:cipl Datc: /1/lf/!2o(O EPA Reg. Number: :)5/7- /?uT - --- Check List Item Ves No NIA 

Has lhc PRIA Fce been Paid; is a copy of the check or(fiiJ M ___ ~~ly.gOV receipt included in the Submission Package? tv X 

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

SLlhl11is~·dlJlI Package, is it completely lilled out and signed X 

induding package type? 

- ----"-~.---

i:-; a Confidential Statement of Formula (EPA Fonn 8570- X 29) .Included in thc Submission Package, is it completely 

n lied out and signed (boxes 1-21 )? 

. -------

Is i.I Formulator's Exemption Statement (EPA FotID 8570- X- 27) Included in the Submission Package? - -.--._.--- --

b u Ccrtificntioll with Respect to Citation of Data (EPA X hll"l1l g570~34) Included in the Submission Package? -.-- -,,-.---~--

------

Is a Unta Mnll·ix (EPA Form 8570-35) Included in the :/ Suhmis!>ion Paclwgc'? "' ~-----

Is u Lnhcllncludcd in the Submission Package? ;< ~. ---'---

Arc Uata Included in the Submission Package? ;( -.~ 

Is the Submission lin Amendment? -~. 

15
-

"",~~OST ... T. EPA Reg. Number: Dale of Issuance: 

" ENVIRONMENTAL PROTECTION AGENCY f .... ~ U.S. 

.~. 2517-147 08118/2011 

,,~ :p'" Office of Pe~licide Programs. 

-'f{ PRQ1\.<;' Term of Issuance; 

Registration Division (7505C) 

Conditional 

1200 Pennsylvania Avenue NW 

Name of Pesticide Product: 

Wa&hingloo, D.C. 20460 

Sergeant's Fipronil + Etofenprox + 

NOTICE OF PESTICIDE, PYliproxyfen Spot On for Cats 

X Registration --

~-

Reregistration 

(uoder FIFRA, as amended) 

Name and Addr= of Reglslraol (Include ZIP Code), 

Sergeant's Pet Care Products, Inc. 

2625 South 1581h Plaza 

Omaha, NE 68130-1770 

No!e; Changes in labeliog differiog in substance from lhnl ae<;epled in connection with this regiW<l~on mUSl be submi"ed 10 aod accepted by the Rt!(lislrnUon 

DivisiOn prior 10 US6 ot the taMI in commerce. In aoy correspondence 00 this product always reter to the above EPA regist",Uon number. 

On the basis of information tumtshe<:l by the regislrant, the above named peslicide is hereby registere<:l/rereg",tered under the Fe<:leral Inseclicide, Funoicide and 

Roden~dde Act. 

R8!1istra~on is in no way to be construed as an endorsement or recommendation of lhis product by the Agency. In order to protect heallh and the environment, 

the Administralor, on his motion, may al any time svspend Or cancel the re!listra~on 01 a pesticide in accordance with the Act. The aCCeptance of any name in 

conneclion with the registration of a proouCl under this Act is nol to be construed as giving the registrant a right 10 exclusive use of lhe name Or to il3 use if ~ 

has been coverfHl by others. 

This product is registered in accordance weth FIFRA sec 3(c)(7)(A), contingent on the following: 

L Make the following labeling changes before you release the product for shipment: 

a. Revise the EPA Registration Number to read: "EPA Registration No. 2517-147". 

b. Revise the signal word to "Caution". 

Signature of Approving O1ficial: Oate: 

See page 4 

Richard Gebken, August 18, 2011 

Product Manager (RM 10) 

Insecticide Branch 

Rel!istration Division(MC 7505P) 

EPA Form 8570-6 

16
2 

c. Delete the ABN "VetSpof'; implies / could be confused with FDA approved product. 

d. Under subtitle "[Multiple Infestations], revise claim to read [Three {3/ Way 

Protection]; only three (3) active ingredients on label. 

2. This registration is time-limited and expires two years from the date this product is first released fOf 

shipment. 

You must provide the Agency with a projected "release for shipment date", in writing within 30 days 

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

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

3. Only one basic confidential statement offorrnula (CSF) will be on file for this product at any time (i.e., 

no alternate formulations or minor formulation amendments will be submitted and/or approved for this 

product, except to allow for alternate sources of any individual inert ingredient). 

4. You must submit the following data within the timeframes described below: 

Within sixteen (16) months of the date on this Notice of Registration, provide to the Agency 

acceptable data packages for Guideline Studies: OPPTS 830.6320 (Corrosion Characteristics) and 

OPPTS 830.6317 (Storage Stability). 

5. You must submit quarterly enhanced incident reports and quarterly sales information in doses sold for 

this product for the quarter that begins on October 1, 2011. 

The quarterly reports are due two months after the end of each quarter. Please flag any Confidential 

Business Information CBI) as such. Enhanced incident reporting should be submitted to the Product 

Manager. Qualterly sales information should be submitted to the Registration Division, Immediate 

Office (attn: Kimberly Nesci). 

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

EPA Registration Number 

Product name (brand name) 

Lot # 

Where purchased: internet, store, Veterinarian 

Active Ingredient(s) 

Weight range for product 

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

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

Registrant case # 

Species: dog, cat, other (specify) 

Breed: (as reported by pet owner) 

Age: months or years 

Sex: M, F, or neutered 

Weight: pounds 

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

Body System: neurological, dennatological, GI, respiratory, ocular, other Major signs noted 

with separate colun1l1 for each sign, using standard terminology 

17
Time to Onset: (hours, days) 

Treated by veterinarian: yes or no 

First time product used: yes or no 

3 

Misuse: lise 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 

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

include the following details: 

a. All minor dennal and ocular irritation reports. 

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

and oral exposure would be reported as ocular exposure. 

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

of each severity code for each route of exposure. 

d. Summary table for dogs and table for cats showing number of incidents that are believed due to 

secondary exposure (e.g., mUlti-pet households). 

e. A summruy table for cats showing number of incidents for each severity code for these age 

ranges: <3 months, 3-6 months, 6-9 months, 9-12 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr, 6 yr, 7 yr, 

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

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

weight range on the product label (if applicable}. 

g. 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). 

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

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

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

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

18
4 

7. You must submit andlor cite all data required for registration of your product under FIFRA Section 

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

acceptable responses required for re-registration (registration review) of your product under FIFRA 

section 4. 

If EPA detennines that future mitigation measures are necessary for all pet spot-on products, the Agency will 

infolm all registrants concerned. If mitigation measures are necessary, EPA may take regulatory action. 

Two copies of the finished labeling must be submitted prior to releasing the product for shipment. 

If you fail to comply with the above stated conditions, the registration will be su~ject to cancellation 

in accordance with FIFRA sec. 6(e) and/or automatically expire. Your release for shipment of the 

product constitutes your acceptance of these conditions. 

A copy of your label stamped "Accepted with Comments" is enclosed for your records. If you have 

any questions conceming this action, please contact Dr. B. A. Akinlosotu via (703) 605-0653 or 

akinlosotu.bonaventure@epa.gov. 

Sincerely, 

e J~'/ UI<----. 

Richard Gebken, 

Product Manager (RM 10) 

Insecticide Branch 

Registration Division (MC 7505P) 

Ellclosures 

Stamped Label 

19
Sergeant's@ Master Label 

29 June 2011 Version 10.3 EPA Reg, No, 2517-RUT 

Information in [ ] is optional. Page 1 of 8 EPA Efficacy Review 

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

in s;iD'i' q0iiiibi.~"'ljkfio~r side lab~,~"'I, P~,~;I~,I ',i'?"?"'ii'i;;,,:"!,"?' 

Sergeant's FiproniI + Etofenprox + Pyriproxyfen Spot 

On for eats 

[ABNs:] 

[(Sergeant's@)(Sentry®)VetSpotTM(SpotOn)forcats] 

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

[(Sergeant's@)(Sentry@)EctoadvanceTM(SpotOn)forcats] 

[(Sergeant's®) (Sentry®) FrontspotT>1 (Spot On) for cats] 

[(Sergeant's,) (Sentry,) Firstline (Spot On) for cats] 

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

[(Sergeant's@)(Sentry') FrontguardTM (Spot On) for cats] 

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

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

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

[Apply to kittens over 12 weeks old] 

[Apply to kittens 12 weeks or older] 

ACCEPTED 

With COMMENTS 

In EPA Letter Dated: 

AUG 18 1011 

Under the Fedemllnsecticide, Fungicide 

and Rodenticide Act, As amended, for the 

paS1icide Registered under EPA Reg. No: 

7,.~n~/.f1 

[For use ONLY on cats [[&][and] kittens 12 weeks or older]OF ALL WEIGHTS] 

[For use ONLY on cats][of ALL weights] [over 12 weeks of age] 

[Mosquitoes] 

[-Kills mosquitoes] 

[Adult Fleas] 

[. [Full or Partial Brand Name] kills adult fleas for up to six weeks] 

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

[-Kills Fleas that may cause flea allergy demmtitis, flea bite anemia, and tapeworm 

infestation] 

[-Stops and prevents reinfestation] 

[-Controls flea reinfestation [for up to six weeks 11 

[- [Full or Partial Brand Name] kills adult fleas for up to six weeks] 

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

[-Prevents and controls reinfestations] 

[Flea Eggs and Larvae] 

[-Stops and prevents infestations] 

[-Controls flea reinfestation for up to 6 weeks] 

[. [Full or Partial Brand Name] kills adult fleas, flea eggs, [and] flea larvae [and prevents 

pupae] for up to six weeks] 

[-[Full or Partial Brand Name] prevents development of all flea stages for up to 6 weeks] 

[-Prevents all flea stages (adult fleas, flea eggs, flea pupae and flea larvae)] 

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

20
Sergeant's® Master Label 

29 June 2011 Version 10.3 EPA Reg. No. 2517-RUT 

Infonnation in [ ] is optional. Page 2 of 8 EPA Efficacy Review 

[Ticks] 

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

[- [Seven][Six] [Five] [7] [6] [5]Way Protection [Kills fleas, ticks, [mosquitoes,] chewing 

lice, flea eggs, [and] flea larvae [and prevents flea pupae]]] 

[-With Pyriproxyfen Insect Gwwth Regulator which Breaks the Flea Life Cycle] 

[-With Pyriproxyfen to Break Flea Life Cycle] 

[. With Insect Gro-wth Regulator to Break Flea Life Cycle J 

[-Triple Action [!] :Fipronil and Etofenprox with Pyriproxyfen IGR] [Effectively Breaks 

the Flea Life Cycle II 

[-Triple Action [I]: Effectively Breaks the Flea Life Cycler!]] 

[-Kills all stages of the flea life cycle] 

[-Kills Flea Eggs & Flea Larvae [for up to 3 months]!] 

[-Prevents Flea Eggs From Developing Into Biting Adults] 

[-Prevents and controls reinfestationsJ 

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

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

[-Kills Deer Ticks (which may transmit Lyme disease) for up to [4 weeks] [1 month] [30 

days]] 

[-Kills Ticks (Including Deer Ticks) for up to 4 weeks] 

[-Kills American Dog Ticks for up to 4 weeks] 

[-Kills [Brown], [American] [and Lone Star] dog ticks for up to 4 weeks] 

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

[Multiple Infestations] 

[(Full or Partial Brand Name) provides convenient and effective flea, tick, [and] chewing 

lice [and mosquito] control for cats and kittens [12 weeks or older]] 

[-Controls reinfestation for up to 4 weeks] 

[- Flea & Tick Control for Cats & Kittens 12 weeks old or older] 

[-Kills fleas, ticks,[&] chewing lice [& mosquitoes]] 

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

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

[-[Four][Three] [4][3] Way Protection] 

[-[4 Week] [Flea and Tick Treatment]] 

[-[Four (4) Week] [Flea Tick, [Mosquito] and Chewing Lice Control]] 

[-When used monthly [Full or Partial Brand Name] completely breaks the flea life cycle 

and controls tick and chewing lice infestations.] 

[-Once A Month Flea and Tick Treatment] 

[-Kills Fleas and Ticks for up to 4 weeks 1] 

[-Starts to kill fleas and ticks in an hour, continues to kill for a month] 

[-Kills [fleas] in 4 hours [and] [ticks in one hour]] 

[ [Full or Partial Brand Name] kills fleas in 4 hours and Dennacentor ticks in one hour] 

[-Kills ticks in 1 hour] 

[-Kills fleas and ticks in [24 hours] [1 day]] 

[-Starts killing fleas and ticks in as little as 1 hour] 

21
Sergeant's@ Master Label 

29 June 2011 Version 10.3 EPA Reg. No. 2517-RUT 

Information in [ ] is optional. Page 3 of 8 EPA Efficacy Review 

[All Others] 

[-Stops and prevents infestations] 

[-Por Cats and Kittens 12 weeks of age or older] 

[oFast Acting] 

[-Cats can be bathed 24 hours after treatment] 

[oWaterproof] 

[0 Long Lasting] 

[-Past Action against chewing lice infestations] 

[0 Three Applications] [3 Month Supply] [12 Week Supply] 

[- Best if used year round!] 

[0 (ICON Showing 4 Week Protection)] 

[04 Week Dose!] 

[0 1 Month Dose!] 

[- Easy to Use Application] 

[0 Specially Fonnulated for Cats and Kittens [12 weeks or older]] 

[0 [Free] Calendar Stickers Inside!] 

[0 [Free] Brochure Inside!] 

[- [Free] Brochure and Calendar Stickers Inside] 

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

[- Convenient to use] 

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

[insert]] 

[oPatent Pending] 

[03 applications] 

ACTIVE INGREDIENTS: 

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

Etofenprox .................................................. 15.00% 

Pyriproxyfen .............................................................. 2.20% 

OTHER INGREDIENT[**] .... _ ...................... 73.00 % 

TOTAL: 100.00% 

[**diethylene glycol monoethyl ether] 

KEEP OUT OF REACH OF CHILDREN 

WARNING 

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

NET CONTENTS: 

[3][Three] 0.017 fl oz [0.50 ml] applicators 

22
Sergeant's® Master Label 

29 June 20 II Version 10.3 EPA Reg. No. 25 I 7-RUT 

Infonnation in [ J is optional. Page 4 of 8 EPA Efficacy Review 

[BACK/SIDE CARTON LABEL - MASTER LABEL] 

[Full or Partial Brand Name) contains FiproniI, Etofenprox and [the insect growth 

regulator] [IGR) Pyriproxyfen to effectively kill fleas, ticks, [mosquitoes) and chewing lice. 

The active ingredients in [Full or Partial Brand Name] features a sustained-release fonnula 

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

[for 30 days] on cats [and kittens 12 weeks or older]. 

READ ENTIRE LABEL BEFORE EACH USE. 

USE ONLY ON CATS AND KITTENS OVER 12 WEEKS OF AGE. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS. WARNING. Causes substantial but temporary eye injury. Do not 

get in eyes or on clothing. Wash thoroughly with soap and water after handling and before 

eating, drinking, chewing gum, or using tobacco. Remove and wash contaminated clothing 

before reuse. Hannful if swallowed. Harmful if absorbed through skin. 

HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on kittens under 12 

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

[Some cats may experience temporary startle effects when any product is applied.] If signs 

persist, or become more severe within a few days of application, consult a veterinarian 

immediately. If your pet has an unusual reaction to the initial application, consult a veterinarian 

before repeating treatment. Certain medications can interact with pesticides. Consult a 

veterinarian before using on medicated, debilitated or aged animals. Call 1·800-224·PETS 

[7387] for 24-hour assistance. 

If In Eyes 

Clothing 

If Swallowed 

FIRST AID 

• Hold eye open and rinse slowly and gently with water for 15·20 minutes. 

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

eye. 

• Call a control center or doctor for further treatment advice. 

• Take off contaminated clothing. 

• Rinse skin immediately with plenty of water for 15-20 minutes. 

• Call a control center or doctor for treatment advice. 

• Call a poison control center or doctor immediately for treatment advice. 

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

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

• 

you center or , or 

treatment. For more information on this pesticide product (including health concerns, medical 

. or· caUl-SOO·781-473S. 

23
Sergeant's@ Master Label 

29 June 2011 Version 10.3 EPA Reg. No. 2517-RUT 

Information in [ ] is optionaL Page 5 of 8 EPA Efficacy Review 

24
Sergeant's® Master Label 

29 June 2011 Version 1003 EPA Reg. No. 25 I 7-RUT 

Information in ( ] is optional. Page 6 of 8 EPA Efficacy Review 

DIRECTIONS FOR USE 

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

READ ENTIRE LABEL BEFORE EACH USE. 

FOR EXTERNAL USE ON CATS ONLY. Do not use on kittens under 12 weeks of age. Do not 

treat your cat with more than one pesticide product at a time. Over dosing your cat can result in 

serious illness and even death. Best if used year round. Consult a veterinarian before using this 

product on debilitated, aged, medicated cats. Consult a veterinarian before using on cats with 

known organ dysfunction. Separate the treated cat from all other cats and dogs for 24 hours after 

treatment has been applied. Cats and dogs that actively groom or engage in close physical 

contact with treated cat may be at risk of serious hannful effects. The most common signs of 

ingestion are excessive salivation and foaming at the mouth. If these symptoms occur, 

immediately feed your cat and continue to monitor your pet for the next 24 hours. 

Sensitivities may occur after using ANY pesticide product on cats. If signs of sensitivity 

occur bathe your cat with a mild soap and rinse with large amounts of water. If signs 

continue, consult a veterinarian immediately by calling 1-800-781-4738. 

[Optional diagram mayor may not appear on the finished label] 

~)pt ~ 

[{Outer Packaging} 1 

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

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

the narrow end at the notches with scissors. 

How to apply: 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 tube 

[vial] of {Full or Partial Brand Name} [as a stripe, starting high on the back of the cat's neck 

to in front of the shoulder blades] [as a spot between the shoulder blades]. Hold the cat for a few 

seconds to give the solution time to be absorbed into the cat's coat. When finished, wrap the tube 

[vial] in paper and put into the trash. Only one applicator per treatment is needed. 

FREQUENCY OF APPLICATION 

Use [Full or Partial Brand Name] monthly for complete control of flea, tick [and] chewing lice 

[and mosquito] infestations. [Full or Partial Brand Name] kills fleas for up to six weeks, and flea 

eggs, [and] flea larvae [and prevents flea pupae] for up to 12 weeks. 

Apply monthly, if your pet is at high risk for flea reinfestation [, or in a highly infested 

environment]. Apply monthly to control ticks, [mosquitoes] and chewing lice. [[Full or Partial 

Brand Name] kills mosquitoes within 24 hours for up to 14 days, and within 48 hours for up to 

28 days.] [Full or Partial 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. 

25
Sergeant's® Master Label 

29 June 2011 Version 10.3 EPA Reg. No. 2517-RUT 

Information in [ 1 is optional. Page 7 of 8 EPA Efficacy Review 

STORAGE AND DISPOSAL 

PESTICIDE STORAGE: Do not remove tube from the pack tmtil ready to use. 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. Never place unused product down any indoor or outdoor drain. 

[WARRANTY 

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

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

believed to adequate and must be followed carefully. It is impossible to eliminate all risks 

associated with the use of this product. Unintended consequences may result because of 

unknown factors. All such risks shall be assumed by the user or buyer.J Sergeant's is committed 

to providing high quality products. To the extent consistent with applicable law, Sergeant's 

makes no warranties, express or implied, of merchantability or of fitness for a particular purpose 

or otherwise, that extend beyond statements on this label, To the extent consistent with 

applicable law, Sergeant's, the manufacturer, or the Seller shall not be liable for indirect, special, 

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

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

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

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

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

[Made in USA) 

Distributed by: 

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

P.O. Box 540399 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-RUT 

EPA Est. No. XXXXX-XX-XXX 

26
Sergeant's® Master Label 

29 June 2011 Version 10.3 EPA Reg. No. 25 I 7-RUT 

Information in [ ] is optional. Page 8 of 8 EPA Efficacy Review 

{START - OPTIONAL INSERT OR PACKAGE COPY} 

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

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

applicator labeling.1 

[Application Instructions][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: 

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

2. Apply contents of one tube [vial] of {Full or Partial Brand 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 firmly to apply all of the solution to the 

cat's skin.] 

[Optional diagram mayor may not appear on the finished label] 

[Flea life cycle diagram] 

[Look at the Label (Look at the Label icon) [Easy] 6 Step 

[Easy] [Spot On] [Squeeze-On] [Topical] Checklist 

• [11 Read the label completely and follow directions 

• [2] Weigh your pet 

• [3] Do NOT use Dog products on Cats 

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

• [5] Separate animals after treatment to avoid chance of ingestion 

• [6] Do NOT split tubes between pets] 

[Full or Partial Brand Name] 

[Monthly reminder card] 

[Apply [Full or Partial Brand Name] monthly for continuous protection against fleas, ticks, flea 

eggs, flea larvae [and] chewing lice [and mosquitoes].] 

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

27
Sergeant's® Master Label 

29 June 2011 Version 10.3 EPA Reg. No. 25l7-RUT 

Information in [ 1 is optional. Page 9 of 8 EPA Efficacy Review 

[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)] 

[calendar stickers with Full or Partial Brand Name] [Place stickers on your calendar as a 

reminder to reapply [Full or Partial Brand Name} in 30 days. 

[Monthly Application Reminder Magnet (image of reminder magnet) 

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

start the clock. After 30 days the magnet will flash (and beep) reminding you to reapply [Full or 

Partial Brand Name}. This application reminder can be used for future treatments. Just press the 

reset button and in another 30 days the reminder magnet will flash (and beep) reminding you to 

reapply.] 

[Optional graphics which mayor may not appear anywhere on the finished label] 

"Fleas 

~ Ticks 

~Mosquitoos 

" Chewing lice 

Front Label 

{Brand Name} [For use only on cats/kittens 

12 weeks or older] 

FiproniI9.8% w/w, Etofenprox 15% w/w, 

Pyriproxyfen 2.2% w/w 

0.017 fl oz [0.50 mL] (label code} 

@ Fleas 

® Ticks 

@ Mosqunoes 

@ ChewingUce 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

WARNING: Read directions and precautions 

before using. Use scissors to open. 

EPA REG. No. 25l7-RUT (label code} 

28
I</-'7 

RE: NOR for Sergeant's 2517-1A5Cl 

Bonaventure Akinlosotu to: Richard Gebken 

Cc: Marion Johnson 

08/22/2011 10:48 AM 

Richard: As stated in my note to you and Kim (with the draft NORs), I 

questioned the PPE requirement, per Byron's Tox/PL review. Seemingly 

unjustifiable, but since you didn't object, I assumed it was part of the 

'spot-on' mitigation issue. I spoke with Jim on Friday to inform him that you 

will clarify with Kim and Byron, and corrections will be make appropriately. 

Thanks, SA 

-----Richard Gebken/DC/USEPAjuS wrote; 

======================= 

To: "Jim Messina" <jmessina@exponent.com>, Marion Johnson/DC/USEPA/US@EPA 

From: Richard Gebken!DC/USEPA/US 

Date: 08/19/2011 09:27AM 

Cc: Bonaventure Akinlosotu/DC/USEPA/US@EPA 

Subject: RE: NOR for Sergeant's 2517-145 

Jim, 

Protective eyewear is not required for products that are homeowner products. 

BA will need to amend the letter, unless it is part of Kimberly's label review 

If so, I'll talk to her about this. 

Whatever the tox category is for the particular product (based on the acute' 6 

pack) will determine the signal word. It's not dependent upon eyewear. 

I never gleaned over the specifics of the label very close before signing as 

it was late at work, and I needed to get out of the office for a dinner 

engagement with my daughter and family. When I scanned the labels at the 

office, a couple of pages may have gone through the scanner stuck together. 

Sorry about this confusion and delay. I'm including Marion into the 

discussion, and he can place value on the need for PPE for homeowner products. 

I'm headed off today for Dr. visits and I'll call you this afternoon from 

home, since it's my day off. 

Regards, 

Richard Gebken 

BA, 

Can you check to see how this got on the letter. who determined that 

protective eyewear was needed? In addition, please get the full label to Jim 

for 2517-147. 

-----"James Messina" <jmessina@exponent.com> wrote: 

To; Richard Gebken/DC/USEPA/US@EPA 

From; "James Messina" <jmessina@exponent. com> 

Date: 08/19/2011 08:16AM 

Cc: Marion Johnson/DC/USEPA/US@EPA, Bonaventure Akinlosotu/DC/USEPA/US@EPA 

Subject: RE: NOR for Sergeant's 2517-145 

Richard, 

29
I have reviewed the labels and have a few questions: 

1. Is 1b mandatory that we add the wear protective eyewear and change 

the signal word to Caution or is it optional and the label can stay as Warning 

with no eyewear? 

2. 2517-147 is missing the full label. Can you please send the complete 

label? 

Best Regards, 

James Messina 

Exponent 

202.772.4932 office 

301.908.1l81 mobile 

From: Gebken.Richard@epamail.epa.gov [mailto:Gebken.Richard@epamail.epa.gov] 

Sent: Thursday, August 18, 2011 11:36 PM 

To: James Messina 

Cc: Johnson.Marion@epamail.epa.gov; Akinlosotu.Bonaventure@epamail.epa.gov 

Subject: NOR for Sergeant's 2517-145 

Jim, 

I tried to bundle all 4 of your labels into a single email but the server will 

not push information from my home to the Agency's system fast enough, so I'm 

sending these signally as 4 separate emails. 

I hope all finds you well 

Burning the midnight oil right with you consultants! 

Call me if you have any questions about the ABN and marketing strikes on all 

the labels. 

I'll be in Missouri until Tuesday of next week. 

Regards 

Richard Gebken 

30
Re: Thanks! ['j 

Kimberly Nesci to; Bonaventure Akinlosotu 

From: Kimberly Nesd/DC/USEPA/US 

To: Bonaventure Akinlosotu/DC/USEPAlUS@EPA 

you're welcome, Bonaventurel anytime, of course. 

Kimberly 

Bonaventure Akinlosotu 

From: 

To: 

Date: 

Subject: 

Hi Kimberly: 

Bonaventure Akiniosolu/DC/USEPAIUS 

Kimberly Nesci/DC/USEPAlUS@EPA 

08/18/2011 09:30 AM 

Re: Thanks! 

08/18/2011 09:38 AM 

08/18/2011 09:30:51 AM 

Your comments are on point and the NOR is being revised accordingly. Thanks for your prompt 

response, and for your usual diligence. 

B.A 

Kimberly Nesci No problem; I will review right now!! ----- OrigL. 

Bonaventure Akinlosotu 

----- Original Message -----

From: Bonaventure Akinlosotu 

Sent; 08/18/2011 08:45 AM EDT 

To: Kimberly Nesci 

Subject: Re; Thanks! 

