REGISTRATION

2517-141

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2
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OffiCE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

April 6, 2011

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South 158" Plaza

Omaha, NE 68130

Subject: CSF Notification(s) for Pesticide Registration Notice 98-10

Dear: Kelly Hoskins:

The Agency is in receipt of your Application for Pesticide Notification under Pesticide

Registration Notice (PRN) 98-10 dated March 24, 2011 for the following product(s).

Sergeant's Fipronil +Nylar Squeeze-On for Dogs (EPA Reg. No. 2517-141)

The Registration Division (RD) has conducted a review ofthis request for its applicability under

PRN 98-10 and finds that the action(s) requested fall within the scope ofPRN 98-10. The Confidential

Statement of Formula (CSF) andlor label submitted with the application has (have) been stamped

''Notification'' and will be placed in'our records.

If you have any questions, please contact Regina Foushee'-Smith at 703-605-0780.

Sincerely""

~t/. /,. Ai C'j{ce~~/ L(lc2,:Aj~ Richard Oebken

Product Manager

Insecticide Branch

Registration Division

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OffiCE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

April 6, 2011

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South 158" Plaza

Omaha, NE 68130

Subject: CSF Notification(s) for Pesticide Registration Notice 98-10

Dear: Kelly Hoskins:

The Agency is in receipt of your Application for Pesticide Notification under Pesticide

Registration Notice (PRN) 98-10 dated March 24, 2011 for the following product(s).

Sergeant's Fipronil +Nylar Squeeze-On for Dogs (EPA Reg. No. 2517-141)

The Registration Division (RD) has conducted a review ofthis request for its applicability under

PRN 98-10 and finds that the action(s) requested fall within the scope ofPRN 98-10. The Confidential

Statement of Formula (CSF) andlor label submitted with the application has (have) been stamped

''Notification'' and will be placed in'our records.

If you have any questions, please contact Regina Foushee'-Smith at 703-605-0780.

Sincerely""

~t/. /,. Ai C'j{ce~~/ L(lc2,:Aj~ Richard Oebken

Product Manager

Insecticide Branch

Registration Division

3
o~

4

* Claimed confidential by submitter*
Sergeant's Pet Care Products, Inc.

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

March 24, 2011

Richard Gebken, PMI 0

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Document Processing Desk (NOTIF)

Room S-4900, One Potomac Yard

2777 South Crystal Dtive

Arlington, VA 22202

Subject: Notification Submission per PR Notice 98-10 to Add an Alternate #2 CSF for

Sergeant's Fipronil +Nylar Squeeze-On for Dogs (EPA Registration Number

2517-141)

Dear Mr. Gebken:

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

1770, EPA Company Number 2517) is submitting a notification pursuant to PR Notice 98-10

to add an alternate formulation #2 and new Formulator's Exemption Statement to support the

registration of Sergeant's Fipronil +Nylar Squeeze-On for Dogs (EPA Registration Number

2517-141). Please find enclosed the following documentation in support ofthis registration:

• Cover letter (this document);

• Application for Registration (EPA Form 8570-1);

• Copy of Current EPA Approved Confidential Statement of Formulas (Basic and

Alternate #1);

• Copy ofthe new proposed Alternate #2 CSF Formulation (two copies); and

• Updated Formulator's Exemption Statement (EPA Form 8570-27).

does not change the toxicological category or chemical properties ofthe

product. Further, this notification does not require any change to the current EPA approved

label language.

This notification is consistent with the provisions ofthe PR Notice 98-10 and EPA

regulations at 40 CFR 152.46, and no other changes have been made to the labeling or the

confidential statement offonnula ofthis product. I understand that it is a violation of 18

U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if

this notification is not consistent with the terms ofPR Notice 98-10 and 40 CFR 152.46, this

product may be in violation of FIFRA and I may be subject to enforcement action and

penalties under sections 12 and 14 ofFIFRA.

Sergeant's Pet Care Products, Inc.

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

March 24, 2011

Richard Gebken, PMIO

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Document Processing Desk (NOTIF)

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Notification Submission per PR Notice 98-10 to Add an Alternate #2 CSF for

Sergeant's Fipronil +Nylar Squeeze-On for Dogs (EPA Registration Number

2517-141)

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 a notification pursuant to PR Notice 98-10

to add an alternate formulation #2 and new Formulator's Exemption Statement to support the

registration of Sergeant's Fipronil +Nylar Squeeze-On for Dogs (EPA Registration Number

2517-141). Please find enclosed the following documentation in support ofthis registration:

• Cover letter (this document);

• Application for Registration (EPA Form 8570-1);

• Copy of Current EPA Approved Confidential Statement of Formulas (Basic and

Alternate #1);

• Copy ofthe new proposed Alternate #2 CSF Formulation (two copies); and

• Updated Formulator's Exemption Statement (EPA Form 8570-27).

does not change the toxicological category or chemical properties ofthe

product. Further, this notification does not require any change to the current EPA approved

label language.

This notification is consistent with the provisions ofthe PR Notice 98-10 and EPA

regulations at 40 CFR 152.46, and no other changes have been made to the labeling or the

confidential statement offormula ofthis product. I understand that it is a violation of 18

U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if

this notification is not consistent with the terms of PR Notice 98-10 and 40 CFR 152.46, this

product may be in violation of FIFRA and I may be subject to enforcement action and

penalties under sections 12 and 14 ofFIFRA.

5

* Claimed confidential by submitter*
sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 4D2.938.7091 • www.sergean1s.com

Please note infonnation found in this letter and enclosures is considered CONFIDENTIAL

BUSINESS INFORMATION and must not be released to any party outside ofEPA.

If you have any questions regarding this submission, please contact me at 402-938-7079.

Sincerely,

~,Manager ofRegulatory Affairs

Sergeant's Pet Care Products, Inc.

Enclosures

cc: Rosanna Louie-Juzwiak, EPA

sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergean1s.com

Please note infonnation found in this letter and enclosures is considered CONFIDENTIAL

BUSINESS INFORMA TION and must not be released to any party outside ofEPA.

If you have any questions regarding this submission, please contact me at 402-938-7079.

Sincerely,

~,Manager ofRegulatory Affairs

Sergeant's Pet Care Products, Inc.

Enclosures

cc: Rosanna Louie-Juzwiak, EPA

6
b , I ti fi AF d OMB N 2070 0060 A 0531 98

" Plea<:e read' " rns ruc ons on reverse e ore comp e ng orm. "m pprove o. - pprova expires - -

Uniled Stales D Registration OPP Idenlifier Number

EPA Environmental Protection Agency o Amendment

Washinglon, DC 20460 r;;:g Other

Application for Pesticide - Section I

,. Company/Produc1 Number 2. EPA Produc1 Manager 3. Proposed Classificalion

2517-141 Richard Gebk.en

4. Company/Produc1 (Name) PM# 10 ~None DReslric1ed Sergeanl's Pel Care Producls. Inc. I Sergeanl's Fipronil + Nylar SqueezeOn For DOQS

5. Name and Address of Applicanl (Include liP Code) 6. Expedited Review. In accordance with FIFRA Sec1ion 3{C)(3)(b)(1), my

Sergeant's Pet Care Products, Inc. produc1 is similar or idenlical in composilion and labeling 10:

2625 South 15S1h Plaza NOTIFICATION

Omaha, NE 68130-1770 EPA Reg. No.

Product Name APK ti LUi

D Check ifIhis is a new address

Section II

o Amendment - Explain below. o Final prinled labels in response 10 Agency letter daled XX-XX-XX

o Resubmission in response 10 Agency letter daled XX-XX·XX o "Me Too" Applicalion

Notification - Explain below. D Olher - Explain below.

Explanalion: Use addilional page(s) if necessary. (For section I and Section 11.)

Submission of Alternate #2 Confidential Statement of Formula and a Formulator's Exemption

as a Notification Pursuant to PR Notice 98·10.

Section III

1. Malerial This Product Will Be Packaoed In:

Child-Resistanl Packaging Unil Packaging Waler Soluble Packaging 2. Type of Conlainer

l'Zl Yes· c><J y" DYes DMelal

ONo o No c><J No l'Zl Plaslic

If "Yes" No. per If "Yes" No. per DGlaSS

*Certification must Unil Packaging wgl. Container Package wgl. Conlainer

DPaper be submitted 0.023 fl 02 (0.67 ml)

0.045 fl 02 (J.34 mil 3 vials I DOlher (SpeCify) Plaslic Bag

0.091 fl 02 (2.68 ml)

0.136 fl 02 (4.02 ml)

3. Localion ofNel Conlenls Information 4, Size(s) Relail Container 5. Localion of Label Directions

k:S]Label D Conlainer 0.017 fl 02 (0.50ml) Don Label

[2JOn Labeling accompanying producl

6. Manner in Which Label is Affixed 10 Product DLithograPh l'Zlolher

DPaper glued

DSlenciled

Section IV

,. Conlac1 Poinl (Complete rlems directlv below for identification ofirtdividual to be conlacled, ifnecessary. 10 process fhis applicalion.)

Name Tille Telephone No. (Include Area Code)

Kelly R. Hosk.ins Manager of Regulalory Affairs 402938·7079

Certification 6 Date Application

I certify Ihallhe slalemenls I have made on this form and all allachmenls thereto are lrue, accurale and complele. I Received

acknowledge Ihal any knowingly false or misleading slatement may be punishable by fine or imprisonmenl or bolh (Stamped)

under applicable law.

~yS;90al"" )(Ii /Uk 3. Tille

Manager of Regulalory Affairs

4, Typed Name: f Kelly R. Hdskins 5. Dale: 0312412011

b , I ti fi AF d OMB N 2070 0060 A 0531 98

" Plea<:e read' " rns ruc ons on reverse e ore comp e ng orm. "m pprove o. - pprova expires - -

Uniled Stales D Registration OPP Idenlifier Number

EPA Environmental Protection Agency o Amendment

Washinglon, DC 20460 r;;:g Other

Application for Pesticide - Section I

,. Company/Produc1 Number 2. EPA Produc1 Manager 3. Proposed Classificalion

2517-141 Richard Gebk.en

4. Company/Produc1 (Name) PM# 10 ~None DReslric1ed Sergeanl's Pel Care Producls. Inc. I Sergeanl's Fipronil + Nylar SqueezeOn For DOQS

5. Name and Address of Applicanl (Include liP Code) 6. Expedited Review. In accordance with FIFRA Sec1ion 3{C)(3)(b)(1), my

Sergeant's Pet Care Products, Inc. produc1 is similar or idenlical in composilion and labeling 10:

2625 South 15S1h Plaza NOTIFICATION

Omaha, NE 68130-1770 EPA Reg. No.

Product Name APK ti LUi

D Check ifIhis is a new address

Section II

o Amendment - Explain below. o Final prinled labels in response 10 Agency letter daled XX-XX-XX

o Resubmission in response 10 Agency letter daled XX-XX·XX o "Me Too" Applicalion

Notification - Explain below. D Olher - Explain below.

Explanalion: Use addilional page(s) if necessary. (For section I and Section 11.)

Submission of Alternate #2 Confidential Statement of Formula and a Formulator's Exemption

as a Notification Pursuant to PR Notice 98·10.

Section III

1. Malerial This Product Will Be Packaoed In:

Child-Resistanl Packaging Unil Packaging Waler Soluble Packaging 2. Type of Conlainer

l'Zl Yes· c><J y" DYes DMelal

ONo o No c><J No l'Zl Plaslic

If "Yes" No. per If "Yes" No. per DGlaSS

*Certification must Unil Packaging wgl. Container Package wgl. Conlainer

DPaper be submitted 0.023 fl 02 (0.67 ml)

0.045 fl 02 (J.34 mil 3 vials I DOlher (SpeCify) Plaslic Bag

0.091 fl 02 (2.68 ml)

0.136 fl 02 (4.02 ml)

3. Localion ofNel Conlenls Information 4, Size(s) Relail Container 5. Localion of Label Directions

k:S]Label D Conlainer 0.017 fl 02 (0.50ml) Don Label

[2JOn Labeling accompanying producl

6. Manner in Which Label is Affixed 10 Product DLithograPh l'Zlolher

DPaper glued

DSlenciled

Section IV

,. Conlac1 Poinl (Complete rlems directlv below for identification ofirtdividual to be conlacled, ifnecessary. 10 process fhis applicalion.)

Name Tille Telephone No. (Include Area Code)

Kelly R. Hosk.ins Manager of Regulalory Affairs 402938·7079

Certification 6 Date Application

I certify Ihallhe slalemenls I have made on this form and all allachmenls thereto are lrue, accurale and complele. I Received

acknowledge Ihal any knowingly false or misleading slatement may be punishable by fine or imprisonmenl or bolh (Stamped)

under applicable law.

~yS;90al"" )(Ii /Uk 3. Tille

Manager of Regulalory Affairs

4, Typed Name: f Kelly R. Hdskins 5. Dale: 0312412011

7 * Claimed confidential by submitter*
Pages 8-11 - *Confidential Statement of Formula may be entitled to confidential treatment*
Form approved. OMS No. 2070-0060, 2070-0057, 2070-0t07, 2070-0t22, 2070-0164.

a EPA

United States

Environmental Protection Agency

Washington, DC 20460

Formulator's Exemption Statement

(40 CFR 152.85)

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

Sergeant's Pet Care Products, Inc. 2517-141

2625 South 158th Plaza Product Name

Omaha, NE 68130 Sergeant's Fipronil + Nylar Squeeze-0n for Dogs

Date of Conlidential Statement of Formula (EPA Form 8570-4)

03/24/2011

As an authorized representative of the applicant for registration of the product identified above, I certify that:

(1) This product contains the tollowing active ingredient(s):

Fipronil (9.8%)

Pyriproxyfen (2.0%)

(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 manufacturirrg,

formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by

us from another person and meets the requirements of 40 CFR section 158.50(e)(2) or (3).

(3) Indicate by checking (A) or (6) below which paragraph applies:

71 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified prodUct is allached to this statement,

That formula statement indicates. by company name, registration number. and product name, the source of the active irrgredient(s) listed in

paragraph (1),

OR

"I (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) referenced above and on file with t~1e Er;A "s comple,&: cUI,'en!, an

accurate and contains the information required on the current CSF,

(4) The following active ingredients in this product qualify for the formulator's exemption.

Source

Active Ingredient Product Name Registratior I~UmUl;:r

Fipronil

Fipronil

Fipronil

Pyriproxyfen

S19'::V r! II/'Ii Name and Title Date

Kelly R. Hoskins, Manager " 03/24/2011

EPA Form 857 • .,. ,.., '. n n ,.., -_ ... nn.

py pp py

Form approved. OMS No. 2070-0060, 2070-0057, 2070-0t07, 2070-0t22, 2070-0164.

pppy py

a EPA

United States

Environmental Protection Agency

Washington, DC 20460

Formulator's Exemption Statement

(40 CFR 152.85)

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

Sergeant's Pet Care Products, Inc. 2517-141

2625 South 158th Plaza Product Name

Omaha, NE 68130 Sergeant's Fipronil + Nylar Squeeze-0n for Dogs

Date of Conlidential Statement of Formula (EPA Form 8570-4)

03/24/2011

As an authorized representative of the applicant for registration of the product identified above, I certify that:

(1) This product contains the tollowing active ingredient(s):

Fipronil (9.8%)

Pyriproxyfen (2.0%)

(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 manufacturirrg,

formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by

us from another person and meets the requirements of 40 CFR section 158.50(e)(2) or (3).

(3) Indicate by checking (A) or (6) below which paragraph applies:

71 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified prodUct is allached to this statement,

That formula statement indicates. by company name, registration number. and product name, the source of the active irrgredient(s) listed in

paragraph (1),

OR

, (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) referenced above and on file with t~1e Er;A "s comple,&: cUI,'en!, an

accurate and contains the information required on the current CSF,

(4) The following active ingredients in this product qualify for the formulator's exemption.

Source

Active Ingredient Product Name Registratior I~UmUl;:r

Fipronil

Fipronil

Fipronil

Pyriproxyfen

Sl9'gj,/ II/'Ii Name and Title Date

Kelly R. Hoskins, Manager " 03/24/2011

EPA Form 8579 7 {R"'.O'l"" Copy t EPA

C, 2 -A licant co

12 *Product ingredient source information may be entitled to confidential treatment*
U.S. ENVIRONMENTAL PROTECTION

AGENCY

Office ofPesticide Programs

Rcgistrll1ion Division (7504P)

1200 Pennsylvania Ave., N.W.

Washing)on, D.C. 20460

EPA Registration No.

2517-141

Date of Issuance:

MAR 2 3 2011

NOTICE OF PESTICIDE,

0' Registration

D Reregistration

(under the Federal Insecticide, Fungicide,

and Rodenticide Act, as amended)

Name and Address of Registrant (include ZIP Code):

Sergeant's Pet Care Products, Inc.

c/o Exponent, Inc.

2625 South 15Sth Plaza

Omaha, NE 68130

Term of Issuance:

Conditional Registration

Time-limited: see conditions below

Name ofPesticide ProdUCl:

Sergeant's Fipronil + Nylar Squeeze-on

for Dogs

Not" do

to 'he ,hove

"V",'v

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

Federal Insecticide, Fungicide and Rodenticide Act.

Registration is in no way to be construed as an endorsement or recommendation ofthis 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 ofthe

name or to its use if it has been covered by others.

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

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

for shipment.

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

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

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

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

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

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

3. As a condition ofregistration for this product, within one year from t~e date ofthis registration,

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

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

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

Page 1 of5

U.S. ENVIRONMENTAL PROTECTION

AGENCY

Office ofPesticide Programs

Rcgistrll1ion Division (7504P)

1200 Pennsylvania Ave., N. W.

Washing)on, D.C. 20460

EPA Registration No.

2517-141

Date ofIssuance:

MAR 2 3 2011

NOTICE OF PESTICIDE:

0' Registration

D Reregistration

(under the Federal Insecticide, Fungicide,

and Rodenticide Act, as amended)

Name and Address ofRegistrant (include ZIP Code):

Sergeant's Pet Care Products, Inc.

c/o Exponent, Inc.

2625 South 15Sth Plaza

Omaha, NE 68130

Term ofIssuance:

Conditional Registration

Time-limited: see conditions below

Name ofPesticide ProdUCl:

Sergeant's Fipronil + Nylar Squeeze-on

for Dogs

N~~~:qh#ii~~@i~~liBg•.·~i#~F#gi#~~~~~~~ft4~.th~t@~~Jl~#i#2(j~~~fiq~0iWWi§r~gi§~@(jB$1~st~§4~iriiH~#.f(j§~ •••• )i iiacc¢ptcd:byth¢l~.¢gistrati()ilPi'{isi()iipriort()l.i~c()fthcliJ.lJ¢liIic()i11iri¢rcc,In·.ilriJ¢()rr¢spoildC1l¢e()ri.this ••prOdlll:taIWays•.iefer.:.·.i...."'. i.~~I~A~~ye?g~·!fgi#§~i8ilitiWj1i§¢~.··.i.i:i.·....········ ,··.·.·••·.·.·.·/i'.·.·.·.·.·.·.·i/i·..·ii·.:iii· ·.i ii ·..··.. i'..·.·• i.'.""""'·"""""'" '.

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

Federal Insecticide, Fungicide and Rodenticide Act.

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

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

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

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

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

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

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

for shipment.

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

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

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

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

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

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

3. As a condition ofregistration for this product, within one year from t~e date ofthis registration,

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

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

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

Page 1 of5

13
4. Within one year ofthe date on this Notice ofRegistration, and prior to formulating this product,

you must provide the Agency the following:

a. The registration number and establishment number ofthe manufacturing or technical

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

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

obtained; and

c. A copy ofthe bill ofsale for this manufacturing product(s).

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

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

delivery, used to support the data required for this product

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

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

two months after each quarter ends.

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

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

Registration Division (7504P), to the Product Manager's attention.

The following is a list ofinfonnation 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 ofExposure: dermal, oral, other animal, inhalation, other

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

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

Time to Onset (hours, days)

Treated by veterinarian: yes or no

First time product used: yes or no

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

Page 2 of 5

4. Within one year ofthe date on this Notice ofRegistration, and prior to formulating this product,

you must provide the Agency the following:

a. The registration number and establishment number ofthe manufacturing or technical

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

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

obtained; and

c. A copy ofthe bill ofsale for this manufacturing product(s).

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

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

delivery, used to support the data required for this product

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

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

two months after each quarter ends.

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

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

Registration Division (7504P), to the Product Manager's attention.

The following is a list ofinfonnation 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 ofExposure: dermal, oral, other animal, inhalation, other

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

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

Time to Onset (hours, days)

Treated by veterinarian: yes or no

First time product used: yes or no

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

Page 2 of 5

14
7. Along with the enhanced incident reporting, you must submit an analysis ofthe incidents seen, to

include the following details:

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

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

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

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

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

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

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

incidents of each severity code for each route ofexposure.

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

due to secondary exposure (e.g., nU1lti~pet households).

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

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

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

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

weight range on the product label.

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

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

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

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

product weight range.

Table showing number of incidents for each dog breed.

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

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

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

8. You must submit and/or cite all data reql1ired for registration of your product under FIFRA

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

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

All labeling comments below are in reference to the proposed master label, dated March 10. 20 II. These

comments apply to all submitted draft labeling, including the master labeL the color mock~up labels. and

the proposed text and graphics for the stickers and magnet:

9. Thr011ghout the entire label, per the Acute Toxicity and Companion Animal Safety review,

change "up to 22 Ibs" to "4 to 22 lbs" to include the lowest weight range.

1O. On page 1 under the header Fleas, revise the following claims to add the underlined words, or

Page 3 of5

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

include the following details:

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

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

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

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

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

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

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

incidents of each severity code for each route ofexposure.

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

due to secondary exposure (e.g., nU1lti~pet households).

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

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

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

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

weight range on the product label.

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

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

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

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

product weight range.

Table showing number of incidents for each dog breed.

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

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

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

8. You must submit and/or cite all data reql1ired for registration of your product under FIFRA

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

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

All labeling comments below are in reference to the proposed master label, dated March 10. 20 II. These

comments apply to all submitted draft labeling, including the master labeL the color mock~up labels. and

the proposed text and graphics for the stickers and magnet:

9. Thr011ghout the entire label, per the Acute Toxicity and Companion Animal Safety review,

change "up to 22 Ibs" to "4 to 22 lbs" to include the lowest weight range.

1O. On page 1 under the header Fleas, revise the following claims to add the underlined words, or

Page 3 of5

15
delete struck-out words (because the submitted data do not support these claims), as follows:

"[ResearcH E!efl'l0nstrates that [branE! name] kills adult fleas, flea eggs, and flea larvae anE!

prevents pupae for more up to three fl'lonths.]"

"[Prevents all flea stages, flea eggs, flea pupae, and flea larvae.]"

"[Kills flea eggs [larvae] preYents [pupae] for more than [63 days] [9 weeks]]"

''[Kills Flea for Up to [4 weeks!] [2 months] [3 months]]"

II. On pages I and 2 under Multiple Infestations, revise the following claims to add the underlined

words, or delete struck-out words, as follows:

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

''[Kills Flea Eggs & Flea Larvae for up to more tHan [63 days], [9 weeks]!]"

"[Kills all stages ofthe flea life cycle]"

"[Prevents and controls reinfestations of listed pests for up to [I month] [4 weeks]]"

I2. On pages 2 and 3 under All Others, revise the following claims to add the underlined words, or

delete struck-out words, as follows:

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

"[[Free] BrochHre Inside!]"

"[[Free] Brochure anE! Calendar Stickers Inside]"

"[Pre,,'ents and controls reinfestations of listed pests]"

"[[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [e+if:l] [eaffi]]"

13. On page 3, delete the statement "[Ingredient Statement may be on front or back label]" because

the ingredient statement must be placed on the Front Panel.

14. On page 3 in the Ingredients Statement, all Inert ingredients must be identified when electing to

list the inert ingredients.

15. On page 5 in the How to Apply section, correct the reapplication interval from "4 weeks" to "30

days" to be consistent with the interval stated under Frequency of Application.

16. On pages 5 and 6 under the Frequency of Application, add the underlined words and delete the

struck-out text in the following statement:

"[Studies show that] [branE! name] kills fleas (in as little as 1 hour) for up to three months]."

"[Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, then

within 48 hours for up to 28 days]."

17. On page 6 under the Storage and Disposal statement, replace "Container Handling" with

"Container Disposal."

18. On page 6 in the Warranty statement, remove the brackets within the paragraph so that if used, the

Warranty statement is present in its entirety.

19. On page 8 under the End-back/side Panel section, delete the "Optional Insert or Package Copy"

statement because the Agency has not reviewed the optional insert as part ofthe labeling for

approvaL

20. Note that should au wish to add a reference to the com any's website on your label, then the

Page40f5

delete struck-out words (because the submitted data do not support these claims), as follows:

"[ResearcH E!efl'l0nstrates that [branE! name] kills adult fleas, flea eggs, and flea larvae anE!

prevents pupae for more up to three fl'lonths.]"

"[Prevents all flea stages, flea eggs, flea pupae, and flea larvae.]"

"[Kills flea eggs [larvae] preYents [pupae] for more than [63 days] [9 weeks]]"

''[Kills Flea for Up to [4 weeks!] [2 months] [3 months]]"

II. On pages I and 2 under Multiple Infestations, revise the following claims to add the underlined

words, or delete struck-out words, as follows:

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

''[Kills Flea Eggs & Flea Larvae for up to more tHan [63 days], [9 weeks]!]"

"[Kills all stages ofthe flea life cycle]"

"[Prevents and controls reinfestations of listed pests for up to [I month] [4 weeks]]"

I2. On pages 2 and 3 under All Others, revise the following claims to add the underlined words, or

delete struck-out words, as follows:

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

"[[Free] BrochHre Inside!]"

"[[Free] Brochure anE! Calendar Stickers Inside]"

"[Pre,,'ents and controls reinfestations of listed pests]"

"[[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [e+if:l] [eaffi]]"

13. On page 3, delete the statement "[Ingredient Statement may be on front or back label]" because

the ingredient statement must be placed on the Front Panel.

14. On page 3 in the Ingredients Statement, all Inert ingredients must be identified when electing to

list the inert ingredients.

15. On page 5 in the How to Apply section, correct the reapplication interval from "4 weeks" to "30

days" to be consistent with the interval stated under Frequency of Application.

16. On pages 5 and 6 under the Frequency of Application, add the underlined words and delete the

struck-out text in the following statement:

"[Studies show that] [branE! name] kills fleas (in as little as 1 hour) for up to three months]."

"[Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, then

within 48 hours for up to 28 days]."

17. On page 6 under the Storage and Disposal statement, replace "Container Handling" with

"Container Disposal."

18. On page 6 in the Warranty statement, remove the brackets within the paragraph so that if used, the

Warranty statement is present in its entirety.