08/18/2011 09:10:25 AM 

The PRIA due date is 09/12111, but Marion wants the action completed today. I will be out of 

the office next week. if you are can't get to it today, I believe Richard can stamp and mail the 

labels next week. 

Thanks. 

Kimberly Nesci 

From: Kimberly NescllDC/USEPAIUS 

To: Bonaventure Akinlosotu/DC/USEPAlUS@EPA 

Date: 08/17/2011 03;35 PM 

Subject Thanks! 

~=---~=--------------------------------------

Hi Bonaventure! I saw your package for review/concurrence on the Sergeant's products. Thank you! 

Can you let me know the PRIA date? Friday would be best for me, but I can get you comments sooner, if 

needed. 

Thanks, 

Kimberly 

Kimberly Nesci 

Special Assistant 

31
ROUTING & TRANSMITTAL SLIP August 17, 2011 

TO: (Name, office symbol, room number, building, Agency/Post) Initials Date 

1. Kimberly Nesci \\1 Registration Division/JO '/' J,' 

'" /'. / ' ,,' , 

, "/ ' 

2, Richard J, Gebken, PM 10 

Insecticide Branch/Registration Division J g~'l'Wll 

Action File Justify 

X ApprovaJ!Cuncurrecnce For Clearance Note and Return 

As Requested For Correction Per Our 

Conversation 

Circulate For Your Prepare Reply 

Information 

X Comment For Your Siqnature See Me 

Coordination Investigate 

REMARKS: 

NIB - Urgent review and response requested 

For your review and concurrence, Conditional NOR for Sergeant's Cat Spot On Products 

(2517-145, 146, 147 & 148). Products contain different combinations of Fipronil, 

Etofenprox, Methoprene, Pyriproxyfen, Nylar. 

Thanks for your timely response. 

, , 

(>1, J{, 

.. ; : t 

dJL J//',- J/,/ '---' 

FROM: (Name, org. symbol, ~ency/post) 

Room No. - Building: 

~1$117)~ 5-7232 - Potomac Yard South 

. A. Akinlosotu, PhD Phone No. 

Risk Manager (703) 605-0653 

Insecticide Branch/Reqistration Division 

32
/;If{ 0J4 "'"'f' 'VLIMJ ~fV' ::fA) ~ ~cv,J.uJ . , 

<- EPA Reg. Date ~f Issuance: U.S. ENVIRONMENTAL PROTECTION AGENCY ,;."EO toT-of}: 

. '. Number: i A' Office of Pesticide Programs 08118/2011 

t~·)~) Registration Division (7505C) 2517·145 

""lJt, PRot,,(j 1200 Pennsylvania Avenue NW Term of Issuance: 

Washington, D.C. 20460 

Conditional 

NOTICE OF PESTICIDE: 

L Registration Name of Pesticide Product: 

Reregistration Sergeant's Fipronil + Etofenprox + 

(under FIFRA, as amenoed) Methoprene Spot On for Cats 

Name and Address of Registrant (indudeZIP Code): 

Sergeant's Pet Care Products, Inc. 

2625 South 158'" Plaza 

Omaha, NE 68130·1770 

, Ni}t~::.C·hangeS 'i~)~beii~g differing ,in sllbsia"nce from',that accepted in connegion with thhnegisir'atjon must b~'sOQmitted to and 

, ~~~p~~~ 'by th~'Ii~'gi;;tra'no~'Division'~rlor to use ot'the tabe! in commerce. In any correspondence on this produ~ always refer'io the 

;b:;;V~ :'~PA,~~i,~ti~t(;;n ~~ri1b~r. " ", '. ,~ 

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

Insecticide, Fungicide and Rodenticide Act. 

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

and the environment, the Administrator, on his motion, may at any time suspend or cancel the registration of a pesticide in accordance 

with the Act. The acceptance of any name in connection with the registration of a product under this Act is not to be construed as giving 

the registrant a right to exclusive use of the name or to its use if it has been covered by others. 

This product is registered in accordance with FIFRA sec 3(c)(7)(A), contingent on the following: 

I. Make the following labeling changes before you release the product for shipment: 

a. Revise the EPA Registration Number to reacl: "EPA Registration No. 2517-145". 

b. Revise the precautionary statements to include: "Wear protective eyewear": and youj 

may change the signal word to "Caution". 

Signature of Approving Official: 

Richard Gebkin, 

Product Manager (RM 10) 

Insecticide Branch 

Registration Division (Me 7505P) 

EPA Form 8570·6 

~'. 

/~,'-, 

) /( ; 

Date: 

August 18, 2011 

v ~:) r. '" c' .'J : " 

{" 

"- :,</J 

, " . 

33
2 

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

shipment. 

You must provide the Agency -with a projected "release for shipment date", in writing within 30 days 

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

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

3. Only one basic confidential statement of formula (CSF) will be on file for this product at any time (i.e., 

no alternate formulations or minor formulation amendments will be submitted and/or approved for this 

product). \..-,r-,..V{or 

... " .'._-

4. You must submit the following data within the time:frames describecl below: /\ 

Within sixteen (16) months of the date on this Notice of Registration, provide to the Agency 

acceptable data packages for Guideline Studies: OPPTS 830.6320 (Corrosion Characteristics) and 

OPPTS 830.6317 (Storage Stability). 

5. You must submit quarterly enhanced incident reports and quarterly sales information in doses sold for 

this product for the quarter that begins on October 1,2011. 

The quarterly reports are due two months after the end of each quarter. Please flag any Confidential 

Business Informati01ICBI) as such. Enhanced incident reporting should be submitted to the Product 

Manager. Quarterly srues information should be submitted to the Registration Division, Immediate 

Office (attn: Kimberly Nesci). 

The following is a list of infonnation 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. (mrnldd/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 f!-eutered 

Weight: pounds 

Primary Route of Exposure: dennal, 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 

34
3 

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 

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

include the following details: 

a. All minor dermal and ocular irritation reports. 

b. 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. 

c. A similar sununary table for dogs (misuse or secondary exposure) showing number of incidents 

of each severity code for each route of exposure. 

d. Summary table for dogs and table for cats showing number of incidents that are believed due to 

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

e. 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, 15 yr, >15 yr. 

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

weight range on the product label (if applicable). 

g. 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). 

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

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

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

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

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

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

acceptable responses required for re-registration (registration review) of your product under FIFRA 

section 4. 

35
4 

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

inform all registrants concerned. If mitigation measures are necessary, EPA may take regulatory action. 

Please note that the label for this product was approved with the understanding that it is consistent 

-with the labeling for similar pet spot on products. Two copies of the finished labeling must be 

submitted prior to releasing the product for shipment. If you fail to comply with the above stated 

conditions, the registration will be subject to cancellation in accordance with FIFRA sec. 6(e) andlor 

automatically expire. Your release for shipment of the product constitutes your acceptance of these 

conditions. 

A copy of your label stamped "Accepted with Comments" is enclosed for your records. If you have 

any questions concerning this action, please contact Dr. B. A. Akinlosotu via (703) 605-0653 or 

akinlosotu ,bonaventure@epa.gov. 

Enclosure 

" 

36
July 26, 2011 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLL\JTIO;\, PREVENTIO:"i 

OFFlCE OF PESTICIDE PROGRAMS 

REGISTRATIO;\' DIVISION (7505P) 

MEMORANDUM 

Subject: Name of Pesticide Product: 

EPA Reg. No. IFile Symbol: 

DP Barcode: 

Decision No.: 

Action Code: 

PC Codes: 

SERGEANT'S FIPRONIL + ETOFENPROX + 

METHOPRENE SPOT-ON FOR CATS 

2517-RUL 

DP 391870 

442446 

R310 

129121 (Fipronil: 9.8%) 

128965 (Etofenprox: 15%) 

105402 (S-Methoprene: 11.8%) 

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

Technical Review Branch 

Registration Division (7505P) 

n t. ().,....lI.--. t"", 1-t.. - -z.,., " J..-']- rr '1~~ To: Bonaventure AkinlosotuiRichard Gebken, RM 10 

Insecticide Branch 

Registration Division (7505P) 

Registrant: SERGEANT'S PET CARE PRODUCTS, INC. 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

129121 Fipronil 

128965 Etofenprox 

105402 S-Methoprene 

Other Ingredient( s): 

TOTAL 

ACTION REQUESTED: The Risk Manager requests: 

bywt. 

9.80% 

15.00% 

11.80% 

63.40% 

100.00"/0 

"For your review: Response to EPA's DER dated May 16, 2011 for CAS study (MRJD 48302108) to 

upgrade initial review from supplemental to acceptable data, in support of the registration for 4 

products (2517-RUL, RUA, RUT and RUI). 

I 

37
BACKGROUND: 

The material received includes a document (MRID 48513201) titled: Support Data to Upgrade the 

Study "Companion Animal Safety Evaluation of a Spot-On Containing Two Toxicants and Two 

Insect Growth Regulators on Kittens and Cats" From Supplemental to Acceptable EPA Reg. No. 

25 1 7-RUT, 25 1 7-RUA, 25 1 7-RUL, 25l7-RUI MRID 48302108. 

COMMENTS AND RECOMMENDA TrONS: 

1. With the additional information in MRID 48513201, IRB has revised the DER for the companion 

animal safety study (MRID 48302108) and its accompanying data analysis report (MRID 

48302109). 

2. There were dermal effects. Two adult cats in group Bl (IX) scratched the application site and lost 

hair after application, and the report states that these lesions were considered to be a result of 

exposure to the test material. One of these cats (963 FES) had preexisting alopecia (measuring 3 

mm x 3 mm on the dorsal neck, between the ears) on days ~ 7 and -1, and then had a scratch mark 

(20 mm x 10 nun) on days + 1 and + 7 at the application site, "moving anterior." The second (966 

2C7) had no preexisting condition, but then had a scratch mark at the application site on study 

days +1, +7, and +14. In the discussion on p. 38 ofMRID 48513201 it is stated that: "The de 

novo hair loss and local sensory irritation (scratch marks) recorded for cat 966 2C7 must be 

assumed to be a consequence of the application of Sergeant's test substance. However, its 

immediate onset (within 24 hours) suggests that this was not an irritant but rather an allergic 

reaction to a component, or components, of the test substance to which this cat may have been 

previously exposed. Although the history of this cat in this test facility is not available, it is 

known that ... this facility was active in the testing of fipronil-containing me-too products, 

including spot-ons (that may have also contained the same or similar inerts) .... there is a 

substantial possibility that cat 966 2C7 had been previously used in such testing and recycled into 

Sergeant's protocol." None of the adult cats in the 5X group had any dermal effects. 

Because the dermal effects in the two IX adult cats were relatively minor, did not require 

treatment, and because similar effects were not observed in the 5X group, TRB concludes that 

these effects should not impact on either the registration or labeling of the supported products. 

One kitten (CCO F92)in the IX (AI) group had scabs on the back of the head from day 7 to 14 

and scabs between the shoulder blades on days 7 and 8; this kitten was an albino. One kitten 

(female CC2 AB1) in the 5X group (also an albino) had acute wet eczema on the neck and 

shoulders from day 3 to 14, and this required treatment with Dennavet Cream. It is stated (p. 36) 

that this lesion: " ... was considered to be related to the application of the test substance." 

From page 37 ofMRID 48513201 both of the albino kittens were littennates, and there were no 

other kittens (albino or otherwise) from this litter in this study. As noted on p. 37 ofMRID 

48513201: "It is unfortunate that albino kittens, a comparative rarity in the cat population, were 

included in a companion animal safety study. The literature on defects or susceptibilities 

associated with albinism in cats describes a propensity for deafuess, but nO references to 

dermatologic effects. However, one must suspect that the unique skin reactions in the area of test 

substance application to these two albino kittens may not properly be extrapolated to what will 

occur in the US cat population when this product may be released onto the market." 

2 

38
3. TRB has concluded that the most probable explanation for the observed effects in the albino 

kittens is that the toxicity was due to a fipronil photodegradate (MB46513, also known as fipronildesulfinyl) which is more toxic than the parent compolUld. It has been established that fipronil 

accumulates in sebaceous glands. The dose-related response observed in the albino kittens (which 

lack melanin, which would normally block light from reaching fipronil) is consistent with 

fonnation of this photodegradate (particularly as effects appeared on day 3 in the 5X kitten and on 

day 7 in the IX kitten). The possibility also exists that the presence of one or more of the other 

ingredients in this formulation may have enhanced the formation of this photodegradate in the 

albino kittens. 

4. The registrant should provide the Agency with any additional information available from this 

study relevant to the formation of the fipronil degradate, including (if possible) the fur coloration 

of the animals at the application site and the level and type of lighting that the cats and kittens 

were exposed. This information should be received within 6 months of the issuance of a 

registration. 

5. This companion animal safety study in adult cats and kittens is upgraded to Acceptable and does 

satisfy the guideline requirement for a companion animal safety study (OPPTS 870.7200) in cats 1 5 and/or kittens with the stipulation that labeling indicates that this product is not to be used on 

6 Lalbino cats or kittens. 

6. Refer to the attached DER for additional comments. 

3 

,~ 

I( 

! ' 

39
EPA Primary Reviewer: Byron T. Backus, Ph.D. 

Technical Review Branch, Registration Division (7505P) 

EPA Tertiary Reviewer: Kit Fanvell, D.V.M. 

Risk Assessment Branch VII, HED (7509P) 

Signature: (3 ~'\'. (3.......J--... 

Date: :r~t.1 l,..~ ~l' 

//-'A-f 

Signature: _~/I.A~~,--c;tc:---;-r-- Date: 7 /:;1£ 1-;:; eil 

Template version 02106 

I DATA EVALUATION RECORD 

STUDY TYPE: Companion animal safety study- cats!kittens - OPPTS 870.7200 

PC CODES: 129121: Fipronil; 105401: S-Methoprene; 

128965: Etofenprox; 129032: Pyriproxyfen 

DP BARCODE: 385149 

TEST MATERIAL (PURITYl: Cat Spot on Soup, containing Fipronil (9.83%), S-Methoprene 

(11.76% w/w), Etofenprox (15.78%) and Pyriproxifen (2.34%) 

TRADE NAME: Not provided 

CITATIONS: Delport, P. (2010) Companion Animal Safety Evaluation ofa Spot-On Containing 

Two Toxicants and Two Insect Growth Regulators On Kittens and Cats (Sergeant's Fipronil + 

Etofenprox + Methoprene Spot-On for Cats). Project Number: CV/09/660, SERl1009/1. July 13, 

2010. Unpublished study prepared by Clin Vet International. 118 p. MRID 48302108. 

Miller, T. (2010) Companion Animal Safety Evaluation of a Spot-On Containing Two Toxicants and 

Two Insect Growth Regulators on Kittens and Cats (Sergeant's Fipronil + Etofenprox + Methoprene 

Spot-On for Cats). Project Number: CV/09/660. April 13,2010. Unpublished study prepared by 

Thomas A. Miller. 13 p. MRlD 48302109. 

Hoskins, K. (2011) SUppOlt Data to Upgrade the Study "Companion Animal Safety Evaluation of a 

Spot~On Containing Two Toxicants and Two Insect Growth Regulators on Kittens and Cats" From 

Supplemental to Acceptable. Project Number: CV/09/660/SUPPLEMENT. June 16, 20 II. 

Unpublished study prepared by Sergeant's Pet Care Products, Inc. 41 p. MRID 4851320 I. 

SPONSOR: Sergeant's Pet Care Products, Plano, Texas 

EXECUTIVE SUMMARY: In a companion animal safety study (MRID 48302108), three groups, 

each containing 3 male and 3 female adult c::: 1 year of age) cats (body weights: males: 2.98-4.92 kg; 

females: 1.92-3.06 kg; source: ClinVet cattery) and three groups, each contai~ing 3 male and 3 female 

kittens (12-16 weeks of age; body weights: males: 1.08-1.84 kg; females: 0.82-1.68 kg) were treated 

with either 0.5 mL (1X) or 2.5 mL (5X 0.5 mL) of Cat Spot on Soup (containing Fipronil: 9.83%; SMethoprene: 11.76%; Etofenprox: 15.78%; and Pyriproxyfen: 2.34%) or with 1.45 mL (5X 0.29 mL) 

of the control substance or placebo. The groups and the amounts of test material or placebo 

administered to each cat or kitten are given below: 

4 

40
Kittens Adult Cats 

Group Al (n 6) Kitlens (12-16 weeks old);siugle (0.5 mL) 

a~nlieation of Cat Snot on So'up . 

Group B I (n 6) Aduli cats (> I year old) 

Single (0.5 mi;' application of Cat Spot on Soup 

Group A2 (n 6) Kittens (12-16 weeks old); five 0.5 mL Group 82 (n 6) Adult cats (> I year old); five 0.5 mL 

applications of Cal Spot on Soup adminislered at one hour applications of Cal SpOI on Soup administered at one hour 

intervals iutervals 

Group C I (n-6) Kittens (12-16 weeks old); five 0.29 mL Group C2 (n-6) Adults (> 1 year old); five 0.29 mL 

aDolieations of Placebo administered at one hour intervals aODlicaIions ofPlaeebo administered at one hour intervals 

The test and control substances were applied by syringe along the back of each animal, starting on the 

neck behind the ears and then extending towards the base of the tail. According to the report the 

objective was to limit application of the test material to areas where it would be difficult for the 

animal to "lick off' (and presumably ingest) the substances, although any material at the base of the 

tail (or even along part of the back) would be accessible for grooming purposes. Cats and kittens 

receiving 0.5 mL Cat Spot on Soup received a single application; cats and kittens receiving 2.5 mL 

received five 0.5 mL applications, with approximately one hour between applications. Cats and 

kittens receiving 1.45 mL control substance received five 0.29 mL applications, with approximately 

one hour between applications. 

The animals were observed daily for general health. Clinical examinations (which included pulse rate, 

respiratory rate, rectal temperature, and examination of mucous membranes, eyes, motility, lymph 

nodes, abdominal palpation, thoracic auscultation and evaluation of skin condition) were performed 

on days -14, -7, -1, + 1, +7, and +14, and the animals were also weighed on these days. Blood samples 

were collected for clinical chemistry and hematology on days -6, + 1, +7 and + 14. All animals were 

sedated (Rompun 2%,0.12 mLlkg 1M) to facilitate blood specimen collection. 

All animals survived to the end of the study, and there were no indications of any systemic toxicity. 

No effects were observed in the hematology or blood chemistry results or body weight values. Most 

cats and kittens showed no dose-related changes in food consumption, although one Group A2 (5X) 

female kitten scored 2 for meat consumption on Day +2 (kittens received pellets and meat, with 

separate scoring for their consumption of these two items). Of 522 observations for the consumption 

of meat, there were 518 "4's" (>75 to 100% consumption); 3 "3's" (>50-75% consumption), and one 

"2" (>25-50% consumption). Remarkably, the score of"2" involved the 5X albino kitten (CC2 ABI) 

observed to have a "hotspot on side of neck behind ear" starting on Day +3 which necessitated 

treatment. On every other pre- and post-treatment day of the study this kitten scored "4" for meat 

consumption. 

There were dermal effects. Two adult cats in group Bl (1 X) scratched the application site and lost 

hair after application, and the report states that these lesions were considered to be a result of exposure 

to the test material. One of these cats (963 FE5) had preexisting alopecia (measuring 3 mm x 3 mm 

on the dorsal neck, between the ears) on days -7 and -1, and then had a scratch mark (20 mm x 10 

mm) on days +1 and +7 at the application site, "moving anterior." The second (966 2C7) had no 

preexisting condition, but then had a scratch mark at the application site on study days + 1, +7, and 

+ 14. In the discussion on p. 38 ofMRID 48513201 it is stated that: "The de novo hair loss and local 

sensory irritation (scratch marks) recorded for cat 966 2C7 must be assumed to be a consequence of 

the application of Sergeant's test substance. However, its immediate onset (v.rithin 24 hours) suggests 

that this was not an irritant but rather an allergic reaction to a component, or components, of the test 

substance to which this cat may have been previously exposed. Although the history of this cat in this 

test facility is not available, it is known that ... this facility was active in the testing offipronil5 

41
containing me-too products, including spot-ons (that may have also contained the same or similar 

inerts) .... there is a substantial possibility that cat 966 2C7 had been previously used in such testing 

and recycled into Sergeant's protocol." None of the adult cats in the 5X group had any dermal effects. 

One kitten (CCO F92) in the IX (AI) group had scabs on the back of the head from day 7 to 14 and 

scabs between the shoulder blades on days 7 and 8; this kitten was an albino. One kitten (female CC2 

ABl) in the 5X group (also an albino) had acute wet eczema on the neck and shoulders from day 3 to 

14, and this required treatment with Dermavet Cream. It is stated (p. 36) that this lesion: " ... was 

considered to be related to the application of the test substance." 

From page 37 ofMRID 48513201 both of the albino kittens were littermates, and there were no other 

kittens (albino or otherwise) from this litter in this study. As noted on p. 37 of MRID 48513201: "It is 

unforttmate that albino kittens, a comparative rarity in the cat population, were included in a 

companion animal safety study. The literature on defects or susceptibilities associated with albinism 

in cats describes a propensity for deafness, but no references to dennatologic effects. However, one 

must suspect that the unique skin reactions in the area of test substance application to these two albino 

kittens may not properly be extrapolated to what will occur in the US cat population when this product 

may be released onto the market." 

TRB has concluded that the most probable explanation for the observed effects in the albino kittens is 

that the toxicity was due to a fipronil photodegradate (MB465l3, also known as fipronil-desulfinyl) 

which is more toxic than the parent compound. It has been established that fipronil accumulates in 

sebaceous glands. The dose-related response observed in the albino kittens (which lack melanin, 

which would nonnally block light from reaching fipronil) is consistent with fonnation of this 

photodegradate (particularly as effects appeared on day 3 in the 5X kitten and on day 7 in the IX 

kitten). The possibility also exists that the presence of one or more of the other ingredients in this 

formulation may have enhanced the formation of this photodegradate in the albino kittens. 

Hourly observations for adult cats and kittens for the four hours after last application are reported in 

MRID 48513201. For adults (from p. 11 of MRlD 48513201) one B2 female (8B 1 C65) showed 

restless rolling with a duration of ~ 10 minutes after the third application (this observation was unique, 

as it was made before the series of 5 applications of test material had been completed), but had calmed 

down one hour later, then (from p. 9 ofMRlD 48513201) was restless at the first hourly observation 

post-application, and was showing signs of estrus at the next observation, but showed no signs at the 

next two observations. Two B2 males showed crystals (presumably from evaporation at the 

application site), one at the 2 hour observation, and both at the 3 and 4-hour observations. The 

crystals were still present on one male on Days 1 and 2. 

For kittens, no signs were observed in the four hours following the last application, and the only signs 

that were observed were dermal effects in 5X albino kitten CC2 AB 1 (first noted on Day 3) and scabs 

behind head and between shoulder blades in 1 X albino kitten CCO F92 (first observed on Day 7). 

From the confidential attachment to MRID 48513201, it has been confirmed that the solvent(s) and/or 

inerts present in the test material are the same as those in the products which will be supported by this 

study. 

This companion animal safety study in adult cats and kittens is upgraded to Acceptable and does 

satisfy the guideline requirement for a companion animal safety study (OPPTS 870.7200) in cats 

6 

42
and/or kittens with the stipulation that labeling indicates that this product is not to be used on albino 

cats or kittens. 

COMPLIANCE: Signed and dated GLP, Quality Assurance and [No] Data Confidentiality 

statements were provided for ClinVet International. According to the GLP statement, Pathcare 

Veterinary Laboratory (Bloemfontein), which conducted the hematology and clinical chemistry 

analyses is an ISO 15189 accredited facility and their clinical veterinary department is GLP 

accredited. 

7 

43
1. MATERIALS AND METHODS 

A. MATERIALS: 

1. Test material: 

Cat Spot on Soup 

Description: 

Batch #: 

Purity: 

Storage: 

Compound Stability: 

CAS#: 

Control substance 

Description: 

Batch #: 

Purity: 

Storage: 

Compound Stability: 

CAS#: 

Not provided 

FPIO 12/09 

Fipronil 9.83%; S.Mclhoprene 11.76%; Etofenprox 15.78%; Pyriproxyfen 2.34% 

At room temperature 

Expiration date: September 30, 20 10 

Not provided 

Not provided 

012004-09 

Transcutol CG 99.92% [identified on the Internet as Diethylene glycol monoethyl ether I 

At room temperature 

EXpiration date: Feblllary 2011 

Not provided 

2. Vehicle control: See control substance described above. 

3. Test animals: 

Species: 

Strain: 

Age/weight 

Source: 

Housing: 

Diet: 

Water: 

Environmental conditions: 

Temperatllfe: 

Humidity: 

Air changes: 

Photoperiod: 

Acclimation period: 

Domestic Cat (adults ~ I year of age; kittens: 12-16 weeks of age) 

Not specificd (short to mediUm haired) 

Adult cats ~ I year of age: males: 2.98-4.60 kg; females: 1,92-3.06 kg 

Kittens 12-16 weeks old: males: 1,08-1.84 kg; females: 0.82-1.68 kg 

ClinVet cattery 

Individually housed in cages: [From p. 18 ofMRID 48302 J08: adult cat cages: 

0.74 m x 0.67 m x 0.6 m; kitten cages: 1,5 m x 1.5 m x 1 m (kittens were in larger 

cages than adults?)]. 

Adults (> I year) were fed IAlvIS Multi cat I + cat food (Eukanuba) 

Kittens (12-16 weeks) were fed kitten and junior 0-1 food and Purina Friskies 

" ... supplied in stainless steel bowls." 

20 ±4° C 

Not provided 

12-15 air changeS/hr 

12 hours lightJI2 hours dark 

Fourteen days 

8 

44
B. STUDY DESIGN: 

1. In life dates: Adult: Acclimatization start (day ~14): October 27,2009; Experimental start (day 

0): November 10,2009; Experimental termination date: November 24, 2009. 

Kitten: Acclimatization start (day ~14): December 15,2009; Experimental start (day 0); December 

29,2009; Experimental termination date: January 12,2010. 

2. Animal assignment: Thirty-six animals were assigned to the study, with an additional four adults 

and four kittens enrolled on day -14 as possible replacements. 

For the adult cats, the genders were separated and the cats allocated to study groups within the age 

requirements using randomization through minimization with body weight as the only criterion. 

Within each gender, animals were blocked into three blocks of three cats each. The three heaviest 

cats fonned block 1; the next three heaviest cats formed block 2 and the lightest cats formed block 

3. \Vithin blocks, cats were allocated to one of three groups, 1,2 or 3. The first animal of block 1 

was assigned to group 1, the second to group 2 and the third to group 3. The first animal of block 2 

was assigned to group 3, the second to group 2 and the third to group 1. The first animal of block 3 

was assigned to group 1, the second to group 2 and the third to group 3. Groups 1,2 and 3 were 

then randomly assigned to the actual groups B 1, B2 and C2 using Excel rand between. Kittens 

were similarly assigned to groups AI, A2 and CI. 