19. On page 8 under the End-back/side Panel section, delete the "Optional Insert or Package Copy"

statement because the Agency has not reviewed the optional insert as part ofthe labeling for

approvaL

20. Note that should au wish to add a reference to the com any's website on your label, then the

Page40f5

16
website becomes labeling under FlFRA and is subject to review by the Agency. Ifthe website

content is false or misleading, the product would be deemed misbranded and unlawful to sell or

distribute under FIFRA §12(a)(I)(E). 40 CFR 156. IO(a)(5) list examples ofstatements EPA may

consider false or misleading. In addition, regardless ofwhether a website is referenced on your

product's label, claims made on the website may not substantially differ from those claims

approved through the registration process. Therefore, should the Agency find or ifit is brought to

our attention that a website contains false or misleading statements, or claims substantially

differing from the EPA-approved registration, the website may be referred to the EPA's Office of

Enforcement and Compliance Assurance.

21. Revise the EPA Registration Number to read: "EPA Registration No. 2517~141."

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

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

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

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

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

constitutes acceptance ofthese conditions. A copy ofyour label stamped "Accepted with Comments" is

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

Enclosure: Sergeant's Fipronil +Nylar Squeeze-on for Dogs Label, Stamped Acceptedwith Comments

Signature of Approving Official:

&LL (lJJeRichard Gebken, Product Manager (10)

Registration Division, Insecticide Branch

EPA Form 8570_6

Page 5 of5

Date:

MAR 23 2011

website becomes labeling under FlFRA and is subject to review by the Agency. Ifthe website

content is false or misleading, the product would be deemed misbranded and unlawful to sell or

distribute under FIFRA §12(a)(I)(E). 40 CFR 156. IO(a)(5) list examples ofstatements EPA may

consider false or misleading. In addition, regardless ofwhether a website is referenced on your

product's label, claims made on the website may not substantially differ from those claims

approved through the registration process. Therefore, should the Agency find or ifit is brought to

our attention that a website contains false or misleading statements, or claims substantially

differing from the EPA-approved registration, the website may be referred to the EPA's Office of

Enforcement and Compliance Assurance.

21. Revise the EPA Registration Number to read: "EPA Registration No. 2517~141."

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

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

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

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

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

constitutes acceptance ofthese conditions. A copy ofyour label stamped "Accepted with Comments" is

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

Enclosure: Sergeant's Fipronil +Nylar Squeeze-on for Dogs Label, Stamped Acceptedwith Comments

Signature of Approving Official:

&LL (lJJeRichard Gebken, Product Manager (10)

Registration Division, Insecticide Branch

EPA Form 8570_6

Page 5 of5

Date:

MAR 23 2011

17
10 March 201 1

Information in [ ] is optional.

Sergeant's® Master Label

Version 10.1 EPA Reg. No. 25 17-RUR

Page lof9

[Apply to puppies over 12 weeks old]

[Apply to puppies 12 weeks or older]

[ABNs]

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

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

[Option text appears in brackets-the final product label may include some or all ofthe optional

text on front, back or side panels. The CRP required text will not change.]

Sergeant's Fipronil + Nylar Squeeze-On for Dogs

ACCEPTED

with CoMMENTS

In EPA Letter Dated:

MAR 2 3 2011

Under the Federal Insecticide

Fungicide, 800 RodenticideAct:

as amended, for the pesticide

registered under4lA Reg. No.

2517-/

[Mosquitoes]

[0Kills mosquitoes] [within 24 hours for up to 7 days] [ood within 48 hours for up to 28

days]

[oKills mosquitoes]

[Fleas]

[eR"search demonstrates that [brand name] kills adult fleas, flea eggs, and flea laryae and

prevents pupae for up to three months.]

[o[brood naroe] prevents development of all flea stages for up to [63 days] [9 weeks].]

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

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

[oKills flea eggs [larvae] [pfe,'enls pupae] for more than [63 days][9 weeks]]

[oWith Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle]

[0With Nylar® to Break Flea Life Cycle]

[oWith Insect Growth Regulatorto Break Flea Life Cycle]

[oDual Action [I]: Fipronil with Nylar® lGR Effectively Breaks the Flea Life

Cycle]

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

[oKills Fleas for Up to [4 weeks!] [2 months] [3 months]]

[Multiple Infestations]

[oFlea & Tick Control for Dogs & Puppies 12 Weeks Old ood Older]

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

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

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

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

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

[0[4 Week] [Flea ood Tick & Treatment]]

[0 [Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,]

chewing lice, flea eggs, flea larvae [&] [and] prevent the development of flea pupae]]

[0 [Six] [6] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,]

10 March 2011

Information in [ ] is optional.

[Apply to puppies over 12 weeks old]

[Apply to puppies 12 weeks or older]

[ABNs]

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

[(Sergeant's~ (Sentry~ EctoadvanceTM (Spot On) for dogs]

Sergeant's® Master Label

Version 10.1 EPA Reg. No. 25 17-RUR

Page 10f9

Sergeant's Fipronil + Nylar Squeeze-On for Dogs

ACCEPTED

with COMMENTS

In EPA Letter Dated:

MAR 2 3 2011

Under the Federal Insecticide

Fungicide, 800 Rodenticide Act: as amended, for the pesticide

registered under4lA Reg. No.

2517-/

[Mosquitoes]

[-Kills mosquitoes] [within 24 hours for up to 7 days] [and within 48 hours for up to 28

days]

[-Kills mosquitoes]

[Fleas]

[-R"search demonstrates that [brand name] kills adult fleas, flea eggs, and flea laryae and

prevents pupae for up to three months.]

[-[brand name] prevents development of all flea stages for up to [63 days] [9 weeks].]

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

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

[-Kills flea eggs [larvae] [prevents pupae] for more than [63 days][9 weeks]]

[-With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle]

[-With Nylar® to Break Flea Life Cycle]

[-With Insect Growth Regulator to Break Flea Life Cycle]

[-Dual Action [!]: Fipronil with Nylar® lOR Effectively Breaks the Flea Life

Cycle]

[-Dual Action [!]: Effectively Breaks the Flea Life Cycle[!]]

[-Kills Fleas for Up to [4 weeks!] [2 months] [3 months]]

[MultipIe Infestations]

[-Flea & Tick Control for Dogs & Puppies 12 Weeks Old and Older]

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

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

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

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

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

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

[- [Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,]

chewing lice, flea eggs, flea larvae [&] [and] prevent the development of flea pupae]]

[- [Six] [6] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,]

18
Sergeant's® Master Label

10 March 2011 Version 10.1 EPA Reg. No. 2517-RUR

Information in [ ] is optional. Page 2 of9

chewing lice, flea eggs [&] [and] flea larvae]

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

['Kills Flea Eggs & Flea Larvae for up to fRo,e than [63 days], [9 weeks]!]

[-Prevents Flea Eggs From Developing Into Biting Adults]

['Kills all stages ofthe flea life cycle]

['Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to 4 Weeks]

[-4 week Flea and Tick Treatment!]

[Once A Month Flea and Tick Treatment]

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

[-When used monthly [brand name] completely breaks the flea life cycle and controls tick

and chewing lice infestations.]

[-Prevents and controls reinfestations oflisted pests for up to [1 month] [4 weeks]]

[Ticks]

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

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

['Kills Ticks for Up to [4 weeks]I]

[-Kills [all stages ofJ Deer Ticks (vector ofLyme Disease) for up to 4 weeks]

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

[·Kills [Brown], [American,] [and Lone Star ]Dog Ticks for up to 4 weeks]

[-Kills Rhipicephalus sanguineus for up to 4 weeks]

[All Others]

[-For Dogs and Puppies 12 weeks of age or older]

['For Dogs ["I' ±to 221bs], [23-441bs], [45-88 lbs], [89-1321bs]

[-Controls flea reinfusta-tion for up to [3 months] [12 vieeks]]

[·Fast Acting]

['Waterproof]

[.Long Lasting]

['Apply monthly]

[-A once montWy application is required for chewing lice.]

[Apply monthly to control chewing lice.]

[-Rapid elimination of chewing lice infestations]

[-Controls mites that may cause sarcoptic mange]

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

[-Best if used year round!]

['(lCON Showing 4 Week Protection)]

[,4 Week Dose!]

['1 Month Dose!]

[·Easy to Use Application]

[-Specially Fonnulated for Dogs and Puppies over 12 weeks old]

[·[Free] Calendar Stickers Inside!]

[·fF..e] BfOchffie Inside!]

[-[Free] Broehure and Calendar Stickers Inside]

['Patented Technology]

['Apply once every [4 weeks] [month]!]

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

Sergeant's® Master Label

10 March 2011 Version 10.1 EPA Reg. No. 2517-RUR

Information in [ ] is optional. Page 2 of9

chewing lice, flea eggs [&] [and] flea larvae]

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

['Kills Flea Eggs & Flea Larvae for up to fRo'e than [63 days], [9 weeks]!]

[-Prevents Flea Eggs From Developing Into Biting Adults]

['Kills all stages ofthe flea life cycle]

['Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to 4 Weeks]

[-4 week Flea and Tick Treatment!]

[Once A Month Flea and Tick Treatment]

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

[-When used monthly [brand name] completely breaks the flea life cycle and controls tick

and chewing lice infestations.]

[-Prevents and controls reinfestations oflisted pests for up to [1 month] [4 weeks]]

[Ticks]

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

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

['Kills Ticks for Up to [4 weeks]I]

[-Kills [all stages ofJ Deer Ticks (vector ofLyme Disease) for up to 4 weeks]

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

[·Kills [Brown], [American,] [and Lone Star ]Dog Ticks for up to 4 weeks]

[-Kills Rhipicephalus sanguineus for up to 4 weeks]

[All Others]

[-For Dogs and Puppies 12 weeks of age or older]

['For Dogs ["I' ±to 221bs], [23-441bs], [45-88 lbs], [89-1321bs]

[-Controls flea reinfusta-tion for up to [3 months] [12 vieeks]]

[·Fast Acting]

['Waterproof]

[.Long Lasting]

['Apply monthly]

[-A once montWy application is required for chewing lice.]

[Apply monthly to control chewing lice.]

[-Rapid elimination of chewing lice infestations]

[-Controls mites that may cause sarcoptic mange]

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

[-Best if used year round!]

['(lCON Showing 4 Week Protection)]

[,4 Week Dose!]

['1 Month Dose!]

[·Easy to Use Application]

[-Specially Fonnulated for Dogs and Puppies over 12 weeks old]

[·[Free] Calendar Stickers Inside!]

[·fF..e] BfOchffie Inside!]

[-[Free] Broehure and Calendar Stickers Inside]

['Patented Technology]

['Apply once every [4 weeks] [month]!]

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

19
Sergeant's® Master Label

10 March 2011 Vcrsion10.! EPA Reg. No. 2517-RUR

Infonnation in [ ] is optional. Page 3 of 9

[-Prevents and controls reinfestations of listed pests]

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

leaN]]

[-3 applications]

[-Fiponil (9.8%) + [pyrproxyfen] [Nylar®] (2.0%)]

[-US and Foreign patents pending]

[-Lift [here] for more information]

[-For year round protection, apply (brand name) monthly]

[3 Applications]

[For use ONLY on dogs]

[Yj> :1: to 22 Ibs]

[23-44Ibs]

[45-88Ibs]

[89-1321bs]

[over 12 weeks of age]

[For Dogs & Puppies (12 weeks or older and)] [and]lup 1014 to 22 1bs.]

[For Dogs 23-44 Ibs.]

[For Dogs 45-881bs.]

[For Dogs 89-132 1bs.]

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

or Side Label Panels

[Ingredient Statement may be on frSHt or back label]

ACTIVE INGREDIENTS:

Fipronil 9.8%

Pyriproxyfen 2.00/0

OTHER INGREDIENTS *: 88.2%

TOTAL: ...............................•................................... 100.0%

[*diethylene glycol monoethyl ether]

[Nylar® is a registered trademark of McLaughlin Gormley King Company.

U.S. Patent No. 5,942,525]

KEEP OUT OF REACH OF CHILDREN

WARNING

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

NET CONTENTS:

Contains (3) [0.023 fl oz] [0.67 ml] applicators

Contains (3) [0.045 fl oz] [1.34 m1] applicators

Contains (3) [0.091 fl oz] [2.68 ml] applicators

Contains (3) [0.136 fl oz] [4.02 m1] applicators

Sergeant's® Master Label

10 March 2011 Vcrsion10.! EPA Reg. No. 2517-RUR

Infonnation in [ ] is optional. Page 3 of 9

[-Prevents and controls reinfestations of listed pests]

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

leaN]]

[-3 applications]

[-Fiponil (9.8%) + [pyrproxyfen] [Nylar®] (2.0%)]

[-US and Foreign patents pending]

[-Lift [here] for more information]

[-For year round protection, apply (brand name) monthly]

[3 Applications]

[For use ONLY on dogs]

[Yj> :1: to 22 Ibs]

[23-44Ibs]

[45-88Ibs]

[89-1321bs]

[over 12 weeks of age]

[For Dogs & Puppies (12 weeks or older and)] [and]lup 1014 to 22 1bs.]

[For Dogs 23-44 Ibs.]

[For Dogs 45-881bs.]

[For Dogs 89-132 1bs.]

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

or Side Label Panels

[Ingredient Statement may be on frSHt or back label]

ACTIVE INGREDIENTS:

Fipronil 9.8%

Pyriproxyfen 2.00/0

OTHER INGREDIENTS *: 88.2%

TOTAL: ...............................•................................... 100.0%

[*diethylene glycol monoethyl ether]

[Nylar® is a registered trademark of McLaughlin Gormley King Company.

U.S. Patent No. 5,942,525]

KEEP OUT OF REACH OF CHILDREN

WARNING

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

NET CONTENTS:

Contains (3) [0.023 fl oz] [0.67 ml] applicators

Contains (3) [0.045 fl oz] [1.34 m1] applicators

Contains (3) [0.091 fl oz] [2.68 ml] applicators

Contains (3) [0.136 fl oz] [4.02 m1] applicators

20
Version 10.1

Page 4 of9

Sergeant's® Master Label

EPA Reg. No. 25l7-RUR

[ is optional.

10 March 2011

Information in [

[BACK/SIDE CARTON LABEL - MASTER LABEL]

[brand name] contains fipronil and the insect growth regulator (IGR) Nylar® to effectively

kill fleas, ticks [(including those that may transmit Lyme Disease)], and kill[s] flea eggs, flea

larvae, mosquitoes and chewing lice. The active ingredients in [brand name] feature a sustained

release formula developed for fast acting [and long lasting] control of fleas, ticks, [mosquitoes]

and chewing lice for up to [1 month] [[4] [four] weeks] on dogs.

READ ENTIRE LABEL BEFORE EACH USE.

USE ONLY ON DOGS AND PUPPIES 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. Harmful ifswallowed. Harmful if absorbed through skin. Prolonged or

frequently repeated skin contact may cause allergic reactions in some individuals. Wash hands

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.

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

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

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

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

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

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

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

medicated, pregnant, nursing, debilitated or aged dogs. Call 1-800-781-4738 for 24-hour

assistance.

FIRST AID

IfIn Eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes.

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

eye.

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

IfOn Skin • Take off contaminated clothing.

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

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

IfSwallowed • 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.

• Do not give anything bv mouth to an unconscious person.

HOT LINE NUMBER

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

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

emergencies or pesticide incidents), you may call 1-800-781-4738.

NOTE TO PHYSICIAN OR VETERINARIAN

Treat patient symptomatically

Sergeant's® Master Label

10 March 2011 Version 10.1 EPA Reg. No. 25l7-RUR

Infonnation in [ [is optional. Page 4 of 9

RRQNY!i&\R~N',g!J:~?',Wmj\:i'm$1'!t0'@;;:"\T ::M '/i"/"::,/:i'ii,":,',,'!:'Li:2,,,,:}}I{;':: :;X":/:!,:',:i':'::,";".';H'!, :':L:i:gg,~i;:~,R!!~,~~~':g~

~JgHQNJ~~~A.R

[BACK/SIDE CARTON LABEL - MASTER LABEL]

[brand name] contains fipronil and the insect growth regulator (IGR) Nylar® to effectively

kill fleas, ticks [(including those that may transmit Lyme Disease)], and kill[s] flea eggs, flea

larvae, mosquitoes and chewing lice. The active ingredients in [brand name] feature a sustained

release fonnula developed for fast acting [and long lasting] control of fleas, ticks, [mosquitoes]

and chewing lice for up to [1 month] [[4] [four] weeks] on dogs.

READ ENTIRE LABEL BEFORE EACH USE.

USE ONLY ON DOGS AND PUPPIES 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. Harmful ifswallowed. Hannful if absorbed through skin. Prolonged or

frequently repeated skin contact may cause allergic reactions in some individuals. Wash hands

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.

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

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

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

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

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

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

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

medicated, pregnant, nursing, debilitated or aged dogs. Call 1-800-781-4738 for 24-hour

assistance.

FIRST AID

IfIn Eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes.

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

eye.

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

IfOn Skin • Take off contaminated clothing.

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

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

IfSwallowed • 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.

• Do not give anything by mouth to an unconscious person.

HOT LINE NUMBER

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

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

emergencies or pesticide incidents), you may call 1-800-781-4738.

NOTE TO PHYSICIAN OR VETERINARIAN

Treat patient symptomatically

21
Version 10.1

Page 5 of9

Sergeant's® Master Label

EPA Reg. No. 25 I 7-RUR

] is optional.

10 March 2011

Information in [

DIRECTIONS FOR USE

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

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

AND YOUR DOG, READ ENTIRE LABEL BEFORE EACH USE. FOLLOW ALL

DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL

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

ANIMALS.

DO NOT USE ON CATS. May be toxic and potentially fatal if applied to or ingested by cats.

FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks of age.

Weigh your dog to be sure you are applying the right dose formulated for the weight of your dog.

Do not treat your dog with more than one pesticide product at a time. Over dosing your dog can

result in serious illness and even death. Best if used year round. Certain medications can

interact with pesticides. Consult a veterinarian before using this product on debilitated, aged,

medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known

organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated

dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that

actively groom or engage in close physical contact with treated dog may be at risk ofserious

hannful effects. The most common signs ofingestion are excessive salivation and foaming at

the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your

dog for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats

exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately.

If your dog is exhibiting signs of and/or are being treated for skin dermatitis, talk to your vet

before applying any topical flea and tick control product.

Sensitivities may occur after using ANY pesticide product on dogs. Dogs may experience

some temporary irritation at the site of product application. Ifsigns ofsensitivity occur

bathe your dog with a mild soap and rinse with large amounts of water. Ifsigns continue,

consult a veterinarian immediateIiby calling 1-800-781-4738.

[{Outer Packaging}]

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

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

the narrow end at the notches with scissors.

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

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

necessary, but do not apply more often than once every 30 days 4 weeks.

[Optional drawings that mayor may not appear on finished

label]

FREQUENCY OF APPLICATION

Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill

mosquitoes] [infestations]. [£tudies show that] [brand name] kills fleas for up to three moR-ths.

If your pet is at high risk for flea reinfestation [, or in a highly infested environment], apply

Version I 0.1

Page 5 of9

Sergeant's@ Master Label

10 March 2011 EPA Reg. No. 2517-RUR

Information in [ ] is optional.

DIRECTIONS FOR USE

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

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

AND YOUR DOG, READ ENTIRE LABEL BEFORE EACH USE. FOLLOW ALL

DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL

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

ANIMALS.

DO NOT USE ON CATS. May be toxic and potentially fatal if applied to or ingested by cats.

FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks of age.

Weigh your dog to be sure you are applying the right dose formulated for the weight of your dog.

Do not treat your dog with more than one pesticide product at a time. Over dosing your dog can

result in serious illness and even death. Best if used year round. Certain medications can

interact with pesticides. Consult a veterinarian before using this product on debilitated, aged,

medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known

organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated

dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that

actively groom or engage in close physical contact with treated dog may be at risk ofserious

harmful effects. The most common signs ofingestion are excessive salivation and foaming at

the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your

dog for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats

exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately.

If your dog is exhibiting signs of and/or are being treated for skin dermatitis, talk to your vet

before applying any topical flea and tick control product.

Sensitivities may occur after using ANY pesticide product on dogs. Dogs may experience

some temporary irritation at the site of product application. Ifsigns ofsensitivity occur

bathe your dog with a mild soap and rinse with large amounts of water. Ifsigns continue,

consult a veterinarian immediateIiby calling 1-800-781-4738.

[{Outer Packaging}]

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

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

the narrow end at the notches with scissors.

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

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

necessary, but do not apply more often than once every 30 days 4 weeks.

[Optional drawings that mayor may not appear on finished

label]

FREQUENCY OF APPLICATION

Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill

mosquitoes] [infestations]. [£tudies show that] [brand name] kills fleas for up to three moR-ths.

If your pet is at high risk for flea reinfestation [, or in a highly infested environment], apply

22
Sergeant's® Master Label

10 March 201 I Version 10.1 EPA Reg. No. 25l7-RUR

Information in [ ] is optional. Page 6 of 9

monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills

mosquitoes within 24 hours for up to the first 7 days after treatment, then 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.

For Dogs Weighing up to 22 lbs. [including small dogs and puppies, 12 weeks or older]

{For cartons containing .67 ml (0.023 fl. oz.) applicator tubes}

Apply one tube (.67 ml)(O.023 fl. oz.) [as a spot to the dog's back between the shoulder blades]

[from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 23 - 441bs.

{For cartons containing 1.34 ml (0.045 fl. oz.) applicator tube}

[Apply one tube (1.34 ml)(0.045 fl. oz.) as a spot to the dog's back between the shoulder blades.]

[from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 45 - 881bs.

{For cartons containing 2,68 ml (0.091 fl. oz.) applicator tube}

Apply one tube (2.68 ml)(0.091 fl. oz.) [as a spot on the dog's back between the shoulder] [from

the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing 89 -132 lbs.

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

Apply one tube (4.02 ml)(0.136 fl. oz.) [as a spot on the dog's back between the shoulder] [from

the back ofthe neck to a point midway between the neck and tail].

STORAGE AND DISPOSAL

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

77°F (2s'q] dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight.

CONTAINER DISPOSAL HANDLING: 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. HThe directions for use ofthis product are believed to adequate

and must be followed carefully. It is impossible to eliminate all risks associated with the use ofthis

product. Unintended consequences may result because of unknown factors. All such risks shall be

assumed by the user or buyer.H Sergeant's is committed to providing high quality products. To the

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

merchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this

label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not

be liable for indirect, special, incidental or consequential damages. To the extent consistent with

applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.]

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

P.O. Box 540399, Omaha, NE 68154-0399.]

Sergeant's@ Master Label

10 March 201 I Version 10.1 EPA Reg. No. 25l7-RUR

Information in [ ] is optional. Page 6 of 9

monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills

mosquitoes within 24 hours for up to the first 7 days after treatment, then 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.

For Dogs Weighing up to 22 lbs. [including small dogs and puppies, 12 weeks or older]

{For cartons containing .67 ml (0.023 fl. oz.) applicator tubes}

Apply one tube (.67 ml)(O.023 fl. oz.) [as a spot to the dog's back between the shoulder blades]

[from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 23 - 441bs.

{For cartons containing 1.34 ml (0.045 fl. oz.) applicator tube}

[Apply one tube (1.34 ml)(0.045 fl. oz.) as a spot to the dog's back between the shoulder blades.]

[from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 45 - 881bs.

{For cartons containing 2,68 ml (0.091 fl. oz.) applicator tube}

Apply one tube (2.68 ml)(0.091 fl. oz.) [as a spot on the dog's back between the shoulder] [from

the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing 89 -132 lbs.

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

Apply one tube (4.02 ml)(0.136 fl. oz.) [as a spot on the dog's back between the shoulder] [from

the back ofthe neck to a point midway between the neck and tail].

STORAGE AND DISPOSAL

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

77°F (2s'q] dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight.

CONTAINER DISPOSAL HANDLING: 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. HThe directions for use ofthis product are believed to adequate

and must be followed carefully. It is impossible to eliminate all risks associated with the use ofthis

product. Unintended consequences may result because of unknown factors. All such risks shall be

assumed by the user or buyer.H Sergeant's is committed to providing high quality products. To the

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

merchantability or offitness for a particular purpose or otherwise, that extend beyond statements on this

label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not

be liable for indirect, special, incidental or consequential damages. To the extent consistent with

applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.]

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

P.O. Box 540399, Omaha, NE 68154-0399.]

23
Sergeant's@ Master Label

10 March2011 Version 10.1 EPA Reg. No. 2517-RUR

Infonnation in [ ] is optional. Page 7 of9

In Case of Emergency, call: 1~800~ 781 ~4738 [For more infonnation] [Visit us at] [\vww.senreants.com]

Non-Emergency call1-800-224-PETS (7387) [Made in USA]

Distributed by:

Sergeant's Pet Care Products, Inc.

P.O. Box 540399

Omaha, NE 68154-0399

EPA Reg. No. 2517-RUR

EPA Est. No. XXXXX-XX-XXX

[BAR CODE AREA]

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

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

applicator labeling.]

[Application Instructions] [Directions for Use[

How to open

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

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

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

How to apply:

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

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

back between the shoulder blades.] [or] [from the back ofthe neck to a point midway

between the neck and tail.]

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

fin.II.bel)

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

Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

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

Sergeant's® Master Label

10 March 2011 Version 10.l EPA Reg. No. 2517-RUR

Infonnation in [ ] is optionaL Page 7 of9

In Case ofEmergency, call: 1-800-781-4738 [For more information] [Visit us at] [\vww.senreants.com]

Non-Emergency call 1-800-224-PETS (7387) [Made ill USA]

Distributed by:

Sergeant's Pet Care Products, Inc.

P.O. Box 540399

Omaha, NE 68154-0399

EPA Reg. No. 2517-RUR

EPA Est. No. XXXXX-XX-XXX

[BAR CODE AREA]

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

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

applicator labeling.]

[Application Instructions] [Directions for UseE

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 offthe narrow end at the notches with scissors.

How to apply:

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

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

back between the shoulder blades.] [or] [from the back ofthe neck to a point midway

between the neck and tail.]

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

final label]

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

Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

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

24
Sergeant's@ Master Label

10 March 201 I Version 10.1 EPA Reg. No. 2517-RUR

Infonnation in [ ] is optional. Page 8 of 9

• Separate animals after treatment to avoid chance ofingestion

• Do NOT split tubes between pets]

[Brand Namel

[3] [Month [Treatment] [Application] Tracker]

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

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

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

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

[calendar stickers with brand name]

[Place stickers on your calendar as a reminder to reapply [brand name] [in 30 days.]

[Monthly Application Reminder Magnet (image ofreminder magnet)]

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

the reminder light will blink twice. The reminder tag is now set for 30 days. At the end of 30

days the reminder light will blink, reminding you to reapply [Brand name]. Press the button

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

another 30 days.]

flea eggs

flea larvae

'" Adutt Flea @ AduttFlea

@ fleaeggs

flea larvae

flea pupae ~. flea pupae

,. ticks @ ticks

Brown Dog lick @ Brown Dog lick

Deer Tick @ Deerlick

American Dog lick @ American Dog lick

l' chewing lice @ chewing lice

Lone Starlick @ Lone Starlick

.7J<- mosquitoes .@c mosquitoes

[Optional graphics above mayor may not appear on finished label]

(END OPTIONAL INSERT OR PACKAGE COPY)

Sergeant's® Master Label

10 March 2011 Version 10.1 EPA Reg. No. 2517-RUR

Infonnation in [ ] is optional. Page 8 of 9

• Separate animals after treatment to avoid chance ofingestion

• Do NOT split tubes between pets]

[Brand Name[

[3] [Month [Treatment] [Application] Tracker]

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

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

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

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

[calendar stickers with brand name]

[Place stickers on your calendar as a reminder to reapply [brand name] [in 30 days.]

[Monthly Application Reminder Magnet (image ofreminder magnet)]

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

the reminder light will blink twice. The reminder tag is now set for 30 days. At the end of 30

days the reminder light will blink, reminding you to reapply [Brand name]. Press the button

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

another 30 days.]

Adult Flea @ Adult Flea

.". flea eggs @ flea eggs

., flea larvae flea larvae

.. flea pupae ~.. flea pupae

+ ticks @ ticks

Brown Dog Tick @ Brown Dog lick

DeerTick @ DeerTick

American Dog Tick @ American Dog Tick

Jr chewing lice @ chewing lice

lone Starlick @ lone StarTick

mosquitoes -~ mosquitoes

[Optional graphics above mayor may not appear on finished label]

(END OPTIONAL INSERT OR PACKi\CE COPY)

25
10 March 2011

Information in I ]is optionaL

Sergeant's® Master Label

Version 10.1 EPA Reg. No. 25l7-RUR

Page90f9

Front Label

.i .... ········1 l)OJI!oT

{Brand Name} i@~;:N For Dogs [ap 10 X lbs.] [X-Y lbs.]

Fiproni19.8% w/w, Pyriproxyfen 2.0% w/w

Dog 0.023 fl oz (or) 0.045 fl 02 (or) 0.091 fl 02

(or) 0.136 fl 02 l1abel code}

Back Label

KEEP OUT OF REACH OF CHILDREN

WARNING: Read directions and precautions

before using. Use scissors to open.

EPA REG. No. 2517-RUR {label code}

MAB 2 3

10 March 2011

Information in I ] is optionaL

Sergeant's® Master Label

Version 10.1 EPA Reg. No. 2517-RUR

Page90f9

Front Label

,·············,,··········,,····················1 i@l'XJJlloT , U$l!ON

{Brand Name} I CAn;

For Dogs [up to X lbs.] [X~ Y lbs.]

Fiproni19.8% w/w, Pyriproxyfen 2.0% w/w

Dog 0.023 fl 02 (or) 0.045 fl 02 (or) 0.091 fl 02

(or) 0.136 fl 02 {label code}

Back Label

KEEP OUT OF REACH OF CHILDREN

WARNING: Read directions and precautions

before using. Use scissors to open.

EPA REG. No. 2517-RUR {label code}

26
Brand

><

X m

fordogs

Foruse ONLY on dogs

1

B

---

For use 

EPA Rcg # 

11

Control

cause s

• Waterp

ACTIVE INGRE

P)Ilipso, ylen 

OTHER INGRE

TOTAL: 

'D ne Gly

Vit8mm :E N:cot

J?:jjj/P+

JUTOF REACH OF CHILDREN

WARNING

Seeaad< Lsbel futAdditionill Precaulion.ryStalemenls

Net Contents: Three 0,023 fl oz

(0,67 mL) applicators

11

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NOTE TO PIlYSlCtAIt OR YrnRllWltAIt

::Sw_ 1·C1J alXli""controloenler or doctor •Ho" IT.lA! 10 odtlw,

•Do not ind""''>tITIIting url<",loOj 10 do '" "I' p::isoo corWcl"",:" "doc1or. • Do not "'I'lhing I;jmoutlllo", UrWl>:io", Pl'SCI\

[77777\

Brand X'·

fordogs

READ

lWAlUIS TO HUMAMS- WARliNCl. OOttmPor>rf'l'" Do rJOl getn'l"S" on<lctJlt9.

IiMrtiJ croI>r.l may"'"," WuA",·,:,>',..:",·

IlA1AII tIS TO DOMESllC NlIW.l.S. "'"Orlf. Do iJol "'" on PJPPI!$ uOO« 11_01 a[j>.lndividu:ll_"; IIhiIO ';"":.',"":.":'

1U"'hlM pesfddet.CilMI.talOlM"""" dltilita:sd "llgI'ddog<.Cd 1$181-l1:Jij!llr . '. .' .

Ho.'" the [:Illduct cont>i"", " '/00 ""enClIIfJg 'p;:i>:<l conW Meror doc1". '" gofJg for f" more informal"" '" this oosloo. rmdtx:! heeJth medical emagencks'" pesticiJo Ockkotsl. yerJ rna)' c>l 1-800-181-4138,

II In Eye. 1·1!:4:J ,.". op"'",d n"", .'''1/ "'" wittl..." for nmrt... •R<move 1:«Il",: 1er4eS, i: ,Ner !he!i!SlS then owIi""", nnsi"IJ •Col. poison OO'ltroi oom.r or cko:;lor for!ul1her i'/Jioi

HOTLINE NUMBEll

I: On Skin Or Clo1lling I· Take 0.1 coot:rnm:«lclottirJg. -Rireo ,1(0 irrrn",,,,djill p.,nly of Willer :or : ...

•Cal. poison I:«Ilroll:Ofllor" cko:;lor for

.·.::::::):;:i 00 NOT ALlOW CHILDR Ell TOAPl'ty PPiODUCt TO PRMNTHmlTO \'00 HID YCOil 00:;, fi£,\O ENme LAm.BEFl:'flE EACH \

FOREXTEFWlUll00 00T'S0:'::ii

00 NOT Ull CATS, Ma; te "',;, end pol<rilioJly Iar.I IT 10 Or lr! Fa!OOEl'.'IAL IJSE ON DOOO MY: OJiioli

....." puppifs un;" :1_01

00: Ir",: )OIddog\\ithm<f1l1ll>n "'" ,:atme. reaJ:in «l6.>J'iiIe!<I""''''if<lM1tl;

inter>Clw:h _ Otfor'lJSinj1m prodll:l ..,:.:·",:·,.)".

m"*ated. " nur;in<! dogs. ConsLM a ",!>I, us,," on dog; """ I!>o'iI!1 organ 00 oorlISEON el,'S"': ,',.,.

sninlsla 01h£< lhsn dog<. S!pl!'1ll' the ..:ed dog !rom iI'I olh" dogs 'nd osl'f"11 ""'",,*,,:re.tmonl!los boon sPPiOi C>;oihd llO:;i; .. groom ""'g:»Oin d"" Thilm<l'll i1gtslion He and b;m;;q oil/\> mwltJ. IT th... ij'IIlfl<"lS «:'"mmed""!et{:eed 'I'M<!:'!l"'" iii ITIl'"iI.(':.,·..'......·.:..,·,

)'WI dog Iorlho next N hows, c.:.atili1ing .. ,

hgootionsimuIJ isexhiMiIg ,*"of ""Ii'" is being irMtIJdlors!;inde!m&t!ie;Isll<b";/

)'ilUf vel boIO/'wfr\l sn, tojicllllMand 10k conl:l>l p-tdJct. •..... ;:;....,.......,;,)::;,>,,:)..

Soosilivilies may occur... rnay.....,neno...""lempor"'Y lMIa&Iiilt\ie.d).>'; •.

Prc><\I.Icl apPii;alion. with. mil:l""'l' .ndrIMs. willi lel'i!"'''.'ll'll.01-.KsIiii:·,,"'.,·:....',,·....·,;·.' 0011: =ulI._erm-ialMtbyoahir!g l-Bro-78Hl3S. ;,..;.;..:.•:::.. ;),.::;.-:

, '. Hew It> "odt>o!lubes Itom I/\> PlOk¥- "'" tut.1tom \P. 011'00. lho :u",w<tt ",,1<11.0 en; P>nfrij Up ,.•)'.,,",,)..

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........."Iltom lhotr.e end troj, .. """"" and'lth' nolcheswth "'"""" .,'....:." ......,..;...,..,.•,.,..".,':

....;. HOw to aw!r. lube "'"' dog "'" ...open end :0 I"Ildog', !<lir, SqW<\1, '>W' of :Il> .otLJ\ion 10 til> ,.•:oi;«loo b<Iow, fWporlI ,ppicali:nm'1' te rJliM;: """"""Y, w. do not 'lWmorHI!«I!hao 00:, e,....,. 4wee,,- ......

> fREQUENCY Of APPLICATION

....• U,.BraM X" rn::<l\hlj lor 1:«Ilr<l 011.., t"k;ro<I1,..;ng 1ic>J inl%lctiorts.Sud..>how !hot ilIind X'· 1... 11:0 lJjllo

•• '. three P!l i' aI high risk for b reicW"" ,pplj monttLy to conl7d ltis. snd ch"';ng ire. '., "&Wid m;x;qu:toos »i1h1t 24 hows :.:olho I¥:lt 7days aNer 1J031JI1«Il, :hen within 46 hour; :", lJjl !> days. BI<nd:<'" """'""

,:: """"""'...-en oft" bsthin<!, immersion, "'>polU'e:o Mftghl. Mow .....eo ".. :0 dry lhcroutfl.1lo roIr&Prt'1 f<f:'Q days.

·.·.·Frii Cog< l'llbs" AWlo"':u'" n1!I1'J23101) quest«lS",,,,,,,men!s 'bwtthis

......... 'fJJI:o :hedog'. b>:k :m.'"", Con5umer Res_

U.s,...rF""ign PotJdng P.o, Ilo>; 540099, Oimha, HE 09: 5-I-Om.

•Modo USA Cistributed "'" i'<1 Care ProdJcts, :"" .' '. P.o. eo. 540099, 0mah.1, NE 09: . In c.s. 0: E'""'9""Y.c>l: t-llOO-lat·,lU Rsg. No,2S11AA

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Front

White tube I Black text on awhite label f Colored Strip

8mm

38.tmm

--tOmm

ART INSTRUCTION FOR THE PRINTER

.l1li

6lAC~ IMS 16S

Pri"t~rf'lendor:

Mditicnol Notes:

Dote s~nt:

labels adhere to White Tubes

MAR ! 3

Front

White tube I Black text on awhite la bel f Colored Strip

38.tmm

8mm

..--.-

tOmm

ART INSTRUCTION FOR THE PRINTER

•6lAC~ IMS 16S

Pri "t~ rflen dor:

Mditicnol Notes:

Dote s~nt:

labels adhere to White Tubes

MAR 3

28
( \

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3.000

AppllCaUons

SENTRY.

Bran

for

%!f6 '\::·J/.V

;;fiJi'

KEEP OUTOF REACH OF CHILDREN

WARNING

,.

chewing lice

o:,~(m()t;;nuitoes

Controls mites that may

cause sarcoptic mange

• Waterproof

ACTIVE INGREDIENTS:

Fjp,on;1 9.80%

Pl'fipro~ylen 2.00%

OTHER INGREDIENTS', ,88.20%

TOTAL: ,.,.,.", "" 100.00%

'Diethylone Glycol Monoelhyl Ether,

Vitamin E Nlcollnate

5eella<k LilbtlP"""lfufAdditioneIPr.<a<Jtionlry5Iot.ments II~~.,.c--,

Net Contents: Three 0.045 11 OZ

I I (1.34 mL) applicators ~--_.._---,-_.._.. f f- I ( , , \ I ",,,,__,,1 I ltIISI8

v777~7\

---'t----""r.<.--------'~."....,...."....,...r_.--------+_-__+ ::::3'00D'.. ,",',

AppllCaUons",',' ,

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ACTIVE INGREDIENTS:

Fipronjl •.•......................................•S.80%

Pl'fipro~ylen 2.00%

OTHER INGREDIENTS', , ,88.20%

TOTAL: tOO.OO%

'Diethylone Glycol Monoethyl Ether,

VitamIn E Nleolinate

i"i,..~'rnbsq uitoes

"""'i"'~"Contro'smites that may

cause sarcoptic mange

• Waterproof

v777~7\

"

iAfS::PyfJ

KEEP OUTOF REACH OF CH ILOREN

WARNING

5<1!lla<k Lahti P"""IfurAdditional Pr.<a<Jtionl'Y511t.ments r-=,---------,

Net Contents: Three 0.045 11 OZ

(1.34 mL) applicators

29
Front

White lube /Black leX! on awhile label IColored Strip

; .. Brond Xfor Dog~ 23.JJ Us T-lobel

ART INSTRUCTiON FOR THE PRINTER

•• Pnnter/Vendor:

Additionol Notes:

Dote ~ent:

38.1mm

amm

.--

10mm

Labels adhere to White Tubes

3

Front

White lube /Black leX! on awhile label IColored Strip

38.1mm

8mm

....--...-

10mm

ART INSTRUCTiON FOR THE PRINTER

• Pnnter/Vendor:

Additional Notes:

Dote ~ent:

Labels adhere to White Tubes

30
,-."-.~~-.~.--t--

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SENTRY.

aIDof-~-----I I"--For~~ ONl.:Y-o~ dogs 'j)I

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fordogs

KILLS

\II' fleas

... flea eggs

+ticks

't chewing lice

'?'mosquitoes

;:. Controls mites that may

cause sarcoptic mange

• Waterproof

ACTIYE INGREDIENTS,

Fipronil, 9,80%

P.,.ripro.yfen •..........•...•...•............2.00%

OTHER INGREDIENTS':.. ..88.20%

TOTAL, """",, 100.00%

"Dl"1hylana Glycol Mon""thyl Ethar,

VitaminE Nlco1inata

T OF REACH OF CHILDREN

RNING

kt..l>!IPoneIlw,

Net Contents: Three 0.091 Iloz

(2.68 mL) applicators

\

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:";"S£NTRY

cu

)i:'~controlsmites that may

cause sarcoptic mange

• Waterproof

ACTIVE INGREDIENTS;

Fi pronil,9,80%

P.,..iproxyfen •.•.........•...•...•............2.00%

OTHER INGREDIENTS': 88.20%

TOTAL; 100.00%

'01,,1hylana GlycolMon""thyl Etha r,

Vitaml n E NIco1inata

UTOF REACH OF CHILDREN

RNING

Net Contents: Three 0.091 fl oz

(2.68 mL) applicators

31
Front

White tube f Black text on awhite label f Colored Strip

38.tmm

8mm

--10mm

ART INSTRUCTION FOR THE PRINTER

--

BlACK PMHOO

Printer/Vendor:

Additionol Notes:

Dote sent:

labels adhere to White Tubes

W7-r41

Front

White tube f Black text on awhite label f Colored Strip

38.tmm

8mm

............ 10mm

ART INSTRUCTION FOR THE PRINTER

•BlACK PMHOO

Printer/Vendor:

Additio nol Notes:

Dote sent:

labels adhere to White Tubes

32
\

I 1--- For-use ONLY ~~ dogs\ I)I

,....I '--<

SENTRY

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APPliCatlons

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Brand X'"

fordogs

KILLS

'" fleas .... flea eggs

+ticks " chewing lice

.7J".mosquitoes

,'. Controls mites that may

cause sQrcoptic mange

• Waterproof

ACTIVE INGREDIENTS:

Fipronil 9.80%

PyriprOl<yten" ..2.00%

OTHER INGREDIENTS': •........ 86.20%

TOTAL, 100.00%

"Diethylene Glycol Monoethyl Ether,

Vilam;nE Nicotinate

TOF REACH OF CHILDREN

RNING ~',;. Back LlbdPaMl /orAdditiorlal Pre<autio<\,,,ySt<rt

Net Contents: Three 0,136 II oz

(4,02 mL) applicators

[/7 7-7-~7~7\

I

\

ACTIVE INGREDIENTS:

Fipronil 9.80%

Pyripro"yten 2.00%

OTHER INGREDIENTS': 88.20%

TOTAL, too.OO% •Diethylene GIyeol Monoethyl Ether,

VitaminE Nicotinate

t~~fi~~{~/J~ {:~i:S~:~:win9 Iice ~:thbsq uitoes

,,{'{.• Controls mites that may

cause sarcoptic mange

• Waterproof

TOF REACH OF CHILDREN

. RNING

\ > Back LlbdPaMl /orAdditiorlal Pre<autio<\,,,ySt<rte""'n15

Net Contents: Three 0,136 fl oz

(4,02 mL) applicators

"-----------t---------->-r''----~i:;:ia~:······'·i~~~~---------~'

'APPlicatlons. '. '.

i\S£~'TRY

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Front

White tube f Blacktext on awhite label! Colored Strip

; ... Brand Xlor Dogs B9-132lBs T-lobel

ART

_.

INSTRUCTION FOR THE PR1NTER

BlACK PM~294S

Printer/Vendar:

Additional Note~:

Dote ~cnt:

38.tmm

8mm

.--..

tQmm

Labels adhere to White Tubes

MAR 23

Front

White tube f Blacktext on awhite label! Colored Strip

; ... Brand Xlor Dogs B9-132lBs T-lobel

ART INSTRUCTION FOR THE PR1NTER

•BlACK PM~ 2945

Printer/Vendor:

Addilian0 INate~:

Dote ~cnt:

38.tmm

8mm

...--..

tQmm

Labels adhere to White Tubes

MAR 2 3

34
ART lNSTRUCTlON FOR THE PRINTER

•

BackTube Label

Printer/Vendor:

Additional Notes:

Date mnt:

8mm

38.1mm

-..

10mm

Labels adhere to White Tubes

2-517-1'-\\ M.A.R 2 3

Back Tube Label

KEEP OllT Of REACK OfCKILD REN . WARNI NG, Ro.d direotic", and pr,,",,'"'''' before "'"'H. U." "i,>o"ncopoo, EPA REG, No, 2517·RUR poo;oo;x

8mm

38.1mm

ART lNSTRUCTlON FOR THE PRINTER

•

!lAO(

Printer/Vendor:

Additianal Note;:

Date rent:

Labels adhere to White Tubes

2-517-141 M.A.R

35

2 3
ART INSTRUCTION FOR THE PRINTER

--

BlACK 1MS 173S

Printer/Yendor:

Additional Notel:

Dote sent:

25'n-I,+1

MAR 23

ART INSTRUCTION FOR THE PRINTER

•BlACK 1MS 173S

Printer/Yendor:

Additional Notel:

Dote sent:

MAR 2 3

36
MAR 23

37
r

Q/

38
Decision #: 438358

DP #: (382775)

PRIA

Parent DP #:

Submission #: 880181

DATA PACKAGE BEAN SHEET

Date: 05-0ct-2010

Page t of 2

* * * Registration Information * * *

Registration: ~~JZ::BJlR.~.§_I;R.G_I;~_~·II'§__E!~BgJ~~_b __ __~_Yb~~LS~l! EEZI;-ON ~OR D_Q@~

Company: ~~~!_:_~_~_~~_E!'-~!,_~.~E! __~~_~.§_~R~~l.:!~~~_,_~~~:- _

Risk Manager: ~M 1~-=---F3.~chard Gebken_: (70~)12E:§!9LI3_?_i?~~_~y~ __~_~I_~~! ._

Risk Manager RevIewer: Rosanna Louie RLOUIE

Sent Date: Calcula1ed Due Date: 23-Mar-2011 Edited Due Date:

Type of Registration: Product Re~~ratio~~_~!?~on L

Action DesC". LF3.~.!9L~'§YY ~_132!?_l!_~!l.l2_~:~~~T !~~_~__~_~_~_Ll.:!g.§§__~_~~~~~~_q~E~_~uCI_~~_~~l~_

Ingredients: 1291 ~f~pr0.!:lll(9-.:..~L _

_12903~yriprt?.~!:!:'(2'Y"J _

* ** Data Package Information * **

Expedite: 0 Yes • No Date Sent: 05-0ct-20 fO Due Back:

DP Ingredient: _~~~_~~~:_~y!~_~_T:_~__

129t2f, Fipronil

DP Tille: ~~~!_!_~~_~~~_~r.?_?':19!__~_~_:_f!1_i':'~ry __~:~i:_~ _

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

Organization: RD f TRB

Date In Date Out

/

Last Possible Science Due Date: 21-Feb-2011 ( --------------------

Team Name: CHEM ------------------------

Reviewer Name: lJt.\JsJ tdlti~,.J:L~I;t ---.!?~~~t

Contractor Name:

____O_3-!CXZ/20 {I Science Due Date: .90;lzs-l-a Sub Data Package Due Date:

* * * Studies Sent for Review * * *

Printed on Page 2

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

Can be printed on its own page

** * Data Package Instructions ** *

Attn TRBfCHEM: Please conduct a product chemistry review the attached package in support of Ihe proposed product, containing fipronil and

pyriproxyfen (nylar). Contact Rosanna Louie-Juzwiak at 308,0037 with any questions.

Attachments:

- cover letter

• basic CSF

- draft label

- MRIDs 48189401, -02

Decision #: 438358

DP #: (382775)

PRIA

Parent DP #:

Submission #: 880181

DATA PACKAGE BEAN SHEET

Date: 05-0ct-2010

Page t of 2

* * * Registration Information * * *

Registration: ~~JZ::BJlR.~.§_I;R.G_I;~_~·II'§__E!~BgJ~~_b __ __~_Yb~~LS~l! EEZI;-ON ~OR D_Q@~

Company: ~~~!_:_~_~_~~_E!'-~!,_~.~E! __~~_~.§_~R~~l.:!~~~_,_~~~:- _

Risk Manager: ~M 1~-=---F3.~chard Gebken_: (70~)12E:§!9LI3_?_i?~~_~y~ __~_~I_~~! ._

Risk Manager RevIewer: Rosanna Louie RLOUIE

Sent Date: Calcula1ed Due Date: 23-Mar-2011 Edited Due Date:

Type of Registration: Product Re~~ratio~~_~!?~on L

Action DesC". LF3.~.!9L~'§YY ~_132!?_l!_~!l.l2_~:~~~T !~~_~__~_~_~_Ll.:!g.§§__~_~~~~~~_q~E~_~uCI_~~_~~l~_

Ingredients: 1291 ~f~pr0.!:lll(9-.:..~L _

_12903~yriprt?.~!:!:'(2'Y"J _

* * * Data Package Information * * *

Expedite: 0 Yes • No Date Sent: 05-0ct-20 fO Due Back:

DP Ingredient: _~~~_~~~:_~y!~_~_T:_~__

129t2f, Fipronil

DP Tille: ~~~!_!_~~_~~~_~r.?_?':19!__~_~_:_f!1_i':'~ry __~:~i:_~ _

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

Organization: RD f TRB

Date In Date Out

/

Last Possible Science Due Date: 21-Feb-2011 ( --------------------

Team Name: CHEM ------------------------

Reviewer Name: lJt.\JsJ tdlti~,.J:L~I;t ---.!?~~~t

Contractor Name:

____O_3-!CXZ/20 {I Science Due Date: .90;lzs-l-a Sub Data Package Due Date:

* * * Studies Sent for Review * * *

Printed on Page 2

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

Can be printed on its own page

* * * Data Package Instructions * * *

Attn TRBfCHEM: Please conduct a product chemistry review the attached package in support of Ihe proposed product, containing fipronil and

pyriproxyfen (nylar). Contact Rosanna Louie-Juzwiak at 308,0037 with any questions.

Attachments:

- cover letter

• basic CSF

- draft label

- MRIDs 48189401, -02

39
DP#: (382775)

48189402

48189401

48189402

4818940t

48t89402

48189401

48189401

48189401

48189401

48t89402

Page2

S1udles Sent for Review" ~.,

for Dogs. Project Number:

0/06. Unpublished study prepared by

Sergeant's Pe1 Care Products, Inc.6 p.

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

Fipronll+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/06. Unpublished study prepared by

Sergeant's Pet Care Products, Inc.

6 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pet Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

Fipronil+ Nylar Squeeze·On for Dogs. Project Number:

SERGEANTS/07/1O/06. Unpublished study prepared by

Sergeant's Pet Care Products, Inc.6 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pe1 Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

FipronH+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/06. Unpublished s1udy prepared by

Sergeant's Pet Care Products, Inc.6 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pet Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pet Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pet Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/1O/05. Unpublished study prepared by

Sergeant's Pe1 Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

Fipronil+ Nylar Squeeze-On for D09S. Project Number:

SERGEANTs/07l1 0/06. Unpublished study prepared by

Sergeant's Pet Care Products, Inc.6 p.

Decision#: (438358)

830.7300IDensity/relative density

830.1670/Dlscussion of formation of

impurities

830.6303/Physical slate

830.1550/Productldentity and

composition

830.6302JColor

830.1620/Description of production

process

830.1750/Certified limits

830.1600lDescription of materials

used to produce the product

830.1650lDescription of formulation

process

830.6304/0dor

DP#: (382775)

48169402

48189402

48189401

48189402

4818940t

48t89402

48189401

48189401

48189401

48189401

48t 89402

Page2

~ ~ ~ S1udles Sent for Review ., ~.,

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

Fipronil

+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07l1 0/06. Unpublished study prepared by

Sergeant's Pe1 Care Products, Inc.

6 p.

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

Fipronll

+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/06. Unpublished study prepared by

Sergeant's Pet Care Products, Inc.6 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pet Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

Fipronil

+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/1O/06. Unpublished study prepared by

Sergeant's Pet Care Products, Inc.6 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil

+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pe1 Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

FipronH+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/1 0106. Unpublished s1udy prepared by

Sergeant's Pet Care Products, Inc.6 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pet Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil

+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pet Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil

+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/10/05. Unpublished study prepared by

Sergeant's Pet Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupA Product Chemistry for Sergeant's

Firponil

+ Nylar Squeeze-On for Dogs. Project Number:

SERGEANTS/07/1O/05. Unpublished study prepared by

Sergeant's Pe1 Care Products, Inc. 53 p.

Hoskins, K. (2010) GroupB Product Chemistry for Sergeant's

Fipronil

+ Nylar Squeeze-On for D09S. Project Number:

SERGEANTs/07l1 0106. Unpublished study prepared by

Sergeant's Pet Care Products, Inc.6 p.

Decision#: (438358)

830-7100Niscosity

830.7300IDensity/relative density

830.1670/Dlscussion of formation of

impurities

830.6303/Physical slate

830.1550/Productldentity and

composition

830.6302lColor

830.16201Description of production

process

830.1750/Certified limits

830.1600lDescription of materials

used to produce the product

830.1650lDescription of formulation

process

830.6304/0dor

40
DP BAR CODE NO.: 382775

PC Codels): 129121, 129032

FOOD Use: No

DATE OUT: February 18, 2011

FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358

ACTION CODE: R310

NON-FOOD Use: Yes

SUBJECT; End Use Product Chemistry Review

Product Name: Sergeant's Fipronil + Nylar Squeze-On for Dogs

FROM:

TO:

Hari Mukhoty, Product Chemistry Team

Technical Review Branch I Registration Division (7505P)

Rosanna Louie I Richard Gebken PM -10

Insecticide Branch I Registration Division (750SP)

Company Name:

Formulation Type:

INTRODUCTION:

Sergeant's Pet Care Products, Inc.

Liquid

The Registrant has re-submttted one basic CSF (dated: 02/28/2011), an amended CSF (dated: 02/2812011)

to the aforesaid basic as an alternate formulation (Alt # 1) and a proposed product specific label (dated

08/11/2010) for registration of the aforesaid products under EPA File Symbol No. 2517-RUR. The registrant

submitted product chemistry data under MRIDs: 481894-01 and -02 to support the registration of the

proposed product.

The primary review of the product chemistry data was performed by a contractor (attached as the last page

of this review) and TRB is conducting the secondary review.

TRB has been requested to evaluate the product chemistry data required for the registration of the proposed

basic product.