Table 1. Dosagc Groups 

Kittcns Adult Cals 

Group Al (n 6) Killens (12-16 weeks old);single (0.5 mL) Group B I (n 6) Adult cats (> l year old) 

application of Cal Spol on Soup Sine:!e (0.5 mL) application of Cal Spot on Souo 

Group A2 (n 6) Kittcns (l2~16 weeks old); five 0.5 mL Group B2 (n 6) AdulL cots (> I year old); five 0.5 mL 

applications orCal Spol on Soup administcred at one hour applications orCal Spot on Soup administered at one hour 

intervals intervals 

Group C I (n 6) Killens (12-16 weeks old); five 0.29 mL Group C2 (n 6) Adults (> I year old); five 0.29 mL 

applications orPlacebo adminislered alone hour intervals applications of Placebo admjJl~stered at onc hour intervals 

3. Dose selection rationale: The IX dosage rate (0.017 fluid oz. or 0.5 mL) is consistent with the 

proposed labeling for the products that this study would be used to support. 

4. Preparation and treatment: On Day 0 the cats were held by hand and the test and control 

substances were applied as measured doses from syringes (without needles) to a furrow in the 

9 

45
hair on the back, statting high on the neck behind the ears and extending caudally towards the 

base of the tail. 

Table 2: Doses 

Grouo Material applied Total dose administered 

A 1 (kittens) Cat Spot on Soup 0.5 mL (lX) 

A2 (kittens) Cat Soot on Soup 2.5 mL (5X 0.5 mL) 

Bl (adults) Cat Suot on SauD 0.5 mL (lX) 

B2 (adults) Cat Spot on SouP 2.5 mL (5X 0.5 mL) 

C 1 rki ttens ) Placebo 1.45 mL (5X 0.29 mL) 

C2 (adults) Placebo 1.45 mL (5X 0.29 mL) 

" " Cat Spot on Soup contams Flprontl (9.83%), S-Methoprene (11.76% w/w), Etofenprox (15.78%) and Pynproxtfen (2.34 Yo) 

Placebo IS Identified (p. 12 ofMRID 48302108) as Transcutol CO 99.92%. 

5. Statistics: From p. 40 of MRID 48302108: "All analyses and calculations were performed using 

SAS Version 8.2. Statistical significance was declared at a two-side p-value of 0.05. The data 

from the adult cats and kittens were analysed separately and are presented as such ... " 

The emphasis of the statistical analyses was the change from baseline of each of the hematology 

and clinical chemistry parameters. Individual hematology and clinical chemistry values on test 

days -6,1,7 and 14 were tabulated separately for each variable and each group, together with the 

following descriptive statistics: mean, standard deviation (SD), coefficient of variation (CV %), 

geometric mean, geometric SD, median, minimum, maximum and the number of observations in 

the group. The individual changes and percentage changes from baseline (test day -6) for each of 

the post-treatment days (1, 7 and 14) were calculated and tabulated for each variable and each 

group. The number of post-treatment values that fell outside the reference range was calculated. 

The post-treatment values were compared to the baseline values in an intra-treatment comparison 

by means of an analysis of variance (ANOVA) with an animal and observation time as effects. An 

inter-treatment comparison with respect to the changes from baseline was also performed. The 

post-treatment values of each the two treatment groups for adult cats (BI and B2) were compared 

to their control group (C2). The post-treatment values of each of the two test treatment groups (AI 

and A2) were compared to the control group (CI) for kittens. An analysis of covariance (COANOV A) with a treatment effect and the baseline values as covariate was used for the analyses. In 

addition, the change from baseline values of each of the two treatment groups were compared to 

those of the corresponding control group (e2) for dogs and the two test groups (AI and A2) were 

compared to those of the control group for adult cats and kittens by means of an ANOVA with a 

treatment effect. 

C. METHODS: 

1. Observations: 

a. General health observations: The animals were observed daily for general health. Specific 

health observations were observed hourly on the day of application until four hours after 

application of the test material and twice daily, thereafter, for the duration of the study. 

Observations included, but were not limited to, changes in skin and fur, eyes and mucous 

membranes, nervous signs and behavior pattern as well as vomiting and dialThea. 

10 

46
b. Clinical examinations: Physical examinations were conducted by a veterinarian on Days -14, 

-7, -1, + 1, +7 and + 14. The examinations included but were not limited to pulse rate, 

respiratory rate, rectal temperature, mucous membranes and skin, joints, eyes, ears, mouth and 

genital organs, and auscultation [using a stethoscope to listen to the sounds] of the heart and 

lungs. 

2. Body weight: Animals were weighed on Days -14, -7, -1, +1, +7 and +14. 

3. Food consumption: From p. 26 ofMRlD 48302108: The amount of food offered was measured 

and the food consumption was recorded daily and scored using the following scoring system. 

Fc 1 - 0- 25% 

Fc 2 - >25- 50% 

Fc 3 - >50-75% 

Fc 4 - >75-100% 

4. Hematology and clinical chemistrv: Blood was collected for hematology and clinical chemistry 

assessments on non-fasted animals on the following days: - 6, + 1, +7 and + 14. The tests were 

conducted by Pathcare, Bloemfontein, South Africa, because ClinVet International did not have 

tile expertise and apparatus to perform the analyses. The CHECKED (X) parameters were 

examined. 

a. Hematology 

X Hematocrit (HCT)* X Leukocyte differenlial eount* 

X Hemoglobin (HGB)* X Mean corpuscular HGB (MCH)* 

X Leukocyte count (WBC)* X Mean eorpuse. HGB conc.(MCHC)* 

X Erythrocyte count (RBC)* X Mean corpusc. volume (MCV)* 

X Platelet eount*J Reticulocyte count 

Blood clotting measurements* 

X (Activated Partial Thromboplastin time) 

X (Prothrombin time) 

*Reeommended for compamon aJlJmals safety evaluatIOn based on OPPTS 870.7200 

IFrom p. 27 of MRID 48302108: "In some cases the platelets were microscopically clumped and in Ihose cases the plalclet count 

relumed by the Celldyne 3500 was nOl correct, the actual count should have been higher and the pathologist had to commenl on the 

number of platelets on a blood smear. The platelet count was then indicated as "reduced", "adequate" or "increased". For the sake of 

consistency, a value was linked to these classes. However the variable was handled as a discrete variable and nOl as a continuous 

variable. 

The following criteria were used by the pathologist: 

The historical control value for cats was 300-600 x 109/L 

Platelets appeared reduced: approximately 250 x 109/L 

Platelets appeared adequate: approximately 350 x 109/L 

Platelels appeared increased: approximately 650 x 109

/L 

II 

47
b. Clinical chemistry 

ELECTROLYTES OTHER 

X Calcium* (Ca) X Albumin'" 

X Chloride'" (CI) X Creatinine'" 

Magnesium (Mg) X Urea nitrogen'" 

X Phosphorus'" CP) Total Cholesterol 

X Potassium* (K) X Globulins* 

X Sodium* (Na) X Glucose* 

ENZYMES (more than 2 hepatic enzymes, eg., *) X Total bilirubin * 

X Alkaline phosphatase (AP)* X Total serum protein'" 

Cholinesterase (ChE) Triglycerides 

Creatine kinase X Albumin/Globulin ratio 

Lactic acid dehydrogenase (Lm·I) X Direct bilirubin* 

X Alanine aminotransferase (ALT/also SGPT)* Indirect bilirubin 

X Aspartate aminotransferase CAST/also SGOT)* BUN/Creatinine ratio 

Gamma glutamyl transferase (GGT) TC02 Bicarbonate 

Amylase 

Sorbitol dehydrogenase 

'" Recommended for a compamon ammal safety cvaluatlOn based on OPPIS 870.7200 

5. Urinalysis: Urinalysis was not conducted. 

6. Sacrifice and pathology: The study did not have a scheduled necropsy. 

12 

48
II. RESULTS 

A. ACTUAL DOSES ADMINISTERED: The mg/kg doses of active ingredients were not 

calculated. From information in Table 1 ofMRID 48302109, the rnglkg doses to kittens were 

significantly higher than those to adults (refer to Tables 3 and 4). 

Table 3. Dasa es ofFi ranil and Etofen rox for adult cats 

GROUP SEX ANIMAL AGE WEIGHT DOSAGE OF DOSAGE OF 

NUMBER (YEARS) (KG) FIPRONIL (mg/ke:) ETOFENPROX (mg/kg) 

81 Male 9B3 D3A > I 4.60 10.7 17.2 

81 Male 9847DC > I 4.26 11.5 18.5 

81 Male 963 FE5 >1 3.26 15.1 24.2 

81 Female 9662C7 > I 2.88 17.1 27.4 

81 Female CC5325 > I 2.34 21.0 33.7 

81 Female CDS 170 > I 2.00 24.6 39.5 

Mean values for GrOll 81 > I 3.22 16.7 26.8 

82 Male 965009 > I 4.44 55.3 88.9 

B2 Male BSD BID > I 4,44 55.3 88.9 

82 Male 6DC GeC >1 2.98 82.5 132.4 

82 Female CD4302 > I 2.62 93.8 150.6 

82 Female 881 C65 > I 2.46 99.9 160.4 

82 Female 984080 > I 1.92 128.9 205.5 

Mean values for Group B2 > I 3.14 86.0 137.8 

C2 Male 6D6 BEB > I 4.92 0 0 

C2 Male 700 A83 > I 3.96 0 0 

C2 Male 70D F55 > I 3.40 0 0 

C2 Female CD3 D77 > I 3.06 0 0 

C2 Female 6BD 8B8 > I 2.28 0 0 

C2 Female CD3 E61 > I 2.20 0 0 

Mean values for GrOll C2 > I 3.30 0 0 

Table 4. D 

GROUP SEX ANIMAL AGE WEIGHT DOSAGE OF DOSAGE OF 

NUMBER (DAYS) (KG) FIPRONIL (m!!lke) ETOFENPROX(m!!lke) 

Al Male E4653D 112 1.76 27.9 44.8 

Al Male CCI D85 92 1.34 36.7 58.9 

Al Male CCOF92 92 1.22 40.3 64.7 

Al Female CCO 4A8 92 1.48 33.2 53.3 

AI Female CCI26E 84 1.34 36.7 58.9 

Al Female CCI COA 84 1.00 49.2 78.9 

Mean values for Group Al 92.7 1.36 37.3 59.9 

A2 Male E9F FD4 112 1.84 133.6 214.4 

A2 Male CCO B97 100 1.32 186.2 298.9 

A2 Male CC2 DI3 84 1.22 201.4 323.4 

A2 Female CCI EED 113 1.68 146.3 234.8 

A2 Female CCO 38A 92 1.30 189.0 303.5 

A2 Female CC2 ABI 92 1.12 219.4 352.2 

Mean values for Grou A2 98.8 1.41 179.3 287.9 

CI Male CC06CC 84 1.52 0.0 0.0 

CI Male CCO D09 100 1.48 0.0 0.0 

CI Male CC3 AEO 84 1.08 0.0 0.0 

CI Female EAI63C 113 1.42 0.0 0.0 

CI Female CCO F9D 92 1.38 0.0 0.0 

CI Female CCI7F8 92 0.82 0.0 0.0 

Mean values for GrOll CI 94.2 1.28 0.0 0.0 

13 

49
50
B. OBSERVATIONS: 

1. Clinical signs and application site effects: For the adult cats, two animals in group Bl (IX) 

scratched the application site and lost hair after application. One of these cats (966 2C7) had 

preexisting alopecia (days ~ 7 and -1) measuring 3 mm x 3 mm on dorsal neck (between ears) at the 

time of application. For group B2 (5X) there were no abnormal signs, although one cat (CD4 302) 

had hair loss (5 mm x 5 mm) on the right ear and neck on days -7 and -1. One cat came into estrUs 

on day + 1. For the controls ee2), one cat had tongue ulcers on days +7 and + 14 (improving on day 

+ 14), confirmed as a case of mycoplasmosis. For the kittens, one group Al (IX) kitten (CeO F92, 

an albino) developed scabs behind the head and between the shoulder blades on day +7, which 

were still present on day +14. For group A2 (5X) one kitten (CC2 AB1, an albino) had acute wet 

eczema on the neck and shoulders on day 3, and this was still present on day +14. This required 

treatment with Dermavet Cream, It is stated (p, 10 ofMRID 48302108) that: "The test substance 

caused scabs and eczema in two albino kittens." Oue control kitten (CCO F9D) had loose feces on 

day +9. 

Table 5a - Signs in Group BI (adults IX) 

AnimallO Sex Study Days Siens 

9B3 D3A M No abnormal SigJ1S 

9B470C M No abnormal signs (p, 30, 32) [but, from p. 29, treated on days +2 through 

+6 with Lincomycin HCI50 mg by injection for mucopurulent nasal 

discharge (left)1' 

963 FE5 M +1, +7, +14 Scratch mark (20 mm x 10 mm) on application site, moving anterior (p. 30) 

+1 to +14 Local hair loss on application site (p. 33) 

9662C7 F -7, -1 Alopecia 3 mm x 3mm on dorsal neck (between ears) 

+1, +7 Scratch mark (20 mm x 10 mm) on application site, moving anterior 

+1 to +13 Local hair loss on application site (from p. 33) 

+610+12 Scratch mark (from·p. 33) 

CC5325 F -I Scratch mark anterior to ri ht ear ( .30) 

CD5 170 F No abnormal si ns 

Table Sb - Signs in Group B2 (adulls 5X) 

AnimallD S" Study Days Signs 

965009 M No abnormal si ns 

B80 BID M No abnormal signs 

60C OCC M No abnormal si 

C04302 " F -7, -I Hair loss ri tear&neck5 mmx5mm .31 ) 

8BI C65 F -14, -7 Alopecia left lateral neck (p. 31) 

+1 Estrus (p. 31) 

984080 F No abnormal si ns 

Table Sc - Signs in Group C2 (adulls -OX) 

AnimallD S" Study Days Signs 

606 BEB M No abnormal signs 

700 A83 M +7, +14 Ton ue ulcers Om rovin onda l +14 ( .31 

700 F55 M -7 Thinning of hair iJmcr thighs (p. 31) 

C03077 F -7, -I, +1, +7 Wound left lateral neck; estrus day +7 (p. 31) 

6BO 8B8 F No abnormal si ns 

CD3 E61 F No abnormal signs 

15 

51
Table 6a - Signs in Group Al (kittens IX) 

AnimallD So< Study Days Signs 

E4653D M No abnormal signs 

CCI D85 M No abnormal signs 

CCO F92 M +7, +14 Scabs behind head and between shoulder blades (p, 32) 

+7 to +14 Seabs behind the head (p. 34) 

+7 to +8 Scabs between shoulder blades (p. 34) 

CCO 4A8 F No abnormal signs 

CCI26E F No abnormal si , 

CCI COA F No abnormal si ns 

Table 6b - Signs in Group A2 (kittens 'X) 

AnimallD Sex Study Days Signs 

E9FFD4 M No abnormal si ns 

CCO B97 M +1 Lacrimation in the ri ht eye (p. 31) 

CC2 Dl3 M No abnormal si ns 

CCIEED F No abnormal si ns 

CCO 38A F No abnormal signs 

CC2ABI F +3 to+14 Acute wet eczema (p. 32, 34 

Table 6c - Signs in Group CI (kittens OX) 

AnimallD So< Study Days Signs 

CC06CC M No abnormal si , CCO D09 M No abnormal signs 

CC3 AEO M No abnormal signs 

EAI63C F No abnormal si ns 

CCO F9D F +9 Loose feces 

CCl7F8 F No abnormal signs 

From p. 33 ofMRlD 48302108 (for adult cats): "Cats 963 FES and 966 2C7 (group BI) lost hair 

on the application site and the lesions were visible from day + 1 till the end of the study ... A 

scratch mark was visible in this lesion of cat 966 2C7 from day +6 to + 12. These lesions were 

considered to be a result of the application of the test substance ... In group B2, two cats (965 009 

and BSD BID) developed crystals on the hair tips after application. On cat 965 009 it was visible 

on day 0 at the +2 hour and +3 hour observations, while the crystals were visible from +1 hour till 

day +2 on BSD BID. These were considered to be cosmetic changes. SBI C65 was restless and 

came into oestruS on day 0 ... No abnonnal signs were recorded amongst the cats in group C2." 

From p. 34 ofMRlD 48302108 (for kittens): "cco F92 (group AI) developed scabs behind the 

head [that were detected?] on day +7 that lasted to the end of the study and scabs between the 

shoulder blades that disappeared by the end of day +8 ... CC2 ABI (albino kitten in group A2) 

developed wet eczema on day +3, it became infected on day +7 and was bleeding on day +S. 

After therapy [from p. 29: Derrnavet topical once or twice a day on days +8 to + I 0] the lesions 

started to heal towards the end ofthe study ... " From p. 36: "CC2 AB 1 (albino kitten in group A2) 

developed wet eczema behind the ear on day +3. On day +5 it had spread to the shoulder blades, 

the sides of the neck and below the chin. This lesion was improving by day + 14 and was 

considered to be related to the application of the test substance." 

2. Mortality: All adult cats and all kittens survived to the end of the study. 

16 

52
B. BODY WEIGHT AND WEIGHT GAIN: Body weight data for adults are presented in Table 7, 

and for kittens in Table 8. There are no indications of any significant differences between the 

different adult dosage groups, or the different kitten dosage groups. 

Table 7: Mean bod wei ht and bod wei ht chan es for adult cats" 

Body weiebt (k Bod wei ht chan es (k 

Group N Day -1 Day +1 Day +7 Day +14 Day wI Day -1 to Day -1 to 

to + 1 +7 +14 

Bl (adult males) IX 3 4.04 4.01 3.99 4.01 -0.03 -0.05 -0.03 

81 (adult females IX 3 2.41 2.41 2.47 2.51 0.00 +0.06 +0.10 

81 (combined IX 6 3.22 3.21 3.23 3.26 -0.01 +0.01 +0.04 

82 (adult males 5X 3 3.95 3.88 3.92 4.02 -0.07 -0.03 +0.07 

82 (adult females 5X 3 2.33 235 2.28 2.27 +0.02 -0.05 ·0.06 

8? (combined) 5X 6 3.14 3.12 3.10 3.15 -0.02 -0,04 +0.01 

C2 (adult males OX 3 4.09 4.08 3.98 3.99 -0.01 ·0.11 -0.10 

C2 adult females OX 3 2.51 2.52 2.53 2.55 +0.01 +0.02 +0.04 

C2 (combined) OX 6 3.30 3.30 3.25 3.27 0.00 -0.05 -0.03 

'Calculoted by the reviewer from dota on page 37, MRlD 48302108 

Table 8: Mean body weight and body weight changes for kittens' 

Bod wei ht k Bod weight chan " k 

Group N Day-l Day +1 Day+7 Day +14 Day -1 Day -1 to Day-Ito 

to +1 +7 +14 

Al (male kitten~11X 3 1.44 1.43 1.51 1.72 -0.01 +0.07 +0.28 

Al (female kittens) IX 3 1.27 1.27 1.37 1.55 0.00 +0.10 +0.28 

Al (combined IX 6 1.36 1.35 1.44 1.64 -0.01 +0.08 +0.28 

A2 (male kittens 5X 3 1.46 1.45 1.53 1.68 -0.01 +0.07 +0.22 

A2 female kittens 5X 3 1.37 1.37 1.47 1.61 0.00 +0.10 +0.24 

A2 (combined) 5X 6 1.41 1.41 1.50 1.65 0.00 +0.09 +0.24 

CI (male kittens OX 3 1.36 1.33 1.43 1.59 -0.03 +0.07 +0.23 

CI (female kittens OX 3 1.21 1.21 1.25 1.39 0.00 +0.04 +0.18 

CI (combined) OX 6 1.28 1.27 1.34 1.49 -0.01 +0.06 +0.21 

'Caleulated by the reviewer from·data on pages 37-38, MRlD 48302108 

C. FOOD CONSUMPTION: No treatment-related effects were reported. Most cats and kittens 

showed no dose-related changes in food consumption, although one Group A2 (5X) female kitten 

scored 2 for meat consumption on Day +2 (kittens received pellets and meat, with separate scoring 

for their consumption of these two items). Of 522 observations for the consumption of meat, there 

were 518 "4 's" (>75-100% consumption); 3 "3 's" (>50%-75% consmnption) and one "2" (>25-

50% consumption. Remarkably, the score of"2" involved the 5X albino kitten (CC2 ABI) 

observed to have a "hotspot on side of neck behind ear" starting on Day +3 which necessitated 

treatment. On every other pre- and post-treatment day of the study, this kitten scored "4" for meat 

consumption. 

17 

53
The following Tables are from p. 39 ofMRID 48302108: 

Table 9. Mean daily and weekly food consumption values for the adult groups 

Study Day Group Bl (IX) 

-13 3.67 

-12 3.17 

-11 3.67 

-10 3.83 

-9 3.83 

-8 3.83 

-7 3.67 

Mean days -13 to-7 week 1 3.67 

-6 3.83 

-5 3.00 

-4 3.50 

-3 3.67 

-2 3.83 

-1 3.83 

0 3.67 

Mean days -6 to 0 (week 2) 3.62 

+1 4.00 

+2 3.33 

+3 3.83 

+4 3.83 

+5 3.33 

+6 4.00 

+7 3.33 

Mean da s+lto+7 week 3 3.67 

+8 3.33 

+9 3.67 

+10 3.83 

+11 3.50 

+J2 4.00 

+13 3.67 

+14 3.83 

Mean da s +8 to +14 weck4 3.69 

Food consumption was scored daily using the following scoring system. 

1 = 0-25% 

2 = >25· 50% 

3 = >50-75% 

4=>75-100% 

Groull 82 5X) Group C2 (OX) 

3.33 3.33 

3.67 117 

3.67 3.33 

3.83 3.33 

3.83 3.50 

3.50 3.33 

3.50 3.50 

3.62 3.36 

3.33 3. J7 

2.67 2.83 

3.17 4.00 

3.33 3.67 

3.33 3.83 

3.67 3.67 

3.50 3.50 

3.29 3.52 

3.33 3.50 

2.67 2.83 

3. J7 3.83 

3.33 4.00 

3.50 3.17 

3.67 3.17 

3.50 3.17 

3.31 3.38 

3.00 2.83 

3.33 3.17 

350 3.83 

333 3.67 

3.67 3.17 

3.33 3.33 

3.17 3.50 

3.33 3.36 

Individual daily food consumption scores for adult cats from day -14 to + 14 arc reported on p. 6 of MRID 4851320 I. 

18 

54
Table 10. Mean daily and weekly food consumption values for the kitten groups 

Stndv Day Group Al IX) Group A2 (5X) 

Pellets Meat Pellets Meat 

·13 3.42 4.00 3.50 4.00 

·12 3.92 4.00 4.00 4.00 

·11 4.00 4.00 3.92 4.00 

·10 3.92 3.83 3.92 4.00 

·9 4.00 4.00 3.92 4.00 

·8 3.83 4.00 3.92 4.00 

·7 4.00 4.00 4.00 4.00 

Mean da s M13 to-7 week I 3.87 3.98 3.88 4.00 

·6 3.92 4.00 4.00 4.00 

., 3.83 4.00 3.92 4.00 

·4 3.92 4.00 4.00 4.00 

·3 4.00 4.00 4.00 4.00 

·2 3.83 4.00 4.00 4.00 

·1 3.83 4.00 4.00 4.00 

0 3.83 4.00 4.00 4.00 

Mean da s -6 to 0 week 2 3.88 4.00 3.99 4,00 

+1 3.92 4.00 4.00 4.00 

+2 3.83 4.00 3.58 3.67 

+3 4.00 4.00 3.83 4.00 

+4 3.58 4.00 3.67 4.00 

+5 3.92 4.00 4.00 4.00 

+6 3.92 4.00 3.75 4.00 

+7 4.00 4.00 3.92 4.00 

Mean days +1 to +7 (week 3). 3.88 4.00 3.82 3.95 

+8 4.00 4.00 3.92 4.00 

+9 3.83 4.00 4.00 4.00 

+10 3.58 4.00 4.00 4.00 

+11 3.83 4.00 3.58 4.00 

+12 4.00 4.00 3.83 4.00 

+13 4.00 4.00 4.00 4.00 

+ 14 3.83 4.00 3.83 4.00 

Mean days +8 to +14 (week 3.87 4.00 3.88 4.00 

4l 

Food consumption was scored daily using the following scoring system. 

1 = 0·25% 

2 = >25· 50% 

3 =>50-75% 

4=>75-100% 

1 ndividual daily food consumption scores for kittens are reported 011 p. 20-21 ofMRID 4851320 I. 

D. CLINICAL PATHOLOGY ANALYSES: 

Group CI 

Pellets 

3.42 

3.83 

3.83 

3.92 

3.92 

3.75 

3.83 

3.79 

3.75 

3.75 

3.92 

3.58 

3.67 

3.92 

4.00 

3.80 

3.75 

3.67 

4.00 

3.50 

3.83 

3.75 

3.42 

3.70 

3.67 

3.50 

3.67 

3.75 

4.00 

4.00 

3.67 

3.75 

OX 

Meat 

4.00 

3.83 

3.83 

4.00 

4.00 

4.00 

4.00 

3.95 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

4.00 

1. Statistical considerations: From p. 43 ofMRID 48302108: "The statistical analysis was 

designed to screen the results in order to point out differences between each of the 2 test 

treatment groups eBI and B2 in the case of adult cats and Al and A2 for kittens) and the 

corresponding control groups eC2 for adult cats and CI for kittens) that should be considered 

more closely from a clinical and safety point of view. The following strategy was followed to 

point out these differences for further review: 

a. If there were any values on either test days 1,7 or 14 in at least one animal in a particular test 

group that were outside the reference range, and 

19 

55
b. If the difference in the mean values for a particular parameter between a specific test group 

and the control group was statistically significant from the between~group comparison (from 

either the ANOVA or CO-ANOV A analysis) and 

c. If the within-group comparison for the particular test group from test day ~6 (baseline) to the 

post-treatment day was statistical[ly] significant." 

2. Hematology: From p. 44 ofMRID 48302108 no treatment~related changes were observed in 

adult cats. For kittens: "The mean prothrombin time [for group AI, the IX kittens] decreased 

from 8.52 to 7.03 ... from baseline (day -6) to day +7, with 5 of the 6 kittens (CCO 4AS, CCO 

F92, CCI 26E, CCI COA and CC DS5) having values 6.S, 6.S, 6.1, 7.2 and 7.5 respectively, 

all of which were below the reference range of7.8 to 8.9." The group A2 kittens also had 

significantly reduced prothrombin times for days 7 and 14. For group A2 (5X kittens): "The 

mean aPTT [activated partial thromboplastic time] decreased from 15.33 to 13.25 ... from 

baseline (test day -6) to test day -I, with I of the 6 kittens (CCO B97) having a value ofll.O, 

which was below the reference range of12.7 to 17.9." However, pathology for PT and aPTT 

generally involves increased values. 

Table II. Statistically significant changes from baseline in hematology parameters for kitten groups 

Hematology Kitten Day -6 Day+1 p-value Day +7 p~value Day +14 p-value 

Parameter Group Mean Mean Mean Mean 

Prothrombin 

Time (se~)-

AI(IX) 8.52 8.22 0.0913 7.03 0.0048 7.22 0.0006 

prothro~~~n A2(5X) 8.43 8,58 0.6560 7.85 0.0127 7.57 0.0048 

Time (sec 

Partial A2(5X) 15.33 13,25 0.0375 13.97 0.1629 13.48 0.1259 

thromboplastin time 

(sec) 

2. Clinical Chemistry; For adult cats, from p. 44 ofMRID 48302108: "The mean albumin value 

[of group BIl decreased from 30.0 to 29.0 ... from baseline (test day -6) to test day 7, with I of 

the adult cats (963 FE5) having a value of24, which was below the reference range of25 to 

34." 

For group B 1: "The mean total bilirubin value increased from 7.17 to 8.0 ... from baseline (test 

day -6) to test day 14, with 1 of the 6 adult cats (CC5 325) having a value of 12, which was 

above the reference range of 4 to 11 ... At no other days in any of the two groups were all 

three ofthe conditions set out. .. [see statistical considerations, above] met for any other clinical 

chemistry parameters in the adult cats." 

For kittens, from p. 45 ofMRID 4830210S for group AI (IX): "The mean total chloride value 

increased :fi:om 121.2 to 125 ... from baseline (test day -6) to test day 7, with 1 of the 6 kittens 

(CC 1 COA) having a value of 126, which was above the reference range of 117 to 125 ... " 

Also for group AI: "The mean total protein value increased from 59.3 to 62.0 .. ,from baseline 

(test day -6) to test day 14, with I of the 6 kittens (CCI COAl having a value of6S, which was 

above the reference range of 56 to 67 ... " 

20 

56
These findings appear to be sporadic, and unrelated to exposure to the test material. 

III. DISCUSSION AND CONCLUSIONS 

A. INVESTIGATORS' CONCLUSIONS: The study author concluded [po 116 ofMRlD 48302108J 

that two adult cats developed minor lesions after application ofa single dose of the test substance, 

but no signs were recorded in the group that received five times the dose. 

In group B2 (5X) two cats developed crystals on the hair tips after application. On one cat these 

were visible on day 0 at the 2- and 3-hour observations, while they were visible from 1 hour until 

day 2 on the other. These were considered to be cosmetic changes. 

One kitten developed scabs after application ofa single dose of the test substance and one kitten 

developed wet eczema after receiving five times the dose (both were albino kittens). 

According to the discussion on p. 7 of MRID 48302109: "It is not apparent if the delayed 

appearance of eczema and scabs was coincidentally unrelated, or a direct consequence of the 

application of the test substance. An earlier CASS study repmi (MRID 46161309) in which cats 

and kittens were also treated at IX and 5X but with larger until dose volumes (0.7 and 1.4 mL, 

instead of 0.5 mL) and with an etofenprox-Nylar test substance containing a much higher level of 

etofenprox (55% vs. 15%) did not describe any dermatopathology ... However, the present CASS 

test substance also contained fipronil, a different class of active that has been very widely used 

now for years, apparently without gathering a reputation for inducing significant 

delmatopathology. " 

From p. 37 of MRlD 48513201; "Kitten CC2 AB1 (group A2, 5x dose) had "hot spots" on the 

side of its neck and between its shoulder blades, first observed on the third day after treatment and 

persisting through day 14, reported as starting to resolve on day 9 ... Kitten CCO F92 (group AI, 

Ix dose) had scabs on the back of its head recorded from days 7 to 14 and between its shoulder 

blades on days 7 and 8 (resolved on day 9) ... Both of these kittens were littermate albinos and 

there were no other kittens (albino or otherwise) from this litter enrolled in the study. There were 

no other dermatologic reaction reports for any of the other kittens in any group in the study. It is 

unfortunate that albino kittens, a comparative rarity in the cat population, were included in a 

companion animal safety study .... However, one must suspect that the unique skin reactions in 

the area of test substance application to these two albino kittens may not properly be extrapolated 

to what will occur in the US cat population when this product may be released onto the market." 

B. REVIEWER'S COMMENTS AND CONCLUSIONS: From the confidential attachment to 

MRlD 48513201, it has been confirmed that the solvent(s) andlor inerts present in the test material 

are the same as those in the products which will be supported by this study. 

All animals survived to the end of the study, and there were no indications of any systemic 

toxicity. There were no effects on body weights. Most cats and kittens showed no dose-related 

changes in food consumption, although one Group A2 (5X) female kitten scored 2 for meat 

consumption on Day +2 (kittens received pellets and meat, with separate scoring for their 

consumption of these two items). Of 522 observations for the consumption of meat, there were 

21 

57
518 "4's" (>75 to 100% conswnption); 3 "3's" (>50-75% consumption), and one "2" (>25-50% 

consumption). Remarkably, the score of"2" involved the 5X albino kitten (CC2 AB1) observed 

to have a "hotspot on side of neck behind ear" starting on Day +3 which necessitated treatment. 

On every other pre- and post-treatment day of the study this kitten scored "4" for meat 

consumption. 

Hourly observations for adult cats and kittens for the four hours after last application are reported 

in MRID 4851320!. For adults (from p. 11 ofMRlD 48513201) one B2 female (8Bl C65) 

showed restless rolling with a duration of ~ 10 minutes after the third application (this observation 

was unique, as it was made before the series of 5 applications oftest material had been 

completed), but had calmed down one hour later, then (from p. 9 ofMRID 48513201) was restless 

at the first hourly observation post-application, and was showing signs of estrus at the next 

observation, but showed no signs at the next two observations. Two B2 males showed crystals 

(presumably from evaporation at the application site), one at the 2 hour observation, and both at 

the 3 and 4-hour observations. The crystals were still present on one male on Days I and 2. 

For kittens, no signs were observed in the four hours following the last application, and the only 

signs that were observed were dermal effects in 5X albino kitten CC2 AB1 (first noted on Day 3) 

and scabs behind head and between shoulder blades in 1X albino kitten CCO F92 (first observed 

on Day 7). 

There were dennal effects. Two adult cats in group Bl (IX) scratched the application site and lost 

hair after application, and the report states that these lesions were considered to be a result of 

exposure to the test material. One of these cats had preexisting alopecia (measuring 3 mm x 3 mm 

on the dorsal neck, between the ears) on days -7 and -1, and then had a scratch mark (20 mm x 10 

mm) on days +1 and +7 at the application site, "moving anterior." The second had no preexisting 

condition, but then had a scratch mark at the application site on study days +1, +7, and +14. None 

of the adult cats in the 5X group showed any dermal signs. One kitten in the IX group had scabs 

on the back of the head from day 7 to 14 and scabs between the shoulder blades on days 7 and 8; 

this kitten was an albino. One kitten in the 5X group (also an albino) had acute wet eczema on the 

neck and shoulders from day 3 to 14, and this required treatment with Dermavet Cream. It is 

stated (p. 36) that this lesion: " ... was considered to be related to the application of the test 

substance." 

From page 37 ofMRlD 48513201 both of the albino kittens were littermates, and there were no 

other kittens (albino or otherwise) from this litter in this study. As noted on p. 37 ofMRID 

48513201: "It is unfortW1ate that albino kittens, a comparative rarity in the cat population, were 

included in a companion animal safety study. The literature on defects or susceptibilities 

associated with albinism in cats describes a propensity for deafness, but no references to 

dermatologic effects. However, one must suspect that the unique skin reactions in the area oftest 

substance application to these two albino kittens may not properly be extrapolated to what will 

occur in the US cat population when this product may be released onto the market." 

TRB has concluded that the most probable explanation for the observed effects in the albino 

kittens is that the toxicity was due to a fipronil photodegradate (MB46513, also known as fipronildesulfinyl) which is more toxic than the parent compound. It has been established that fipronil 

accumulates in sebaceous glands. The dose-related response observed in the albino kittens (which 

lack melanin, which would normally block light from reaching fipronil) is consistent with 

22 

58
formation of this photodegradate (particularly as effects appeared on day 3 in the 5X kitten and on 

day 7 in the IX kitten). The possibility also exists that the presence of one or more of the other 

ingredients in this formulation may have enhanced the fonnation of this photodegradate in the 

albino kittens. 

The registrant should provide the Agency with any additional information available from this 

study relevant to the formation of the fipronil degradate, including (if possible) the fur coloration 

of the animals at the application site and the level and type oflighting that the cats and kittens 

were exposed. This information should be received within 6 months of the issuance of a 

registration. 

This companion animal safety study in adult cats and kittens is upgraded to Acceptable and does 

satisfy the guideline requirement for a companion animal safety study (OPPTS 870.7200) in cats 

and/or kittens with the stipulation that labeling indicates that this product is not to be used on 

albino cats or kittens. 

23 

59
1. DP BARCODE: 385149 

2. PC CODES: 129121 (Fipronil); 105401: (S-Methoprene); 128965: (Etofenprox); 129032 

(Pyriproxyfen) 

3. CURRENT DATE: July 26, 2011 

4. TEST MATERIAL: Cat Spot on Soup, containing Fipronil (9.83%), S-Methoprene (11.76% 

w/w), Etofenprox (15.78%) and Pyriproxifen (2.34%) 

Study/SpeciesiLab MRID Results Tax. Core 

Studv # I Date Cat. Grade 

Companion Animal Safety 48302108 Three groups, each containing 3M N/A A 

Study/AdultCats & Kittens 48302109 & 3F adult cats, and 3 groups, each 

48513201 containing 3M & 3F kittens (12-16 

ClinVet International; weeks of age) were treated (along 

Bloemfontein, South Africa the back of each animal) with 

either 0.5 mL (IX) or 2.5 mL (5X) 

Study CV 09/660 1 July 13, 2010. of test material or with 1.45 mL (5 

x 0.29 mL) of the control material. 

Dermal effects occurred in two IX 

adults (but none of the 5X adults) 

and in one IX and one 5X kitten. 

Both affected kittens were albino. 

No indications of any effect 

involving hematological, clinical 

chemistry, or body weights. Food 

(meat) consumption data indicates 

a possible effect on the 5X albino 

kitten on Day 2, shortly before the 

appearance (Day 3) of dennal 

effects. TRB has concluded that 

the most probable explanation for 

the observed effects in the albino 

kittens is that the toxicity was due 

to a photodegradate offipronil. 

Labeling should stipulate that this 

product is not to be used on albino 

cats or kittens. 

Core Grade Key: A - Acceptable, S - Supplementary, U - Unacceptable, W - WaIved 

24 

60
/ "~ FW: Sergeant's Cat Labels 

~ ~:::::~n:inlOSotu 07/14/2011 02:01 PM 

Cc: 

Marion Johnson, Be Wanda Alexander 

Hide Details 

From: "James Messina" <jmessina@exponent.com> 

To: Bonaventure Akinlosotu/DCIUSEP A/US@EPA 

Page 1 of2 

Cc: Marion Johnson/DCIUSEP A/US@EPA, Be Wanda AlexanderlDCIUSEP A/US@EPA 

4 Attachments 

25 I 7-RUT Final 

~ Label vI O.3.docx 25l7 H RUL Final Label VIO.3.docx 25 I 7-RUI Final Label vlO.3.docx 

6~'l 3J 

25 I 7-RUA Final Label vI O.3.docx 

B.A., 

These are the !abels I mentioned during our call today. 

Best Regards, 

James Messina 

Exponent 

202.772.4932 office 

301.908.1181 mobile 

From: James Messina 

Sent: Wednesday, July 06, 2011 4:02 PM 

To: Akinlosotu.Bonaventure@epamail.epa.gov 

file:IIC:\Documents and Settings\BAkinlos\Local Settings\Temp\notes87944B\-web6892.... 8116/2011 

61
Page 2 of2 

Cc: Mary Hunt 

Subject: Sergeant's Cat Labels 

Bonaventure, 

Please find attached updated labels (per EPA efficacy reviews and minor language corrections) for the following 

four pending registration applications: 

• Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats (2517-RUT) 

• Sergeant's Fipronil + Nylar Spot-On for Cats (2517-RUA) 

• Sergeant's Fipronil + Etofenprox + Methoprene Spot-On for Cats (2517-RUL) 

• Sergeant's Fipronil + Etofenprox Spot-On for Cats (2S17-RU!) 

Please confirm the new PRIA due date for the above pending applications as I have not received any official 

correspondence related to the date change. My calculations have it atJuly 13, 2011. Can you please let me know 

if we are on track to meet this date? 

Best Regards, 

James Messina 

Principal Regulatory Consultant 

Exponent 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

202-772-4932 

202-772-4979 fax 

301-908-11B1 cell 

CONFIDENTIALITY NOTICE: This electronic transmission (including any files attached hereto) may contain 

information that is privileged, confidential and protected from disclosure. The information is intended only for the 

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

reader of this message is not the intended recipient or- any employee or agent responsible for delivering the 

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

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

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

by telephone. Thank you 

0"""..."" 

62
Efficacy Review 

Date: May 25, 2011 

Efficacy Reviewer: Clayton Myers, Ph.D., )Oiiiomoloo;"'~~iJ, mvers.clavlOn(a:!epa.gov ' 

703-347-8874 ' 

,_~----; ~- 1\ '- S-,-' 

Risk Manager Rev.: Rosanna Louie 

Products: Sergeant's Fipronil + Etofenprox + Nylar Spot-on for Cats 

EPA Reg. #: 25 I 7-RUT 

A.L's: Fipronil (9.8%), Etofenprox (15.0%), Pyriproxyfen (2.2%) 

Decision #s: 442431 

DP#s: 385137 

Submission: R31 0, New Products, RD Science Review 

MRIDs: Submitted: 48302110,48302111,48302112,48302113,48302114 

Cited: Selective Cite-All for efficacy (Merial) 

GLP: No 

MRID 48302110 

Title: Immediate Efficacy ofa Combined Application of Frontline Plus with Etofenprox as a 

Squeeze-on against Fleas (Ctenocephalidesfelis) and Ticks (Dermacentor variabilis) on Cats. 

Guideline: OPPTS 810.3300 

Materials and Methods: A laboratory study was conducted with an experimental fonnulation, 

with etofenprox (12.6%) added to a registered fipronil + s-methoprene pet product. Etofenprox 

technical was added to Merial's Frontline Plus (65331-4), with dosages applied in accordance 

with the parent product label. Cats receiving the experimental fonnulation received a 0.58 mL 

dosage, regardless of cat body weight. 18 cats, provisioned with cone collars, were allocated to 3 

groups (control, experimental formulation, and positive control). One day prior to treatment, 

cats were infested with 100 fleas and 50 ticks (Dermacentor), with subsequent weekly 

reinfestation on days 8, 15, 22, and 28 after treatment. Flea and tick counts were taken at I and 4 

hours after application on the day of treatment, and similarly after reinfestation on days 8, 15,22, 

and 28 to measure speed of kill, as evidence ofrepellency. COl.mts were also made at 24 and 48 

63
hours after treatment and after each re-infestation on days 1, 2, 9, 10, 16, 17, 23, 24, 29, and 30. 

Fleas and ticks were not removed or destroyed until the last count in each re-infestation cycle, 

which was done by comb removal. Effiacy was calculated using Abbott's fonnula. 

Study Summary of the Results: 

1. Efficacy against both fleas and ticks exceeded 90% for the duration of the efficacy study, 

30 days after treatment. 

Entomologist's ObservationslDiscussion: 

1. The 1-4 hour efficacy evaluations are suitable for evaluating claims of 'quick acting', but 

are not appropriate for evaluating repellence. For repellence to be demonstrated, a study 

would have to be done to demonstrate 90% reduction in tick attachmentlretention. 

2. I hour efficacy data indicates that the fonnula containing etofenprox starts killing fleas 

and ticks within one hour at a higher level than the fonnula with fipronil alone. 

MRID 48302111 

Title: Immediate Efficacy of a Combined Application of Frontline Plus with Etofenprox as a 

Squeeze-on against Fleas (Ctenocephalis felis) and Ticks (Dermacentor variabilis) on Cats. 

Guideline: OPPTS 810.3300 

Materials and Methods: Etofenprox was added to Frontline plus at 12.6% for immediate 

efficacy evaluations. Etofenprox technical was added to Merial's Frontline Plus (65331-4), with 

dosages applied in accordance with the parent product label. Cats receiving the experimental 

formulation received a 0.58 mL dosage, regardless of cat body weight. 9 cats, provisioned with 

cone collars, were allocated to 3 groups (control, experimental fonnulation, and positive control). 

One day prior to treatment, cats were infested with 100 fleas and 50 ticks (Dermacentor), with 

subsequent weekly reinfestation on days 8, 15,22, and 28 after treatment. Flea and tick counts 

were taken at 1 and 4 hours after application on the day of treatment, and similarly after 

reinfestation on days 8,15,22, and 28 to measure speed of kill, as evidence of repellency. 

Counts were also made at 24 and 48 hours after treatment and after each re-infestation on days 1, 

2, 9, 10, 16, 17, 23, 24, 30, and 31. Fleas and ticks were not removed or destroyed until the last 

count in each re-infestation cycle, which was done by comb removaL Effiacy was calculated 

using Abbott's fonnula. 

Study Summary of the Results: 

1. Flea efficacy on day of treatment was significantly higher for the treatment including 

etofenprox than fipronil alone (25% vs. 0% at 1 hour post-treatment, and 88% vs. 

14% at 4 hours post-treatment). Tick efficacy on the day of treatment was 

64
significantly higher for the etofenprox treatment at 4 hours after application (53% vs. 

0%). 

2. Mean efficacy against fleas exceeded 90% when assessed at 1-2 days after treatment 

or reinfestation with parasites, through 17 days after treatment. 

3. Mean efficacy against ticks exceeded 90% when assessed at 1-2 days after treatment 

or reinfestation with parasites through 31 days after treatment. 

Entomologist's ObservationslDicussion: 

1. The 1-4 hour efficacy evaluations are suitable for evaluating claims of 'quick acting', but 

are not appropriate for evaluating repellence. For repellence to be demonstrated, a study 

would have to be done to demonstrate 90% reduction in tick attachment/retention. 

2. 1-4 hour efficacy data indicates that the formula containing etofenprox starts killing fleas 

and ticks within four hours at a higher level than the fonnula with fipronil alone. 

MRID 48302112 

Title: Dose Titration with S-Methoprene Squeeze-On Cats Measuring Flea Egg Sterilization 

Guideline: OPPTS 810.3300 

Materials and Methods: A laboratory dose titration study was conducted to evaluate (and 

project) the residual protection time for cats treated with varying dosages of s-methoprene. 

Prevention of larval development, pupation, and adult flea emergence was evaluated, with dose 

rates ranging from 2.1 to 130.8 mg/kg body weight. Six treatment groups were established with 

2 cats each, and 6 additional cats were assigned to an untreated control group. Cats were fitted 

with Elizabethan collars to prevent grooming and pest removal Cats were infested with fleas 1 

day after treatment, and reinfested once weekly thereafter. Drop pans were used to collect flea 

eggs on the 2nd and 6th day after each infestation. Eggs were sorted and incubated for 3 days to 

measure fertility. Other eggs were incubated on a flea growing medium for 21-35 days to 

evaluate flea emergence. % hatch and % adult development were calculated for each cat. 

Efficacy (compared to controls) was calculated using Abbott's fonnula. Efficacy was plotted 

against dosage to develop a regression equation, used to detennine the relationship between 

dosage and duration of residual flea ovisterilant efficacy using regression analysis. 

Study Summary of the Results: 

1. Progressive failures in preventing egg hatch occurred after the 14th day, with the 

lowest rates. 

2. Based on inhibition of adult flea emergence, the analysis supports a claim for up to 4 

months for smaller cats, and no less than 1 month for large cats. 

Entomologist's ObservationslDiscussion: 

1. This data is supplemental in tenns of supporting s-methoprene claims, as existing 

data already support claims for breaking of the flea life cycle for up to 3 months. 

65
Because this product does not contain s-methoprene, this citation is not relevant to 

supporting any claims beyond those already supported by cited pyriproxyfen data. 

MRID 48302113 

Title: Comparative efficacy evaluation of Sergeant's squeeze-on and Frontline Plus for the 

treatment of adult cat flea (Ctenocephalisfelis) and Tick (Haemaphysalis elliptica, 

Rhipicephalus turanicus, and Dermacentor variabilis) infestations on cats. 

Guideline: OPPIS 810.3300 

Materials and Methods: Etofenprox was added to Frontline plus at 15.0% for efficacy 

evaluations on cats. 7 treatment groups were evaluated, including an untreated control, and 2 

rates each of FrontLine Plus (Fipronil + S-methoprene), Sergeant's 1 (Fipronil + S-methoprene), 

and Sergeant's 2 (Fipronil + S-methoprene + Etofenprox). The 2 rates of the experimental 

treatments were 0.5 mL and 0.055 mL of each treatment. 42 cats, ranging in weight from 5-15 

lbs, were provisioned with cone collars, and allocated randomly to the 7 groups (6 cats per 

group) Cats were all qualified for health and parasite retention. 50 ticks were placed at various 

times during the study. D. variabilis were used on days -6, -1, 21, and 28. R. turanicus were 

used on day 7. H elliptica were used on day 14. Infestations of 100 fleas were made on days -6, 

-1,7,14,21, and 28. 1 and 4 hour in situ assessments were made on the day of placement for 

each parasite. 24 and 48 hour assessments were made one and two days after the placement for 

all parasites. Fleas and ticks were not removed or destroyed until the last count in each reinfestation cycle, which was done by comb removal. Effiacy was calculated using Abbott's 

formula. 

Study Summary of the Results: 

1. Mean efficacy against ticks exceeded 90% when assessed at 1 day after reinfestation 

at 28 days post treatment, with the exception of H elliptica, but efficacy exceeded 

90% for all species when evaluated at 2 days after reinfestations. The lower rates did 

not demonstrate adequate efficacy. 

2. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment 

and reinfestations, for both treatment rates. 

3. Immediate efficacy on fleas (i.e. kill!repellence within 4 hours of treatment) ranged 

from 0-75% for 1-4 hours immediately after treatment. With reinfestations after 7, 

14,21,28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all 

only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for 

reinfestations on days 14,21,28, or 35 days after treatment. 

4. Immediate efficacy on ticks ranged from 11-71 % for 1-4 hours immediately after 

treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy 

exceeded 90% within 4 hours for only the 7 day reinfestation. Efficacy did not 

exceed 90% within 4 hours for reinfestations on days 14,21,28, or 35 days after 

treatment. 

Entomologist's ObservationslDicussion: 

66
1. Efficacy against fleas and ticks was adequate to support controls claims through 30 

days for the squeeze-on product containing etofenprox, applied at a label rate of 0.5 

mL per cat. 

MRID 48302114 

Title: Comparative efficacy evaluation of Sergeant's Squeeze-on and Frontline Plus for the 

treatment of adult cat flea (Ctenocephalidesfelis) and tick (Haemaphysalis elliptica, 

Rhipicephalus turanicus, and Dermacentor variabilis) infestations on cats. 

Guideline: OPPTS 810.3300 

Materials and Methods: Etofenprox was added to Seargeant's Fipronil-Methroprene 

fonnulation Frontline plus at the rate of 15% for efficacy evaluations. This treatment was 

compared to a 2 positive controls, Merial's Frontline Plus and a Sergeant's Fipronil + smethoprene combo, and an untreated control. The 3 treatments were split whereby one group 

received a fulllabe1 dose, while ther second group received a dosage based on a titration from 

the largest animal (20lbs cat) dose, to simulate the lightest possible dosage according to label 

directions. Each group consisted of 6 animals. These treatments were evaluated for efficacy 

against pre-existing fleas and ticks (Dermacentor var;abilis). Residual efficacy was measured 

against R. turanicus, H. elliptica, and D. variabilis over 30 days following treatment. Cats were 

infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 14, 21, and 28 days 

after treatment. Counts were made at 1 and 4 hours post treatment and also after every 

reinfestation~this was to measure speed of kill and/or repellency. Counts were also made at 24 

and 48 hours after initial infestation and all re-infestations. Flea counts were only made at 48 

hours after treatment and each re-infestation. Mortality was calculated using Abbott's fonnula. 

For speed ofkill/repeUence, the number of killed/repelled fleas on the liner below each treated 

cat was divided by the total number of fleas placed on the cat (all x 100), adjusted for 'normal' 

attrition on control dogs. 

Study Summary of the Results! 

1. Mean efficacy against fleas exceeded 90% when assessed at all assessment times up 

to 30 days after treatment. 

Entomologist's ObservationslDiscussion: 

1. Efficacy against fleas and ticks was adequate to support controls general claims 

through 30 days (one month) after treatment. 

2. No immediate efficacy claims (i.e., within 1-4 hours of application or reinfestation by 

parasites) are supported by this data. 

Overall Review of Label Claims and Directions: 

67
-killing claims against flea pupae are unsupported and thus, unacceptable 

-repellence claims against ticks are unsupported and thus, unacceptable 

Based upon submitted efficacy data, claims for the product to start working within I hour, or 

within hours are acceptable. 

Claims supported by selective and cite-all methods: 

-kill claims against fleas, flea eggs & larvae, ticks, including those that may transmit Lyme 

disease, chewing lice, and mosquitoes 

-fast acting 

-long-lasting 

-waterproof 

wdescription of product spread over pet's skinlhair 

-prevents all flea stages (eggs, larvae, pupae) from developing 

wstops existing infestations and prevents establishment of new infestations 

-kills fleas which may cause flea allergy dermatitis 

-kills all stages ofticks (larva, nymph, and adult), including deer ticks, brown dog tick, American 

dog tick, and Lone Star tick. 

-kills ticks that may transmit Lyme disease, Rocky Mountain spotted fever, erlichosis, and other 

tick-borne diseases 

-rapidly minimizes chewing lice infestations 

-kills mosquitoes 

w When used monthly, xxxx breaks the flea life cycle and controls ticks and chewing lice 

infestations. Do not reapply for 30 days. 

-Controls fleas for up to 6 weeks. 

-Kills mosquitoes within 24 hours for up to 14 days, and within 48 hours for up to 28 days with a 

monthly application 

wkeeps working even if the cat gets wet 

-fleas, ticks, and chewing lice are killed quickly after corning into contact with a treated cat. 