SUMMARY OF FINDINGS:

1. Name of Active Ingredient(s): Fipronil (9.8%) and Pyriproxyfen (2.0%).

2. The source materials of the active ingredients are registered with the Agency.

3. All inert ingredients have been screened by IIAB on 02/2212011 and have found to be approved for nonfood uses only.

DP BAR CODE NO.: 382775

PC Codels): 129121, 129032

FOOD Use: No

DATE OUT: February 18, 2011

FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358

ACTION CODE: R310

NON-FOOD Use: Yes

SUBJECT; End Use Product Chemistry Review

Product Name: Sergeant's Fipronil + Nylar Squeze-On for Dogs

FROM:

TO:

Hari Mukhoty, Product Chemistry Team

Technical Review Branch I Registration Division (7505P)

Rosanna Louie I Richard Gebken PM -10

Insecticide Branch I Registration Division (750SP)

Company Name:

Formulation Type:

INTRODUCTION:

Sergeant's Pet Care Products, Inc.

Liquid

The Registrant has re-submttted one basic CSF (dated: 02/28/2011), an amended CSF (dated: 02/2812011)

to the aforesaid basic as an alternate formulation (Alt # 1) and a proposed product specific label (dated

08/11/2010) for registration of the aforesaid products under EPA File Symbol No. 2517-RUR. The registrant

submitted product chemistry data under MRIDs: 481894-01 and -02 to support the registration of the

proposed product.

The primary review of the product chemistry data was performed by a contractor (attached as the last page

of this review) and TRB is conducting the secondary review.

TRB has been requested to evaluate the product chemistry data required for the registration of the proposed

basic product.

SUMMARY OF FINDINGS:

1. Name of Active Ingredient(s): Fipronil (9.8%) and Pyriproxyfen (2.0%).

2. The source materials of the active ingredients are registered with the Agency.

3. All inert ingredients have been screened by IIAB on 02/2212011 and have found to be approved for nonfood uses only.

41
DP BAR CODE NO.: 382775

PC Code(s): 129121, 129032

FOOD Use: No

4. Confidential Statement of Formula(s):

FILE SYMBOL NO.: 2517·RUR DECISION NO.: 438358

ACTION CODE: R310

NON~FOOD Use: Yes

[XJ Basic- Dated: 0811112010 resubmitted - Dated: 02/28/2011

[X) Alternate # . Dated: 0212812011

Alternate CSF(s) complies with 40CFR §152.43: [X JYes [[ No.

5. Product label

a. Ingredient statement Nominal concentration of AI listed on CSF(s) concur with product label (PR

Notice 91-2)

[X [Yes

Metallic equivalent: [ 1Yes [X [NA;

Soluble arsenic: [J Yes [ X [NA

Isomeric ratios: [[Yes [ X [ NA

b. Health related sub statements:

Petroleum distillate at > 10%: [J Yes [ JNo [X JNA

Methanolat>4%: [ JYes r [No [X [NA

c. Physical chemical hazard statement: Product label requires a statement per 40 CFR §156.78 for:

flammability, explosive potential or electric insulator breakdown?

[ X [Yes [[ No The label needs a flammability statement: Combustible. Do not use or store near

heat or open flame.

Is the sub statement in compliance with PR Notice 97-6? [X [YES - Uses the term "Other

Ingredients"

, if not, explain below:

d. Label' requires an additional Storage and Disposal statement: [ [Yes [X [No - from product

chemistry point of view; if yes explain below:

Final decision of overall label acceptance will be made by the PM.

2

DP BAR CODE NO.: 382775

PC Code(s): 129121, 129032

FOOD Use: No

4. Confidential Statement of Formula(s):

FILE SYMBOL NO.: 2517·RUR DECISION NO.: 438358

ACTION CODE: R310

NON~FOOD Use: Yes

[XJ Basic- Dated: 0811112010 resubmitted - Dated: 02/28/2011

[X) Alternate # . Dated: 0212812011

Alternate CSF(s) complies with 40CFR §152.43: [X JYes [[ No.

5. Product label

a. Ingredient statement Nominal concentration of AI listed on CSF(s) concur with product label (PR

Notice 91-2)

[X [Yes

Metallic equivalent: [ 1Yes [X [NA;

Soluble arsenic: [J Yes [ X [NA

Isomeric ratios: [[Yes [ X [ NA

b. Health related sub statements:

Petroleum distillate at > 10%: [J Yes [ JNo [X JNA

Methanolat>4%: [ JYes r [No [X [NA

c. Physical chemical hazard statement: Product label requires a statement per 40 CFR §156.78 for:

flammability, explosive potential or electric insulator breakdown?

[ X [Yes [[ No The label needs a flammability statement: Combustible. Do not use or store near

heat or open flame.

Is the sub statement in compliance with PR Notice 97-6? [X [YES - Uses the term "Other

Ingredients"

, if not, explain below:

d. Label' requires an additional Storage and Disposal statement: [ [Yes [X [No - from product

chemistry point of view; if yes explain below:

Final decision of overall label acceptance will be made by the PM.

2

42
DP BAR CODE NO.: 382775

PC Code(s): 129121, 129032

FOOD Use: No

6. Group A: Product Chemistry Data

FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358

ACTION CODE: R310

NON~FOOD Use: Yes

TRB's determination of the acceptability of the data for the proposed product is listed in the tables

below.

Data submitted

Guideline TRB's

No. Study Title Assessment MRID Nos.

of Data 481894-01 Yes No

Product Identity & Composition A "

830.1550 X

Description of materials used to A "

830.1600 oroducetheoroduct X

Description of formulation X A "

830.1650 orocess

Discussion on the formation of X "

830.1670 impurities A

830.1700 Preliminarv analvsis NA

Standard certified

Limits X A "

Certified

limits Proposed Limits

(158.350) Justification for

830.1750 wider limits

Enforcement analytical method Cited MRID:

481226-01 from

A- GC using EPA Reg. No.

830.1800 X FID 2517-140

A =Acceptance, NA = Not Acceptable, G = Data Gap,

W = Waiver Request, I = In Progress, NA =Not Applicable

3

DP BAR CODE NO.: 382775

PC Code(s): 129121, 129032

FOOD Use: No

6. Group A: Product Chemistry Data

FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358

ACTION CODE: R310

NON~FOOD Use: Yes

TRB's determination of the acceptability of the data for the proposed product is listed in the tables

below.

Data submitted

Guideline TRB's

No. Study Title Assessment MRID Nos.

of Data 481894-01 Yes No

Product Identity & Composition A "

830.1550 X

Description of materials used to A "

830.1600 oroducetheoroduct X

Description of formulation X A "

830.1650 orocess

Discussion on the formation of X "

830.1670 impurities A

830.1700 Preliminarv analvsis NA

Standard certified

Limits X A "

Certified

limits Proposed Limits

(158.350) Justification for

830.1750 wider limits

Enforcement analytical method Cited MRID:

481226-01 from

A- GC using EPA Reg. No.

830.1800 X FID 2517-140

A =Acceptance, NA = Not Acceptable, G = Data Gap,

W = Waiver Request, I = In Progress, NA =Not Applicable

3

43
DP BAR CODE NO.: 382775

PC Code(s): 129121, 129032

FOOD Use: No

7. Group B:

FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358

ACTION CODE: R310

NONMFOOD Use: Yes

Guideline Study Title Value or Qualitative TRS's MRIDNos.

No. Description Assessment 481894-02

of Data "

830.6303 Physical State Liquid A "

830.6315 Flammabilitv Flash Point is > 194 Cl F A "

No explosive material in the

830.6316 Explodability formulation NA "

Not soluble/dispersible in

830.7000 pH water A "

Density (Specific

830.7300 aravltv) 1.02M 1.06 qr/cc A "

A =Acceptance, N = Not Acceptable, G =Data Gap, W = Waiver request,

NA =Not applicable, I = In progress

CONCLUSIONS:

1. TRS has reviewed the CSFs (dated: 02/28/2011) for the proposed basic and alternate (Alt. # 1) products

and has found them to be acceptable. The CSFs are attached with this review in OPPIN CHEM DOCS.

2. Product chemistry Group A and Group B data, with the exception of one year storage stability (830.6317)

and corrosion characteristics (830.6320) are satisfied and acceptable.

3. The registrant must generate one year storage stability (830.6317) and corrosion characteristics

(830.6320) data on the proposed product. It is required that the observations be made at 0, 3, 6, 9, and 12

month intervals. The results must be submitted to the Agency in electronic and hard copy format.

4. The proposed label was screened as it pertains to the product chemistry requirements. The final review

of the proposed label and uses are the purview of the PM team.

4

DP BAR CODE NO.: 382775

PC Code(s): 129121, 129032

FOOD Use: No

7. Group B:

FILE SYMBOL NO.: 2517-RUR DECISION NO.: 438358

ACTION CODE: R310

NONMFOOD Use: Yes

Guideline Study Title Value or Qualitative TRS's MRIDNos.

No. Description Assessment 481894-02

of Data "

830.6303 Physical State Liquid A "

830.6315 Flammabilitv Flash Point is > 194 Cl F A "

No explosive material in the

830.6316 Explodability formulation NA "

Not soluble/dispersible in

830.7000 pH water A "

Density (Specific

830.7300 aravltv) 1.02M 1.06 qr/cc A "

A =Acceptance, N = Not Acceptable, G =Data Gap, W = Waiver request,

NA =Not applicable, I = In progress

CONCLUSIONS:

1. TRS has reviewed the CSFs (dated: 02/28/2011) for the proposed basic and alternate (Alt. # 1) products

and has found them to be acceptable. The CSFs are attached with this review in OPPIN CHEM DOCS.

2. Product chemistry Group A and Group B data, with the exception of one year storage stability (830.6317)

and corrosion characteristics (830.6320) are satisfied and acceptable.

3. The registrant must generate one year storage stability (830.6317) and corrosion characteristics

(830.6320) data on the proposed product. It is required that the observations be made at 0, 3, 6, 9, and 12

month intervals. The results must be submitted to the Agency in electronic and hard copy format.

4. The proposed label was screened as it pertains to the product chemistry requirements. The final review

of the proposed label and uses are the purview of the PM team.

4

44
DATA EVALUATION RECORD

FIPRONIL

PYRIPROXIFEN

(Sergeant's Fipronil + Nylar Squeeze-On for Dogs)

STUDY TYPES; Product Identity and Composition (OPPTS 830.1550)

Description of Materials Used to Produce the Product (OPPTS 830.1600)

Description of Production Process (830.1620)

Discussion of Formation ofImpurities (OPPTS 830.1670)

Preliminary Analysis (OPPTS 830.1700)

Certified Limits (OPPTS 830.1750)

Enforcement Analytical Method (OPPTS 830.1800)

Physical and Chemical Characteristics (OPPTS 830.6302-830.7950)

MRIDs 481894-01 and 481894-02

Prepared for

Registration Division

Office ofPesticide Programs

U.S. Environmental Protection Agency

One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Prepared by

Toxicology and Hazard Assessment Group

Environmental Sciences Division

Oak Ridge National Laboratory

Oak Ridge, TN 37831

Task Order No. 1-45

Primary Reviewer:

Eric B. Lewis, M.S.

Secondary Reviewers:

Sylvia Milanez, Ph.D., D.A.B.T.

Robert H. Ross, M.S., Group Leader

Quality Assurance:

Kimberly G. Slusher, M.S.

Disclaimer

Signature:

Date:

Signature:

Date:

Signature:

Date:

Signature:

Date:

Ie tb uJ \{ Ro.wJ

JM 1 1 1011

This review may have been altered subsequent to the contractor's signatures above.

Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC.\ for the U.S. Department of Energy under

Contract No. DE-ACOS-000R2272S.

DATA EVALUATION RECORD

FIPRONIL

PYRIPROXIFEN

(Sergeant's Fipronil + Nylar Squeeze-On for Dogs)

STUDY TYPES; Product Identity and Composition (OPPTS 830.1550)

Description of Materials Used to Produce the Product (OPPTS 830.1600)

Description of Production Process (830.1620)

Discussion of Formation ofImpurities (OPPTS 830.1670)

Preliminary Analysis (OPPTS 830.1700)

Certified Limits (OPPTS 830.1750)

Enforcement Analytical Method (OPPTS 830.1800)

Physical and Chemical Characteristics (OPPTS 830.6302-830.7950)

MRIDs 481894-01 and 481894-02

Prepared for

Registration Division

Office ofPesticide Programs

U.S. Environmental Protection Agency

One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Prepared by

Toxicology and Hazard Assessment Group

Environmental Sciences Division

Oak Ridge National Laboratory

Oak Ridge, TN 37831

Task Order No. 1-45

Primary Reviewer:

Eric B. Lewis, M.S.

Secondary Reviewers:

Sylvia Milanez, Ph.D., D.A.B.T.

Robert H. Ross, M.S., Group Leader

Quality Assurance:

Kimberly G. Slusher, M.S.

Disclaimer

Signature:

Date:

Signature:

Date:

Signature:

Date:

Signature:

Date:

2011

~,~?r~'<7,/~A5J~'1,lJ-I;h,f/JiUjt JAN 1 I LOll

This review may have been altered subsequent to the contractor's signatures above.

Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC.\ for the U.S. Department of Energy under

Contract No. DE-ACOS-000R2272S.

45
DATA PACKAGE BEAN SHEET

Date: 05-0ct-2010

Page 1 of2

Decision #: 438358

DP #: (382776)

PRIA

Parent DP #:

Submission #: 880181 * * * Registration Information * * *

Registration: ~~7-~UR,-g~G~A!'lT'SFll'llON-'-Lc+_f'l'(LA_R SqUEEZE:Qi'l£Q[l_D_OQ! /Vs,,-0 r 11 /

Company 25t7-SERGEANTSPETCAREPRODUCTS,INC _ ~. L.k r

Risk Manager ~_~ t~ ~c~~_rd_~~£~~~ -F~3) 30?:6~O t Ri?9m# ':':r:~_ ~:T?E________ \ ~~ Risk Manager Reviewer Rosanna lOUie RlOUIE y rJ'

Sen! Date: Calculated Due Date: 23-Mar-20 t t Edited Due Dale:

Type of Registration: Product Registration - Seclion_~_

Action Desc: \~~_!~t~§~~~2!?-~~!~~2_~_~~~_~_!_!~~_~J~~~~_~~~~_~§~~~_Q~_PRC2QlJ~!_g!i_~~!~

Ingredients: t29~fiproni~@~_%) _

* * * Data Package Information * * *

Expedite: 0 Yes. No Date Sent: 05-0ct-2010 Due Back:

DP Ingredient: 129032, Pyriproxyfen

DP Title: ~25 t2:~.!:!.~~~.£0~I.9.?~L~~¥_~~":'~t::~ _

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

Organization: RD I TRB

Date In Date Out ~/

..................-.-.-- last Possible Science Due Date: ~!:Fe~~~1J. _

Team Name: TOX Science Due Date:

Reviewer Name:

Contractor Name:

Sub Data Package Due Date: _

** * Studies Sent for Review * * *

Printed on Page 2

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

Can be printed on its own page

* * * Data Package Instructions * * *

Attn TRBfTOX: Please conduct an acute toxicity review of the attached package in support of the proposed product. Contact Rosanna

louie-Juzwiak at 308.0037 with any questl(lns.

Attachments:

• cover letter

- basic CSF

- drafllabel

• Data Matrix

DATA PACKAGE BEAN SHEET

Date: 05-0ct-2010

Page 1 of2

Decision #: 438358

DP #: (382776)

PRIA

Parent DP #:

Submission #: 880181 * * * Registration Information * * *

Registration: ~~7-~UR,-g~G~A!'lT'SFll'llON-'-Lc+_f'l'(LA_R SqUEEZE:Qi'l£Q[l_D_OQ! /Vs,,-0 r 11 /

Company 25t7-SERGEANTSPETCAREPRODUCTS,INC _ ~. L.k r

Risk Manager ~_~ t~ ~c~~_rd_~~£~~~ -F~3) 30?:6~O t Ri?9m# ':':r:~_ ~:T?E________ \ ~~ Risk Manager Reviewer Rosanna lOUie RlOUIE y rJ'

Sen! Date: Calculated Due Date: 23-Mar-20 t t Edited Due Dale:

Type of Registration: Product Registration - Seclion_~_

Action Desc: \~~_!~t~§~~~2!?-~~!~~2_~_~~~_~_!_!~~_~J~~~~_~~~~_~§~~~_Q~_PRC2QlJ~!_g!i_~~!~

Ingredients: t29~fiproni~@~_%) _

* * * Data Package Information * * *

Expedite: 0 Yes. No Date Sent: 05-0ct-2010 Due Back:

DP Ingredient: 129032, Pyriproxyfen

DP Title: ~25 t2:~.!:!.~~~.£0~I.9.?~L~~¥_~~":'~t::~ _

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

Organization: RD I TRB

Date In Date Out ~/

..................-.-.-- last Possible Science Due Date: ~!:Fe~~~1J. _

Team Name: TOX Science Due Date:

Reviewer Name:

Contractor Name:

Sub Data Package Due Date: _

** * Studies Sent for Review * * *

Printed on Page 2

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

Can be printed on its own page

* * * Data Package Instructions * * *

Attn TRBfTOX: Please conduct an acute toxicity review of the attached package in support of the proposed product. Contact Rosanna

louie-Juzwiak at 308.0037 with any questl(lns.

Attachments:

• cover letter

- basic CSF

- drafllabel

• Data Matrix

46
DP#: (382776)

Page2

••• Studies Sent for Review··• Decision#: (438358)

48129604

48129603

48129608

48129606

48129607

48129604

48129605

Leoni, A. (2010) Acute Dermal Toxicity (Limit Test) with Dog

Products (in Rats): Final Report. Project Number: 100138B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 34 p.

Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with

Dog Products (in Rats): Final Report. Project Number: 100137B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 45 p.

Stelter, D. (2010) Test for Sensitization (Guinea Pig Maximisallon

Test) with Dog Products (in Guinea Pigs): Final Report. Project

Number: t00141B. Unpublished study prepared by BSL

Bioservice Scientific Laboratories Gmbh. 41 p.

Ahuja, V. (20 to) Acute Eye Irritation/Corrosion with Dog Products

(in Rabbits): Final Report. Project Number: 100140B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 33 p.

Ahuja, V. (20 to) Acute Dermal Irritation/Corrosion with Dog

Products (in Rabbits): Final Report. Project Number: 100139B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 29 p.

Leoni, A. (2010) Acute Dermal Toxicity (Limit Test) with Dog

Products {in Rats}: Final Report. Profect Number: 100138B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 34 p.

Hoskins, K. (2010) Waiver Request of Requirement for Further

Testing for Acute Inhalation Toxicity for Following Sergeant's

Products: Sergeant's Fipronil+ Cyphenothrin Squeeze-On for

Dogs, Sergeant's Fipronil

+ Cyphenothrin+ Methoprene

Squeeze-On for Dogs, Sergeant's Fipronil+ Cyphenothrin+ Nylar

Squeeze-On for Dogs, Sergeant's Fipronil

+ Nylar Squeeze-On for

Dogs, Sergeant's Fipronil

+ Etofenprox Spot-On for Cats,

Sergeant's Fipronil+ Etofenprox+ Methoprene Spot-On for Cats,

Sergeant's Fipronil

+ Etofenprox+ Nylar Spot-On for Cats,

Sergeant's Fipronil

+ Nylar Spot-On for Cats. Project Number:

SERGEANTS/06/10/0S. Unpublished study prepared by

Sergeant's Pet Care Products, Inc.6 p.

870.1000/Acute Toxicity

testing-background

870.t100/Acute Oral Toxicity

870.2600/Skin sensitizallon

870.2400/Acute eye irritation

870.2500/Acute dermal irritation

870.1200/Acute dermal toxicity

870.1300/Acute inhalation toxicity

DP#: (382776)

Page2

••• Studies Sent for Review··• Decision#: (438358)

48129604

48129603

48129608

48129606

48129607

48129604

48129605

Leoni, A. (2010) Acute Dermal Toxicity (Limit Test) with Dog

Products (in Rats): Final Report. Project Number: 100138B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 34 p.

Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with

Dog Products (in Rats): Final Report. Project Number: 100137B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 45 p.

Stelter, D. (2010) Test for Sensitization (Guinea Pig Maximisallon

Test) with Dog Products (in Guinea Pigs): Final Report. Project

Number: t00141B. Unpublished study prepared by BSL

Bioservice Scientific Laboratories Gmbh. 41 p.

Ahuja, V. (20 to) Acute Eye Irritation/Corrosion with Dog Products

(in Rabbits): Final Report. Project Number: 100140B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 33 p.

Ahuja, V. (20 to) Acute Dermal Irritation/Corrosion with Dog

Products (in Rabbits): Final Report. Project Number: 100139B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 29 p.

Leoni, A. (2010) Acute Dermal Toxicity (Limit Test) with Dog

Products {in Rats}: Final Report. Profect Number: 100138B.

Unpublished study prepared by BSL Bioservice Scientific

Laboratories Gmbh. 34 p.

Hoskins, K. (2010) Waiver Request of Requirement for Further

Testing for Acute Inhalation Toxicity for Following Sergeant's

Products: Sergeant's Fipronil+ Cyphenothrin Squeeze-On for

Dogs, Sergeant's Fipronil

+ Cyphenothrin+ Methoprene

Squeeze-On for Dogs, Sergeant's Fipronil+ Cyphenothrin+ Nylar

Squeeze-On for Dogs, Sergeant's Fipronil

+ Nylar Squeeze-On for

Dogs, Sergeant's Fipronil+ Etofenprox Spot-On for Cats,

Sergeant's Fipronil+ Etofenprox+ Methoprene Spot-On for Cats,

Sergeant's Fipronil

+ Etofenprox+ Nylar Spot-On for Cats,

Sergeant's Fipronil

+ Nylar Spot-On for Cats. Project Number:

SERGEANTS/06/10/0S. Unpublished study prepared by

Sergeant's Pet Care Products, Inc.6 p.

870.1000/Acute Toxicity

testing-background

870.t100/Acute Oral Toxicity

870.2600/Skin sensitizallon

870.2400/Acute eye irritation

870.2500/Acute dermal irritation

870.1200/Acute dermal toxicity

870.1300/Acute inhalation toxicity

47
Decision #: 438358

DP #: (382777)

PRIA

Parent DP#:

Submission #: 880181

DATA PACKAGE BEAN SHEET

Date: 05-0ct-2010

Page 1 of2

* * * Registration Information * * *

Registration: ~~tT:R!Jlt::,,§,~g@!;ANT§J:-'ERQ_NIL_~_~J'bAR ~qU~EZE:9_~"--E9J~J)g@,~

Company: 2517 - SERGEANTS PET CARE PRODUCTS, INC,

Risk Manager: RM to - Richard Gebken - (703) ~95~Q)__!39_<:'f.T.l.~_'=X!_§_~!~~? _

Risk Manager Reviewer: Rosanna Louie RLDUJE

Sent Dale: Calculated Due Date: 23-Mar-2011 Edited Due Dale:

Type of Registration: ~roduct Registration - Section 3 _

Action Desc: (R310L~_~~__P._~2~~~_~~~2~~~_~_~_! __~~~_~_I~CL_~Q~§_~~~~~_~_2f_f'ROOUCT ~_~~~JS~

Ingredients: ~291~!~.Yipronilt~,~~) _

* * * Data Package Information * **

Expedite: 0 Yes. No Date Sent: 05-0ct-2010 Due Back:

DP Ingredient: !3_~.0_~~~_~t~P~c.T=-~ N _

129121, Fipronil

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

Organization: _~L!:R~__.. _

Team Name: TOX

Date In Date Out

/

Last Possible Science Due Date: 21-Feb-2011,/

Science Due Date:

Reviewer Name: Sub Data Package Due Date:

Contractor Name:

* * * Studies Sent for Review * * *

Printed on Page 2

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

Can be printed on its own page

* * * Data Package Instructions * * *

Attn TRBrrOX: Please conduct a companion animal safety study review of the attached package in support of the proposed product. Contact

Rosanna Louie-Juzwiak at 308.0037 with any questions.

Attachments:

- cover letter

- draft label

- data matrix

- c...Sv:

Decision #: 438358

DP #: (382777)

PRIA

Parent DP#:

Submission #: 880181

DATA PACKAGE BEAN SHEET

Date: 05-0ct-2010

Page 1 of2

* * * Registration Information * * *

Registration: ~~tT:R!Jlt::,,§,~g@!;ANT§J:-'ERQ_NIL_~_~J'bAR ~qU~EZE:9_~"--E9J~J)g@,~

Company: 2517 - SERGEANTS PET CARE PRODUCTS, INC,

Risk Manager: RM to - Richard Gebken - (703) ~95~Q)__!39_<:'f.T.l.~_'=X!_§_~!~~? _

Risk Manager Reviewer: Rosanna Louie RLDUJE

Sent Dale: Calculated Due Date: 23-Mar-2011 Edited Due Dale:

Type of Registration: ~roduct Registration - Section 3 _

Action Desc: (R310L~_~~__P._~2~~~_~~~2~~~_~_~_! __~~~_~_I~CL_~Q~§_~~~~~_~_2f_f'ROOUCT ~_~~~JS~

Ingredients: ~291~!~.Yipronilt~,~~) _

* * * Data Package Information * **

Expedite: 0 Yes. No Date Sent: 05-0ct-2010 Due Back:

DP Ingredient: !3_~.0_~~~_~t~P~c.T=-~ N _

129121, Fipronil

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

Organization: _~L!:R~__.. _

Team Name: TOX

Date In Date Out

/

Last Possible Science Due Date: 21-Feb-2011,/

Science Due Date:

Reviewer Name: Sub Data Package Due Date:

Contractor Name:

* * * Studies Sent for Review * * *

Printed on Page 2

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

Can be printed on its own page

* * * Data Package Instructions * * *

Attn TRBrrOX: Please conduct a companion animal safety study review of the attached package in support of the proposed product. Contact

Rosanna Louie-Juzwiak at 308.0037 with any questions.

Attachments:

- cover letter

- draft label

- data matrix

- c...Sv:

48
DP#: (382777)

43121111

43121110

46166108

43863802

47849609

43577711

48129614

43121111

43444905

43121110

43863802

Page2

*** Studies Sent for Review * * * Decision#: (438358)

~~Topical Spray"(F E. ~=~~;;;( Project Number: 94423: PS-232DAS. Unpublished study

prepared by White Eagle Toxicology Labs. 171 p.

Arnaud, J.; Consalvi, P. (1993) Domestic Animal Safety:

Assessment of the Tolerance of

a 0.25% RM 1601 Spray in

Nursing Puppies Administered Twice ata 28 Day IntelVal ata

Dose Rate of

6 mllkg: Revised: Lab Project Number CLI 180.

Unpublished study prepared by Rhone Merieux, Inc. 32 p.

Arnaud, J.; Consalvl, P. (1993) Assessment of Tolerance ofa

0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg

When Applied6 times to the Haircoat at 28 Day IntelVals:

Revised: Lab Project Number CLl138. Unpublished study

prepared by Rhone Merieux, Inc. 69 p.

Kuhn, J. (2003) Companion Animal Safety Study in Dogs:

Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project

Number; 7650/03. Unpublished study prepared by Stillmeadow,

Inc. and Miller, Thomas A. 53 p.

Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by

Topical Administration to Dogs: Fipronil Spo1 Treatment (RM

1601E): Lab Project Number: MRX 23/950406. Unpublished

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

Delport, P. (2009) Companion Animal Safely Evaluation on Dogs

of Spot-On Products Containing Multiple Toxicants and Insect

Growth Regulators: Final Report. Project Number: 2517FEGEN,

CV/08/551. Unpublished study prepared by Clin Vet International.

129 p.

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.

Hoskins, K. (2010) Companion Animal Safety for Sergeanl's 870.7200/Companion animal safety

Fipronil

+ Cyphenothrin Squeeze-On for Dogs. Project Number:

SERGEANTS/06/10106. Unpublished study prepared by

Sergeanl's Pet Care Products, Inc. 39 p.

Amaud, J.; Consalvi, P. (1993) DomesUcAnimal Safety: 870.7200/Companion animal safety

Assessment of the Tolerance of

a 0.25% RM 1601 Spray in

Nursing Puppies Administered Twice ata 28 Day IntelVal ata

Dose Rate of

6 ml/kg: Revised: Lab Project Number CLl180.

Unpublished study prepared by Rhone Merieux, Inc. 32 p.

Schwartz, E. (1994) Domestic Animal Safety Study of RM1601C 870.7200/Companion animal safety

Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab

Project Number: 94423: PS-232DAS. Unpublished study

prepared by White Eagle Toxicology Labs. 171 p.

Arnaud, J.; Consalvi, P. (1993) Assessment of Tolerance ofa 870.7200/Companion animal safety

0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg

When Applied6 times to the Haircoat at28 Day IntelVals:

Revised: Lab Project Number CLl138. Unpublished study

prepared by Rhone Merieux, Inc. 69 p.

Powell, L.; Paffett, R. (t995) Domestic Animal Safety Study by 870.7200/Companion animal safety

Topical Administration to Dogs: Fipronil Spot Treatment (RM

t601 E): Lab Project Number: MRX 23/950406. Unpublished

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

DP#: (382777)

43121111

43121110

46166108

43863802

47849609

43577711

48129614

43121111

43444905

43121110

43863802

Page2

*** Studies Sent for Review * * * Decision#: (438358)

~~Topical Spray"(F E. ~=~~;;;( Project Number: 94423: PS-232DAS. Unpublished study

prepared by White Eagle Toxicology Labs. 171 p.

Arnaud, J.; Consalvi, P. (1993) Domestic Animal Safety:

Assessment of the Tolerance of

a 0.25% RM 1601 Spray in

Nursing Puppies Administered Twice ata 28 Day IntelVal ata

Dose Rate of

6 mllkg: Revised: Lab Project Number CLI 180.

Unpublished study prepared by Rhone Merieux, Inc. 32 p.

Arnaud, J.; Consalvl, P. (1993) Assessment of Tolerance ofa

0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg

When Applied6 times to the Haircoat at 28 Day IntelVals:

Revised: Lab Project Number CLl138. Unpublished study

prepared by Rhone Merieux, Inc. 69 p.

Kuhn, J. (2003) Companion Animal Safety Study in Dogs:

Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project

Number; 7650/03. Unpublished study prepared by Stillmeadow,

Inc. and Miller, Thomas A. 53 p.

Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by

Topical Administration to Dogs: Fipronil Spo1 Treatment (RM

1601E): Lab Project Number: MRX 23/950406. Unpublished

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

Delport, P. (2009) Companion Animal Safely Evaluation on Dogs

of Spot-On Products Containing Multiple Toxicants and Insect

Growth Regulators: Final Report. Project Number: 2517FEGEN,

CV/08/551. Unpublished study prepared by Clin Vet International.

129 p.

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.

Hoskins, K. (2010) Companion Animal Safety for Sergeanl's 870.7200/Companion animal safety

Fipronil

+ Cyphenothrin Squeeze-On for Dogs. Project Number:

SERGEANTS/06/10106. Unpublished study prepared by

Sergeanl's Pet Care Products, Inc. 39 p.

Amaud, J.; Consalvi, P. (1993) DomesUcAnimal Safety: 870.7200/Companion animal safety

Assessment of the Tolerance of

a 0.25% RM 1601 Spray in

Nursing Puppies Administered Twice ata 28 Day IntelVal ata

Dose Rate of

6 ml/kg: Revised: Lab Project Number CLl180.

Unpublished study prepared by Rhone Merieux, Inc. 32 p.

Schwartz, E. (1994) Domestic Animal Safety Study of RM1601C 870.7200/Companion animal safety

Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab

Project Number: 94423: PS-232DAS. Unpublished study

prepared by White Eagle Toxicology Labs. 171 p.

Arnaud, J.; Consalvi, P. (1993) Assessment of Tolerance ofa 870.7200/Companion animal safety

0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 mllkg

When Applied6 times to the Haircoat at28 Day IntelVals:

Revised: Lab Project Number CLl138. Unpublished study

prepared by Rhone Merieux, Inc. 69 p.

Powell, L.; Paffett, R. (t995) Domestic Animal Safety Study by 870.7200/Companion animal safety

Topical Administration to Dogs: Fipronil Spot Treatment (RM

t601 E): Lab Project Number: MRX 23/950406. Unpublished

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

49
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

February IS, 2011

MEMORANDUM

Subject: Name of Pesticide Product:

EPA Reg. No. IFile Symbol:

DP Barcodes:

Decision No.:

Action Code:

PC Codes:

SERGEANT'S FlPRONIL + NYLAR SQUEEZEON FOR DOGS

2517-RUR

DP 382776, 382777

438358

R310

129121 (Fipronil: 9.8%)

129032 (Pyriproxyfen: 2.0%)

From:

To:

Registrant:

Byron T. Backus, Ph.D., Toxicologist

Technical Review Branch

Registration Division (7S05P)

Rosanna Loiue-JuzwiakJRichard Gebken RM 10

Insecticide Branch

Registration Division (7505P)

SERGEANT'S PET CARE PRODUCTS, INC.

FORMULATION FROM LABEL:

Active lngredient(s):

129121 Fipronil

129032 Pyriproxyfen

Other lngredient(s):

TOTAL

ACTION REQUESTED: The Risk Manager requests:

bvwt.

9.8%

2.0%

88.2%

100.0%

For DP 382776: " ...Please conduct an acute toxicity review of the attached package in support of

the proposed product. .. "

Page I of4

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

February 15,2011

MEMORANDUM

Subject:

From:

To:

Registrant:

Name of Pesticide Product: SERGEANT'S FlPRONIL + NYLAR SQUEEZE~

ON FOR DOGS

EPA Reg. No. IFile Symbol: 2517-RUR

DP Barcodes: DP 382776, 382777

Decision No.: 438358

Action Code: R310

PC Codes: 129121 (Fipronil: 9.8%)

129032 (Pyriproxyfen: 2.0%)

Byron T. Backus, Ph.D., Toxicologist

Technical Review Branch

Registration Division (7505P)

Rosanna Loiue-JuzwiaklRichard Gebken RM 10

Insecticide Branch

Registration Division (7505P)

SERGEANT'S PET CARE PRODUCTS, INC.

FORMULATION FROM LABEL:

Active Ingredient(s):

129121 Fipronil

129032 Pyriproxyfen

Other Ingredient(s):

TOTAL

ACTION REQUESTED: The Risk Manager requests:

bvwt.

9.8%

2.0%

88.2%

100.0%

For DP 382776: " ...Please conduct an acute toxicity review of the attached package in support of

the proposed product .. "

Page I of 4

50
For DP 382777: " ...Please conduct a companion animal safety study review of the attached

package in support of the proposed product. .. "

BACKGROUND:

The material received for review includes a data matrix, a CSF (dated 8/11/2010) and a proposed

label for this product, indicating use on adult dogs and puppies 12 weeks of age and older.

COMMENTS AND RECOMMENDATIONS:

1. The five cited acute toxicity studies (48129603, 48129604, 48129606 - 48129608) were

conducted on a formulation containing as active ingredients: Fipronil (9.8%), (S)-Methoprene

(8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as

acceptable (TRB memorandwn dated November 23, 2010 for 2517-~RUN), and can be used to

support the registration of2517-RUR. The signal word is WARNING, based on the eye

irritation potential (MRlD 48129606).

2. The material in the inhalation waiver request in MRlD 48129605 is applicable to 2517~RUR.

Refer to the TRB memorandum dated November 23,2010 for 2517~RUN which states: "Based

on the arnOlmt of formulation applied (0.5-4.5 mL), the packaging of these products (single~use

containers or ampoules), the non-volatile nature ofthe formulations, and the application method

(directly to the skin ofthe dog or cat) which does not result in any respirable particles, TRB

concludes that a waiver for the acute inhalation study requirement is appropriate, and that these

products can be assigned to EPA Toxicity Category IV by this exposure route."

3. The proposed label dosage rates for 2517-RUR are 0.67 mL for dogs up to 221bs; 1.34 mL

for dogs 23-441bs; 2.68 mL for dogs 45-881bs; and 4.02 mL for dogs 89-1321bs. The cited

companion animal safety studies include l\1RID 47849609, in which six Group A2 puppies were

treated with 5 applications ofsubstance lA (containing 8.2% cyphenothrin and 9.8% fipronil)

and 5 applications ofsubstance II (55.16% etofenprox, 8.78% methoprene and 2.31 %

pyriproxyfen). The mean total dose was 1.84 (range: 1.79-1.88) mLlkg for test substance IA and

6.88 (range: 6.69-7.05) mLlkg for substance 11. Group B2 adults were treated with 5 applications

ofsubstance IA and 5 applications ofsubstance TIl (8.90% methoprene, 2.43% pyriproxyfen).

The mean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance fA and 0.395 (range:

0.352-0.443) mLlkg for substance III. Asswning that the test substances and proposed product

have a specifiC gravity = 1.0, the puppies were treated with means of 180 mg fipronil/kg, and 159

mg pyriproxyfen/kg. Dividing these values by 5 would give 36 mg fipronil/kg and 31.8 mg

pyriproxyfen/kg. In terms ofthe formulation for 25l7~RUR these values would be 0.367, and

1.59 mLlkg, respectively, indicating that 0.67 mL would be acceptable for puppies weighing

1.83 (0.67 mL divided by 0.367 mLlkg) kg or more. 1.83 kg is 4.03 1b, so (applying a 5X safety

factor) we can accept the data for dogs weighing 4 pounds or more. The cited companion animal

safety studies adequately support the use ofthis product on dogs and puppies 12 weeks old or

older. Labeling should indicate a minimum weight of 4 lbs for dogs or puppies.

Page 2 of4

For DP 382777: " ...Please conduct a companion animal safety study review of the attached

package in support of the proposed product. .. "

BACKGROUND:

The material received for review includes a data matrix, a CSF (dated 8/11/2010) and a proposed

label for this product, indicating use on adult dogs and puppies 12 weeks of age and older.

COMMENTS AND RECOMMENDATIONS:

1. The five cited acute toxicity studies (48129603, 48129604, 48129606 - 48129608) were

conducted on a formulation containing as active ingredients: Fipronil (9.8%), (S)-Methoprene

(8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as

acceptable (TRB memorandwn dated November 23, 2010 for 2517-~RUN), and can be used to

support the registration of2517-RUR. The signal word is WARNING, based on the eye

irritation potential (MRlD 48129606).

2. The material in the inhalation waiver request in MRlD 48129605 is applicable to 2517~RUR.

Refer to the TRB memorandum dated November 23,2010 for 2517~RUN which states: "Based

on the arnOlmt of formulation applied (0.5-4.5 mL), the packaging of these products (single~use

containers or ampoules), the non-volatile nature ofthe formulations, and the application method

(directly to the skin ofthe dog or cat) which does not result in any respirable particles, TRB

concludes that a waiver for the acute inhalation study requirement is appropriate, and that these

products can be assigned to EPA Toxicity Category IV by this exposure route."

3. The proposed label dosage rates for 2517-RUR are 0.67 mL for dogs up to 221bs; 1.34 mL

for dogs 23-441bs; 2.68 mL for dogs 45-881bs; and 4.02 mL for dogs 89-1321bs. The cited

companion animal safety studies include l\1RID 47849609, in which six Group A2 puppies were

treated with 5 applications ofsubstance lA (containing 8.2% cyphenothrin and 9.8% fipronil)

and 5 applications ofsubstance II (55.16% etofenprox, 8.78% methoprene and 2.31 %

pyriproxyfen). The mean total dose was 1.84 (range: 1.79-1.88) mLlkg for test substance IA and

6.88 (range: 6.69-7.05) mLlkg for substance 11. Group B2 adults were treated with 5 applications

ofsubstance IA and 5 applications ofsubstance TIl (8.90% methoprene, 2.43% pyriproxyfen).

The mean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance fA and 0.395 (range:

0.352-0.443) mLlkg for substance III. Asswning that the test substances and proposed product

have a specifiC gravity = 1.0, the puppies were treated with means of 180 mg fipronil/kg, and 159

mg pyriproxyfen/kg. Dividing these values by 5 would give 36 mg fipronil/kg and 31.8 mg

pyriproxyfen/kg. In terms ofthe formulation for 25l7~RUR these values would be 0.367, and

1.59 mLlkg, respectively, indicating that 0.67 mL would be acceptable for puppies weighing

1.83 (0.67 mL divided by 0.367 mLlkg) kg or more. 1.83 kg is 4.03 1b, so (applying a 5X safety

factor) we can accept the data for dogs weighing 4 pounds or more. The cited companion animal

safety studies adequately support the use ofthis product on dogs and puppies 12 weeks old or

older. Labeling should indicate a minimum weight of 4 lbs for dogs or puppies.

Page 2 of4

51
4. The following is the acute toxicity profile for Sergeant's Fipronil + Nylar Squeeze-On for

Dogs (EPA File Symbol 2517-RUR), based on the results of the acute toxicity studies:

Acute oral toxicity

Acute dennal toxicity

Acute inhalation toxicity

Primary eye irritation

Primary dermal irritation

Dennal sensitization

III

III

(IV)

II

IV

Positive

Cited

Cited

Waived

Cited

Cited

Cited

MRID 48129603

MRID 48129604

(MRID 48129605)

MRID 48129606

MRID 48 I29607

MRID 48129608

5. Based on the acute toxicity profile above, and taking into consideration the proposed uses

specified on the label and information in the CSF, the following would be the precautionary and

first aid labeling for EPA File Syrnbol25 17-RUR [Sergeant's Fipronil + Nylar Squeeze-On for

Dogs] as obtained from the Label Review System;

PROOUCT 10 #:

PRODUCT NAME:

002517-00141

SERGEANT'S FIPRONIL + NYLAR SQUEEZE-ON FOR DOGS

PRECAUTIONARY STATEMENTS

SIGNAL WORO: WARNING

Hazards to Humans and Domestic Animals:

Restricted Use Pesticide due to toxicity categories. For retail sale to and use only by Certified Applicators

or persons under their direct supervision and only for those uses covered by the Certified Applicator's

certification. Child Resistant Packaging Required.

causes substantial but temporary eye injury. Harmful if absorbed through skin. Harmful if swallowed. Do

not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses). Wash

thoroughly with soap and water after handling and before eating, drinking, cheWing gum, or using

tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin. Wear long~

sleeved shirt and long pants, socks, shoes, and gloves.

Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.

First Aid:

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.

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.

Page 3 of4

4. The following is the acute toxicity profile for Sergeant's Fipronil + Nylar Squeeze-On for

Dogs (EPA File Symbol 2517-RUR), based on the results of the acute toxicity studies:

Acute oral toxicity

Acute dennal toxicity

Acute inhalation toxicity

Primary eye irritation

Primary dermal irritation

Dennal sensitization

III

III

(IV)

II

IV

Positive

Cited

Cited

Waived

Cited

Cited

Cited

MRID 48129603

MRID 48129604

(MRID 48129605)

MRID 48129606

MRID 48 I29607

MRID 48129608

5. Based on the acute toxicity profile above, and taking into consideration the proposed uses

specified on the label and information in the CSF, the following would be the precautionary and

first aid labeling for EPA File Syrnbol25 17-RUR [Sergeant's Fipronil + Nylar Squeeze-On for

Dogs] as obtained from the Label Review System;

PROOUCT 10 #:

PRODUCT NAME:

002517-00141

SERGEANT'S FIPRONIL + NYLAR SQUEEZE-ON FOR DOGS

PRECAUTIONARY STATEMENTS

SIGNAL WORO: WARNING

Hazards to Humans and Domestic Animals:

Restricted Use Pesticide due to toxicity categories. For retail sale to and use only by Certified Applicators

or persons under their direct supervision and only for those uses covered by the Certified Applicator's

certification. Child Resistant Packaging Required.

causes substantial but temporary eye injury. Harmful if absorbed through skin. Harmful if swallowed. Do

not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses). Wash

thoroughly with soap and water after handling and before eating, drinking, cheWing gum, or using

tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin. Wear long~

sleeved shirt and long pants, socks, shoes, and gloves.

Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.

First Aid:

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.

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.

Page 3 of4

52
~Do not give anything to an unconscious person.

NOTE TO PHYSICIAN: Note to PM(CRM(Registrant: 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,

According to the LRS, this product is a candidate for restricted use because it is in Toxicity

Category II for eye exposure. However, TRB concludes that, based on the packaging (in

ampules) and proposed product use (direct application to the skin of dogs or cats), the risk of eye

exposure is adequately reduced, and a restricted use classification is not necessary.

6. The CSF (dated 8/1112010) for 2517-RUR should also be reviewed and accepted by the TRB

Chemistry Team.

Page 4 of 4

~Do not give anything to an unconscious person.

NOTE TO PHYSICIAN: Note to PMfCRMfRegistrant: 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,

According to the LRS, this product is a candidate for restricted use because it is in Toxicity

Category II for eye exposure. However, TRB concludes that, based on the packaging (in

ampules) and proposed product use (direct application to the skin of dogs or cats), the risk of eye

exposure is adequately reduced, and a restricted use classification is not necessary.

6. The CSF (dated 8/1112010) for 2517-RUR should also be reviewed and accepted by the TRB

Chemistry Team.

Page 4 of 4

53
Decision #: 438358

DP #: (382778)

PRIA

Parent DP #:

Submission #: 880181 '* '* '* Registration Information '* '* '*

DATA PACKAGE BEAN SHEET

Date: 05-0ct M 2010

Page t ot 2

l't I

Registration: 2517 MRUR M §ERG~l~.T~£I~B,Q~!"__!_~~f(hARJ?g~~~zEMON FOR DO~§

Company: 2517 - SERGEANTS PET CARE PRODUCTS, INC.

Risk Manager: ~~_!9_':_~S:~_<l.~?_Qt::!?~t::~_E:~~L~_5-6Z2!B_oom.!_~,!!_~.:?~~?_

Risk Manager Reviewer: Rosanna Louie RLOUIE

Sent Date: Calculated Due Dale: 23-Mar-20t1 Edited Due Date:

Action Desc: LI3_~_~QL~~~_~_'3_Q~~~~~~~N-FAST T~f~j~~LUQES _REV~~~_~QE:£RQQ~£r~_r:tE~~?_l

Ingredients: g_~t2t. FipronJl~.:.-8_~ _

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

Expedile: 0 Yes. No Date Sent: 05-0ct-20tO Due Back:

DP Ingredient: !3_~_?_~3,_!:'_'t':~~~~_:~__

_t_?_~_!?~_, __,=_i~E~~~ _

DP Title: #2517-RUR: CRP Review

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

Organization: RD I TRB

Date In

... 0757/0 ...••...••..............

Date Out ---------------

r, l2:3\/.o last Possible Science Due Date: 2t-Feb-20t 1

Science Due Date:

Reviewer Name: Sub Dala Package Due Date:

Contractor Name:

* * * Studies Sent for Review * * *

Printed on Page 2

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

Can be printed on its own page

'I< 'I< 'I< Data Package Instructions 'I< 'I< 'I<

Attn TRBlCRP: Please conduct a CRP Packaging review of the attached package in support of the proposed product. Contact Rosanna

louie-Juzwiak at 308.0037 with any questions.

Attachments:

- cover letter

- letter for CRP certification (including cited studies)

- letler for CRP intormation

- basic CSF

- draft label

- data matrix

NOTE: with regards to CRP review, there is no greater toxicity from pyriproxyfen exposure (i.e., does not trigger need for CRP) that would

exceed Ihat ot fipronil.

Decision #: 438358

DP #: (382778)

PRIA

Parent DP #:

Submission #: 880181 '* '* '* Registration Information '* '* '*

DATA PACKAGE BEAN SHEET

Date: 05-0ct M 2010

Page t ot 2

l't I

Registration: 2517 MRUR M §ERG~l~.T~£I~B,Q~!"__!_~~f(hARJ?g~~~zEMON FOR DO~§

Company: 2517 - SERGEANTS PET CARE PRODUCTS, INC.

Risk Manager: ~~_!9_':_~S:~_<l.~?_Qt::!?~t::~_E:~~L~_5-6Z2!B_oom.!_~,!!_~.:?~~?_

Risk Manager Reviewer: Rosanna Louie RLOUIE

Sent Date: Calculated Due Dale: 23-Mar-20t1 Edited Due Date:

Action Desc: LI3_~_~QL~~~_~_'3_Q~~~~~~~N-FAST T~f~j~~LUQES _REV~~~_~QE:£RQQ~£r~_r:tE~~?_l

Ingredients: g_~t2t. FipronJl~.:.-8_~ _

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

Expedile: 0 Yes. No Date Sent: 05-0ct-20tO Due Back:

DP Ingredient: !3_~_?_~3,_!:'_'t':~~~~_:~__

_t_?_~_!?~_, __,=_i~E~~~ _

DP Title: #2517-RUR: CRP Review

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

Organization: RD I TRB

Date In

... 0757/0 ...••...••..............

Date Out ---------------

r, l2:3\/.o last Possible Science Due Date: 2t-Feb-20t 1

Science Due Date:

Reviewer Name: Sub Dala Package Due Date:

Contractor Name:

* * * Studies Sent for Review * * *

Printed on Page 2

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

Can be printed on its own page

'I< 'I< 'I< Data Package Instructions 'I< 'I< 'I<

Attn TRBlCRP: Please conduct a CRP Packaging review of the attached package in support of the proposed product. Contact Rosanna

louie-Juzwiak at 308.0037 with any questions.

Attachments:

- cover letter

- letter for CRP certification (including cited studies)

- letler for CRP intormation

- basic CSF

- draft label

- data matrix

NOTE: with regards to CRP review, there is no greater toxicity from pyriproxyfen exposure (i.e., does not trigger need for CRP) that would

exceed Ihat ot fipronil.

54
DP#: (382778)

48059804

48059806

48059805

Page

2

*** Studies Sent for Review***

D09~""~ Applicator with label Indicator

F=1 asa Poison Prevention Package f~;S';g'''-'.':'. Pet Care

Products, Inc.: Final Report. Project Number: 1746f002.

Unpublished study prepared by Perritt laboratories, Inc. 28 p.

Ward, R. (20 to) Evaluation of the Dog Squeeze on 1.34ml White

Applicator with Green label Indicator (3x), Scissors to Open

- F'"t

asa Poison Prevention Package for Sergeant's Pet Care

Products, Inc.: Final Report. Project Number: 1746f003.

Unpublished study prepared by Perritllaboratories, Inc. 28 p.

Ward, R. (20tO) Evaluation of the Dog Squeeze on 4.02ml White

Applicator with Blue label Indicator (3x), Scissors to Open

- F::::1

asa Poison Prevention Package for Sergeant's Pet Care

Products, Inc.: Final Report. Project Number: 1746f005.

Unpublished study prepared by Perritllaboratories, Inc. 28 p.

Ward, R. (20 to) Evaluation of the Dog Squeeze on 2.68ml White

Applicator with Red label Indicator (3x), Scissors to Open

- F=1

asa Poison Prevention Package for Sergeant's Pet Care

Products. Inc.: Final Report. Project Number: t746f004.

Unpublished study prepared by Perritllaboratories, Inc. 28 p.

DP#: (382778) Decision#: (438358)

48059804

48059806

48059805

Page2

* * * Studies Sent for Review * * *

D09~""~ Applicator with label Indicator

F=1 asa Poison Prevention Package f~;S';g'''-'.':'. Pet Care

Products, Inc.: Final Report. Project Number: 1746f002.

Unpublished study prepared by Perritt laboratories, Inc. 28 p.

Ward, R. (20 to) Evaluation of the Dog Squeeze on 1.34ml White

Applicator with Green label Indicator (3x), Scissors to Open

- F'"t

asa Poison Prevention Package for Sergeant's Pet Care

Products, Inc.: Final Report. Project Number: 1746f003.

Unpublished study prepared by Perritllaboratories, Inc. 28 p.

Ward, R. (20tO) Evaluation of the Dog Squeeze on 4.02ml White

Applicator with Blue label Indicator (3x), Scissors to Open

- F::::1

asa Poison Prevention Package for Sergeant's Pet Care

Products, Inc.: Final Report. Project Number: 1746f005.

Unpublished study prepared by Perritllaboratories, Inc. 28 p.

Ward, R. (20 to) Evaluation of the Dog Squeeze on 2.68ml White

Applicator with Red label Indicator (3x), Scissors to Open

- F=1

asa Poison Prevention Package for Sergeant's Pet Care

Products. Inc.: Final Report. Project Number: t746f004.

Unpublished study prepared by Perritllaboratories, Inc. 28 p.

Decision#: (438358)

55
UNITED STATES ENVIRONMENTAL PROTECTiON AGENCY

WASHINGTON, D.C. 2H-I6U

OFF!{'E OF C1JnnC.\L S,\.FETY

.\1'0 POLI.(TTlOl' 1'IHXENT!ON

December 23, 2010

NOTE TO RM 10 Rosanna Louie-Juzwiak

SUBJECT: Certification to Compliance with Chiid-Resistant Packaging Reguiations

EPA FILE NO: 2517-RUR, DP 382778, Decision # 438358

The August 11, 2010 eRP certification and bridging lelter (indicating the same size

and color package as package tested) for EPA Registration No. 2517-RUR are

acceptabie. The August 11,2010 label for EPA Registration No. 2517-RUR has the

same CRP directions as were used in the CRP testing,

All the requirements for CRP have been met for EPA Registration No. 2517-

RUR. The directions on opening the package given to consumers must be identical

to those given to the seniors during testing.

Shouid 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.

Thank you for your cooperation in this malter. If you have any questions please

contact me at (703)-308-7368.

Rosalind L. Gross

UNITED STATES ENVIRONMENTAL PROTECTiON AGENCY

WASHINGTON, D.C. 2H-I6U

OFF!{'E OF C1JnnC.\L S,\.FETY

.\1'0 POLI.(TTlOl' 1'IHXENT!ON

December 23, 2010

NOTE TO RM 10 Rosanna Louie-Juzwiak

SUBJECT: Certification to Compliance with Chiid-Resistant Packaging Reguiations

EPA FILE NO: 2517-RUR, DP 382778, Decision # 438358

The August 11, 2010 eRP certification and bridging lelter (indicating the same size

and color package as package tested) for EPA Registration No. 2517-RUR are

acceptabie. The August 11,2010 label for EPA Registration No. 2517-RUR has the

same CRP directions as were used in the CRP testing,

All the requirements for CRP have been met for EPA Registration No. 2517-

RUR. The directions on opening the package given to consumers must be identical

to those given to the seniors during testing.