Fleas and ticks do not need to bite the cat in order to die. 

Line by Line Review of Label Claims 

Mosquitoes. Kills mosquitoes: Acceptable 

Adult Fleas. Studies show that [brand name] kills adult fleas for up to six weeks: Acceptable, 

but strike the statement "studies show". 

Kills Fleas [Up to[4][6J weeks]!: Acceptable 

Kills Fleas that mav cause flea allergy dermatitis, flea bite anemia, and tapeworm infestation: 

Acceptable 

Stops and prevents reinfestation: Acceptable 

68
Controls flea reinfestation for up to [six weeks]: Acceptable 

[brand name] kills adult fleas for up to six weeks: Acceptable 

If cat is a high risk for flea reinfestation a once month application may be needed: Acceptable 

Dual Action [!l: Fipronil and Etofenprox Effectively Breaks the Flea Life Cvcle: Unacceptable, 

as the life cycle claim is driven by Nylar efficacy. 

Prevents and controls reinfestations: Acceptable 

Flea Eggs and Larvae: Acceptable 

Stops and prevents infestations: Acceptable 

Controls flea reinfestation for up to 6 weeks: Acceptable 

Research demonstrates that [brand name] kills adult fleas. flea eggs. flea larvae and pupae for up 

to six weeks: Pupae claim is unacceptable. Pupal development is prevented by treatment, but 

the product was not shown to actually kill pupae directly. 

[brand name] prevents development ofal! flea stages for up to 6 weeks: Acceptable 

Prevents all flea stages (adult fleas, flea eggs, flea pupae, and flea larvae): Acceptable 

If cat is a high risk for flea reinfestation a once month application mav be needed: Acceptable 

Kills flea eggs [larvae][pupaeJ for up to [3 monthslfI2 weeks]: Pupae claim is unacceptable. 

Pupal development is prevented by treatment, but the product was not shown to actually kill 

pupae directly. 

rSeven][7] Way protection [kills fleas. ticks. mosquitoes. lice, flea eggs, flea larvae and flea 

pupae]: Pupae claim is unacceptable. Pupal development is prevented by treatment, but the 

product was not shown to actually kill pupae directly. 

With Nylar Insect Growth Regulator which Breaks the Flea Life Cycle: Acceptable 

With Nylar to Break Flea Life Cycle: Acceptable 

With Insect Growth Regulator to Break Flea Life Cycle: Acceptable 

Triple Action [!]: Effectively Breaks the Flea Life Cycler!]: Acceptable 

Kills all stages of the flea life cycle: Acceptable 

Kills Flea Eggs & Flea Larvae for [(up to 3 months)!]: Acceptable 

69
Prevents Flea Eggs From Developing Into Biting Adults: Acceptable 

Prevents and controls reinfestations: Acceptable 

Ticks: Acceptable 

Kills Ticks including those that may transmit Lyme disease: Acceptable 

Kills Ticks for Up to [4 weeksl!: Acceptable 

Kills Deer Ticks (vector of Lyme Disease) for up to 4 weeks: Change parenthetical statement to 

"which may transmit Lyme Disease". 

Kills Ticks (Including Deer Ticks) for up to 4 weeks: Acceptable 

Kills rand repelslfAmerican Dog Ticks for up to 4 weeks): Repels statement is unacceptable, kill 

claim is acceptable 

Kills [Brown]. fAmericanl[and Lone Star} dog ticks for up to 4 weeks: Acceptable 

Kills r& Repels] American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks: Repels 

statement is unacceptable, kill claim is acceptable 

Multiple Infestations: 

(Brand Name) provides convenient and effective flea, tick. chewing lice and mosquito control 

for cats and kittens: Acceptable 

Controls reinfestation for up to 4 weeks: Acceptable 

Flea & Tick Control for Cats & Kittens 12 weeks old and older: Acceptable 

Kills fleas, ticks. chewing lice & mosquitoes: Acceptable 

Kills fleas. ticks. mosquitoes. and (chewing) lice: Acceptable 

Monthly flea. tick. mosquito and lice protection: Acceptable 

Kills fleas. ticks. mosquitoes. and lice: Acceptable 

[Fourl[4] Way Protection: Acceptable 

[4 Week] [Flea and Tick & Treatment!]: Acceptable 

[Four (4) WeeklfFlea. Tick. Mosquito and Lice control]: Acceptable 

70
When used monthly [brand name] completely breaks the life cycle and controls tick and chewing 

lice infestations: Acceptable 

4 week Flea and Tick Treatment!: Acceptable 

Once A Month Flea and Tick Treatment: Acceptable 

Kills Fleas and Ticks for up to 4 weeks!: Acceptable 

Starts to kill fleas and ticks in an hour. continues to kill for a month: Acceptable 

Kills [93% of fleas] in 4 hours [and] [98 to 100% of tick] in one hour: Explicit percentage 

claims are unacceptable and must be removed. 

Research shows that [Brand Name] kills 93% of fleas in 4 hours and 98% to 100% of 

Demmcentor ticks in one hour: Explicit percentage claims are unacceptable and must be 

removed. 

Kills more than 50% of ticks in 1 hour: Explicit percentage claims are unacceptable and must be 

removed. 

Kills 100% of fleas and ticks in [24 hoursl[1 day]: Explicit percentage claims are unacceptable 

and must be removed. 

Starts killing fleas and ticks in as little as 1 hour: Acceptable 

Stops and prevents infestations: Acceptable 

Fast Acting: Acceptable 

Cats can be bathed 24 hours after treatment: Acceptable 

Waterproof: Acceptable 

Long Lasting: Acceptable 

Once a month treatment recommended: Acceptable 

A once monthly application is recommended for chewing lice: Acceptable 

Fast Action against chewing lice infestations: Acceptable 

[brand namel contains FiproniL Etofenprox and the insect growth regulator OaR) Nylarto 

effectively kills fleas. ticks. mosquitoes and chewing lice. The active ingredients in [brand 

71
name] work by collecting in the hair follicles and skin oils. This product features a sustainedrelease fonnula that discharges from the cat'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 ofFipronil. Etofenprox and Nvlar IGR collecting and being 

released from hair follicle]: Acceptable 

FREQUENCY OF APPLICATION 

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

infestations. [Studies show that]fbrand namel kills fleas for up to six weeks. and flea eggs. flea 

larvae. and flea pupae for up to 12 weeks. 

If your pet is high risk for flea reinfestation [. or in a highly infested environment]. apply 

monthly. Apply monthly to control ticks. mosquitoes and chewing lice. [Brand Name] kills 

mosquitoes within 24 hours for up to 14 days. and within 48 hours for up to 28 days. (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: The statement "studies show" and 

claim against 'flea pupae' must be removed. The remainder of the claim is acceptable. 

72
May 24, 201 I 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

Subject: Name of Pesticide Product: 

EPA Reg. No. !File Symbol: 

DP Barcode: 

Decision No.: 

Action Code: 

PC Codes: 

SERGEANT'S FIPRONIL + ETOFENPROX + 

NYLAR SPOT-ON FOR CATS 

2517-RUT 

DP 385135 

442431 

R310 

129121 (Fipronil: 9.8%); 128965 (Etofenprox: 

15.0%); 129032 (Nylar: 2.2%) 

From: 

Technical 

Byron T. Backus, 

Review 

Ph.D., 

Branch 

Toxicologist 0 ~7 ,,,~ __ r 0 

<--

-~ \ o~, -.--.. 

,-, 

~ '" 

Registration Division (7505P) r-/ /11 _ 

To: Richard Gebken RM 10 ~. f",;y./COI-0Gl'( 

Insecticide Branch 

Registration Division (7505P) 

Registrant: SERGEANT'S PET CARE PRODUCTS 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

129121 Fipronil 

128965 Etofenprox 

129032 Nylar 

Other Ingredient(s): 

TOTAL 

ACTION REQUESTED: The Risk Manager requests: 

bywt. 

9.80% 

15.00% 

2.20% 

73.00% 

100.00% 

"Attn TOX please conduct a companion animal safety review of the attached studies in support 

of a new cat spot-on product containing fipronil, pyriproxyfen and etofenprox ... " 

Page 1 of2 

73
BACKGROUND: 

The material received for review includes a cover letter dated 11118/2010, and a data matrix 

which cites a number of cat and kitten companion animal safety studies, a proposed label, and a 

CSF (dated 11116/2010). 

The citations include a recently reviewed companion animal safety study (in MRID 48302108) 

titled: "Companion animal safety evaluation of a spot~on containing two toxicants and two insect 

growth regulators on kittens and cats," as well as a data analysis report on this study (in MRID 

48302109). In addition, the registrant is citing a number of additional studies (MRIDs 46161309 

[Kuhn, J. (2003) Companion Animal Safety Study for an Etofenprox-IGR Spot-On Kittens and 

Cats: Final Report. Project Number: 7652/03. Unpublished study prepared by Stillrneadow, Inc. 

70 p.]; 43577711 [Walker, K. (1995) Discussion in Support of Bridging Domestic Animal Safety 

Data on Frontline Spray Treatment to Frontline Spot Treatment Data Package. Unpublished 

study prepared by Rhone Merieux, Inc. 6 p.]; 43577713 [Everett, R; Cunningham, 1.; Tanner, P. 

(1995) Positive Referenced and Untreated Controlled Dose Confirmation Trial ofRM1601E 

10% SPOT-ON Fonnulation Applied to Cats for Control of the Cat Flea Ctenocephalides [elis: 

Lab Project Numbers: RM VSR-250LT: ARC #RMC194: P-250LT. Unpublished study prepared 

by AgResearch Consultants, Inc. 30 p.]; 43577716 [Villageliu, J.; Lopez, S.; Genna, M.; et aI. 

(1994) Percutaneous Absorption and Distribution of Radioactivity in Hair, Skin, and Fat After 

Spot-On Application of (Carbon 14)-RM160 1 in Cats: Lab Project Numbers: CD-93/3748F. 

Unpublished study prepared by Centro de Investigacion y Desarrollo Aplicado, S.A.L. 42 p.]; 

43444904 [Schwartz, E. (1994) Domestic Animal Safety Study ofRM1601C Topical Spray 

(Frontline Spray Treatment) in Juvenile Cats: Lab Project Number: 94424: PS-234DAS. 

Unpublished study prepared by White Eagle Toxicology Labs. 168 p.]; 43272401 [Schwartz, E. 

(1994) Domestic Animal Safety Study ofRM1601C 0.25% Topical Spray in Juvenile Cats: 

Interim Report: Lab Project Number: 94424. Unpublished study prepared by White Eagle 

Toxicology Lab. 112 p.]; and 43121112 [Arnaud, J.; Consalvi, P. (1993) Domestic Animal 

Safety: Assessment of the Tolerance ofa 0.25% RM 1601 Spray Formulation in Cats at 3, 9, and 

15 mllkg When Applied 6 Times to the Haircoat at 28 Day Intervals: Revised: Lab Project 

Number: eLI 137. Unpublished study prepared by Rhone Merieux, Inc. 62 p.]. 

COMMENTS AND RECOMMENDA nONS: 

1. TRB hasrecently (May 16, 2011; Review for 2517-RUA under DP 385149) reviewed the 

cited companion animal (adult cats and kittens) study in MRID 48302108 with the 

accompanying data analysis report (MRID 48302109). 

2. As stated in the TRB review dated May 16,2011, the study in MRID 48302108 for adult cats 

and kittens is currently classified as Supplementary data and does not currently satisfy the 

guideline requirement for a companion animal safety study (OPPTS 870.7200) in cats andlor 

kittens. The study can be upgraded to acceptable and can be used to support the proposed 

registration(s) if the additional information indicated in the May 16 review is provided and 

there are no indications of significant adverse effects. Until then, it cannot be used to support 

the registration of2517-RUT and similar products. 

Page 2 of2 

74
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.709t • www.sergeants.com 

May 18,2011 

Richard Gebken, PMlO 

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: Offer to Pay Compensation in Support of Pending Registration 

Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats 

EPA File Symbol Number 25 1 7-RUT 

Dear Mr. Gebken: 

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

1770, EPA Company Number 2517) is submitting the following infonnation in accordance 

with FIFRA 3( c)(l)(F) and 3( c)(2)(B) to support the required data for the subject product, 

Sergeant's Fiproni1 + Etofenprox + Nylar Spot-On for Cats (2517-RUT). Please find enclosed 

the following support documents: 

• A copy of the offer to pay letter dated March 1, 2011 to Merial Limited; and 

• A copy ofthe USPS certified mailing receipt and delivery confilmation 

dated March 3, 2011. 

If you have any questions regarding this submission, please contact me at 402-938-7079. 

Sincerely, 

Kelly R. Hoskins 

Manager of Regulatory Affairs 

Sergeant's Pet Care Products, Inc. 

Enclosures 

cc: Bonaventure Akinlosotu, EPA 

75
Pet Care products, Inc, 

2625 South 100th Plaza • Omaha, NE 68130~1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergoants.com 

U.S. Registered Mail 

March 1,2011 

Merial Limited 

Amention: Regulatory Manager 

3239 Satellite Blvd., Bldg 500 LOC 106B 

Duluth, GA 30096 

Subject: Offer to Pay Compensation Under FIFRA Section 3(c)(1)(F) 

Sergeant's Pet Care Products, Inc. Proposed Product Sergeant's Fipronil + Etofenprox 

+ Ny1ar Spot-On for Cats ("Product'') 

To 'Nhom It May Concern: 

As required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 

3(c)(1)(F), and implementing regulations at 40 CFR Part 152 Subpart E, Sergeant's Pet Care 

Products, Inc. ("Sergeant's") hereby notifies Merial Limited, EPA Company Number 65331 

("CaMP ANY") that it intends to cite data regarding fiproni1 on file with the U.s. Environmental 

Protection Agency ("DSEPA" or "Agency") related to your end-use products containing fipronil 

to support the USEPA registration of an end-use Product containing the active ingredient. 

According to the USEPA's Listing of Pesticide Data Submitters (dated March 31, 2010), 

Sergeant's has identified COMPANY as an Original Data Submitter who has end-use product 

data on file with the Agency for the active ingredient fipronil. 

Sergeant's hereby notifies COMPANY: 

1. that it is the intent of Sergeant's to submit to the USEPA an application for pesticide 

registration for the Product containing the active ingredient fipronil; 

2. that Sergeant's offers to pay compensation regarding data, as appropriate, to 

COMPANY, with regard to the approval of this registration application, to the extent 

required by FIFRA Section 3(c)(l)(F); and 

3. Sergeant's offers to commence negotiations to detennine the amount and tenns of 

compensation, if any, to be paid for the use of any data. 

If COMPANY intends to request compensation for the use of COMPANY's dare, with 

regard to the approval of Sergeant's registration application, Sergeant's respectfunY'~~quests that 

COMPANY indicate, by return correspondence, the amount and tenns of suth req'le'stec 

compensation and the following infonnation for each Study for which c(,mp~nsation is 

requested: 

1 

76
sargeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1 no • Telephone 402,938.7000 • Fax 402.938.7091 • www.sergeants.com 

I. the MRID number, 

2. the Study Title, 

3. the date of Study submission, and 

4. the amount of any compensation previously received by COMPANY for the use of 

these data from other parties. 

Sergeant's requests a response from COMPANY within 90 days from the date of this 

letter. If Sergeant's does not receive a response within 90 days, it will understand that no data 

compensation is requested by COMPANY. 

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

Sincerely, 

Jkit;iUIJ--

Kelly Hoskins 

Manager of Technical Affairs 

Sergeant's Pet Care Products, Inc. 

cc: Larry Nouvel, Sergeant's Pet Care Products, Inc. 

2 

77
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Item 41f Restricted Delivery Is desired, III Print your name and address on tha reverse 50 that we can retum tha card to you. 

Ill: Attach this card to the back of the mallplece. 

or on the front If space permits. 

1. Article Addressoo 10: 

Merial Limited 

Atttention: Regulatory Manager 

3239 Satellite Blvd., Bldg 500 LOC 106B 

Duluth, GA 30096 

D. !~ delillery address 

!f YES, en1m' der~.I\d:lres~ below: 

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Merlal Limited 

Atttention: Regulatory Manager 

3239 Satellite Blvd., Bldg 500 LOC 106B 

Duluth, GA 30096 

J DAgont 

C. Date of Dellw 

If YES, enter delivery address below: 0 No 

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Merial Limited 

Amention: RegulatolY Manager 

3239 Satellite Blvd., Bldg 500 LOC 106B 

.Duluth, GA 30096 

D. Is delivery address dtfferent from item 11 Ye~ 

If YES, enlerd!!llvery addre5s belOW: 0 No 

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PS Form 3811. February 2004 Domllstic Re!urn Re;eipt 

78
U~!)S - Track & Confirm Page I of I 

~ UNITED STIlTES Home I .!:k!.Il: I 

Jl!iiiiII POST ilL SERVICEe Sign In 

Track & Confirm 

Search Results 

Label/Receipt Number: 7010 1670 0000 7307 8209 

Status: Delivered 

Your item was delivered at 10:43 am on March 03, 2011 in DULUTH, GA 

30096. A proof of delivery record may be available through your local 

Post Office for a fee. 

Additional information for this item is stored in Illes offline. 

Custom", Sarvlce Gov'1 Service" 

Copyrightl0 201 0 USPS. All Rights Reserved. No FEAR Aot EEO Data 

htto:lltrkcnfrm I .smi. USPS. comIPTSlnternetW eb/l nterLabel Inquiry .do 

Track & Confirm FAQs 

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Ente~,L.a,~IZf3ec.~,ipt __ l-Ju_!!lber. 

Terrno orUoe Buorness C""tom~f G~levl1Jy 

5/17/201 I 

79
DATE OUT: 

SUBJECT: 

FROM: 

TO: 

Company Name: 

Formulation Type: 

INTRODUCTION: 

0385133; FILE SYMBOL No.: 2517-RUT; PRODUCT NAME: Sergeant's Fipronll + 

DECISION No.: 442431; PC Code(s): 128965, 129121, 129032; 

May 12, 2011 

End Use Product Chemistry Review 

Product Name: Sergeant's Fipronil + Etofenprox +Nylar Spot-On for Cats 

, U ,V'I--1 \' \) I 

Shyam Mathur, . <\~V'd -~ \ 

Product Chemistry Team Leader 'is <. r 

Technical Review BranchlRD (7505P) 9 C,;)9-

Rosanna Louie I Richard Gebken, RM 10 

Insecticide Branch I RD (7505P) 

Seargent's Pet Care Products Incorporation 

Spot-On for Cats 

S- It 1/1') 

The registrant has submitted an application for the registration of the new end use product "Sergeant's 

Fipronil + Etofenprox+Nylar Spot-On for Cats". In support of the registration application, the registrant has 

submitted 830 series group A & group B data with MRID Nos. 483026-01 & 483026-02.The registrant has 

also submItted CSF's for basic & alternate formulations (both dated 11-16-10) and the product label. TRB has 

been asked to detennine the acceptability of product chemistry data submitted to support the proposed basic 

and alternate CSF's. 

SUMMARY OF FINDINGS: 

1. Name of Active Ingredient(s): Fipronil (9.8%), Etofenprox (15.0%) & Pyriproxyfen (2.2%; Nylar) 

2. Has the registrant claimed substantial similarity to a registered product? 

II Yes; [Xl No; [ 1 NA; if yes, provide the registration number of the cited product. 

EPA Reg. No: 

3. All of the source materials of the active ingredient are derived from registered sources- [Xl Yes; [ 1 No 

4. All inert ingredients have been screened by IIAB (11-29-10) and found to be approved for the proposed 

labeled uses. 

5. Confidential Statement of Formula(s): 

[Xl Basic - Dated: 11-16-10; Re-submitted - Dated: 

[Xl Alternate CSF #1- Dated: 11-16-10; Re-submitted - Dated: 

Alternate CSF(s) complies with 40CFR§152.43: [Xl Yes; [ 1 No; [ 1 NA 

80
DP BARCODE No.: D385133; FILE SYMBOL No.: 2517-RUT; PRODUCT NAME: Sergeant's Fipronil + 

Etofenprox +Nylar Spot-On for Cats; DECISION No.: 442431; PC Code{s): 128965, 129121. 129032; 

ACTION CODE: R 310; FOOD Use: No 

6. Product label 

a. Ingredient statement: Nominal concentration of AI listed on CSF{s) concurs with product label 

(PR Notice 91-2). 

[Xl Yes, if not, explain below: 

Is the sub statement in compliance with PR Notice 97-6 (inert ingredient vs other ingredient) 

[Xl Yes; [ 1 No; if not, explajn below: 

Metallic equivalent: [ 1 Yes [Xl NA; 

Soluble arsenic: [l Yes [Xl NA 

Isomeric ratios: [[ Yes [Xl NA 

Acid Equivalent: [[ Yes [Xl NA; acid equivalent = 

b. Health related sub statements: Product contains? 

Petroleum distillate at > 10%: 

Methanol at > 4%: 

Sodium nitrate/Sodium nitrite 

[ [Yes [XI No [ [ NA 

[ [Yes [XI No [ [ NA 

[ [Yes [XI No [ [NA 

c. Physical chemical hazard statement Product label requires a statement per 40 CFR §156.78 for: 

flammability, explosive potential or electric insulator breakdown? 

[[Yes [X] No 

Is the sub statement in compliance with PR Notice 98-6 (Total Release Fogger)? 

[ 1 Yes; [ 1 No; [Xl NA; if not, explain below 

d. Label requires, an additional Storage and Disposal statement: [ [Yes [Xl No; if yes explain below: 

2 

81
DP BARCODE No.: 0385133; FILE SYMBOL No.: 2517-RUT; PRODUCT NAME: Sergeant's Fipronil + 

Etofenprox +Nylar Spot-On for Cats; DECISION No.: 442431; PC Code(s): 128965. 129121. 129032; 

ACTION CODE: R 310; FOOD Use: No 

7. Group A: Product Chemistry Data 

TRB's determination of the acceptability for the proposed product is listed in the tables below. 

Data submitted 

TRB's Guideline 

No. Study Title Assessment MRID Nos. of Data 

Yes No 

Product Identity & Composition 

830.1550 X A 483026-01 

Description of materials used to 

830.1600 produce the product X A 483026-01 

Description of formulation 

830.1650 process X A 483026-01 

Discussion on the formation of 

830.1670 impurities X A 483026-01 

830.1700 Preliminary analysis NA 

Standard certified 

limits X A 

Certified 

limits Proposed Limits 

(158.350) Justification for 

830.1750 wider limits 

830.1800 Enforcement analytical method X A 481226-01 

A = Acceptance, N = Not Acceptable, G = Data Gap, W = Waiver Request, I = In Progress, NA = Not 

Applicable; U = Upgradeable. 

3 

82
DP BARCODE No.: D385133; FILE SYMBOL No.: 2517~RUT; PRODUCT NAME: Sergeant's Fipronil + 

Etofenprox +Nylar Spot~On for Cats; DECISION No.: 442431; PC Code(s): 128965, 129121. 129032; 

ACTION CODE: R 310; FOOD Use: No 

8. Group B: 

Guideline Study Title Value or Qualitative TRB's MRID Nos. 

No. Description Assessment 

of Data 

830.6303 Physical State Liquid A 483026-02 

830.6315 Flash point >90'C (194'F) A 483026-02 

830.6316 Explodabilitv None A 483026-02 

Not soluble or dispersible in 

830.7000 pH water A 483026-02 

830.7300 Density (units) 1.03-107 glee A 483026-02 

A = Acceptance, N = Not Acceptable, G = Data Gap, W = Waiver request, NA = Not applicable, I = In 

progress; U = Upgradeable. 

4 

83
DP BARCODE No.: D385133; FILE SYMBOL No.: 2517-RUT; PRODUCT NAME: Sergeant's FiproniJ + 

Etofenprox +Nylar Spot-On for Cats; DECISION No.: 442431; PC Code(s): 128965. 129121, 129032; 

ACTION CODE: R 310; FOOD Use: No 

CONCLUSIONS: 

The TRB has reviewed the product chemistry data submitted for the proposed end-use product and has 

concluded that 

1. The proposed CSF for basic formulation & the CSF for alternate formulation #1 (both dated 11-16-10) are 

acceptable. 

2, The data submitted corresponding to guidelines 830.1600 (description of materials used to produce the 

product), 830,1650 (description of formulation process), and 830.1670 (discussion on the formation of 

impurity), 830.1750 (certified limits) for the basic & altemate formulations are acceptable. 

3. The data cited for the guideline 830.1800 (enforcement analytical method) is acceptable. 

4. The product chemistry data submitted corresponding to the guidelines 830.6303 (physical state), 830.6314 

(oxidation/reduction), 830.6315 (flammability), 830,6316 (expJodabllity), 830.6319 (miscibility), 830.7000 (pH), 

830.7100 (viscosity), and 830 7300 (density) are acceptable, 

5, The registrant has not submitted the product chemistry corresponding to the studies for one year storage 

stability (830,6317) and corrosion characteristics (830.6320). The registrant has stated that these two 

studies are in progress and the results will be submitted to the Agency when the studies are completed. 

It is recommended that the observations should be made at 0, 3, 6, 9, and 12 month intervals 

and the result must be submitted to the Agency at the end of the studies 

5 

84
April 22, 2011 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

Subject: 

From: 

To: 

Registrmlt: 

Name ofpesticide Product: SERGEANT'S FIPRONIL + ETOFENPROX + 

NYLAR SPOT-ON FOR CATS 

EPA Reg. No.lFi1e Symbol: 25I7-RUT 

DP Barcode: DP 385134 

Decision No.: 442431 

Action Code: R310 

PC Codes: 129121 (Fiproni1: 9.8%); 129032 (Pyriproxyfen: 

2.2%); 128965 (Etofenprox: 15%) 

Byron T. Backus, Ph.D., Toxicologist 0 ~rr-. '(1 _ ... 11 .,... 

Technical Review Branch Af<~ t _ ""L"\..- 1....0 l \ , 

Registration Division (7505P) ~.' ~ 

Rosanna Louie-IuzwiakIRichard Gebken RM 10 "r 

Insecticide Branch 

Registration Division (7505P) 

SERGEANT'S PET CARE PRODUCTS 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

129121 Fipronil 

128965 Etofenprox 

129032 Pyriproxyfen 

Other Ingredient(s): 

TOTAL 

ACTION REQUESTED: The Risk Manager requests: 

bywt. 

9.80% 

15.00% 

2.20% 

73.00% 

100.00% 

"Attn TOX please conduct an acute toxicity review on the attached studies in support of a new 

cat spot-on product containing fipronil, pyriproxyfen and etofenprox ... " 

Page 1 (lO 

85
BACKGROUND: 

The material received for review includes a cover letter dated 11/18/20 I 0, a data matrix which 

references 5 acute toxicity studies (MRIDs 483021-03 through 483021-07), a proposed label, and 

aCSF(dated 11116/2010). 

COMMENTS AND RECOMMENDATIONS: 

I. All five of the acute toxicity studies have been previously reviewed (TRB memorandum 

dated 04/22/11 for DP 385123) and classified as acceptable. After comparing the CSF for 

2517-RUT with the material that was tested, TRB concludes that these studies satisfy all 

acute toxicity data requirements for the registration of EPA File Symbol 2517-RUT except 

for acute inhalation. It is noted that the test material contained S-Methoprene in addition to 

the active ingredients present in 2517-RUT. 

2. Given the product use (a spot-on for cats), and the lack of any significant potential inhalation 

exposure, TRB recommends for a waiver of the acute inhalation toxicity study requirement. 

3. The following is the acute toxicity profile for EPA File Symbol 2517-RUT (SERGEANT'S 

FIPRONIL + ETOFENPROX + NYLAR SPOT-ON FOR CATS), based on the results of the 

cited toxicity studies: 

Acute oral toxicity III Cited MRID 48302103 

Acute dermal toxicity III Cited MRID 48302104 

Acute inhalation toxicity IV Waived 

Primary eye irritation III Cited MRID 48302105 

Primary dennal irritation IV Cited MRID 48302106 

Demlal sensitization Negative Cited MRID 48302107 

4. Based on the acute toxicity profile above, and taking into consideration the proposed uses 

specified on the label and infonnation in the esp, the following is the precautionary and first 

aid labeling for EPA File Symbol 2517-RUT (SERGEANT'S FIPRONIL + ETOFENPROX 

+ NYLAR SPOT-ON FOR CATS) as obtained from the Label Review System: 

PRODUCT 10 #: 

PRODUCT NAME: 

002517-00147 

SERGEANT'S FIPRONIL + ETOFENPROX + NYLAR SPOT-ON FOR 

CATS 

PRECAUTIONARY STATEMENTS 

SIGNAL WORD: CAUTION 

Hazards to Humans and Domestic Animals: 

Harmful if absorbed through skin. Harmful if swallowed. Causes moderate eye irritation. Avoid contact 

with skin, eyes or clothing, Wash thoroughly with soap and water after handling and before eating, 

drinking, chewing gum, using tobacco Or using the toilet. Remove and wash contaminated clothing before 

reuse. [Wear protective eyewear.]* 

*[Protective eyewear may be specified, if appropriate]. 

Page 2 of3 

86
First Aid: 

If on skin: 

-Take off contaminated clothing. 

-Rinse skin immediately with plenty of water for 15-20 minutes. 

-Call a poison control center or doctor for treatment advice. 

If swallowed: 

-Call a pOison control center or doctor immediately for treatment advice. 

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

-Do not induce vomiting unless told to by a poison control center or doctor. 

-Do not give anything to an unconscious person. 

If in eyes: 

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

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

-Call a poison control center or doctor for treatment advice. 

NOTE TO PHY5IOAN: Note to PMjCRMjRegistrant: The proposed label should contain a "Note to 

Physician". The following statements are suggested types of information that may be included, if 

applicable: - technical information on symptomatology; - use of supportive treatments to maintain life 

functions; - medicine that will counteract the specific physiological effects of the pesticide; - company 

telephone number to specific medical personnel who can provide specialized medical advice. 

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-xxx-xxxx for emergency medical treatment information. 

5. The CSF (dated 11/16/2010) for 25 I 7-RUT should also be reviewed and accepted by the 

TRB Chemistry Team. 

6. This review does not address the requirements for companion animal safety studies (or 

citations for such studies) to support the registration of2517-RUT. 

Page 3 00 

87
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

NOTE TO RM 10 Richard Gebken 

OFFICE OF 

CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Certification to Compliance with Child-Resistant Packaging Regulations 

EPA FILE NO: 2517-RUT (147) DP 386764, Decision: D442431 

DATE: APR 1 1 

" 

1 

Please note that EPA FILE NO: 2517-RUT certification for the 9.8% fipronil-containing 

spot-on cat product (0.50 ml) regarding child-resistant packaging (CRP) has been reviewed, and 

is acceptable regarding compliance with the standards of 40 CPR 157.32. The submitted CRP 

Self-Certification sununary, dated March 7, 2011, in support of the subject proposed product 

cited a previously-submitted study, Wlder MRlD 48279601. It is noted that although there is an 

additional active ingredients (etofenprox and pyriproxyfen) in this proposed product, the 

applicant notes that there is no significant increase in fonnulation toxicity with regards to CRP. 

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 the requirement to submit additional data 

for these products to establish that they are CRP. 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. Please place a copy of this note in the registration jacket for the above named product. 

Please advise the registrant that this CRP certification is acceptable. If you have any questions, 

please contact me at (703) 308-0037. 

Rosanna Louie-Juzwiak, R 

~L%eo14 'ti«Jr 

Rosalind L. Gross, Secondary Reviewer 

88
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 

March 7, 2011 

Richard Gebken, PMIO 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Certification 

Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats 

EPA File Symbol 2517-RUT 

Dear Mr. Gebken: 

I certifY that the packaging used for the following product meets the standards of 40 CFR 157.32, 

including the revised standards in 16 CFR 1700.l5(b), when tested by the revised testing 

procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21,1995): 

• Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats (EPA File Symbol 2517-

RUT). 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158'" Plaza, Suite 100, Omaha, NE 

68130-1703, EPA Company Number 2517) submitted a child resistant packaging study under 

EPA Reg. No. 2517-137, MRID 48279601 (Perritt study 1746-01). The submitted data comply 

with current CRP regulations. 

The results from this CRP study 0.5 mL applicator are being submitted to support the pending 

product registration for Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats (EPA File 

Symbol 2517-RUT). CRP data are required for the above-referenced pending registration 

because of the inclusion of the active ingredient fipronil (9.8%) in the spot-on product. The 

submitted CRP testing for the cat product was conducted on a standard package size and white 

color configuration containing 0.5 mL fill volume for a product containing fipronil (9.8%). For 

children opening the applicators, opening of one applicator was considered an individual failure. 

The above-referenced Sergeant's cat product can rely upon the same CRP data because it 

contains fipronil at 9.8%, and consequently requires CRP packaging. Although the product also 

contains etofenprox and pyriproxyfen as active ingredients, they do not significantly add to the 

toxicity of the formulation. Additionally, Sergeant's or Pet Logic LLC (EPA Company Number 

69332, owned by Sergeant's), already have cat spot-on products registered by EPA containing 

etofenprox and pyriproxyfen, and none of them are subject to CRP. 

89
The fill size for each product is 0.5 mLjust as the fill size of the cat product tested in MRlD 

48279601. fl/7ple5~ 

When this new cat product is marketed, it wit have the same applicator color (white), same fill 

volume (0.5 mL), and same fill weight color as for the cat product used in the submitted and 

referenced CRP testing. Therefore, Sergeant's is relying on MRlD 48279601 to address the CRP 

testing requirements. 

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

Sincerely, 

il . 0 0, ,fWl!to} LA.b K~~ns Manager of Technical Affairs 

Enclosure 

cc: Larry Nouvel 

2 

90
• Identify which package is associated with the CRP test data; 

MRID number 48279601 was conducted on a three-pack of 0.5 mL white applicator tubes with a 

purple stripe connected to each other. The applicator consists of three parts, which are an 

applicator tip, a cap, and a main chamber body. The applicator looks like a tube in a rectangle of 

plastic. At the top area of the applicator extending from the cap there is a narrow (needle like) 

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

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

area at the notches with scissors. There are three applicators with a purple 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 one size, 0.5 ml. 

• A description ofthe package tested including a photograph ofthe package; 

The test package was the cat spot-on 0.5 ml white applicator (base color) with a purple label 

indicator. Each applicator contains a single application and the applicators were tested in a three 

pack configuration. 

The following outlines the detailed specifics of the spot-on applicator: 

Material Specifications: Opaque White PVClHigh Barrier HDLDPE with EVOH 240175 Yield I (;'ominal) 1665 sa. inllb., 3670 sa. inlh. 

Outer Layer: FDA grade opaque White PVC (Poly Vinyl Chloride), colour code 035, 

240 micron (:0096") +/- 5%. 

Adhesive Layer: Novacote pre-polymer two component cross linked system - 1.5 Ibs. per 

ream. 

Inner (Sealant/Barrier) HOPE (High Density Polyethylene) - EVOH (Ethyl Vinyl Acetate/Ethyl 

Layer-Non-Peelable: Vinyl Alcohol Copolymer) - LLDPE (Linear Low Density Polyethylene) 

LDPE'(iow Densltv'Polvethvlene)blend 75 micron-;:003") +/- 5%. 

-PVC comphes wIth FDA Code of Federal RegulatiOns, Title 21, sections 178.2010, 178.2650, 178.3297, 

178.3690, and 178.3790. 

-Adhesive comp!ies with FDA Code of Federal Regulations, Title 21, section 175.105. 

-PE complies with FDA Code of Federal Regulations, Title 21, section 177.1520. 

-EVOH !ayer complies with FDA Code of Federal Regulations, Title 21, sections 175.105 and 177.1360. 

A photograph of the package (front and back) is shown below: 

3 

91
• The directions on the package used for Senior Adult Use Effectiveness (SAVE) 

Testing along with any additional directions provided to the Seniors during SAVE 

Testing; 

Directions on a label on the back ofthe applicator stated "Use scissors to open." 

Additional directions to open the package, which will appear on the label, were used for SAUE 

Testing. These directions read: 

"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." 

• If the package is considered unit packaging- (answer the next three bullets) 

Sergeant's cat spot-on product is considered unit packaging. The CRP testing was conducted on 

a three-count (3) of 0.5 mL applicators connected to each other. 

4 

92
o Define the number of units that represent a child failure; 

The toxicity of any cat product containing 9.8% fipronil is based on the toxicity of the active 

ingredient fipronil. The toxic or harmful amount of fipronil for an 11.4 kg child is 2.5 kglkg 

times 11.4 kg, which equals 28.5 mg. Access to a toxic or harmful amount = 28.5 mg divided by 

[1025 mg/ml x 0.098 fipronil] ~ 0.284 ml ~ 0.28 ml for fipronil cat products. 

Access to one applicator represents a failure for a child for all applicator sizes equal to or greater 

than 0.28 m!. 

o State the number of units a child receives at the beginning ofthe test; 

Each child was provided one three-count (3) package of applicators connected to each other at 

the beginning of the CRP test. 

o The number of children opening/accessing a toxic or harmful amount or 

opening or gaining access to more than 8 individual units, whichever number 

is lower during the full to minutes of testing. 

The CRP data resulted in zero (0) children being successful at opening or gaining access to the 

contents of the Sergeant's 0.5 mL applicator; therefore, the child-resistant effectiveness is 

100.0% 

5 

93
",-' .,." .. ;., ". 0"" "" __ " ! . r·~·~, ',·r, .. '~" 0",) ·,U. 'I'~'·.~',:,,, I ~""r> '\I'I""'~~ ~'-'Ul ..;". :~ln·CU60 I Fum ",.,roved OMB No. Z07D-«160 

UNITE]) STATES ENVIRONMENTAL PROTECTION AGENCY 

s!< 401 M Street, S. W. 

WASHINGTON, D.C. 20460 

Paperwork Redm:tion Ad Notice: The public reporting burden for this C(Il1edion ofllformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for 

reregistration and special review activities. including time for reading the instruction and C(Impleting the necesslUy forms. Send comments regarding the burden estimate or any other aspeltofthis C(Illcction of 

infurmation, including suggestions for reducing the burden to Director; OPPE Infurmatkm Management Division (2137) U.S. Environmental Prole(:tionAgency, 401 M Street, S. W .• Washington, OC 20460. Do 

not send the form to this address. 

DATA MATRIX 

Date: Febru 17,2011 EPARe No.lFile~ol 2517~RlIT Page I of3 

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

Sw!eant's Pct Care Products., Inc. 2625 South 158th Plaza, Omaha, NE 68130~1770 Nylar Spot~On For Cats 

I edients: Fi ronil, Etofen rox, and ri ro ,n 

Guideline Reference Number Guideline Stud Namc MRIDNumber Submitter Status Note 

830.1550, 830.1600, 830.1620, Product Properties Data for Sergeant's Fipronil + Etofenprox + 48302601 Sergeant's Pet Care Products, Inc. OWN 

830.1650,830.1670, 830.1750 ~ylar ~t~On For Cats 

830.1800 Enforcement anal 'cal method 48122601 Se eant's Pet Care Products Inc. OWN 

830.6302, 830.6303, 830.6304, Product chemistry of Sergeant's Fipronil + Etofenprox + Nylar 48302602 Sergeant's Pet Care Products, Inc. OWN 

830.6313, 830.6314. 830.6315. Spot-On For Cats 

830.6316, 830.6317, 830.6319, 

830.6320,830.6321,830.7000, 

830.7100,830.7300,830.7520 

830.6317,830.6320 Storage stability and corrosion characteristics To be conducted Sergeant's Pet Care Products, Inc. OWN 

870.1100 Acute Oral Toxicity Up and Down Procedure with Cat Products 48302103 Sergeant's Pet Care Products, Inc. OWN 

870.1200 Acute Dennal Toxicity (Limit Test) with Cat Products 48302104 Sergeant's Pet Care Products, Inc. OWN 

870.]300 Waiver Request of Requirement for Furthcr Testing for Acute 48129605 Sergeant's Pet Care Products, Inc. OWN 

Inhalation Toxicity 

870.2400 Acute Eye Irritation/Corrosion with Cat Products 48302105 Sergeant's Pet Care Products, Inc. OWN 

870.2500 Acute Dermal Irritation/Corrosion with Cat Products 48302106 sergeant's Pet Care Products, Inc. OWN 

870.2600 Test for Sensitization (Guinea Pig Maximisation Test) with Cat 48302107 Sergeant's Pet Care Products, Inc. OWN 

Products 

870.7200 Companion animal safety evaluation of a spot-on containing two 48302108 Sergeant's Pet Care Products, Inc. OWN 

toxicants and two insect gr~wth rel!Ulators on kittens and cats 

870.7200 Companion animal safcty evaluation of a spot-on containing two 48302109 Sergeant's Pet Care Products, Inc. OWN 

toxieants and two insect growth regulators on kittens and cats. 

Executive SUmmary of Data and Conclusions. 

870.7200 Companion Animal Safety Study for an Etofenprox-IGR Spot-On 46161309 Pet Logic, L.L.C. OWN 

Kittcns and Cats 

870.7200 Domestic Animal Safety: Assessment of the Tolerance of a 0.25% 43121112 Mcrial Limited OLD 

RM 1601 Spray Fonnulation in Cats at 3, 9, and 15 ml/kg When 

j\ppiied.~ Times to the Haircoat at 28 Day Intervals: 

Sig",tu<' K{~ ,f,L ~ Name and Title Date 

Kelly R. Hoskins, Manager of Technical Affairs 02/17/2011 

EP"FomoSS10--l5(9- ecttooio.u>lP.pe,v ~bl._ sub",~onlyP.l"fversion. "S-qbl..-..al.U .. copy 

94
~'::;':-";., .:":--, . :.~ .' -.. "". - , --- -._,- .. ,- ,,_.. - .. - -- . ~,-:.-' "".",. ,,'i>T.,' ~" .<.,. G':;" I c "'-' ...... , . ,'c_,,_.,,: ;'~'<l ,'.. , .. " ",", ; . ~,.,,,, '''-'''''''~ "~I;;" 

F_ Appnvtd OMS Ne, %07"-

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ,~ 401 M Street, S. W. 

P. W ASHlNGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection ofnfonnation is estimated to a'Yerage 0.25 hours per response for registration aclivities and 0.25 hours per response for 

reregistration and special review actiuties, including time for reading the in2eregistrationcompletingthe necessary foons. Send comments regarding the burden estimate or ooy other aspect of this collection 

ofinfonnation, including suggestions for reducing the burden to Director: OPPE Infonnation MlUlagementDivision (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., Wa91ingmn, DC 

20460: Do not sen~~ form to dtis address, 

DATAMATRlX 

Date; Febru 17,2011 EPA Reg No,/File Symbol 2517-RUT Paj!;e 2 of3 

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

Seri!:eant's Pet Care Products, [nc. 2625 South. 158th Plaza, Omaha, NE 68130-1770 Nylar Spot-On For Cats 

In ients: Fi roni!, Etofenprox, and Pyriproxyfen 

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

870.7200 Domestic Animal Safety Study ofRMI601C 0.25% Topical 43272401 Merial Limited OLD 

Spray in Juvenile Cats 

870.7200 Domestic Animal Safety Study ofRMI601C Topical Spray 

I (Frontline Spray Treatment) in Juvenile Cats 

43444904 Merial Limited OLD 

870.7200 Discussion in Support of Bridging Domestic Animal Safety 43577711 Merial Limited OLD 

Data on:~~tIine Spray Treatment to Frontline Spot Treatment 

Data Pae e. 

870.7200 Positive Referenced and Untreated Controlled Dose 43577713 Merial Limited OLD 

Confirmation Trial ofRMl601E I ()I'A. SPOT-ON Fonnulation 

Applied to Cats for Control of the Cat Flea Ctenocephalides 

felis 

870.7200 Percutaneous Absorption and Distribution of Radioactivity in 43577716 Medal Limited OLD 

Hair, Skin, and Fat After Spot-On Application of (Carbon 14)-

RMI601 in Cats 

810.3300 Immediate Efficacy of a Combined Application of Frontline 48302110 Sergeant's Pet Care Products. Inc. OWN 

Plus with Etofenprox as a Squeeze-on against Fleas 

(Ctenocephalidesjelis) and Ticks (Dermacentor variabilis}) on 

Cats. Studv ID 185C 

810.3300 Immediate Efficacy of a Combined Application of Frontline 483021 II Sergeant's Pet Care Products, Inc. OWN 

Plus with Etofenprox as a Squeeze-on against Fleas 

(Ctenocephalidesjelis) and Ticks (Dermacentor variabilis) on 

Cats. Studv lD 181C 

810.3300 Comparative efficacy evaluation of Sergeant's Squeeze-on and 48302113 Sergeant's Pet Care Products, Inc. OWN 

Frontline Plus for the treatment of adult cat flea 

(Ctenocephalides/elis) and tick (Haemaphysalis elliptica, 

Rhipicephalus turanicus and Dermacentor variabilis) 

infestations on cats. 

810.3300 Comparative efficacy evaluation of Sergeant's Squeeze-on and 48302114 Sergeant's Pet Care Products, Inc. OWN 

Frontline Plus for the treatment of adult cat flea 

(Ctenocephalidesfelis) and tick (Haemaphysalis elliptica, 

Rhipicephalus turanicus and Dermacentor variabilis) l ~~estations on cats. Executive Summary of Data and 