Shouid 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.

Thank you for your cooperation in this malter. If you have any questions please

contact me at (703)-308-7368.

Rosalind L. Gross

56
Sergeant's Pet Care Products, Inc.

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

August 11, 2010

Richard Gebken, PMI 0

Office ofPesticide Programs (7504P)

u.s. Environmental Protection Agency

Document Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlinglon, VA 22202

Subject: Child Resistant Packaging Certification

Sergeant's Fipronil + N?",~<!! .§.gPeeze-On for Dogs

EPA File Symbol 25 I7-)\lBW {-(\.tit...

Dear Mr. Gebken;

!Zvl\

• Sergeant's Fiprorril +Nylar Squeeze-On for Dogs (EPA File Symbo12517~

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 (Jn1y 21, 1995);

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

EPA Company Number 2517) is submitting this child resistant packaging certification to support

for the new endwuse product Sergeant's Fipronil + Nylar Squeeze-On for Dogs (EPA File

Symbol 25 I7-NEW). All product labels have language specifying the use ofscissors 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 402w938w7079.

Sincerely,

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

Sergeant's Pet Care Products, Inc.

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

August 11,2010

Richard Gebken, PM1 0

Office ofPesticide Programs (7504P)

u.s. Environmental Protection Agency

Document Processing Desk

Room SA900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Child Resistant Packaging Certification

Sergeant's Fipronil + N?",~<!! .§.gPeeze-On for Dogs

EPA File Symbol 2517wpEW (2...iJ..K

fZvf\ • Sergeant's Fipronil +Nylar Squeeze-On for Dogs (EPA File Symbo12517~

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 3771 0 (July 21, 1995):

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

EPA Company Number 251 7) is submitting this child resistant packaging certification to support

for the new endwuse product Sergeant's Fipronil + Nylar Squeeze-On for Dogs (EPA File

Symbol 2517wNEW). All product labels have language specifying the use ofscissors 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 402w938w7079.

Sincerely,

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

57
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

August II, 2010

Rosalind Gross

c/o Richard Gebken

Registration Division

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 Infonnation

Ser~t's Fipronil + Nylar Squeeze-On for Dogs (EPA File Symbol: 2517-

pmw) (.2 \,l(l..

Dear Ms. Gross:

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

EPA Company Number 2517) is submitting a request to rely on previously submitted Child

Resistant Packaging (CRP) studies to support this new registration. The CRP data were

submitted to EPA on April 12, 2010 in support ofthe pending registration applications under

EPA File Symbols: 25 I7-RGT, 25 I7-RGA, 2517-RGL, and 2517-RGU (all of which contain

Fipronil at 9.7-9.8%).

Sergeant's generated CRP data on a standard white applicator in sizes 0.67, 1.34,2.68, and 4.02

mL. The following is a summary table ofthe applicators that were tested and submitted to EPA

in the CRP data:

Use Annlicator Base Color Fill Wei2htlmL) Color

Dog Up to 22 Ibs White 0.67 Orange ,/

D0223-441bs White 1.34 Green \ /-

Dog 45-88 lbs "White 2.68 Red V

Doa 89-132 Ibs White 4.02 Blue V

CRP data is required for this new product because ofthe inclusion ofthe activf' ingredient

fipronil (9.8%) in the pet squeeze-on product. The CRP testing was conducted. or1 a standard

package size and color configuration that is identical for this product. The Ser3~3'1~'s Fip:-o;:il

Nylar Squeeze-On for Dogs product being submitted today also contains fiproni: at 9.8%

Additionally, Sergeant's already has dog squeeze-on products approved by EPA ccntaining 2%

Nylar (EPA Registration Numbers 2517-127 through 2517-129) that are not ,,'h!ect to CRP. This

new product contains 2% nylar.

I

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

August 11,2010

Rosalind Gross

c/o Richard Gebken

Registration Division

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 Information

~_~~t's Fipronil + Nylar Squeeze-On for Dogs (EPA File Symbol: 2517~

p.rEW) r VAl.

Dear Ms. Gross:

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

EPA Company Number 2517) is submitting a request to rely on previously submitted Child

Resistant Packaging (CRP) studies to support this new registration. The CRP data were

submitted to EPA on April 12, 2010 in support ofthe pending registration applications under

EPA File Symbols: 2517-RGT, 2517-RGA, 2517-RGL, and 2517-RGU (all ofwhich contain

Fipronil at 9.7~9.8%).

Sergeant's generated CRP data on a standard white applicator in sizes 0.67, 1.34,2.68, and 4.02

mL. The following is a summary table ofthe applicators that were tested and submitted to EPA

in the CRP data:

Use Applicator Base Color Fill Weight (mL) Color

Dog Up to 22 Ibs White 0.67 Orange /

Dog 23-44 Ibs White 1.34 Green \/.

Dog 45-88 Ibs "White 2.68 Red V,

Dog 89-132 Ibs White 4.02 Blue -:L

CRP data is required for this new product because ofthe inclusion ofthe activf' ingredient

fipronil (9.8%) in the pet squeeze-on product. The CRP testing was conducted. or1 a standard

package size and color configuration that is identical for this product. The Ser3~3'1~'s Fip:-o;:il .:-

Nylar Squeeze-On for Dogs product being submitted today also contains fiproni: at 9.8%

Additionally, Sergeant's already has dog squeeze-on products approved by EPA ccntaining 2%

Nylar (EPA Registration Numbers 2517-127 through 2517-129) that are not sllhiect to CRP. This

new product contains 2% ny1ar.

1

58
Sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www,sergeants.CQm

Furthennore, Sergeant's does not anticipate any additional toxicity through the combination of

fipronil and nylar. \Vhen Sergeant's Fipronil + Nylar Squeeze-On for Dogs is marketed, it will

utilize the same applicator color (white) and fill weight colors per mL fill weight as waS used in

the submitted and referenced CRP testing. Based on available infonnation, the density range of

the pending products on which the CRP data were generated is the same as the new product (1.0-

1.5 gr/cc). Therefore, Sergeant's is relying on MRlD's: 480591jll3, 48059804, 4805Z§lJ5, and

48059806 to fulfill the CRP data requirements for Sergeant's'Fipronil +Nylar Squeeze-On for

Dogs. V

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

Sincerely,

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

2

Sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www,sergeants.CQm

Furthennore, Sergeant's does not anticipate any additional toxicity through the combination of

fipronil and nylar. \Vhen Sergeant's Fipronil + Nylar Squeeze-On for Dogs is marketed, it will

utilize the same applicator color (white) and fill weight colors per mL fill weight as waS used in

the submitted and referenced CRP testing. Based on available information, the density range of

the pending products on which the CRP data were generated is the same as the new product (1.0-

I.S gr/cc). Therefore, Sergeant's is relying on MRID's: 480S~~3,480S9804, 480SZ§.OS, and

480S9806 to fulfill the CRP data requirements for Sergeant's'Fipronil +~Iar Squeeze-On for

Dogs. V

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

Sincerely,

UJl~ ?- - tk~lu-~ 1J2~T

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

2

59
Decision #: 438358

DP #: (382779)

PRIA

Parent DP#:

Submission #: 880181

DATA PACKAGE BEAN SHEET

Date: 05-0ct-2010

Page t of 2

* * * Registration Information * * *

Registration: ~~1!::~Ylt:.~~~~GJ;~~NI:~J:H~BQ_~_'-~_~J~fLLA~t~'-QUEEZE-ON FOR DO_G§

Company: ?~ 17_-_~~~§~!i!~-!:ET ~~~~~~Q~~~!S,_!NC. _

Risk Manager: RM)O - Richard Gebken - (703) 3~-.:-~~9_1_!3.<:I<:I~~_f_'(] __§.:?:.~~_~~ _

Risk Manager Reviewer: Rosanna Louie RlOUIE

Senl Date: Calculated Due Date: 23-Mar-2011 Edited Due Date:

Action Desc: (R310) NEW PRODUC~~ON-YAS"I Tf¥.C!5j!ti~~~Q~_!3.~Y.~~~_2~_~~.2g9g_!_~!:!~_~~~_,

Ingredients: ! 291~:!.cXipr~~J!@~~~ _

* * * Data Package Information * * *

Expedite: 0 Yes. No Dale Sen!: 05-0ct-2010 Due Back:

OP Ingredienl: 129032, Pyriproxyfen

!?~~~!~£i~~_~il ._. _

DP Title: ~_~!!_:RU_f3___=_~!!!.~_~9:'.~~Je~ _

CSF Included: 0 Yes. No Label Included: • Yes 0 No Parenl DP #:

Date In Date Out

Last Possible Science Due Date: 21-Feb-2011

Team Name: Efficacy (IS) Science Due Date:

Reviewer Name: Sub Data Package Due Dale: _

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 * * *

Attn Efficacy Reviewer: Please conduct an efficacy review of the attached package in support of the proposed product. Contact Rosanna

Louie-Juzwiak at 308.0037 wilh any questions.

Attachments:

- cover letter

- draft label

- data matrix

Decision #: 438358

DP #: (382779)

PRIA

Parent DP#:

Submission #: 880181

DATA PACKAGE BEAN SHEET

Date: 05-0ct-2010

Page t of 2

* * * Registration Information * * *

Registration: ~~1!::~Ylt:.~~~~GJ;~~NI:~J:H~BQ_~_'-~_~J~fLLA~t~'-QUEEZE-ON FOR DO_G§

Company: ?~ 17_-_~~~§~!i!~-!:ET ~~~~~~Q~~~!S,_!NC. _

Risk Manager: RM)O - Richard Gebken - (703) 3~-.:-~~9_1_!3.<:I<:I~~_f_'(] __§.:?:.~~_~~ _

Risk Manager Reviewer: Rosanna Louie RlOUIE

Senl Date: Calculated Due Date: 23-Mar-2011 Edited Due Date:

Action Desc: (R310) NEW PRODUC~~ON-YAS"I Tf¥.C!5j!ti~~~Q~_!3.~Y.~~~_2~_~~.2g9g_!_~!:!~_~~~_,

Ingredients: ! 291~:!.cXipr~~J!@~~~ _

* * * Data Package Information * * *

Expedite: 0 Yes. No Dale Sen!: 05-0ct-2010 Due Back:

OP Ingredienl: 129032, Pyriproxyfen

!?~~~!~£i~~_~il ._. _

DP Title: ~_~!!_:RU_f3___=_~!!!.~_~9:'.~~Je~ _

CSF Included: 0 Yes. No Label Included: • Yes 0 No Parenl DP #:

Date In Date Out

Last Possible Science Due Date: 21-Feb-2011

Team Name: Efficacy (IS) Science Due Date:

Reviewer Name: Sub Data Package Due Dale: _

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 * * *

Attn Efficacy Reviewer: Please conduct an efficacy review of the attached package in support of the proposed product. Contact Rosanna

Louie-Juzwiak at 308.0037 wilh any questions.

Attachments:

- cover letter

- draft label

- data matrix

60
DP#: (382779)

Page2

...... Studies Sent for Review"" .. Decision#: (438358)

810.3300rrreatments to control

pests of humans and pets

45620501

43121114

45612701

43121116

4312t115

46346601

48129610

43121117

45620505

48t29611

43121122

43121118

45866902

45620504

Pengo, G,; Pollmeier, M.; Barrick,

R (2000) An Efficacy Study of

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

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

Report: Lab Project Number: PR&D 002210t, PR&D 00221.

Unpublished study prepared by Centro Veterinario Oriolo. 24 p.

{OPPTS 81 0.3300}

Everett, R; Cunningham, J. (1993)

A Dose Titration Study to

Determine the Optimal Spray Concentration of RM 1601 for Long

Term Control of the Cat Flea Ctenocephalides felis and the Brown

Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab

Project Number: RMD 292: P/214LT. Unpublished study prepared

by Agresearch Consultants. 53 p.

Ahmed, Z. (2002) StUdy Summaries: Frontline Plus For Dogs.

Unpublished study prepared by Merial. 40 p.

Everett, R,; Cunningham, J. (1993)A Comparative Evaluation of

Two Treatment Regimes Using RM 1601 Spray for Control of the

Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project

Number. RMD 692: P/222LT. Unpublfshed study prepared by

Agresearch Consultants, Inc. 40 p.

Cruthers, L. (t993) Product Performance:A Dose Confirmation

Study to Verify the Optimal Spray Concentration of RM 1601 for

Long Residual Control of the Cat Flea (Ctenocephalides felis) and

the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog:

Revised: Lab Project Number: 9251: PI215LT. Unpublished study

prepared by Professional Labs and Research Services, Inc. 51

p.

Cruthers, L. (2003) Dose Titration ofa Pyriproxyfen Spot.On

Formulation For Flea Ova Sterilization. Project Number:

PLRS/0242. Unpublished Study Prepared By Professional

Laboratory& Research Services, Inc. 53 p.

Sharp, M. (2009) Immediate Efficacy ofa Combined Application of 81 0.3300rrreatments to control

Frontline Plus with Cyphenothrin asa Squeeze-On Against Fleas pests of humans and pets

(Ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on

Dogs: Analyses of Data Conclusions. Project Number: MS/1641D.

Unpublished study prepared by Sharp Veterinary Research. 24 p.

McCall, J,; McTier, T. (1993) Laboratory Evaluation of RM t601

Spray for Control Dermacentor variabilis and Rhipecephalus

sanguineus on the Dog: Lab Project Number: RMrrKSI93/1 L:

PS1229LT. Unpublished study prepared by TRS Labs, Inc. t8 p.

Gaxiola, S.; Alva, R; Irwin, J. (2001) PR& 00052301: Frontline

Spray/Frontline Spot-On/ML-2, 095, 988

509TlDogslSolutionrropical: Final Report: Lab Project Number:

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

University of Sinaloa. 40 p. (DPPTS 810.3300}

Sharp, M. (2010) Immediate Efficacy Following Application of

Frontline with Cyphenothrin Squeeze-On Against Fleas

(ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on

Dogs: Analyses of Data Conclusions. Project Number: MS/183D.

Unpublished study prepared by Sharp Veterinary Research. 29 p.

Cruthers, L. (1993) Efficacy of RM1601C at3 mllkg and6 mllkg

Against Ixodes scapularisldammini Nymphs, Dermacentor

variabilis Nymphs, Amblyomma amerlcanum Nymphs,

Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides

Adults Using Treated Dog Hair as the Testing Substrate: Revised:

Lab Project Number: 9320: P/225LT. Unpublished study prepared

by Professional Lab and Research Services, Inc. 28 p.

Everett, R; Cunningham, J. (t993) An Investigation Study to

Evaluate the Effect of Bathing of Laboratory Dogs on the Efficacy

of RM1601 Spray: Revised: Lab Project Number: RMD 592:

P/220LT. Unpublished study prepared by Agresearch

Consultants, Inc. 43 p.

McCall, J.; Alva, R; Irwin, J.; et a1. (2002)A StUdy to Evaluate the

Efficacy of Frontline Plus for Control of Mosquitoes, Aedes

aegypti, on Dogs: Final Report: Lab Project Number: PR&D

0055201. Unpublished study prepared by TRS Labs, Inc. 24 p.

(OPPTS 81 0.3300}

Marchiondo, A. (2001) PR & 0 002410t: Frontline Spray/Frontline

Spot-On/ML-2, 095, 988 509T/DogslSolutionrropical: Final

Report: Lab Project Number: PR&D 0024101: PR&D 00241.

Unpublished study prepared by Slillmeadow, Inc. 29 p. {DPPTS

810.3300)

DP#: (382779)

Page2

...... Studies Sent for Review"" .. Decision#: (438358)

810.3300rrreatments to control

pests of humans and pets

45620501

43121114

45612701

43121116

4312t115

46346601

48129610

43121117

45620505

48t29611

43121122

43121118

45866902

45620504

Pengo, G,; Pollmeier, M.; Barrick,

R (2000) An Efficacy Study of

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

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

Report: Lab Project Number: PR&D 002210t, PR&D 00221.

Unpublished study prepared by Centro Veterinario Oriolo. 24 p.

{OPPTS 81 0.3300}

Everett, R; Cunningham, J. (1993)

A Dose Titration Study to

Determine the Optimal Spray Concentration of RM 1601 for Long

Term Control of the Cat Flea Ctenocephalides felis and the Brown

Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab

Project Number: RMD 292: P/214LT. Unpublished study prepared

by Agresearch Consultants. 53 p.

Ahmed, Z. (2002) StUdy Summaries: Frontline Plus For Dogs.

Unpublished study prepared by Merial. 40 p.

Everett, R,; Cunningham, J. (1993)A Comparative Evaluation of

Two Treatment Regimes Using RM 1601 Spray for Control of the

Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project

Number. RMD 692: P/222LT. Unpublfshed study prepared by

Agresearch Consultants, Inc. 40 p.

Cruthers, L. (t993) Product Performance:A Dose Confirmation

Study to Verify the Optimal Spray Concentration of RM 1601 for

Long Residual Control of the Cat Flea (Ctenocephalides felis) and

the Brown Dog Tick (Rhipicephalus sanguineus) in the Dog:

Revised: Lab Project Number: 9251: PI215LT. Unpublished study

prepared by Professional Labs and Research Services, Inc. 51

p.

Cruthers, L. (2003) Dose Titration ofa Pyriproxyfen Spot.On

Formulation For Flea Ova Sterilization. Project Number:

PLRS/0242. Unpublished Study Prepared By Professional

Laboratory& Research Services, Inc. 53 p.

Sharp, M. (2009) Immediate Efficacy ofa Combined Application of 81 0.3300rrreatments to control

Frontline Plus with Cyphenothrin asa Squeeze-On Against Fleas pests of humans and pets

(Ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on

Dogs: Analyses of Data Conclusions. Project Number: MS/1641D.

Unpublished study prepared by Sharp Veterinary Research. 24 p.

McCall, J,; McTier, T. (1993) Laboratory Evaluation of RM t601

Spray for Control Dermacentor variabilis and Rhipecephalus

sanguineus on the Dog: Lab Project Number: RMrrKSI93/1 L:

PS1229LT. Unpublished study prepared by TRS Labs, Inc. t8 p.

Gaxiola, S.; Alva, R; Irwin, J. (2001) PR& 00052301: Frontline

Spray/Frontline Spot-On/ML-2, 095, 988

509TlDogslSolutionrropical: Final Report: Lab Project Number:

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

University of Sinaloa. 40 p. (DPPTS 810.3300}

Sharp, M. (2010) Immediate Efficacy Following Application of

Frontline with Cyphenothrin Squeeze-On Against Fleas

(ctenocephalides felis) and Ticks (Rhipicephalus sanguineus) on

Dogs: Analyses of Data Conclusions. Project Number: MS/183D.

Unpublished study prepared by Sharp Veterinary Research. 29 p.

Cruthers, L. (1993) Efficacy of RM1601C at3 mllkg and6 mllkg

Against Ixodes scapularisldammini Nymphs, Dermacentor

variabilis Nymphs, Amblyomma amerlcanum Nymphs,

Rhipicephalus sanguineus Nymphs, and Ctenocephalides felides

Adults Using Treated Dog Hair as the Testing Substrate: Revised:

Lab Project Number: 9320: P/225LT. Unpublished study prepared

by Professional Lab and Research Services, Inc. 28 p.

Everett, R; Cunningham, J. (t993) An Investigation Study to

Evaluate the Effect of Bathing of Laboratory Dogs on the Efficacy

of RM1601 Spray: Revised: Lab Project Number: RMD 592:

P/220LT. Unpublished study prepared by Agresearch

Consultants, Inc. 43 p.

McCall, J.; Alva, R; Irwin, J.; et a1. (2002)A StUdy to Evaluate the

Efficacy of Frontline Plus for Control of Mosquitoes, Aedes

aegypti, on Dogs: Final Report: Lab Project Number: PR&D

0055201. Unpublished study prepared by TRS Labs, Inc. 24 p.

(OPPTS 81 0.3300}

Marchiondo, A. (2001) PR & 0 002410t: Frontline Spray/Frontline

Spot-On/ML-2, 095, 988 509T/DogslSolutionrropical: Final

Report: Lab Project Number: PR&D 0024101: PR&D 00241.

Unpublished study prepared by Slillmeadow, Inc. 29 p. {DPPTS

810.3300)

61
Efficacy Review

Date: December 6, 2010

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

111 -'ers.cla 'ton((i)e a.QOv . ? A'

703-347-8874 \

Risk Manager Rev.: Rosanna Louie

Products:

EPAReg.#:

A.I.'s:

Decision #s:

DP#s:

Submission:

MRIDs:

i'L,l0f

Sergeant's Fipronil + Cyphenothrin + Methoprene'Squeeze-on for Dogs

2517-RUR

Fipronil (9.8%), Cyphenothrin (5.0%), Pyriproxyfen (2.0%)

438358

382779

R3l 0, New Products, RD Science Review

Submitted: 48129609,48129610,48129611,48129612,48129613,

GLP:

MRID 48129609

Cited:

No

43121114,43121115,43121116,43121117,43121118,

43121122,43577712,45612701,45620501,45620504,

45620505,45620506,45628201,45866902,46346601,

47849608

Title: Overview and Summary ofFiproniVCyphenothrin Dog Efficacy for Sergeant's Fipronil +

Cyphenothrin Squeeze-On for Dogs (Overview of other submissions).

Guideline: OPPTS 810.3300

Study Summary of the Results:

This submission is an overall summary and clarification ofthe other submitted MRIDs

associated with this application

Entomologist's ObservationslDiscussion:

Supplementary Infonnation

Efficacy Review

Date: December 6, 2010

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

111 -'ers.cla 'ton((i)e a.QOv . ? A'

703-347-8874 \

Risk Manager Rev.: Rosanna Louie

Products:

EPAReg.#:

A.I.'s:

Decision #s:

DP#s:

Submission:

MRIDs:

i'L,l0f

Sergeant's Fipronil + Cyphenothrin + Methoprene'Squeeze-on for Dogs

2517-RUR

Fipronil (9.8%), Cyphenothrin (5.0%), Pyriproxyfen (2.0%)

438358

382779

R3l 0, New Products, RD Science Review

Submitted: 48129609,48129610,48129611,48129612,48129613,

GLP:

MRID 48129609

Cited:

No

43121114,43121115,43121116,43121117,43121118,

43121122,43577712,45612701,45620501,45620504,

45620505,45620506,45628201,45866902,46346601,

47849608

Title: Overview and Summary ofFiproniVCyphenothrin Dog Efficacy for Sergeant's Fipronil +

Cyphenothrin Squeeze-On for Dogs (Overview of other submissions).

Guideline: OPPTS 810.3300

Study Summary of the Results:

This submission is an overall summary and clarification ofthe other submitted MRIDs

associated with this application

Entomologist's ObservationslDiscussion:

Supplementary Infonnation

62
MRID 48129810

Title: Immediate Efficacy ofa Combined Application of Frontline Plus with Cyphenothrin as a

Squeeze-on against Fleas (Ctenocephalisfelis) and Ticks (Rhipicephalus sanguineus) on Dogs.

Guideline: OPPIS 810.3300

Materials and Methods: Cyphenothrin was added to Frontline plus at 3 fates (5%, 10%, and

15%) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but

dilution was not taken into account for the existing fipronil, therefore fipronil dosage was

slightly lower than that ofFrontline alone. 18 dogs were allocated to 6 groups of 3 dogs each.

Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at

described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and

again at 7 and 14 days after treatment. Counts were made at 1 and 4 hours post treatment and

also on day 14 at 1 and 4 hours post placement-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. Parasites were not removed until the final count. Mortality was calculated using

Abbott's fonnula. For speed ofkilVrepellence, the number ofkilledJrepelled fleas on the liner

below each treated dog was divided by the total number of fleas placed on the dog (all x 100),

adjusted for 'nonnal' attrition on control dogs.

Study Summary of the Results:

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1~2 days after

treatment or reinfestation with parasites, through 14 days after treatment.

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged

from 9-74% for 1~4 hours immediately after treatment. With reinfestations after 14

days from treatment, efficacy exceeded 99% within 4 hours for all treatments that

included cyphenothrin.

3. Immediate efficacy on ticks ranged from 2-64% for 1~2 hours immediately after

treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95%

within 1 hour, for the lowest percentage of cyphenothrin treatment, and exceeded

84% for all treatments.

Entomologist's ObservationslDicussion:

1. Efficacy against fleas and ticks was adequate to support controls claims through 14

days after treatment.

2. While immediate efficacy against fleas and ticks was enhanced when assessed at 1

and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed

90% with any consistency for the treatments evaluated immediately after treatment.

However, after 14 days, this immediate efficacy was observed for reinfestations of

both fleas and ticks. This is likely due to the more complete spread ofthe spot-on

material throughout the animal coat at 14 days. Claims for killing (or'starts killing')

within hours would be supported by this data, but not immediately after treatment of

the animals.

MRID 48129810

Title: Immediate Efficacy ofa Combined Application of Frontline Plus with Cyphenothrin as a

Squeeze-on against Fleas (Ctenocephalisfelis) and Ticks (Rhipicephalus sanguineus) on Dogs.

Guideline: OPPIS 810.3300

Materials and Methods: Cyphenothrin was added to Frontline plus at 3 fates (5%, 10%, and

15%) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but

dilution was not taken into account for the existing fipronil, therefore fipronil dosage was

slightly lower than that ofFrontline alone. 18 dogs were allocated to 6 groups of 3 dogs each.

Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at

described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and

again at 7 and 14 days after treatment. Counts were made at 1 and 4 hours post treatment and

also on day 14 at 1 and 4 hours post placement-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. Parasites were not removed until the final count. Mortality was calculated using

Abbott's fonnula. For speed ofkilVrepellence, the number ofkilledJrepelled fleas on the liner

below each treated dog was divided by the total number of fleas placed on the dog (all x 100),

adjusted for 'nonnal' attrition on control dogs.

Study Summary of the Results:

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1~2 days after

treatment or reinfestation with parasites, through 14 days after treatment.

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) ranged

from 9-74% for 1~4 hours immediately after treatment. With reinfestations after 14

days from treatment, efficacy exceeded 99% within 4 hours for all treatments that

included cyphenothrin.

3. Immediate efficacy on ticks ranged from 2-64% for 1~2 hours immediately after

treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95%

within 1 hour, for the lowest percentage of cyphenothrin treatment, and exceeded

84% for all treatments.

Entomologist's Observations/Dicussion:

1. Efficacy against fleas and ticks was adequate to support controls claims through 14

days after treatment.

2. While immediate efficacy against fleas and ticks was enhanced when assessed at 1

and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed

90% with any consistency for the treatments evaluated immediately after treatment.

However, after 14 days, this immediate efficacy was observed for reinfestations of

both fleas and ticks. This is likely due to the more complete spread ofthe spot-on

material throughout the animal coat at 14 days. Claims for killing (or'starts killing')

within hours would be supported by this data, but not immediately after treatment of

the animals.

63
MRID 48129811

Title: Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze~on

against Fleas (Ctenocephalisfelis) and Ticks (Rhipicephalus sanguineus) on Dogs.

Guideline: OPPTS 810.3300

Materials and Methods: Cyphenothrin was added to Frontline plus at the rate of approximately

5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the

Frontline label, but dilution was not taken into account for the existing tipronil, therefore tipronil

dosage was slightly lower than that of Frontline alone. 18 dogs were allocated to 3 groups of 6

dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline

alone.. Dogs 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. Parasites were not

removed until the final count. Mortality was calculated using Abbott's formula. For speed of

kill/repellence, the number of killed/repelled fleas on the liner below each treated dog was

divided by the total number offleas placed on the dog (all x 100), adjusted for 'nonnal' attrition

on control dogs.

Study Summary of the Results:

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after

treatment or reinfestation with parasites, through 28 days after treatment.

2. Immediate efficacy on fleas (i.e. killirepellence within 4 hours oftreatment) ranged

from 9-68% for I-4 hours immediately after treatment. With reinfestations after 7,

14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all

treatments that included cyphenothrin, but did not exceed 90% within 1 hour after

reinfestation.

3. Immediate efficacy on ticks ranged from 5~75% for I~2 hours immediately after

treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy

exceeded 90% within 4 hours for all dates. For 21 and 28 days from treatment,

adequate efficacy was observed within 1 hour ofreinfestation.

Entomologist's ObsenrationslDicussion:

1. Efficacy against fleas and ticks was adequate to support controls claims through 28

days (one month) after treatment.

2. While immediate efficacy against fleas and ticks was marginally enhanced when

assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did

not exceed 90% with any consistency for the treatments evaluated immediately after

treatment. However, after 7 days, this immediate efficacy was observed for

reinfestations of both fleas and ticks. This is likely due to the more complete spread

ofthe spot-on material throughout the animal coat at 7+ days. Claims for killing (or

MRID 48129811

Title: Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze~on

against Fleas (Ctenocephalisfelis) and Ticks (Rhipicephalus sanguineus) on Dogs.

Guideline: OPPTS 810.3300

Materials and Methods: Cyphenothrin was added to Frontline plus at the rate of approximately

5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the

Frontline label, but dilution was not taken into account for the existing tipronil, therefore tipronil

dosage was slightly lower than that of Frontline alone. 18 dogs were allocated to 3 groups of 6

dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline

alone.. Dogs 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. Parasites were not

removed until the final count. Mortality was calculated using Abbott's formula. For speed of

kill/repellence, the number of killed/repelled fleas on the liner below each treated dog was

divided by the total number offleas placed on the dog (all x 100), adjusted for 'nonnal' attrition

on control dogs.

Study Summary of the Results:

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after

treatment or reinfestation with parasites, through 28 days after treatment.

2. Immediate efficacy on fleas (i.e. killirepellence within 4 hours oftreatment) ranged

from 9-68% for I-4 hours immediately after treatment. With reinfestations after 7,

14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all

treatments that included cyphenothrin, but did not exceed 90% within 1 hour after

reinfestation.

3. Immediate efficacy on ticks ranged from 5~75% for I~2 hours immediately after

treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy

exceeded 90% within 4 hours for all dates. For 21 and 28 days from treatment,

adequate efficacy was observed within 1 hour ofreinfestation.

Entomologist's ObsenrationslDicussion:

1. Efficacy against fleas and ticks was adequate to support controls claims through 28

days (one month) after treatment.

2. While immediate efficacy against fleas and ticks was marginally enhanced when

assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did

not exceed 90% with any consistency for the treatments evaluated immediately after

treatment. However, after 7 days, this immediate efficacy was observed for

reinfestations of both fleas and ticks. This is likely due to the more complete spread

ofthe spot-on material throughout the animal coat at 7+ days. Claims for killing (or

64
'starts killing') within hours would be supported by this data, but not immediately

after treatment ofthe animals.

MRID 48129812

Title: Immediate Efficacy Following Application of Frontline Plus with Cyphenothrin Squeezeon against Fleas (Ctenocephalisjelis) and Ticks (Rhipicephalus sanguineus) on Dogs.

Guideline: OPPTS 810.3300

Materials and Methods: Cyphenothrin was added to Frontline plus at the rate of approximately

5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the

Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil

dosage was slightly lower than that of Frontline alone. 18 dogs were allocated to 3 groups of6

dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline

alone.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7,

14,21,28, and 35 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. Parasites were not

removed until the final count. Mortality was calculated using Abbott's formula. For speed of

kilVrepellence, the number of killed/repelled fleas on the liner below each treated dog was

divided by the total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition

on control dogs.

Study Summary of the Results:

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1M2 days after

treatment or reinfestation with parasites, through 35 days after treatment.

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) 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 hour~ for

reinfestations on days 14, 21,28, or 35 days after treatment.

3. 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:

1. Efficacy against fleas and ticks was adequate to support controls claims through 35

days (one month) after treatment.

2. While immediate efficacy against fleas and ticks was marginally enhanced when

assessed at 1 and 4 hours after treatment (or reinfestation) compared to fipronil alone,

'starts killing') within hours would be supported by this data, but not immediately

after treatment ofthe animals.

MRID 48129812

Title: Immediate Efficacy Following Application of Frontline Plus with Cyphenothrin Squeezeon against Fleas (Ctenocephalisfeiis) and Ticks (Rhipicephalus sanguineus) on Dogs.

Guideline: OPPTS 810.3300

Materials and Methods: Cyphenothrin was added to Frontline plus at the rate of approximately

5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the

Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil

dosage was slightly lower than that of Frontline alone. 18 dogs were allocated to 3 groups of6

dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline

alone.. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7,

14,21,28, and 35 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. Parasites were not

removed until the final count. Mortality was calculated using Abbott's formula. For speed of

kilVrepellence, the number of killed/repelled fleas on the liner below each treated dog was

divided by the total number offleas placed on the dog (all x 100), adjusted for 'normal' attrition

on control dogs.

Study Summary of the Results:

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1M2 days after

treatment or reinfestation with parasites, through 35 days after treatment.

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours oftreatment) 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 hour~ for

reinfestations on days 14, 21,28, or 35 days after treatment.

3. 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:

1. Efficacy against fleas and ticks was adequate to support controls claims through 35

days (one month) after treatment.

2. While immediate efficacy against fleas and ticks was marginally enhanced when

assessed at 1 and 4 hours after treatment (or reinfestation) compared to fipronil alone,

65
the immediate efficacy did not exceed 90% with any consistency for the treatments

evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days

after treatment. This data does not support any claims for faster kill or repellence due

to the addition of cyphenothrin.

MID» 48129813

Title: Comparative efficacy evaluation of Sergeant's Squeeze~on and Frontline Plus for the

treatment of adult cat flea (Ctenocephalidesfelis) and tick (Haemaphysalis elliplica,

Rhipicephalus sanguineus, and Dermacentor variabilis) infestations on dogs.

Guideline: OPPTS 810.3300

Materials and Methods: Cyphenothrin was added to Seargeant's Fipronil~Methroprene

formulation Frontline plus at the rate of approximately 5% for efficacy evaluations. This

treatment was compared to fipronil-methoprene alone, and a positive control, Merial's Frontline

Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mL/kg body

weight, to simulate the dosing at the high end of each respective weight class. Dogs were

subgrouped by weight class with 6 dogs in each subclass (split over time to 3 dogs of each class

in 2 consecutive studies). Group 1, untreated control; Group 2, Fipronil+Methoprene, Group 3,

FiproniI+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs 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. Parasites were not removed until the final count. Mortality

was calculated using Abbott's formula. For speed ofkill/repellence, the number of

killed/repelled fleas on the liner below each treated dog was divided by the total number offleas

placed on the dog (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 2 days after treatment or

reinfestation with parasites, through 28 days after treatment.

2. Immediate group mean efficacy on ticks (all species) overall means were all below

90%.

Entomologist's ObservationslDicussion:

1. Efficacy against fleas and ticks was adequate to support controls general claims

through 35 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.

the immediate efficacy did not exceed 90% with any consistency for the treatments

evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days

after treatment. This data does not support any claims for faster kill or repellence due

to the addition of cyphenothrin.

MID» 48129813

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 sanguineus, and Dermacentor variabilis) infestations on dogs.

Guideline: OPPTS 810.3300

Materials and Methods: Cyphenothrin was added to Seargeant's Fipronil~Methroprene

formulation Frontline plus at the rate of approximately 5% for efficacy evaluations. This

treatment was compared to fipronil-methoprene alone, and a positive control, Merial's Frontline

Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mL/kg body

weight, to simulate the dosing at the high end of each respective weight class. Dogs were

subgrouped by weight class with 6 dogs in each subclass (split over time to 3 dogs of each class

in 2 consecutive studies). Group 1, untreated control; Group 2, Fipronil+Methoprene, Group 3,

FiproniI+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs 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. Parasites were not removed until the final count. Mortality

was calculated using Abbott's formula. For speed ofkill/repellence, the number of

killed/repelled fleas on the liner below each treated dog was divided by the total number offleas

placed on the dog (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 2 days after treatment or

reinfestation with parasites, through 28 days after treatment.

2. Immediate group mean efficacy on ticks (all species) overall means were all below

90%.

Entomologist's ObservationslDicussion:

1. Efficacy against fleas and ticks was adequate to support controls general claims

through 35 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.

66
Overall Review of Label Claims and Directions:

Based upon submitted efficacy data, claims are supported for fleas and ticks through 35 days.

Claims for immediate efficacy are not supported except to state "starts killing within hours" or

"starts killing in as little as one hour", Repellence claims for fleas and ticks are not supported

and must be removed from the label. Kill claims against flea eggs or larvae, are supported.

Control claims against flea eggs or larvae, or claims against breaking the flea life cycle are

supported for up to 9 weeks after treatment.

Line bv Line Review of Label Efficacy Claims

Kills fleas, flea eggs, ticks, chewing lice & mosquitoes: Acceptable

1/<i' JY;",-\,y\

Controls flea reinfestation for up to [12 weeks]: Acceptable \.}¥\ OLL{,4::!;;. J ,.. O,,£:dt1L \.\l1( ''''-' .

Fast Acting: Unacceptable

Kills ticks including those that may transmit Lyme disease: Acceptable

Dogs can be bathed 24 hours after treatment: Unacceptable

Waterproof: Acceptable

Long Lasting: Acceptable

Research demonstrates that [brand name] kills adult fleas, flea eggs, larvae and pupae for up to 3

months): Claim against 'pupae' must be deleted, as no data was submitted indicating the product

kills flea pupae exposed to residue.

[brand name] prevents development of all flea stages for up to 3 months: Acceptable only if

duration is revised to '[63 days] [9 weeks].

Kills fleas, ticks, mosquitoes. (chewing) lice, flea eggs, larvae. and pupae: Claims against pupae

must be deleted.

Prevents all flea stages (adult fleas, flea eggs, flea pupae, and flea larvae): Claims against pupae

must be deleted.

If dog is a high risk for flea re-infestation once a month application may be needed: Acceptable.

Once a month treatment is recommended: Acceptable.

A once monthly application is recommended for chewing lice: Acceptable.

Rapidly eliminates infestations with chewing lice: Acceptable.

Overall Review of Label Claims and Directions:

Based upon submitted efficacy data, claims are supported for fleas and ticks through 35 days.

Claims for immediate efficacy are not supported except to state "starts killing within hours" or

"starts killing in as little as one hour", Repellence claims for fleas and ticks are not supported

and must be removed from the label. Kill claims against flea eggs or larvae, are supported.

Control claims against flea eggs or larvae, or claims against breaking the flea life cycle are

supported for up to 9 weeks after treatment.

Line bv Line Review of Label Efficacy Claims

Kills fleas. flea eggs. ticks. chewing lice & mosquitoes: Acceptable

1/<i' JY;",-\,y\

Controls flea reinfestation for up to [12 weeks]: Acceptable \.}¥\ OLL{,4::!;;. J ,.. O,,£:dt1L \.\l1( ''''-' .

Fast Acting: Unacceptable

Kills ticks including those that may transmit Lyme disease: Acceptable

Dogs can be bathed 24 hours after treatment: Unacceptable

Waterproof: Acceptable

Long Lasting: Acceptable

Research demonstrates that [brand name] kills adult fleas. flea eggs. larvae and pupae for up to 3

months): Claim against 'pupae' must be deleted, as no data was submitted indicating the product

kills flea pupae exposed to residue.

[brand name] prevents development of all flea stages for up to 3 months: Acceptable only if

duration is revised to '[63 days] [9 weeks].

Kills fleas, ticks, mosquitoes. (chewing) lice, flea eggs, larvae. and pupae: Claims against pupae

must be deleted.

Prevents all flea stages (adult fleas, flea eggs, flea pupae, and flea larvae): Claims against pupae

must be deleted.

If dog is a high risk for flea re-infestation once a month application may be needed: Acceptable.

Once a month treatment is recommended: Acceptable.

A once monthly application is recommended for chewing lice: Acceptable.

Rapidly eliminates infestations with chewing lice: Acceptable.

67
Monthly flea. tick, mosquito. lice. and flea egg protection: Acceptable.

Monthly flea, tick. mosquito. and lice protection: Acceptable.

Kills flea eggs (larvae] [pupae] for up more than [63 days] [9 weeks]: Acceptable except claim

against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae

exposed to residue.

Aids in control ofsarcoptic mange: Acceptable.

Kills fleas. ticks. mosquitoes. flea eggs. and lice: Acceptable

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

pupae: '7-way' is an unacceptable nebulous claim. Claims against flea pupae must be deleted

6 [Six] Way Protection! Kills fleas, ticks, mosquitoes. lice, flea eggs & flea larvae: '6-way' is

an unacceptable nebulous claim.

[4 Week] [Flea and Tick & Treatment]: Acceptable

Four (4) Week Flea. Tick. Mosquitoe and Lice Control: Acceptable

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

Dual Action [l]: Fipronil with Nylar® lGR Effectively Breaks the Flea Life Cycle: Acceptable.

Dual Action [I]: Effectively Breaks the Flea Life Cycle[l]: Acceptable

Best if used year round!: Acceptable

Kills Fleas Up to [4 weeks]![2 months] [3 months]: Acceptable

(ICON showing 4 week protection): Acceptable

4 Week Dose!: Acceptable

I Month Dose!: Acceptable

Specially Formulated for Dogs and Puppies: Acceptable

Kills Flea Eggs & Flea Larvae for more than [63 days], [9 weeks]!: Acceptable

Monthly flea. tick, mosquito. lice. and flea egg protection: Acceptable.

Monthly flea, tick. mosquito. and lice protection: Acceptable.

Kills flea eggs (larvae] [pupae] for up more than [63 days] [9 weeks]: Acceptable except claim

against 'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae

exposed to residue.

Aids in control ofsarcoptic mange: Acceptable.

Kills fleas. ticks. mosquitoes. flea eggs. and lice: Acceptable

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

pupae: '7-way' is an unacceptable nebulous claim. Claims against flea pupae must be deleted

6 [Six] Way Protection! Kills fleas, ticks, mosquitoes. lice, flea eggs & flea larvae: '6-way' is

an unacceptable nebulous claim.

[4 Week] [Flea and Tick & Treatment]: Acceptable

Four (4) Week Flea. Tick. Mosquitoe and Lice Control: Acceptable

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

Dual Action [l]: Fipronil with Nylar® lGR Effectively Breaks the Flea Life Cycle: Acceptable.

Dual Action [I]: Effectively Breaks the Flea Life Cycle[l]: Acceptable

Best if used year round!: Acceptable

Kills Fleas Up to [4 weeks]![2 months] [3 months]: Acceptable

(ICON showing 4 week protection): Acceptable

4 Week Dose!: Acceptable

I Month Dose!: Acceptable

Specially Formulated for Dogs and Puppies: Acceptable

Kills Flea Eggs & Flea Larvae for more than [63 days], [9 weeks]!: Acceptable

68
Prevents Flea Eggs From Developing Into Biting Adults: Acceptable

Kills Ticks for Up to 14 weeks]!: Acceptable

Kills [all stages of] Deer Ticks (vector ofLyme Disease) for up to 4 weeks: Acceptable

Kills Ticks (Including Deer Ticks) for up to 4 weeks: Acceptable

Kills [Brown]. [American.] [and Lone Stare] Dog Ticks for up to 4 weeks: Acceptable

Kills Rhipicephalus sanguineus for up to 4 weeks: Acceptable

When used monthly [brand name] completely breaks the flea life cycle and controls tick and

chewing lice infestations: Acceptable

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

Apply once every [4 weeks]!: Acceptable

4 weeks Flea and Tick Treatment: Acceptable

Once A Month Flea and Tick Treatment: Acceptable

Kills Fleas and Ticks for up to 4 weeks!: Acceptable

Kills all stages of the flea life cycle: Acceptable

Kills fleas, Ticks, Flea Eggs & Flea Larvae for up to 4 Weeks: Acceptable

Kills mosquitoes: Acceptable

Dogs can be bathed 24 hours after squeeze~on is applied: Unacceptable

Prevents and controls reinfestations: Unacceptable unless a pest and duration of control is

associated (e.g., 'prevents and controls reinfestations oflisted pests for 1 month [4 weeks]').

BACK/SIDE CARTON LABEL-MASTER LABEL

[brand name] containes Fiproni!. and the insect growth regulator (lOR) Nylar® to effectively kill

[and repel] Fleas. Ticks [(including those that may transmit Lyme Disease)]. and kills flea eggs,

flea larvae, mosquitoes and (chewing) lice. The active ingredients in [brand name] work by

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

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

[and long lasting] control of Fleas and Ticks [(in as little as one hour)]. [and kills mosquitoes]

Prevents Flea Eggs From Developing Into Biting Adults: Acceptable

Kills Ticks for Up to 14 weeks]!: Acceptable

Kills [all stages of] Deer Ticks (vector ofLyme Disease) for up to 4 weeks: Acceptable

Kills Ticks (Including Deer Ticks) for up to 4 weeks: Acceptable

Kills [Brown]. [American.] [and Lone Stare] Dog Ticks for up to 4 weeks: Acceptable

Kills Rhipicephalus sanguineus for up to 4 weeks: Acceptable

When used monthly [brand name] completely breaks the flea life cycle and controls tick and

chewing lice infestations: Acceptable

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

Apply once every [4 weeks]!: Acceptable

4 weeks Flea and Tick Treatment: Acceptable

Once A Month Flea and Tick Treatment: Acceptable

Kills Fleas and Ticks for up to 4 weeks!: Acceptable

Kills all stages of the flea life cycle: Acceptable

Kills fleas, Ticks, Flea Eggs & Flea Larvae for up to 4 Weeks: Acceptable

Kills mosquitoes: Acceptable

Dogs can be bathed 24 hours after squeeze~on is applied: Unacceptable

Prevents and controls reinfestations: Unacceptable unless a pest and duration of control is

associated (e.g., 'prevents and controls reinfestations oflisted pests for 1 month [4 weeks]').

BACK/SIDE CARTON LABEL-MASTER LABEL

[brand name] containes Fiproni!. and the insect growth regulator (lOR) Nylar® to effectively kill

[and repel] Fleas. Ticks [(including those that may transmit Lyme Disease)]. and kills flea eggs,

flea larvae, mosquitoes and (chewing) lice. The active ingredients in [brand name] work by

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

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

[and long lasting] control of Fleas and Ticks [(in as little as one hour)]. [and kills mosquitoes]

69
and chewing lice [for 30 days: All repels claims must be removed from the label. The claims

about movement in hair follicles is deferred to the RM Reviewer and PM.

and chewing lice [for 30 days: All repels claims must be removed from the label. The claims

about movement in hair follicles is deferred to the RM Reviewer and PM.

70
To the Document Center (ITRMD)

*Please transferjacket/mini-jacket to the Product Manager

Team circled below:

Minor Use Section:

Insecticide Branch:

Herbicide Branch:

Fungicide Branch:

PM-5

PM-23

PM-20

PM-13

PM-25

PM-21 PM-22

Insect/Rodent Branch: PM-l PM-7

*Reminder to PM - If applicable, pick-up data from the

Screening Room.

Processed by RD's Completeness Check Team

(Team Member Signature) (Date)

To the Document Center (ITRMD)

*Please transferjacket/mini-jacket to the Product Manager

Team circled below:

Minor Use Section: PM-5

Insecticide Branch: PM -10 PM-13

Herbicide Branch: PM-23 PM-25

Fungicide Branch: PM-20 PM-21 PM-22

Insect/Rodent Branch: PM-l PM-7

*Reminder to PM - If applicable, pick-up data from the

Screening Room.

Processed by RD's Completeness Check Team

(Team Member Signature) (Date)

71
21-Day Screen Completed, by

Contractor

-

21-Day Expires on ---,-9_-/~/_o~~_

Jacket # d!5l7- Rut(

MRID# tf1l gCjcf

Content Screen: Recommended to

J!as.§VFail

86-5 ReVieW:EasS~Faned/NA

Transfer This Jacket to:

21-Day Scree~ Completed, by

Contractor-

::n .

21"""Day Expires on -=--==9---='1 -_

1 D~~~

Jacket # d.5/7- RUrf.

MRID# tf8'f gc;cf

Content Screen: Recommended to fa

86-5 xeview:[?aSSedfFih

Transfer This Jacket to:

72
~--_. ---~~~~-_.~----------- -~---- ---~

Completion of 21-Day Content Screen

PM- )0

EPA Reg. #(File Symbol) /;;2/:;/ r ~)2VJ(

Decision # D _

Data package delivered to

you onr!Zo//o· . (date)

Jacket/Mini-jacket will be

transferred to you today.

(Pick up from Document Center)

Thank you,

Registration Division's 21-Day Content Team

Completion of 21-Day Content Screen

PM- /0

EPA Reg. #(File Symbol) /:2r;;1 r ~)2VJ(

Decision # D------

Data package delivered to

you on "7/20//0. . "", (date)

Jacket/Mini-jacket will be

transferred to you today.

(Pick up from Document Center)

Thank you,

Registration Division's 21-Day Content Team

73
Memorandum

Date: 8' / !'J / /0

To: __-----'P---"-"./\,J"-------'--/!.LQ , Regulatory Manager

From: Information Services Branch, ITRMD

Your receipt ofthis data submission is not an

indication that MRIDs for the enclosed studies have

been posted to OPPIN.

We expect that it will be approximately 5 days

from the above date before the study-level data is

available in OPPIN.

If you have any questions about this process,

please contact Teresa Downs (305-5363).

This is a: fully accepted submission

n partially accepted submission

o rejected submission

Memorandum

Date: 8' / !'J / /0

To: __-----'P---"-"./\,J"-------'--/!.LQ , Regulatory Manager

From: Information Services Branch, ITRMD

Your receipt ofthis data submission is not an

indication that MRIDs for the enclosed studies have

been posted to OPPIN.

We expect that it will be approximately 5 days

from the above date before the study-level data is

available in OPPIN.

If you have any questions about this process,

please contact Teresa Downs (305-5363).

This is a: fully accepted submission

n partially accepted submission

o rejected submission

74
UNITED STATES ENVIRONMENTAL PROTECTION AG&Y

WASHINGTON, D.C. 20460

August 16,2010

'FICEOF

PREVEN~~, PESTICIDES AND

TO:SUBSTANCES

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158TH PLAZA

OMAHA, NE 68130-1703

Report ofAnalysis for Compliance with PR Notice 86-5

Thank you for your submittal of ll-AUG-lo. Our staff has completed.Jreliminary

analysis ofthe material. The results are provided as follows:

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

data contained in PR Notice 86-5. A copy ofyour bibliography is enclosed, altated with

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

all future references to these documents. Thank you for your cooperation. If1 have any

questions concerning this data submission, please raise them with the cognizanroduct Manager,

to whom the data have been released.

UNITED STATES ENVIRONMENTAL PROTECTION AG&Y

WASHINGTON, D.C. 20460

August 16,2010

'FICEOF

PREVEN~~, PESTICIDES AND

TO:SUBSTANCES

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158TH PLAZA

OMAHA, NE 68130-1703

Report ofAnalysis for Compliance with PR Notice 86-5

Thank you for your submittal of ll-AUG-lo. Our staff has completed.Jreliminary

analysis ofthe material. The results are provided as follows:

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

data contained in PR Notice 86-5. A copy ofyour bibliography is enclosed, altated with

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

all future references to these documents. Thank you for your cooperation. If1 have any

questions concerning this data submission, please raise them with the cognizanroduct Manager,

to whom the data have been released.

75
3 Fee For Service: r. ffe·$~ C No

3 BIllable: r. Yes r No

Regulatory Type: Jproduct Registration" section 3

Application Type: INew Registration

Company; ~- ~E'RofANT'S PET CARE PRODUCTS, INC.

IRegistration Division, Risk Management Tearn 10 ,3

;===__"1 ProdUct Nfllne:':eERGEANT'S FIPRONIL NY~AR SQUEEZE·(

Print Letter

Enter More lnfonnation

>

76
TRANSMITTAL DOCUMENT

NAME AND ADDRESS OF SUBMITTER:

Sergeant's Pet Care Products, Inc.

2625 South 158" Plaza

Omaha, NE 68130-1770

CONTACT PERSON (Return to)

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South 158" Plaza

Omaha, NE 68130-1770

REGULATORY ACTION SUPPORTED BY THIS PACKAGE:

This submission is prepared to support an EPA registration application for the new end-use

product Sergeant's Fipronil + Nylar Squeeze-On for Dogs.

SUBMITTAL DATE:

August 11, 2010

Volume Study Title MRIDNo.

1 Administrative Materials

2 Group A Product Chemistry For Sergeant's Fipronil + Nylar 48189401 Saueeze-On For Dogs

3 Group B Product Chemistry For Sergeant's Fipronil + Nylar 48189402 Squeeze-On For Dogs

TRANSMITTAL DOCUMENT

NAME AND ADDRESS OF SUBMITTER:

Sergeant's Pet Care Products, Inc.

2625 South 158" Plaza

Omaha, NE 68130-1770

CONTACT PERSON (Return to)

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South 158" Plaza

Omaha, NE 68130-1770

REGULATORY ACTION SUPPORTED BY THIS PACKAGE:

This submission is prepared to support an EPA registration application for the new end-use

product Sergeant's Fipronil + Nylar Squeeze-On for Dogs.

SUBMITTAL DATE:

August 11, 2010

Volume Study Title MRIDNo.

1 Administrative Materials

2 Group A Product Chemistry For Sergeant's Fipronil + Nylar 48189401 Saueeze-On For Dogs

3 Group B Product Chemistry For Sergeant's Fipronil + Nylar 48189402 Squeeze-On For Dogs

77
UN,') STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

September 7, 2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

OPP Decision Number: D-438358

EPA File Symbol or Registration Number: 2517-RUR

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

EPA Application Receipt Date: II-Aug-2010

EPA Waiver Request Receipt Date: ll-Aug-2010

EPA Company Number: 2517

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

KELLY R HOSKINS

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158TH PLAZA

OMAHA, NE 68130-1703

SUBJECT: Approval of50% Small Business Waiver Request

Dear Registrant:

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

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

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

The Action has been identified as Action Code: R320

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE

CITATIONS);

Ifyou have any questions, please contact the Pesticide Registration Service Fee

Ombudsman, at (703) 308-9362.