onc1usions 

~~~::~:Mg{L. ~€ rZ?subm;.omyp.~rv~M' Name and Tille Date 

Kelly R. Hoskins, Manager ofTcchnical Affairs 02/1712011 A..tJleviJIl ..... o.IU •• C .... 

95
, ___ • _" • __ ' ___ •• _____ •• __ • _____ • __ 0 ____ • " '_' __ ,",., .... _ , __ .. ___ ". •• • • __ •• """ •• ____ • _ • , __ ' ....... _ .~_. _ •• _ • __ ••• __ 'M 

F_ APllnwedOMBN •. lt7'-

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY .. 401 M Street, S.W. 

£ WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: Thc public reporting burden for this collection ofilfonnation is estimated to avcragc 0.25 hours per7esponse for registration activities and 0.25 hours per response for 

reregisttatioo and special review activities, including time for reading the inJeregislratioocompleting the necessary forms. Send comments regarding the burdcn estimate or any other aspect of this collection of 

information, including suggestions fur reducing the burden to Director: OPPE Information Management Division (2131) U.S. Environmental ProtectionAgency, 401 M Street, S.W., Washington, IX:: 20460. 

Do not send the form to this address. 

DATA MATRIX 

Date: February 17,2011 EPA Re No.lFileS bol 2517-RUT P e300 

Applicant'slRcgistrant's Name & Address Product: Sergeant's Fipronil + Etofenprox + 

Ser2eanfs Pet Care Products, Inc. 2625 Soulh 158th Plaza, Omaha. NE 6813Q..1770 Nvlar Soot·On For Cats 

1 redients: Fi ronil, Etofen rox, and ri roxyfen 

Guideline Reference Number Guideline Study Name MRlDNumber Submitter St,,", Note 

810.3300 Selective Cite All Merial Limited OLD/PAY 

lHO.3300 Summary of Analyses of Efficacy Data to Support Label Claims 46161310 Sergeant's Pet Care Products, OWN 

for an Etofenprox·Pyriproxyfen Spot..()n for Use on Cats and Inc. 

0028. 

810.3300 Dose Titration to Detennine the Relationship between Dose Rate 46161316 Sergeant's Pet Care Products, OWN 

ofNylar (Pyriproxyfen) when Applied as a Spot-On to Kittens and Inc. 

the Duration of Residual Flea Ovisterillization. 

40CFRPart 157.32 EvalUaiion of the Cat Squeeze On 0.5ml White Applicator with 48059503 Sergeant's Pet Care Products, OWN 

Purple Label Indicator (3x), scissors to open· F=I as a Poison Joe 

Prevention Package for Sefgeant's Pet Care Products, Inc. 

40 CFR Part 157.32 Amended Report: Evaluation of the Cat Squeeze On O.Sml White 48279601 Sergeant's Pet Care Products, OWN 

Applicator with Purple Label Indicator (3x), scissors to open· F=I Inc. 

as a Poison Prevention Package for Sergeant's Pet Care Products, 

1"", / 

Signature: KJJ{ ,.I/.. / ~ Name and Title Date 

Kelly R. Hosk.ins, Manager ofTcchnical Affairs 0211712011 ''''''-,,~ .,,"-~, I<>-an ", .... _, _~ ... _"....;~. h.".~, ~. " ..... v ... __ •• ,_ "-n_"" T.' ..... ' n,,'-e~v 

96
Care Products, Inc. 

2625 Soulh 1581h Plaza • Omaha, NE 68130-1770 • relephone 402.938.7000 • Fax 402.938.7091 • www.sorgeants.com 

January 17,2011 

Richard Gebken, PMI 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: Child Resistant Packaging Certification 

Sergeant's Fipronil + Etofenprox Spot-On for Cats 

EPA File Symbol 2517-RUT 

Dear Mr. Gebken: 

I certify that the packaging used for the following product meets the standards of 40 CFR 157.32, 

including the revised standards in 16 CFR l700.15(b), when tested by the revised testing 

procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995): 

• Sergeant's Fipronil + Etofenprox Spot-On for Cats (EPA File Symbol 2517-RUT). 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158" Plaza, Suite 100, Omaha, NE 

68130-1703, EPA Company Number 2517) submitted a child resistant packaging study under 

MRID 48279601 to support the pending product registration for Sergeant's Fipronil + 

Etofenprox Spot-On for Cats. The submitted data comply with current CRP regulations to 

support a new product registration. We have enclosed a summary of the requested study to 

support this certification statement. 

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

Sincerely, 

;i!1~ Kelly R. Hoskins 

Manager of Technical Affairs 

Enclosure 

cc: Larry Nouvel 

97
CRP Certification Study Summary 

Sergeant's Pet Care Products, Inc. (Sergeant's) conducted a CRP study and submitted it to EPA 

for review and comment. The study was assigned MRID number 48279601. The study was 

conducted on a tltreeMpack of 0.5 mL white applicator tubes. The following information is 

provided to EPA to summarize the study results. 

Study Title: Amended Report: Evaluation of the Cat Squeeze On 0.5 mL "White Applicator 

with Purple Label Indicator (3x), scissors to open - F=l as a Poison Prevention 

Package for Sergeant's Pet Care Products, Inc. 

MRID: 4827960 I 

• Identify which package is associated with the CRP test data; 

The results from the CRP study regarding Sergeant's Cat Spot-On 0.5 mL applicator is being 

submitted to support the following pending EPA registration applications: 

EPA File Svmbol Product Name 

2517-RUT Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats 

2517-RUA Sergeant's Fipronil + Nylar Spot-On for Cats 

2517-RUL Sergeant's Fipronil + Etofenprox + Methoprene Spot-On for Cats 

2517-RUI Sergeant's Fipronil + Etofenprox Spot-On for Cats 

CRP data are required for the above-referenced pending registrations because of the inclusion of 

the active ingredient fipronil (9.8%) in the spot-on products. The submitted CRP testing for the 

cat product was conducted on a standard package size and color configuration containing 0.50 

mL fill volume for a product containing fipronil (9.8%). For children opening the applicators, 

opening of one applicator was considered an individual failure. 

The aboveMreferenced Sergeant's cat products can rely upon the same CRP data because they 

each contain fipronil at 9.8%, and consequently require CRP packaging. Although each product 

listed above also contains etofenprox, pyriproxyfen and s-methoprene, these active ingredients 

do not significantly add to the toxicity of the fonnulation. Additionally, Sergeant's or Pet Logic 

LLC (EPA Company Number 69332, owned by Sergeant's). already has cat spot-on products 

registered by EPA containing each of the listed active ingredients and none of them are subject to 

CRP. 

The fill size for each product is 0.5 mL just as the fill sire of the cat product tested in MRID 

48279601. 

"When each of the new cat products are marketed, they will have the same applicator color 

(white). same fill volume (0.5 mL), and same fill weight color as for the cat product used in the 

98
submitted and referenced CRP testing. Therefore, Sergeant's is relying on MRID 48279601 to 

address the CRP testing requirement. 

• A description of the package tested including a photograph of the packagej 

The test package was the cat spot~on 0.5 ml white applicator (base color) with a purple label 

indicator. Each applicator contains a single application and the applicators were tested in a three 

pack configuration. 

The following outlines the detailed specifics of the spot-on applicator: 

Material Specifications: I Opaque White PVClHigh Barrier HDLDPE with EVOH 240175 Yield 

I (nominal) 1665 sq, In/lb., 3670 sq. Infkg. 

Outer Layer: FDA grade opaque White PVC (Poly Vinyl Chloride), colour code 035, 

240 micron (0096") +/- 5%. 

Adhesive Layer: Novacote pre~polymer two component cross linked system ~ 1.5 lbs. per 

ream. 

Inner (SealantIBarrier) HDPE (High Density Polyethylene) ~ EVOH (Ethyl Vinyl AcetateiEthyl 

Layer-Non-Peelable: Vinyl Alcohol Copolymer) ~ LLDPE (Linear Low Density Polyethylene) 

LDPE (Low Dens'ity 'Polyethylene) blend, 75 micron (.003") +/~ 5%. 

~PVC complJes WIth FDA Code of Federal RegulatIOns, TItle 21, secttons 178.2010, 178.2650, 178.3297, 

178.3690, and 178.3790. 

~Adhesive complies with FDA Code of Federal Regulations, Title 21, section 175.105. 

opE complies with FDA Code of Federal Regulations, Title 21, section 177.1520. 

-EVOH layer complies with FDA Code of Feder a! Regulations, Title 21, sections 175.105 and 177.1360. 

A photograph of the package is shown below: 

99
• The directions on the package uscd for Senior Adult Use Effectiveness (SAUE) 

Testing along with any additional directions provided to the Seniors during SAUE 

Testing; 

Directions to open the package on the label used for SAUE Testing read: 

"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." 

• The SAUE, the number of females and males in each of the three age groups, the 

number of Seniors tested for each tester, and the number of Seniors obtained or 

tested at each test site (see checklist below for 16 CFR 1700.20 requirements); 

The Senior Adult Use Effectiveness (SAUE) was determined to be 90.0%. The number of female 

and male seniors participating in each of the three age groups (50-54, 55-59, 60-70 years) is 

provided in Table I below. Tables 2 and 3 represent a summary of the number of seniors tested 

with each tester (not to exceed a maximum of 35% of senior adults per tester) and the number of 

seniors tested at each test site (not to exceed a maximum of 24% of seniors per test site). Please 

see report for full details. 

Table I: Total number of male and female senior adults in each age group. 

I Age in Males Females Total Years 

50·54 7 18 25 

55·59 8 17 25 

60·70 15 35 50 

Totals 30 70 100 i 

This study component is in compliance with 16 CFR 1700.20. 

Table 2: Total number of senior adults tested for each tester. 

I Tester No. 

Code Seniors 

7 24 

15 29 

33 30 ! 

37 17 I 

Total 100 ! 

This study component is in compliance with 16 CFR 1700.20 as the number of seniors per tester 

never exceeded 35%. 

100
Table 3: Total number of senior adults obtained or tested at each test site. 

I 

No. 

Test site Seniors 

I H726 I 

, H902 24 

H904 II 

H961 10 

H967 20 

H969 24 

H975 I I 

H980 9 i 

Total 100 

This study component is in compliance with 16 CFR 1700.20 as the number of seniors tested at 

each site never exceeded 24%. 

• For the Child-Resistant Effectiveness (eRE) the CRE, the number of children 

tested, the number of females and males in each of the three age groups, the number 

of children tested for each tester, and the number of children obtained or tested at 

each test site (see checklist below for 16 CFR 1700.20 requirements); 

The Child-resistant effectiveness (CRE) was determined to be 100.0% effective. A total of 50 

children were tested for child-resistant effectiveness and the number of females and males in 

each of the three test groups (42-44, 45-48, 49-51 months) is shown in table 4. Tables 5 and 6 

represent a summary of the number of children tested with each tester (with a maximum of 30% 

of children in each group per tester) and the number of children tested at each test site, (with a 

maximum of 20% of children in each group per test site). Please see report for full details. 

Table 4: Total number of male and female children in each test group 

i

l Age in Males Females Total i Months 

i 

42-44 7 8 IS 

45-48 10 10 20 , 

49-51 8 7 IS , 

Totals 25 25 50 I 

This study component is in compliance with 16 CFR 1700.20 as the age of children for each 

group never exceeded 30%. 40%, or 30%, respectively. Additionally, the difference between 

boys and girls in each age range never exceeded 10% of the number of children in that age range. 

101
Table 5: Total number of children tested for each tester. 

I Tester No. 

Code Children 

I 12 

7 4 i 

I 15 14 , 

i 

I 33 14 

37 6 

Total 50 

This study component is in compliance with 16 CFR 1700.20 as the number of children per 

tester never exceeded 30%. 

Table 6: Number of children obtained or tested at each test site. 

! No. l Test Site Children 

HI69 2 , 

I HI82 8 

I H246 10 

I H260 4 

I H294 10 

H321 10 

H472 4 

H634 2 

Total 50 

This study component is in compliance with 16 CFR 1700.20 as the number of seniors tested at 

each site never exceeded 20%. 

• The number of children opening/accessing the contents in the first 5 minutes, the 

number of children opening/accessing the contents in the full 10 minutes; 

No children were successful in opening or gaining access to the contents of Sergeant's Cat 

SqueezewOn Product during the first 5 minutes or full 10 minutes of the CRE test. 

• If the package is considered unit packaging- (answer the next three bullets) 

Sergeant's cat Spot-On product is considered unit packaging. The CRP testing was conducted on 

a three-count (3) of 0.5 mL applicators in one unit. 

102
o Define the number of units that represent a child failure; 

The tox'wity of any cat product conta'1n'mg 9.3% flpronil is based on the toxicity of the active 

ingredient fipronil. The toxic or hannful amount of fipronil for an 11.4 kg child is 2.5 kg/kg 

times 11.4 kg, which equals 28.5 mg. Access to a toxic or hannful amount == 28.5 mg divided by 

[1025 mg/m! x 0.098 fiproni!J ~ 0.284 m! ~ 0.28 m! for Fipronil cat products. 

Access to one applicator represents a failure for a child for all applicator sizes equal to or greater 

than 0.28 m!. 

o State the number of units a child receives at the beginning of the test; 

Each child was provided one three-count (3) package of applicators at the beginning of the CRP 

test. 

o The number of children opening/accessing a toxic or harmful amount or 

opening or gaining access to more than 8 individual units, whichever number 

is lower during the fuUIO minutes oftesting. 

The CRP data resulted in zero (0) children being successful at opening or gaining access to the 

contents of the Sergeant's 0.5 mL applicator; therefore, the child-resistant effectiveness is 

100.0%. 

103
~, _D STATES ENVIRONMENTAL PR( C, .IN AGENCY 

WASHINGTON, D.C. 20460 

December 14, 2010 

OPP Decision Number: D-442431 

EPA File Symbol or Registration Number: 2517-RUT 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

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

EPA Application Receipt Date: 23-Nov-20 I 0 

EPA Waiver Request Receipt Date: 23-Nov-20 1 a 

EPA Company Number: 2517 

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

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Approval of 50% Small Business Waiver Request 

Dear Registrant: 

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

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

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

The Action has been identified as Action Code: R310 

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

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACy); 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman, at (703) 308-9362. 

Sincerely, 

Oscar Morales, Director 

Information Technology & Resources Management Division 

Office of Pesticide Programs 

104
Sergeant's Information to Address EPA Front-End Deficiencies 

James Messina 

to: 

Rachel Metz 

12/03/201011:33 AM 

Cc: 

KHoskins, "Carrie Daniels", "Matthew Feinberg" 

Show Details 

History: This message has been replied to. 

Ms. Metz, 

Page I of I 

In response to your email dated November 3D, 2010, please find enclosed the following information to upgrade 

the pending submissi90ns for 2517-RUI, 2517-RUT, 2S17-RUl and 2S17-RUA: 

1. Sergeant's has cited MRID 48122601 in the support data matrix for each of the pending products to 

address data requirement 830.1800 (Enforcement Analytical Method), The study is designed to identify 

the active ingredients fipronil, s-methoprene, etofenprox, cyphenothrin and pyriproxyfen in one 

analysis; therefore, Sergeant's can cite it to support each ofthe pending registrations as they contain 

various combinations of the listed active ingredients. 

2. Corrected page 32 for volume 14 ofthe submission under 2S17-RUl. 

3. Corrected Formulator's Exemption forms for 2S17-RUI and 2S17-RUT. We have listed all of the TGAI 

registrations and confirmed the typographical error. 

Please respond to this email to confirm your receipt of it. 

If you have any questions, please contact me. 

Best Regards, 

James Messina 

Senior Managing Regulatory Consultant 

Exponent 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

Washington, DC 20036 

202-772-4932 

202-772-4979 fax 

301-908-1181 cell 

CONFIDENTIALITY NOTICE: This electronic transmission (including any files attached hereto) may contain 

information that is privileged, confidential and protected from disclosure. The information is intended only for the 

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

reader of this message is not the intended recipient or any employee or agent responsible for delivering the 

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

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

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

by telephone. Thank you 

file:IIC:IDocuments and SettingslnnetzlLocal SettingsITemplnotesFCBCEEI-web5469.htm 12/3/20 I 0 

105
Re: Following up on our recent phone call 

KHoskins 

to: 

Rachel Metz 

12/03/2010 09:29 AM 

Cc: 

Aswathy Balan, Sree Nair, LNouvel, Inouvel, "Matthew Feinberg",jmessina 

Show Details 

Ms. Metz, 

Page 1 of3 

Thank you for the update, we did not discuss on Tuesday the 30th that we were on such a limited time frame. 

We will do our best to get them to you today by noon EST. 

Kelly R. Hoskins 

Manager of Regulatory Affairs 

Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza 

Omaha, NE 68130-1770 

ph 402-938-7079 

fx 402-938-7179 

khoskins@sergeants.com 

Metz.Rachel@epamail.epa.gov 

12/03/201007:17 AM 

Dear Mr. Hoskins: 

To KHoskins@SERGEANTS.com 

cc Nair.Sree@epamaiLepa.gov,Balan.Aswathy@epamail.epa.gov 

Subject Re: Following up 011 our recent phone call 

Unfortunately, with expedited processing I'm not able to hold on to your materials 

past noon (EST) today. If the corrections that we'd discussed are ready after that 

time they should be sent directly to the relevant PM. Thank you again for your 

cooperation. 

Sincerely, 

Rachel Metz 

Macfadden, EPA Contractor 

2777 8. Crystal Drive, 84910B 

Arlington, VA 22202 

Ph: 703~305-6177 

Fax: 703-305-5060 

From: KHoskins@SERGEANTS.com 

file:IIC:\Documents and Settinl!s\nnetz\Local Settings\ Temo\notesFCBCEE\-web3 828.htm 12/3/2010 

106
khoskins@sergeants.com 

Metz.Rache!@epamail.epa.gov 

11/30/2010 11:00 AM 

Dear Mr. Hoskins: 

To 

khoskins@sergeants.com 

cc 

Subject 

Following up on our 

recent phone call 

Page 3 of3 

I'm writing to follow up on our recent conversation regarding your submission in 

support of four products: 

Sergeant's Fipronil + Etofenprox Spot-On (2517-RUI) 

Sergeant's Fipronil + Eto£enprox + Nylar Spot-On (2517-RUT) 

Sergeant's Fipronil + Etofenprox + Methoprene Spot-On (2517-RUL) 

Sergeant's Fipronil + Nylar Spot-On (2517-RUA) 

We have found the following deficiencies; 

I} In the data matrix for all four submissions you cite another submission for the 

Enforcement Analytical Method guideline (830.1BOO). R310 End-use products must 

submit this (and all product chemistry data} for each proposed product. 

2) The 13th study/14th volume in the 2517-RUL submission has contradictory 

confidentiality markings. Page 32 of Comparative Efficacy Evaluation of Sergeant's 

Squeeze-On and Frontline Plus for Treatment of Adult Cat Flea and Tick Infestation 

on Cats is marked as confidential. Please either resubmit with the confidentiality 

marking removed from this page or "This statement supersedes all other markings" 

added to the statement of non-confidentiality on page two of the study (PDF or fax 

is 

fastest) . 

3} Two of the submissions have discrepancies between the Confidential Statement of 

Formula and Formulator's Exemption pages that need to be corrected. 

- Firpronil + Etofenprox's (2517-RUI) Formulator's Exemption Form lists the reg. 

numbers on the alternate formulation CSF for Fipronil but not the reg. number on 

the basic formulation CSF for this ingredient {in other words, assuming the basic 

formulation CSF is correct, needs to be added to the Formulator's 

Exemption} . 

- Firpronil + Etofenprox + Nylar's (2517-RUT) Formulator's Exemption has the same 

problem with Fipronil. In addition, it lists as the reg. number for 

Etofenprox whereas the CSF (both basic and alternate formulation) lists 

Thank you for your cooperation, and have a great day! 

Sincerely, 

Rachel Metz 

Macfadden, EPA Contractor 

2777 S. Crystal Drive, S4910B 

Arlington, VA 22202 

Ph: 703-305-6177 

Fax: 703-305-5060 

file:IIC:\Documents and Settings\rmetz\Local Settings\Temp\notesFCBCEE\-web3828.htm 12/3/2010 

107 *Product ingredient source information may be entitled to confidential treatment*
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

November 26, 2010 

SERGEANT'S PET CARE PRODUCTS, INC. 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

Report of Analysis for Compliance with PR Notice 86-5 

OFF!CEOF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of 19-NOV-IO. 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 (MRlDs) assigned to each docwnent 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. 

108
ur..!rrt:D STATES ENVIRONMENTAL PROT .... -, TlUN AGENCY 

WASHINGTON, D,C, 20460 

November 24, 2010 

OPP Decision Number: D-44243I 

EPA File Symbol or Registration Number: 2517-RUT 

OFFICE OF 

PREVENTION, PESTICIDES Ai'JD 

TOXIC SUBSTANCES 

Product Name: SERGEANTS FIPRONlL + ETOFENPROX + NYLAR SPOT-ON FOR CATS 

EPA Receipt Date: 19-Nov-2010 

EPA Company Number: 2517 

Company Name: SERGEANTS PET CARE PRODUCTS, INC.EPA File Symbol or 

Registration Number: 

KELLY R. HOSKINS 

SERGEANTS PET CARE PRODUCTS, INC .. 

2625 SOUTH I 58TH PLAZA 

OMAHA,NE 68130-1703 

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

Dear Registrant: 

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

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

results of the PRN-86-5 screen will be communicated separately. During the administrative 

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

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

The Action has been identified as Action Code: R31 0 

NEW PRODUCT;NON-F AST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); 

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

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

review time period will start on the date of approval. If your waiver request is denied, you will 

receive an invoice for the outstanding balance. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362, 

109
483020-00 

Sergeant's Pet Care Products, Inc. 

2625 South 1581h Plaza • Omaha, NE 68130·1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

November 18, 2010 

Richard Gebken, PMlO 

Office of Pesticide Programs (7504P) (REGFEE) 

u.s. Envirorunental Protection Agency 

Document Processing Desk 

Room S~4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats 

EPA File Symbol 25l7-NEW /" 

f':"f! 

Dear Mr. Gebken: 

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

EPA Company Number 2517) is submitting an EPA registration application for the new end-use 

product Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats [containing the EPA 

registered active ingredients Fipronil (9.8%), Etofenprox (15.0%), and Pyriproxyfen (Nylar) 

(2.2%)]. Please find enclosed the following documentation in support of this registration: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

(15) 

(16) 

(17) 

Transmittal Document; 

Application For Registration (EPA Fonn 8570-1); 

Basic Confidential Statement of Fonnula (EPA Fonn 8570-4) (Two Copies); 

Alternate #1 Confidential Statement ofFonnula (EPA Form 8570-4) (Two Copies); 

Formulator's Exemption Statement (EPA Fonn 8570-27); 

Certification With Respect to Citation of Data (EPA Form 8570-34); 

Data Matrix (EPA Fonn 8570-35) - EPA And Public Versions; 

Product Label (Five Copies); 

Letter of Authorization; 

Child Resistant Packaging (CRP) Certification Statement; : ' c ~ , ; 

Bridging Argument to Cite CRP Data; , 

Submission of EPA Pesticide Registration Improvement Act Inforillat!Qf:'; 

Voluntary Small Business Certification Form; , , : C' 

PRLA Fee Waiver Certification Statement; " , " 

, ", , 

, , , , G L' 

'" ' 

Recent EPA Approval Of50% Small Business Waiver Request (D-425455); ,.,' 

PRIA Category R31 0, Payment Confinnation Receipt; and 

Three Copies ofSuppomng Studies. 

The registration application for Sergeant's Fipronil + Etofenprox + Nylar Squeeze-On for Cats is 

a selective citation registration for a new end-use product. 'Sergeant's is submitting new product 

chemistry studies in support of this end-use product. Additionally, Sergeant's is citing acute 

toxicity studies, companion animal safety data and efficacy studies submitted to EPA on 

November 16, 2010 with the registration application for Sergeant's Fipronil + Etofenprox + 

Methoprene Spot-On for Cats (MRID Numbers have not been assigned yet). The acute toxicity 

110
Sergeant's Pet Care Products, Inc. 

2625 SoU1h 158th Plaza • Omaha, NE 68130-1770 • Te!ephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

and companion animal safety studies were conducted on a "soup" that contains multiple active 

ingredients that can be bridged across multiple fonnulated end~use products. 

This registration application is considered a PRIA Category R31 0 (new end-use product) with a 

PRIA review time of6 months. Sergeant's submitted a PRIA Small Business Waiver Request 

under separate cover on April 14, 2010, and it was approved by EPA on May 4,2010. A copy of 

this approval letter is enclosed. 

We look forward to working with the Agency to register Sergeant's Fipronil + Etofenprox + 

Nylar Spot-On for Cats. If you have any questions or need additional infonnation regarding this 

registration application, please contact me at 402~938~ 7079. 

SkJ;IIlLv lifo 

Kelly 

Manager 

R. Hoskins 

of Technical Affairs 

~ Enclosures 

,( (' 

" ( " 

, ,,( 

"< ( 

111
TRANSMITTAL DOCUMENT 

NAME AND ADDRESS OF SUBMITTER: 

Sergeant's Pet Care Products, Inc. 

2625 South 158'h Plaza 

Omaha, NE 68130-1770 

CONTACT PERSON (Return to) 

Kelly R. Hoskins 

Sergeant's Pet Care Products, Inc. 

2625 South 158'h Plaza 

Omaha, NE 68130-1770 

REGULATORY ACTION SUPPORTED BY THIS PACKAGE: 

This submission is to support the EPA registration application for the new end-use product 

Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats. 

SUBMITTAL DATE: 

November 16, 2010 

Volume Study Title 

I Administrative Materials 

2 Group A Product Chemistry for Sergeant's Fipronil + Etofenprox + 

Nylar Spot-On for Cats 

3 Group B Product Chemistry for Sergeant's Fipronil + 

Etofenprox + Nylar Spot-On for Cats 

MRIDNo. 

48302801 

• • ""', 48302802 . (' . 

. 

.. . 

112
Please read instructions on reverse beforlo np/eting form Form Appro\ OMS No 20700060 Approval expires 05 31 98 . . . 

United States c><:J.Registration OPP Identifier Number 

EPA Environmental Protection Agency D.Amendment 

Washington, DC 20460 o Other 

Application for Pesticide - Section I 

1. companf:~ct NRber.- 2. EPA Product Manager 3. Proposed Classification 

2517- Lt I Richard Gebken 

4. Company/Product (Name) 

Sergeant's Pet Care Products, Inc.! Sergeant's Fipronil + 

5.PM# 10 ~None DRestricted 

Etofenprox + Nylar Spot-On For Cats 

5. Name and Address of Applicant (/nclude ZIP 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 1581h Plaza 

Omaha, NE 68130-1770 EPA Reg. No. 

PlOduct Name 

D Check if this is a new address 

Section II 

o Amendment - Explain below. o Final printed labels in response to Agency letter dated XX-XX-XX 

o Resubmission in response to Agency letter dated XX-XX-XX o "Me Too" Application 

o Notification - Explain betow. ~ Other - Explain below. 

Explanation: Use additional page(s) If necessary. (For section I and Section 11.) 

Submission of a new end-use product registration application. 

Section III 

1. Materiat This Product Will Be Packaged In: 

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

[g] Yes' [g] Yes DYes DMetal 

DNo D No I3J No [2J Ptastic 

If "Yes" No. per If "Yes" No. per DGlaSS 

*Certification must Unit Packaging wgt. Container Package wgt. Container 

DPaper be submitted 0.Ot7 fl oz (O.5omli 3 vials 

I DOther (SpeClfy) Pla~tiC Bag 

3. location of Net Contents Information 4. Size(s) Retail Container 5. Location of label Direc,itA,s 

[2JLabel D Container 0.50 ml DOn Can 

IZJOn labe,;ng accomnanyiP2 product 

6. Manner in Which label is Affixed to Product DUthograph [gJOther - DPaper glued 

DStenClled 

Section IV 

1. Contact Point (Complete items directly below for identificalion ofindividuaJ to be contacted, if necessary, to process this app/icetion.) ._ 

Name Titte Telephone No. (1'1:;l'ideArea Code) 

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

Certification 6. Date Application 

I certify that the statements I have made on this form and att attachments thereto are true, accurate and complete. r Received 

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

under applicable law. 

2. Signature (etl2, 1-./rrfJ ~ 3. Title 

BY: Manager of Technical Affairs 

4. Typed Name: {/ I I 5. Date: 11/16/2010 

Kettv R Hoskins 

113
Pay.gov ~ Online Paymer .. 

Online Payment 

Step 3: Confirm Payment 

Thank you. 

Your transaction has been successfully completed. 

Pay.gov Tracking Information 

Application Name: PRIA Service Fees 

Pay.gov Tracking 10: 25101L54 

Agency Tracking 10: 74122351781 

Transaction Date and Time: 06/1812010 14:30 EDT 

Payment Summary 

Account Holder Sergean1's Pet Care Products, 

Name: Inc 

Payment Date: 06/21/2010 

Decision Number: 

Payment Amount: $2.289.00 Registration Number: 2517~new 

Page 1 of1 

11213 

Account Type: Business Checking 

Routing Number: 1

Account Number: ~""5483 

Company Name: Sergeant's Pet Care Produ 

Company Number: 2517 

Action Code: R310 

https:llwww.pay.gov/paygov/paymen1s/authorizeACHPayment.html 6/18/2010 

114 *Commercial/financial information may be entitled to confidential treatment*
From: SCraft@SERGEANTS.com [mailto:SCraft@SERGEANTS.com] 

Sent: Thursday, November 18, 201010:48 AM 

To: James Messina 

Subject: Fw: P~y.Gov Payment Confinnation 

Susan Craft 

Regulatory Affairs Specialist 

Sergeant's Pet Care Products, Inc. 

2625 S. 158th Plz. 

Omaha, NE 68130 

(402) 938-7021 

(402) 938-7121 (fax) 

-~-~- Forwarded by Susan Craft/SERGEANTS on II! 18/101 0 09:4g AM -----

pavgovadmin@mail.doc.rn'aLgov 

11/17/201001:37 PM 

To "scraft@sergeants.com" 

<scrafi@sergeants.com> 

cc 

Subject Pay.Goy Payment Confinnation 

THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY. 

Your transaction has been successfully completed. 

Transaction Summary 

Application Name: PRIA Service Fees 

Pay. gOY Tracking ID: 251 TL9QS 

Agency Tracking ID: 74152847197 

Name On Account: Sergeants Pet Care Products 

Transaction Type: ACH Debit 

Transaction Amount: $114.50 

Payment Date: Nov 18,2010 

Account Type: Business Checking 

Routing Number: 

Account Number: ************5483 

Transaction Date: Nov 17,20102:37:12 PM 

Number of Payments Scheduled: 1 

Frequency: OneTime 

Decision Number: 

Registration Number: 2517~New 

Company Name: Sergeants Pet Care Produc 

Company Number: 2517 

Action Code: R31 0 

115 *Commercial/financial information may be entitled to confidential treatment*
Form approved. OM6 No. 2070-0060, 2070-0057. 2070·0107, 2070-0122, 2070.01$4. 

Applicant's Name and Address 

Sergeant's Pet Care Products, Inc. 

South 1 58th Plaza 

IOmaha,NE 68130-1770 

United states 

Environmental Protection Agency 

Washington, DC 20460 

Formulators Exemption Statement 

(40 CFR 152.85) 

EPA File SymbollRegistration Number 

25 1 7-RUT 

Product Name 

Date of Confidential Statement of Formula (EPA Fonn 8570-4) 

(1) This product contains the following active Ingredient(s): 

Fipronil 

Etofenprox 

Pyriproxyfen 

11/1612010 

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufactlJrlng, 

formulation or repackaging another product which conlain; that active ingredient which is registered under FIFRA Sedion 3, is purchased by 

us from another person and meets the requirements of 40 CFR section 158.50(e)(2) or (3). 

(3) Indicate by checking (A) or (6) below which paragraph applies: 

'71 (Al An accurate Confidential statement of Formula (EPA FORM 8570-4) forthe above identified product is attached to this ~atement. 

That formula statement indicates, by company name, registration number, and product name, the source ofthe active ingredlenl(s) nsted in 

paragraph (1). 

OR 

I (6) The Confidential Statement of FormUla (CSF)(EPA Form 857Q-4) referenced above ,md on file with the EPA is complete, current, an 

accurate and contains the information required on the current CSF. 

(4) The following active ingredients in this product quanfy for the formulator's exemption. 

I FiF>ron.iI Technical 

IP""n"lI Technical 

I Etolfenprox 

Kelly R. Hoskins, Manager ofTeehnical 12103/2010 

Copy 2· Applicant copy 

116 *Product ingredient source information may be entitled to confidential treatment*
Form Approved OMS Nos. 2070-0060; 20 70 -0 0 57; 2 0 70-010 7; 2070-0122; 2070-0t64 

/"' ... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ,..no.. 

",lOlIIZ ' 1200 Pennsylvania Avenue, N.W . . ::7 

WASHINGTON, p.C. 20460 

Paperwork Reduction Act Notice: The pubtic reporting burden for this collection of information is estimated to average t.25 hours per response for registration 

and 0.25 hours per response for reregistration and special review activities. inetuding time for reading the instructions and completing the necessary forlns. Send 

comments regarding burden estimate or any oihcraspect of this eolleetioll ofinforJnation. including suggestions for reducing the burden to: Direetor, Cotlection 

Strategies Division (2822T), U.S. Environmental Protection Agency, t200 Pennsytvania Avenue, N.W., Washington, DC' 20460. Do not send til.: completed t"onn 

10 this address. 

Certifica1ion wi1h Respect to Citation of Data 

Applicant's/Re!Jistrant's Name. Address, and Telephone Number EPA Re!Jistration Number/File Symbol 

Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha, NE 68130-1770 2517-NEW 

Active Incredient(sl arld/or representative test compoundfs1 Date 

Fiproni~ Etofenprox and Pyriproxyfen t11l6l20to 

General Use Pattern(s) (list all those claimed for this product usin!! 40 CFR Part 158) Product Name 

Domestic indoor non-food Sergeant's Flpronil oj. Etofenprox + Ny1ar Spot-On for Cats 

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

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

0 I am responding 10 a Data-Call-In Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix fonn should 

be used for this purpose). 

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

0 I am using the cite-all method of support, and have included with this fonn 0 t am using the selective method of support {or cite-all option 

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

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

used). 

SECTION II: GENERAL OFFER TO PAY 

IRequired if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements) 

0 I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this applicallon, to the extent required by FIFRA. 

SECTION til: CERTIFICATION 

I certify that this application for registration. this form for reregistration, or this Data-Call-In response is supported by all data Submitted or cited in the 

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

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

subslanllally similar product, or one or more of the ingredients in this product; and (2) is a type of dala that would be required to be submitted under lhe data 

requirements in effect on the date of approval of this application if the application sought the inilial registration of a product of identical or Similar composition and 

uses. 

I certify that for each exclusive use study cHed in support of this registration or reregistration. that I am the original data submitter or that I have obtained 

the written permission of the original data submiller to cite that study. 

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

sub miller; (b) I have obtained the permiSsion of the original data submiller to use the study in support of this applicallon; (c) all periods of eligi~i::t; 'y 

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

offered (I) to pay compensation to the exlent required by sections 3(c)(1 )(F) and/or 3(c)(2)(S) of FIFRA; and (ii) to commence negoijations to c.eterm;,\e the 

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

(certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation a!,d eli,de, ,ce oflheir delivery in 

accordance with seclions 3(c)(1 )(F) and/or 3{c)(2){B) of FIFRA are available and will be submilled to the Agency upon reques\, Should I fail to p'C'd"f'e such 

evidence to the Agency upon request, I understand that the Agency may iniliate action to deny, cancel or suspend the regisvaU".J or my product in confonnity with 

FIFRA. 

I certify that the statements I have made on this form and all attachments to it are true, accurate, and cO,"!"!'l'etp. I acknowledge that any 

knowingly false or misleading statement may be punishable by fine or Imprisonment or both under applicable law. 

S;g""ore k:JJ1 Q,ll f ' rM_ Date Typed or Printed Name and l1Ue 

11/1612010 Kelly R. Hoskins, Manager of Tect:,':;,,1 Affairs 

EPA Form 8570-34 (~3) Electronic and ,",aper versi available. Submit only Paper version. 

117
R 310 

End Use (EP) or Manufacturing Use (MP) product or Technical Grade of the Active Ingredient (TGAI). 

Must submit Group A and B product chemistry data for each proposed product unless it's a 100% 

identical (repack): YES or NO (circle one) 

EP Data MP Data 

Guldeline Group A: Product Chemistry Data Submitted Submitted TGAI 

No. Study Title Yes No Yes No Yes No 

830.1550 Product Identity & Composition X 

Description of materials used to K 830.1600 I produce the product 

830.1650 Description of formulation orocess ;A I 

830.1670 Discussion on the formation of impurities x.. 

830.1700 Preliminary analysis X 

830.1750 Certified limits (158.3451 X. 

830.1800 Enforcement analytical method X 

EP Data MP Data 

Guideline Group B: Product Chemistry Data Study f-So;u",b",m"Titt"e"d'-t=:Su",b",m"Titt"e"d,-+-:-:TG,-,-,A:.-' r:--;--I 

No. 

118
Sergeant's Pet Care ProdlIC!S, Illc. 

;.'ti2:i ~;()11111 158111 filazi"l • Olnahn, NE 68130-1770 • TelellhOll1: 402.938 70UO • Fax 402.938 7099 • V,\Wv SI)I'Wflllls com 

1{ldlanl Cichl,cII 

I'I-u(iIll'1 ;VLlniJ)!.~:I·"'''' 

I)u:.:um<:ll( I'ro<.:es:-Ing. Desk 

() me\: (11'1'1.':-1 i ~'idc Pn )g.ra illS 

t!,S. En\'inllllllt'nial Pf(llcClion AgLIl~'.\' 

Roo!)) S-401l0, One r\llollla~' Yard 

2777 Slllllil Crysl:'11 Drin; 

Arlingloll, VA 22~U2-'-l5(jl 

SL'rgcanl's I'd ('nrc PI"(l(IUClS, Inc. (SL'rgcmll" s. 2625 So\nh 15R1h Pla~.o. Onlilha, Nehraska 

6~ 130-1770, EPA C~1lllpony N(1I11bcl" 2517), il\l!ilnrizes £xpoJlcnl. 1111.'. (115(J CUllllL'ClicUI 

A\"<.:'Il\I<:. NW, Soile 1100, W[lshinglon DC'. 20ll36) to act on o(lr bcbalC as our 

A 1I1ho rl~,cd RcprcSClll all vt::, Jill' illl necessary imertlctiollS regarding !If! of ollr pr()(h Icl 

reglslrali(lll upplic,ltillns (ind registrations. Plcnsl' notL' (his d()es nol ~'hange the currelll 

Jiled /\ll(lwrizcd AgCll1 n.II' Scrg~unl's. 

The E.'(pllllcnt. IllC. C~)jjl[l('l IS ilS fllllo\\'s: 

.1nlllcs Messina :lnd/(ll" Rick Tinsworlh 

Exp(lilent Inc. 

1150 ConnectlC\1I Ave .. N\V 

Suite 1100 

\\!'ushingtoll, DC 10()36 

(201) 772-4932 

(~02) n::-4()79 J~LX 

j IIIC~~ i 11;11:(( cx pOllenl.colll:rIIIIS\\' (lr(h(;-(·~'.\P( 11l~'IlI. <':11111 

Silll'Crch'. 

I~t:£? /1. ~-J£7~ tl 

l(l'lIy R. l'l()skill.<; 

tvlallag.cr ()rTcchniC'dl Alfilir.~ 

CI.:: Junh:s Ml'SSIII'1 

119
Sergeant's Pet Care Products, Inc. 

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

November 16,2010 

Richard Gebken, PMlO 

Office ofpesticide 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 

Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats 

EPA File Symbol 25 1 7-NEW 

Dear Mr. Gebken: 

I certify that the packaging used for the following product meets the standards of 40 CFR 157.32, 

including the revised standards in 16 CFR 1700.15(b), when tested by the revised testing 

procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995): 

• Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats (EPA File Syrnbo12517~ 

NEW) 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South l58'h Plaza, Omaha, NE 68130-1770, 

EPA Company Number 2517) is submitting this child resistant packaging certification to support 

for the new end~use product for Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats 

(EPA File Symbol 25l7-NEW). 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. 

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

sink~rJ~; 

Kelly R. Hoskins 

Manager ofTeclmical Affairs 

cc: Larry Nouvel 

120
Sergeant's Pet Care Products, Inc. 

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

November 16, 2010 

Rosalind Gross 

clo Richard Gebken 

Registration Division 

Office o[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 Support 

Sergeant's Fipronil + Etofenprox + Nylar Spot---On for Cats (EPA File Symbol: 

25 1 7-NEW) 

Dear Ms. Gross: 

Sergeant's Pet Care Products, Inc. (EPA Company Number 2517) is supporting the registration 

of Sergeant' s Fipronil + Etofenprox + Nylar Spot-On for Cats based upon a previously submitted 

Child Resistant Packaging (CRP) study. The previous CRP data was submitted to EPA on April 

12, 2010 in support of the pending registration applications under EPA File Symbols: 2517-RGT 

and 25l7-RGL (all of which contain Fipronil at 9.7-9.8%). 

The April 12, 2010 submission was Sergeant's generated CRP data with a standard white 

applicator in size 0.5 mL. The following is a summary table ofthe applicator that was tested and 

submitted to EPA in the CRP data: 

Use A licator Base Color Fill Wei ht mL Color 

Cats All Weiahts White 0.50 Pu Ie 

CRP data was required for the pending registrations under EPA File Symbols 2517 - RGT and 

2517 - RGL because of the inclusion of the active ingredient fipronil (9.8%) in the squeeze-on 

products. The CRP testing for the cat product was conducted on a standard package size and' 

color configuration containing 0.50 mL fill volume for a product containing fipronil (9.~%). For 

children opening the applicators, opening of one applicator was considered an individua: -fdaure. 

The Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats product beirJg submitte;I,tQQ"y 

also contains fipronil at 9.8%, and consequently requires CRP packaging. AlthougJ this new 

product also contains 15% etofenprox and 2.2% pyriproxyfen, these active il1£Tedients do )Jf)t 

significantly add to the toxicity ofthe fonnulation. Additionally, Pet Logic LL~ ~£PA Cor.lpany 

Number 69332), owned by Sergeant's, already has a cat spot-on product registered by E~t\. 

containing 55% Etofenprox and 2.2% Nylar (EPA Registration Number 69332-3) that is not 

1 

121
Sergeant's Pet Care Products, Inc. 

2625 South 158111 Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

subject to CRP. The fill size for this new product will be 0.5 mLjust as the fill size ofthe cat 

product from the April submission. TIle density of the new combination product is 1.03 - 1.07 

glcc, which is nearly identical to the density range for the previous cat products (1.00 - 1.05 glee). 

When Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats is marketed, it will have the 

same applicator color (white), same fill volume (0.5 mL), and same fill weight color as for the 

cat product used in the submitted and referenced CRP testing. Therefore, Sergeant's is relying on 

MRID specifically 48059503 for the cat 0.5 ml size, to fulfill the CRP data requirement for 

Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats. 

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

sine~R.#~ 

Kelly R. Hoskins W 

Manager of Technical Affairs 

cc: Larry Nouvel 

2 

122
Sergeant's Pet Care Products, Inc. 

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

November 18, 2010 

Richard Gebken, PMI0 

Office o[Pesticide Programs (7504P) (REGFEE) 

u.s. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject Submission of EPA Pesticide Registration Improvement Act Infonnation 

U.S. EPA FIFRA Service Fees: 

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

EPA Company Number 251 7), is submitting Pesticide Registration Improvement Act Fees for 

the following new registration application: 

• Sergeant's Fipronil + Etofenprox + Nylar Spot-On for Cats R31 0, $4,578 (50% fee 

waiver $2,289), Pay.gov Tracking ID: 25101L54, Agency Tracking ID: 74122351781. 

• To account for the FY 20 I IIFY 2012 R310 increase to $4,807 (50% fee waiver 

$2,403.5), $1 14.50 was also submitted; Pay.gov Tracking ID: 25ITL9QS, Agency 

Tracking ID: 74152847197. 

This registration application is for a new end-use product with supporting data and is considered an 

R310, new end-use product, requires review of data package within RD, PRIA review time frame 6 

months, and a fee of$4,807. Sergeant's qualifies for a PRIA fee waiver/reduction of 50% (refer to 

OPP Decision Number D-425455). 

If you have any questions or need additional infonnation regarding this registration application, 

please contact me at 402-938-7079. 

sin~R.k~! 

Kelly 

Manager 

R. Hoskins 

of Technical Affairs 

~ 

123
Voluntary Small Business Certification Form for 

Pesticide Registration Fee WaiverlReduction 

Section 1: Business Identification 

Company Name: Sergeant's Pet Care Products, Inc. 

Address: 2625 SOUtll 158m Plaza 

Omaha, NE 68130-1770 

EPA Company Number: 2517 

Contact Name: Kelly R. Hoskins 

Manager of Technical Affairs 

Phone Number: 402-938-7079 

Fax Number: 402-938-7091 

Email: KHoskins(a)SERGEANTS.com 

Section 2: EPA Pending Action Identification 

Product Name: Sergeant's Fipronil + Etofenprox + Nylar 

Spot-On for Cats 

Description of Action Submitted to EPA: New end-use product with product chemistry 

data 

EPA Identification 2517-NEW 

EPA Fee Category and Fee EP A PRIA fee category R31 0, 6 month 

review, $4,807 (50% fee waiver $2,403.50) 

Section 3: Small Business Information/Documentation 

Fee Waiver Support as a Small Business (as Yes, 50%. 

applicable): 

Is the Applicant a business entity with one or No. Refer to previously filed request ofDmore affiliates? 425455 (May 4, 2010) 

Business structure: include a chart or statement Refer to previously filed request ofDdescribing the applicant's business entity, its 425455 (May 4, 2010) 

relationships to parent/owner company(s) and/or 

affiliate company(s), and the percentage interest 

of each owner/affiliate. 

Including parent and affiliate(s), the applicant's ( ) $10 million/year (75% fee waiver) 

average annual global gross revenue from (x) $60 million/year (50% fee waiver) 

pesticides for the last 3 years was less than or 

equal to: 

Documentation: Include revenue statements for Refer to previously filed request ofDthe Applicant showing annual global gross 425455 (May 4, 20 I 0) 

revenue from pesticides for each ofthe three 

most recent completed fiscal or tax years. . 

Applicant's ( ) fiscal year (x) tax year ends on: September 30 

Applicant's Audited Financial Statements are January 31 

available on/about: 

Does the Applicant now employ 500 or fewer Yes 

employees? 

Documentation: include the most recent IRS 941 Refer to previously filed request ofDor W3 or other official documentation 425455 (May 4, 2010) ---

124
Form App,"ved OMII)'"o. 2070·0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

,~/ _.,.,' 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

PlIpenvork Reductioo Aet Notice: Th~ pub tic repunillg bunicil lor tJlis cn)lccli,lIl of infonnation is estiolatoo to average 0,25 hours perre~pollse lor n:gislnllillu ilctivitics and 0.25 hllUlS pn' ,,,.'pun~e lor 

reregistration and spe<.:iat review activities. including lilll~ fnr readillg the instruction and completing tJlC nccessary [onns, Send eommelllS regarding: llie hurtlell estilllal~ (II' :lIIy ollieI' a~p~'Ct orlhis cllliceliOIl or 

infonnation. including suggestions for reducing thc burd~n tn Director. QPflE Infomlation Mallagcnlcnt Division (2137) U.S, Environlllcntni Protectiull Agmcy, 40) M Str~~t. S.W,. Wa~hillghlll, DC 20460. Du 

not send the form to this addrc~s, 

DATA MATRIX 

Date: November 16, 20 I 0 EPA Re'No./FileS mhol 2517-l*E"WlZLl.T Pa'e) nf3 

Applieant'slRcgistnmf s Name & Ad<hss Product: Sergeant"s Fipronil';- Etofcnprox + 

Ser,geant's Pet Care Products, Inc. 2625 South 158th Pla;.:a, Olnaha, NE 68130-1770 Nylar Spot-On For Cats 

Ingredients: Fipronil, EtotcnprOIl, and Pyriproxyfen 

Guideline Reference Number Gliidclinc Study Name MRlD Number Submittcr Status Note 

830.1550, 830. I 600, lBO.1620. Product Propcrtics Data tor Sergeant's Fipronil + Etofenprox + New submission Sergeant's Pet Care ProdUl:ts, 11Il:. OWN 

830.1650,830.1670. 830.1750 Nylar Spot-On For Cats lte. '6u'"LwO\ 

830.1800 Enforeclncnt analyticallnethod 48122601 Scrgeant's Pet Care I'rodUl:ts, Inl:. OWN 

830.6302, 830.6303, 83fl.6304, Product chcmistry of Sergcant's Fipronil + Etotcnprox + Nylar New submission Sergeant's Pct Care Products, Inc, OWN 

830.63\3,830.6314,830.6315, Spo(-On For Cats 

830.6316, 830.6317, 830.6319, 

830.6320, 830.6321. 830.7000, '-I'03(t2k,0"4 

830.7100, 830,7300. 830.7520 

830.6317, 830.6320 Storagc stability and COITosioll dUiracteristil:S To be submitted Sergeant's Pet Care Products, Inl:, OWN 

UDon completion 

870.1100 Al:utl: Oral Toxicity Up and Dowil Prol:edure with Cat I'rndul:ts Submitted Sergeunt's Pd Care Products, Ilic. OWN 

MRlD Pl:nding 'rB3CZ!O:; 

870,1200 Al:utl: Dermal Toxil:ity (Limit Test) witll Cat Products Submitted Sergeant's I'd Care Produds. Inc. OWN 

up "1ol.t MRID Pelluin' ' ;,;"" .. t 

870.1300 Waivl:r Rl:quest of Requirclnl:nt for Further Testing for Acute Submitted Scrgeallt"s I'd Cllre ProtiUl:ts. Inl:. OWN .,<' 

Inhalation Toxkity MRlD Pending 

870.2400 Acute Eye IrritatinnlCorTllsilln with Cat Products Submitted Sergl:ant" s Pd Cnrc Produds, Inl:, OWN 

MRID 4'5'3007.10'::; Pending 

870.2500 Acute DennallrritationlCorrosinn with Cat Products Submitted Scrgl:ant"s Pet Care Produ(.:!s, InL OWN i+t)?v2tok> MRID Pending 

870.2600 Tcst for Sellsitization (Guinea Pig Mallimisation T(,:$t) with Cat Submitted Sergl:allt"s Pet Care Prnducts, Inl:, OWN 

!fe30?w( Products MRID Pending 

870.7200 COinpanion animal safety evaluatiOiI of a spot-on containing two Submitted Sergelmt" s Pct Care Products, Illc. OWN 49307tO'0 tuxkants and two inscct growth regulators on kittens and cats - M,{ID'?cnding 

870.7200 Companion animal satcty evaluatioll of a spot-on containing two - 3ubm;tted Sergeant's Pd Carl: Producl~, Ilic. OWN 

tnxil:ants and two insl:ct growth rcgulators on kittens and cats. 'M;~lD P~nding 4ft 

Executive Summw' of Data and Conclusions. 

870.7200 Companion Animal Satety Study tor an Etofenprox-IGR Spot-On 46161309 Pct Logk, L.L.c. OWN 

Kittens and Cats , ", ,._._. __ . 

r--:GI21 I 12"- 870.7200 Donlestil: Animal Satcty: Assessml:nt of the Tolerallcc',ofa 0.~:5% ': Merial Limited OLD 

RM 160 I Spray Formulation in Cats at 3, 9, alld 15 ml:kg'Wh'::l; 

Applied 6 Times tll tlleJiaircoat at 28 Day Intcrvals: 

S;g"""" k'o(J}, /f. r l t!. , 

t."" +-r Name and Title Date Kelly R. Hoskins, Malla,ger ofTl:chnil:al Atlllirs 11/1612010 

~I'A fonn S570.)5?/,lt EI"""ook >d I'al'''' 'f,"s'",,,Ayailabl •. Sulti' .m~' '7'!(;iOO' Ag''''1' h"o,"ol Use COP)' 

125
Furm '\1'1,,",,<1 IHIIl :"I». 2070·0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

-~- 401 M Street, S.W . 

• WASHINGTON, D.C. 20460 

Patlcrwork Red»etioll Act Notice: The puhlic reportillg burdCIi for tllis collcction of illl'onnatiOiI is estimated to average 0.25 hours per responxe t'or registl<llion activities nnd 0.25 Iiours pcr response tor 

reregistration allJ sllccial review activities, illcludillg time for n.'aJilig the in2eregistrationcolilpleting the necessary fonns, Send comments regaruing tho.'.' burdcll estimate or any other aspL'Ct or this collection 

ofinfonnation, iliciuJing suggesliolls lor reducing the bllruCIl to Director: OPPE Infomtation Managemcnt Division (2137) U.S. Ellvironmclltal Protcclion Agency, 40 I M Street, S. W., Washillgtoll, DC 

20460. Do not senJ the fOl1n to th'ls aJJn:ss, 

DATA MATRIX 

Date: Novembcr 16, 201 0 EPA Re' Nlj)File Symbol 25 I 7-DU:o-W" RUT l'a"e20f3 

Applicant's/Rcgi~trant's Name & Address Product: Scrgeant"~ Fiprnnil + Etofenprox + 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Nylar Spot-On Fnr ('at~ 

Ingredients: Fiprollil, Etofenprox, and Pyriprnxyfen 

Guideline Refcrence Numbcr Guidelinc Study Name MRID Number Submitter Status Note 

870.7200 Domcstic Animal Safety Study of RM 1601 C 0.25% Topical 43272401 Meriul Lim'llL'<I OLD 

Spray in Juvenile Cats 

870.7200 Domestic Animal Safety Study ofRM 160lC Topical Spray 

I (Frontline Sora Treatment) in Juvenile Cats 

43444904 Merial Limiled OLD 

870.7200 Discussion in Suppnrt of Bridging Domestic Animal Safety 43577711 Merial Limited OLD 

Data on Frontline Spray Treatmcnt to Frontline Spot Treatment 

Data Packa 'e, 

870.7200 Positive Rdcrenced and Untreated Controlled Dose 43577713 Merial Limited OLD 

Contirmation Trial ofRM 1601 E 10% SPOT-ON Fonnulation 

Applicd to Cal~ for Control nf the Cat Fica Ctenocephalides 

felis 

870.7200 Percutaneous Absorption and Distribution of Radioactivity in 43577716 Merial Limitcd OLD 

Hair, Skin, HIlII Fat Atler Spot-On Application of (Carbon 14)-

RMI601 inCms 

8103300 Immediate Efticacy ofa Combined Application of Frontline Submitted Sergeant's Pet Care Pruducts, Inc. OWN 

Plus with Etotenprox as a Squeeze-on againsf Fleas MRID Pending 4'6'"302.uO 

(Cteno~'epltafides/eH:r) and Ticks (Dermacewor l'an'abifi~~) on 

Cats. Study I D 185C 

810.3300 Immediate Efficacy of a Combincd Application of Frontline Submitted Sergeant's Pet Care Prodw.:ts, Inc. OWN 

PIU!; with Etofenprox as a Squeeze-on against Fleas MRJD Pending 

(CtenocephalideS/dis) and Ticks (Dermacentar mn'(fbili~~) on Itt) il 

Cats. Study 10 181C 

810.3300 CompHnltive ellicacy cvalwuinn nf Scrgeant' s Squeeze-on and Submitted Sergeant's Pet Care Frnduets, Inc, OWN 

Frnlltli ne Plus for the treatmellt of adult cat tlea MRJD Pending 

(Ctelll!cepftllfides/elis) and tick (Haemapfly,w/i:r effipHca, 

Rhiplcep/w/II.'; '(; 3c'7, 1';4 (ffl'{lllicIIS and Dermacentor lIoriabllis) 

infestations on cats. 

810.3300 Cnmparatlve elfleacy evaluation of Sergeant's Squeeze-on and Submitted Sergeant's Pet CW'e Prnd(lct~, Inc. OWN 

Frontline Plus for the treatment of adult cat flea MRJD Pending 

(Ctellocep!w/idcsjefis) and tick (Haem(/pltpafis e//iptica, 

RflipiCephaltls 4:rCO';oV I3 tllNmiclIs llfHI Demlr/celltar lIariabilis) 

infestations on cat~. EjCutive Summary of Dafa and 

C'nnclusions 

Signaturc: 1C/J),/ t. f '"" It. -/l 19JiH Name ami Title Date 

Kelly R. Hoskins, Mannger of Technical Affairs II mi120 10 r.PA ~" .,'0_" "_0," ~I M;" 0"_ P .• n" \/M~;"'" .,. ,.,bl,l~ ~ .. "'m' nO P_",,, '. ,n '\",'nM ",.,·,,,.1 'he Com' 

126
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W . 

. ~. WASHINGTON, D.C . • Tl ... ~ .. hJ:~ ."_~ .. ;,, .. ""-'''n forlhi, '" 

reregistration alKl "1JL>ciul review aCl;vilies, inchldi'ng lillie lor rCilding lll~ I 

of infonnalioll, indllding 5uggcsliOliS for reducing the bllrucn 10 Director 

20460. Do no! selld the fonn 10 (his address. 

11 is( ... ., '"vu,., !'~' '~0l'""oe for regi~!rmioll ac(ivi!ic~ lIlid 0.25 houriS per :c~~ons~_ ror 

y fOl1l1s. Send commcills regardillg die burden cslilllmc or ,IllY nUlL'!' aW~Cl 01 \III>; eOIlL"CIiOIl 

_ .. ,.., t37) U.S. Envirolimenl,1I Prolcclion Agency, 4t)] M Sln."CI, S. W .. Washillgton, DC 

DATA MATRIX 

Date: I 

s Pet Care I 

I 810.3300 

I 81 0.3300 

s Name & I.~~,~_ 

"":, Lnc. 2625 South 158th Pla;l-U, Omalm, NE 68130-1770 

;, and l'yriproxykl 

~?tudy Nalile. 

A Prciililinary Study to Evnluatc Illitiul and RC!\idual Efficacy of 

Two RM ](i])1 Spray Fonnulllliull Topieully Applied Jor Control 

uftllc Cat Flc;1 in tile CUI 

A Do'Se COllfirtll<ltion Study to Verify the Optim~l "mnv 

- -, -.r:l~~ Coneclltration of RM 16J1 IC for COlltrol of the Cll 

-/-;,I:S in the COl 

810.3300 Dose-Titratioll (Volume) of RM 160 I Spray for Co 

Cat Flea Ctenoee Imlides felis in the Cat: Revised 

ofthc 

810.3300 An Efficacy Study of Front Ii lie Top Spot for tile Tp 

Control ofFelieola subro'Stratus in the Cat 

I 810.3300 

I 8J 0,3300 

I 810.3300 

An Efficacy Study of Frontline Spray, Frontline Top ~ 

ML-2,095,988 50SQ Jor tile Treatment alld COlilrol ofFclieola 

subrostratus ill lile Cat 

:onHrm the Efficacy ofFipronil Against Lice in Cats I Und(;rField('--,J:·:~·-·· 

Studies to ASL');s the Eftieney of Fro lit line Spot-Oil (J 0% w/y 

Fipronil) in tile Treatmellt of Fc1ille Flea Allergy Dermatitis 

FAD) llilder Field COllditions 

EPA I}, .. c SYlllbol 

s Fiprollil + J 

.0, 

MRIDNulllber 

43121119 I Mcrial 

43121120 I Merial Lilllitcd 

43121121 I Merial Limited 

4562810J I Merial" 

45628J02 I Merial Limited 

45628103 I Merial Limited 

45628104 \ Merinl Limited 

810.3300 A Study to Determine the EJfeet of Treatment with Frontline 45628J05 Merial Limited 

T_"C'~'lt on the PreVlllellee and Severity of Flea Allergy 

"n Cuts 

+ 

I status 

OLD 

I OLD 

I OLD 

I PAY 

I PAY 

I PAY 

I PAY 

810.3300 t sPetCareProducts, IIIC, \ OWN 

I 810.3300 s Pet Care I ",1m;, I OWN 

. . the Duratioll {If Residuul t-tea UVlstentllzmlOl1. 

Pnge30f3 

1 40 CFR Part 157.32 jEValUmion oftll~ Cnt Squeeze .On 0.5ml Wllite Apprleato~ witll 48059503 Sergeant's Pet Care Producls, Ilic. OWN [Y\C.Q,d i"V 

Purple Lubel I ndlcutor (3x), selSS(lrs to orell - F=I as a POison IJ, Y\ {)(.qnyd'.a\€. C ',L 

-,t-""e f{li" Scrgc,lllt''S Pet Care ProcLu.(;t.s, Inc." t1'&17'7b oj J 

.L ~: Name and Title Dule 

Kell R. Hoskins, M<IIla 'cr of Teclillical Amlir" I I il6i2Jl I 0 EPA f"nn 85 ,\"~.,,'). 1",,,,",,,,1\:," Cup)" 

127
Pages 128-129 - *Confidential Statements of Formula may be entitled to confidential treatment*