Sincerely,

jV~~JJ )~3,\ (j--

Oscar Morales, Director

Infonnation Technology & Resources Management Division

Office of Pesticide Programs

UN,') STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

September 7, 2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

OPP Decision Number: D-438358

EPA File Symbol or Registration Number: 2517-RUR

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

EPA Application Receipt Date: II-Aug-2010

EPA Waiver Request Receipt Date: ll-Aug-2010

EPA Company Number: 2517

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

KELLY R HOSKINS

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158TH PLAZA

OMAHA, NE 68130-1703

SUBJECT: Approval of50% Small Business Waiver Request

Dear Registrant:

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

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

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

The Action has been identified as Action Code: R320

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE

CITATIONS);

Ifyou have any questions, please contact the Pesticide Registration Service Fee

Ombudsman, at (703) 308-9362.

Sincerely,

jV~~JJ )~3,\ (j--

Oscar Morales, Director

Infonnation Technology & Resources Management Division

Office of Pesticide Programs

78
PRIA 2 - 21 Day Content Screen Review Worksheet

(EPAJOPP Use Only)

3/23/09

21 Day Screen Start Date: a- -// -I' 0 ./

Experts In-Processing Signature: r-r.c /.{.I'1=A,f I'N~ ;p~ Date 1? -/2 ·/0 Fee Paid: Yes ~V

Division manaoernent contacted on issues No Yes Date 0

EPA Reg. Number: 2::-0- RUR... EPA Receipt Date: J-- 11-10 I

Items for Review Ves No N/A*

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

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

2

dated (EPA Form 8570-4) (Link to fonn) X

a) All inerts (link to http://www.epa.gov/opprdOOl/inertsl), yes no

including fragrances, approved for the proposed uses (see

Footnote A) X

3 Certification with Respect to Citation ofData (EPA Fonn 8570~34) (Link to

fonn) completed and signed (N/A if 100% repack) X

Certificate and data matrix consistent XIf applicant is relying on data that are compensable, is the offer yes no

to pay statement included. (see Footnote B)

If aoolicable, is there a letter of Authorization for exclusive use onlv.

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

4 completed and signed (N/A ifsource is unregistered or applicant owns the )c technical)

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

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

renack)

5 yes no

a) Selective Method (Fee category experts use) K

h) 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/oppfeadlllabeling/lrmD

6 (Electronic

hUp:l!www.epa.gov/pesticjdes/regulating/registering/submissions/index.htm#labels

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

)

1

PRIA 2 - 21 Day Content Screen Review Worksheet

(EPAJOPP Use Only)

3/23/09

21 Day Screen Start Date: a- -// -I' 0 ./

Experts In-Processing Signature: r-r.c /.{.I'1=A,f I'N~ ;p~ Date 1? -/2 ·/0 Fee Paid: Yes ~V

Division manaoernent contacted on issues No Yes Date 0

EPA Reg. Number: 2::-0- RUR... EPA Receipt Date: J-- 11-10 I

Items for Review Ves No N/A*

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

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

2

dated (EPA Form 8570-4) (Link to fonn) X

a) All inerts (link to http://www.epa.gov/opprdOOl/inertsl), yes no

including fragrances, approved for the proposed uses (see

Footnote A) X

3 Certification with Respect to Citation ofData (EPA Fonn 8570~34) (Link to

fonn) completed and signed (N/A if 100% repack) X

Certificate and data matrix consistent XIf applicant is relying on data that are compensable, is the offer yes no

to pay statement included. (see Footnote B)

If aoolicable, is there a letter of Authorization for exclusive use onlv.

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

4 completed and signed (N/A ifsource is unregistered or applicant owns the )c technical)

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

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

renack)

5 yes no

a) Selective Method (Fee category experts use) K

h) 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/oppfeadlllabeling/lrmD

6 (Electronic

hUp:l!www.epa.gov/pesticjdes/regulating/registering/submissions/index.htm#labels

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

)

1

79
7 Is the data package consistent with PR Notice 86-5 (link to PRJ'\! 86-5) X

Notice of Filing (link to

8 http://www.epa.govfpesticides/regulatingltolerance petitions.htm) includcd

with petitions (link to K

http://www.eva.2ov/vesticideslregulating/tolerances.htm) ,

,

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

http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) X

Required Data (link to

http://\vww.epa.gov/pesticides/regulating/data requirements.htm) and/or

data waivers. See Footnote C.

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

10

,

2

7 Is the data package consistent with PR Notice 86-5 (link to PRJ'\! 86-5) X

Notice of Filing (link to

8 http://www.epa.govfpesticides/regulatingltolerance petitions.htm) includcd

with petitions (link to K

http://www.eva.2ov/vesticides/regulating/tolerances.htm) ,

,

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

http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) X

Required Data (link to

http://\vww.epa.gov/pesticides/regulating/data requirements.htm) and/or

data waivers. See Footnote C.

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

10

,

2

80
Comments:

* N/A - Not Applicable

Footnotes

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

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

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

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

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

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

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

eSF and may require submission of data. All infonuation, fonus, data and

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

application withdrawn within the 21 day period. othenvise, the Agencv will reject the

application as described below.

To successfully complete this aspect ofthe 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

Comments:

j 0. .r-... Ii\C I h QC\J r-:}YD \.Dr ('ont»)C\ U}, L 1

* N/A - Not Applicable

Footnotes

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

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

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

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

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

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

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

eSF 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 Agencv will reject the

application as described below.

To successfully complete this aspect ofthe 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

81
site [link to http://www.epa.gov/opprdOOI/inelts/lists.htrnl] and ifthe 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 inelt

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

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

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

delays.

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

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

Branch (nAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe

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

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

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

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

Microbial Pesticides Branch [Link to

http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm].

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

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

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdfJ must also be included

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

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

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

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

fragrance supplier to provide the component 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 infonned of an unapproved inert.

Unapproved Joerts Identified on CSFs

All applications except conventional new products and PIPs

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

applicant with the following options:

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

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

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

approved for the application's uses; or

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

unapproved inert. Ifthis 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

site [link to http://www.epa.gov/opprdOOI/inelts/lists.htrnl] and ifthe 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 inelt

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

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

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

delays.

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

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

Branch (nAB) at inertsbranch@epa.gov and resolve the issue. Copies ofthe

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

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

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

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

Microbial Pesticides Branch [Link to

http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm].

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

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

information [link to http://www.epa.gov/opprdOO1/inerts/tips.pdfJ must also be included

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

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

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

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

fragrance supplier to provide the component 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 infonned of an unapproved inert.

Unapproved Joerts Identified on CSFs

All applications except conventional new products and PIPs

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

applicant with the following options:

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

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

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

approved for the application's uses; or

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

unapproved inert. Ifthis 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

82
3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee

category estimated); or

If none ofthese options is selected and implemented by the applicant within the

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

25% ofthe full fee ofthe category identified.

Conventional New Product Applications

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

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

inert approval (R3ll, 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 information and data needed for the Agency to approve the

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

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

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

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

Agency within the 21 day content review period.)

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

category estimated); or

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

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

the 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. Ifthis option is selected and implemented, the

Agency will discuss harmonizing the timeframe for both actions.

5

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

category estimated); or

If none ofthese options is selected and implemented by the applicant within the

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

25% ofthe full fee ofthe category identified.

Conventional New Product Applications

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

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

inert approval (R3ll, 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 information and data needed for the Agency to approve the

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

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

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

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

Agency within the 21 day content review period.)

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

category estimated); or

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

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

the 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. Ifthis option is selected and implemented, the

Agency will discuss harmonizing the timeframe for both actions.

5

83
3. Withdraw the application (the Agency retains 25% of the full fee for the fee

category estimated); or

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

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

the fee.

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

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

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

A53!. The Agency recommends that authorizations of offers to pay be submitted with

other PRlA 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 ofsuch discussions

should be submitted with the study waiver.

6

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

category estimated); or

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

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

the fee.

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

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

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

A53!. The Agency recommends that authorizations of offers to pay be submitted with

other PRlA 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 ofsuch discussions

should be submitted with the study waiver.

6

84
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

October 4, 2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

OPP Decision Number: D·438358

EPA File Symbol or Registration Number: 2517-RUR

Product Name: SERGEANT'S FIPRONIL +NYLAR SQUEEZE·ON FOR DOGS

EPA Receipt Date: 11·Aug·2010

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: Receipt ofRegistration Application Subject to Registration Service Fee

Dear Registrant:

The Office of Pesticide Programs has received your application and certification of

payment. If you submitted data with this application, the results ofthe 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 previously identified as R320 has been reclassified as as Action Code: R31 0

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

CHEMISTRY;ACUTE TOX1C1TY;PUBLIC HEALTH PEST EFFICACY);

The fee associated "With this aciton is $ 2,289 (50% of$ 4,578). Payment ifthe amount of

$ 5,712 has been received. A refund in the amount of$ 3,423 "Will be issued as soon as the action

is completed.

If you have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308·9362.

Sincerely,

Front End Processing Staf

Infonnation Technolo &

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

October 4, 2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

OPP Decision Number: D·438358

EPA File Symbol or Registration Number: 2517-RUR

Product Name: SERGEANT'S FIPRONIL +NYLAR SQUEEZE·ON FOR DOGS

EPA Receipt Date: 11·Aug·2010

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: Receipt ofRegistration Application Subject to Registration Service Fee

Dear Registrant:

The Office of Pesticide Programs has received your application and certification of

payment. If you submitted data with this application, the results ofthe 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 previously identified as R320 has been reclassified as as Action Code: R31 0

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

CHEMISTRY;ACUTE TOX1C1TY;PUBLIC HEALTH PEST EFFICACY);

The fee associated "With this aciton is $ 2,289 (50% of$ 4,578). Payment ifthe amount of

$ 5,712 has been received. A refund in the amount of$ 3,423 "Will be issued as soon as the action

is completed.

If you have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308·9362.

Sincerely,

Front End Processing Staf

Infonnation Technolo &

85
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

September 1,2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUESTANCES

PLEASE RETURN A COPY OF THIS LETTER WIlli PAYMENT

Or Pay OnMLine at \VWW.Pay.Gov (See Below for Details)

OPP Decision Number: D-438358

EPA File Symbol or Registration Number: 2517-RUR

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

EPA Receipt Date: II-Aug-2010

EPA Company Number: 2517

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

KELLY R. HOSKINS

SERGEANT'S PET CARE PRODUCTS, INC.

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUlli 158TH PLAZA

OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee

Dear Registrant

The Office of Pesticide Programs has received your application for registration. If you

submitted data with this application, the results ofthe PRN-86-S 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 defmed in the Pesticide

Registration Improvement Act.

The Action previously identified as R3l 0 has been reclassified as Action Code: R320

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE

CITATIONS);

The fee associated with this action is $ 5,712 (50% of $ 11,424). Payment in the amount of

$2,289 has been received. Please remit additional payment in the amount of $ 3,423 to:

ByUSPS:

USEPA Washington Finance Center

Pesticide Registration Service Fee

PO Box 979074

St. Louis, MO 63197-9000

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

September 1,2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUESTANCES

PLEASE RETURN A COPY OF THIS LETTER WIlli PAYMENT

Or Pay OnMLine at \VWW.Pay.Gov (See Below for Details)

OPP Decision Number: D-438358

EPA File Symbol or Registration Number: 2517-RUR

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

EPA Receipt Date: II-Aug-2010

EPA Company Number: 2517

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

KELLY R. HOSKINS

SERGEANT'S PET CARE PRODUCTS, INC.

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUlli 158TH PLAZA

OMAHA, NE 68130-1703

SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee

Dear Registrant

The Office of Pesticide Programs has received your application for registration. If you

submitted data with this application, the results ofthe PRN-86-S 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 defmed in the Pesticide

Registration Improvement Act.

The Action previously identified as R3l 0 has been reclassified as Action Code: R320

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE

CITATIONS);

The fee associated with this action is $ 5,712 (50% of $ 11,424). Payment in the amount of

$2,289 has been received. Please remit additional payment in the amount of $ 3,423 to:

ByUSPS:

USEPA Washington Finance Center

Pesticide Registration Service Fee

PO Box 979074

St. Louis, MO 63197-9000

86
By Courier:

U.S. Bank

Government Lockbox 979074

1005 Convention Plaza

SL-MO-C2-GL

St. Louis. MO 63197

Telephone: (412) 236-2294

All payments must be in United States currency by check, bank draft, or money order

dra\¥Il to the order ofthe Environmental Protection Agency. To ensure proper credit, please

write the OPP DECISION NUMBER on your check, and enclose a copy ofthis letter with your

payment.

Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund

transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select

"search by fonn name." From the next page, select "P," then click on "Pesticide Registration

Improvement Act. Fee Payment" and complete the fonn, making certain to use the decision

number and registration number on the invoice you receive from the Pesticide Program in the

space provided.

You may be eligible for a partial waiver ofthe registration service fee if, for example, you

qualify as a small business or are applying for a minor use, or if your application is solely

associated with an IRA tolerance petition. Please be advised that if you intend to request a

waiver, you must do so in writing within 15 days ofreceipt ofthis invoice instead ofremitting

the amount indicated above. OPP will not consider waiver requests after the registration service

fee has been paid. Infonnation regarding eligibility and how th request and document a fee

waiver is available on the OPP Fee for Service web site at www.epa.gov/pesticides/fees.

Please send Registration Service Fee Waiver requests to:

By USPS:

Document Processing Desk (WAIVER)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

1200 Pennsylvania Ave NW

Washington. DC 20460

By Courier:

Document Processing Desk (WAIVER)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room S4900 Potomac Yard 1

2777 S. Crystal Dr.

Arlington. VA 22202

By Courier:

U.S. Bank

Government Lockbox 979074

1005 Convention Plaza

SL-MO-C2-GL

St. Louis. MO 63197

Telephone: (412) 236-2294

All payments must be in United States currency by check, bank draft, or money order

dra\¥Il to the order ofthe Environmental Protection Agency. To ensure proper credit, please

write the OPP DECISION NUMBER on your check, and enclose a copy ofthis letter with your

payment.

Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund

transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select

"search by fonn name." From the next page, select "P," then click on "Pesticide Registration

Improvement Act. Fee Payment" and complete the fonn, making certain to use the decision

number and registration number on the invoice you receive from the Pesticide Program in the

space provided.

You may be eligible for a partial waiver ofthe registration service fee if, for example, you

qualify as a small business or are applying for a minor use, or if your application is solely

associated with an IRA tolerance petition. Please be advised that if you intend to request a

waiver, you must do so in writing within 15 days ofreceipt ofthis invoice instead ofremitting

the amount indicated above. OPP will not consider waiver requests after the registration service

fee has been paid. Infonnation regarding eligibility and how th request and document a fee

waiver is available on the OPP Fee for Service web site at www.epa.gov/pesticides/fees.

Please send Registration Service Fee Waiver requests to:

By USPS:

Document Processing Desk (WAIVER)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

1200 Pennsylvania Ave NW

Washington. DC 20460

By Courier:

Document Processing Desk (WAIVER)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room S4900 Potomac Yard 1

2777 S. Crystal Dr.

Arlington. VA 22202

87
A PRIA decision time review period will not start until a fee waiver is granted and/or the

Agency receives certification that the outstanding fee has been paid. Ifthe Agency does not

receive certification ofpayment for this action or a fee waiver request within the next 30 days,

the Agency will presume that you no longer want to pursue this action. The Agency will then

reject your application and issue an invoice for any applicable outstanding fees.

Ifyou have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308-9362.

Sincerely,

esources Management Division

A PRIA decision time review period will not start until a fee waiver is granted and/or the

Agency receives certification that the outstanding fee has been paid. Ifthe Agency does not

receive certification ofpayment for this action or a fee waiver request within the next 30 days,

the Agency will presume that you no longer want to pursue this action. The Agency will then

reject your application and issue an invoice for any applicable outstanding fees.

Ifyou have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308-9362.

Sincerely,

esources Management Division

88
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Ir.lOIfT\j [to" ::'r.r~'':H e, '''';~-

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8EPA

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C:r=S~ylICiu. No.: _

The jacket for this action can be

requested through the J_ACKETS system.

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ltd OJl'T\Ji [tOf'J t """~'l: Ji l 5,,j n.:;~-

&EPA

Pl\·1: /0

Cr:E!y{IC~Al, No.:

-------,.----------

The jacket for this action can be

r2quested through the J_.1~CICE'TS system.

89
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

August 12,2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

OPP Decision Number: D-438358

EPA File Symbol or Registration Number: 2517~RUR

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

EPA Receipt Date: ll-Aug-20 10

EPA Company Number: 2517

Company Name: SERGEANT'S PET CARE PRODUCTS, INC.EPA File Symbol or

Registration Number:

KELLY R. HOSKINS

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158TH PLAZA

OMAHA, NE 68130-1703

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

Dear Registrant:

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

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

results ofthe PRN-86-5 screen will be communicated separately. During the administrative

screen, the Office ofPesticide Programs has determined that this Action is subject to a Pesticide

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

The Action has been identified as Action Code: R31 0

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

CHEMISTRY;ACUTE TOXIClTY;PUBLIC HEALTH PEST EFFICACY);

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

determination is made regarding your request. If your waiver request is approved, the decision

review time period will start on the date of approvaL If your waiver request is denied, you will

receive an invoice for the outstanding balance.

Ifyou have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308-9362.

S~erely, \'1 IVI..e./.JLl D"h<J"nxL..

Front End Processing Staff

Infonnation Technology & Resources Management Division

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

August 12,2010

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

OPP Decision Number: D-438358

EPA File Symbol or Registration Number: 2517~RUR

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

EPA Receipt Date: ll-Aug-20 10

EPA Company Number: 2517

Company Name: SERGEANT'S PET CARE PRODUCTS, INC.EPA File Symbol or

Registration Number:

KELLY R. HOSKINS

SERGEANT'S PET CARE PRODUCTS, INC.

2625 SOUTH 158TH PLAZA

OMAHA, NE 68130-1703

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

Dear Registrant:

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

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

results ofthe PRN-86-5 screen will be communicated separately. During the administrative

screen, the Office ofPesticide Programs has determined that this Action is subject to a Pesticide

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

The Action has been identified as Action Code: R31 0

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

CHEMISTRY;ACUTE TOXIClTY;PUBLIC HEALTH PEST EFFICACY);

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

determination is made regarding your request. If your waiver request is approved, the decision

review time period will start on the date of approvaL If your waiver request is denied, you will

receive an invoice for the outstanding balance.

Ifyou have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308-9362.

S~erely, \'1 IVI..e./.JLl D"h<J"nxL..

Front End Processing Staff

Infonnation Technology & Resources Management Division

90
IFee for Servicel

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

(8801811-

This package includes the following

@ New Registration

°Amendment

>l] Studies? j{j Fee Waiver?

v

[J volpay % Reduction: 50

for Division

°AD

°BPPD

@RD

Risk Mgr. [JQJ

~:::=::::::--=-=-:::=::::::--=--_:_-=---=-:-------------------;::-~:::=:::::::::=::::::=---=---~-~---~----~--~~-

Receipt No. S-I=8~8~O~18~1=

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

Pin-Punch Date: I 8/11/2010

-'--~-~--~-~----------- ____ ~J

[J This item is NOT subject to FFS action. ~---~----

r---~--Action-etyde: Parent/Child Decisions:

I

: Requested: I j'<,3J 0 I

1 Granted: I R3J () I

LAm:~nt Due: $ Lt. 57&'

Inert Cleared for Intended Use [J Uncleared Inert in Product

Reviewer:.__--"-'vY'I-.JL(fYI=--'-oA.6L-----=- _

Remarks:

Date: 8/1;>"/10

IFee for Servicel

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

(8801811-

This package includes the following

@ New Registration

°Amendment

>l] Studies? j{j Fee Waiver?

v

[J volpay % Reduction: 50

for Division

°AD

°BPPD

@RD

Risk Mgr. [JQJ

~:::=::::::--=-=-:::=::::::--=--_:_-=---=-:-------------------;::-~:::=:::::::::=::::::=---=---~-~---~----~--~~-

Receipt No. S-I=8~8~O~18~1=

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

Pin-Punch Date: I 8/11/2010

-'--~-~--~-~----------- ____ ~J

[J This item is NOT subject to FFS action. ~---~----

r---~--Action-etyde: Parent/Child Decisions:

I

: Requested: I f<,3i 0 I

1 Granted: I R3J () I

LAm:~nt Due: $ Lt. 57&'

Inert Cleared for Intended Use [J Uncleared Inert in Product

Reviewer:.__--"-'vY'I-.JL(fYI=--'-oA.6L-----=- _

Remarks:

Date: 8/1;>"/10

91
Tracking -.-J"

Print letter

Enter More Information

r- No

Yes (' No

j ERGEANT'S PET CARE PROOUC

jRegistration Division, Risk'Management' Team 10

duct Name: kl'E~~R~G~EA·N~T~'S"~F""~;;'O~N~L"~+;:NY~;;L·A~R·S~Q"lJff·~Z~E;-:-(

RegUlatory Type: 'product RegistratIOn: Section 3

Application Type: !NeW,Registration

92
FEE FOR SERVICE

93
Pay.gov Online Payment Page 1 of 1

Online Payment

Step 3: Confirm Payment

Thank you.

Your transaction has been successfully completed.

11213

Payment Date: 06/2112010

Decision Number:

Registration Number: 2517-new

Company Name: Sergeant's Pet Care Produ

Company Number: 2517

Action Code: R310

Pay.gov Tracking Information

Application Name: PRIA Service Fees

Pay.gov Tracking 10: 25101L1D

Agency Tracking 10: 74122352206

Transaction Date and Time: 06/18/2010 14:33 EDT

Payment Summary

Account Holder Sergeant's Pet Care Products,

Name: Inc

Payment Amount: $2,289.00

Account Type: Business Checking

Routing Number:

Account Number: ......5483

httos:/lwww.oav.gov/pavgov/oavments/authorizeACHPavrnent.htmI 6118/2010

Pay.gov Online Payment Page 1 of 1

Online Payment

Step 3: Confirm Payment

Thank you.

Your transaction has been successfully completed.

11213

Payment Date: 06/2112010

Decision Number:

Registration Number: 2517-new

Company Name: Sergeant's Pet Care Produ

Company Number: 2517

Action Code: R310

Pay.gov Tracking Information

Application Name: PRIA Service Fees

Pay.gov Tracking 10: 25101L1D

Agency Tracking 10: 74122352206

Transaction Date and Time: 06/18/2010 14:33 EDT

Payment Summary

Account Holder Sergeant's Pet Care Products,

Name: Inc

Payment Amount: $2,289.00

Account Type: Business Checking

Routing Number:

Account Number: ......5483

httos:/lwww.oav.gov/pavgov/oavments/authorizeACHPavrnent.htmI 6118/2010

94

*Commercial/financial information may be entitled to confidential treatment*
Please rerrd Instructfons on reverse before \.-,Ip/etfng fonn Form Approve JMB No 20700060 - Approval expires 05-31 -98

United States 1l;1Registration OPP Identifier Number

EPA Environmental Protection Agency D_Amendment

Washington, DC 20460 o Other

Application for Pesticide - Section I

1. Company/Product NumbeR 2. EPA Product Manager 3. Proposed Classification

2517-NEW R U Richard Gebken

4. Company/ProdUct (Name) 5.PM# 10 L8JNone DRestricted Sergeant's Pet Care Products, Inc. / Sergeants Fipronil + Nylar SqueezeOn For DOQS

5, Name and Address of Applicant (/nclude ZIP Code) 6. Expedited Review. In accordance with AFRA Section 3(c)(3)(b)(I), my

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

2625 South 158\11 Plaza

Omaha, NE 68130-1770 EPA Reg. No.

Product Name

o Check if this is a new address

Section II

o Amendment - Explain below. D 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 below. other - Explain below.

Explanation: Use additional page(s) if necessary. (For section I and Section 11.)

Submissior. of a new end-use registration application.

Section III

1. Material This Product Will Be Packaqed In:

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2 Type of Container

o Yes' ~Yes DYes D Metal

DNo D No l:8J No [Z] Plastic

If "Yes" No. per If "Yes" No. per DGlaSS

'Certification must Unit Packaging wgt. Container Package wgt. Container

DPaper be submitted 0.023 11 oz (0.67 ml)

0.045 f1 oz (1.34 ml)1 3 vials I DOther(Specify) Plastic Bag

0.091 11 oz (2.68 ml)

0.136 f1 oz (4.02 ml)

3. Location of Net Contents Information 4. Size(s) Relail Conlainer 5. Location of Label Directions

k8JLabel o Container 0.67 ml, 1.34 ml, 2.68 ml, 4.02 ml Don Can

[ZlOn Labeling accompanying product

6. Manner in Which Label is Affixed to Product DLithograph [Z]Other

DPaperglued

DStenCiJed

Section IV

-'-

1. Contact Point (Complete items direcVy be/ow for identificatfon oftndfvidua/ to be contacted, if necessary, to orocessJhis aonlicati':>r) ,

Name Title 11 elephone No. (Inc!ude Area Code)

Kelly R. Hoskins Manager of Technical Affairs . ' 4(1;':~8J8-7079 Certification 6. Date Application

I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I Re<;eived

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

under applicable law.

2. Signature

\{osG.H I:C/tJ

3. Title

BY: ILJ!\j- 12 Manager of Technical Affairs

4. Typed Name: 5. Oate: 08/11/2010

Kellv R. Hoskins

Please rerrd Instructfons on reverse before \.-,Ip/etfng fonn Form Approve JMB No 20700060 - Approval expires 05-31 -98

United States 1l;1Registration OPP Identifier Number

EPA Environmental Protection Agency D_Amendment

Washington, DC 20460 o Other

Application for Pesticide - Section I

1. Company/Product NumbeR 2. EPA Product Manager 3. Proposed Classification

2517-NEW R U Richard Gebken

4. Company/Product (Name) 5.PM# 10 L8JNone DRestricted Sergeant's Pet Care Products, Inc. / Sergeants Fipronil + Nylar SqueezeOn For DOQS

5. Name and Address of Applicant (/nclude ZIP Code) 6. Expedited Review. In accordance with AFRA Section 3(c)(3)(b)(I), my

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

2625 South 158\11 Plaza

Omaha, NE 68130-1770 EPA Reg. No.

Product Name

o Check if this is a new address

Section II

o Amendment - Explain below. D 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 below. other - Explain below.

Explanation: Use additional page(s) if necessary. (For section I and Section 11.)

Submissior. of a new end-use registration application.

Section III

1. Material This Product Will Be Packaqed In:

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2 Type of Container

o Yes' ~Yes DYes D Metal

DNo D No l:8J No [Z] Plastic

If "Yes" No. per If "Yes" No. per DGlaSS

'Certification must Unit Packaging wgt. Container Package wgt. Container

DPaper be submitted 0.023 11 oz (0.67 ml)

0.045 f1 oz (1.34 ml)1 3 vials I DOther(Specify) Plastic Bag

0.091 11 oz (2.68 ml)

0.136 f1 oz (4.02 ml)

3. Location of Net Contents Information 4. Size(s) Relail Conlainer 5. Location of Label Directions

k8JLabel o Container 0.67 ml, 1.34 ml, 2.68 ml, 4.02 ml Don Can

[Zlon Labeling accompanying product

6. Manner in Which Label is Affixed to Product DLithograph [Z]Other

DPaperglued

DStenCiJed

Section IV

-'-

1. Contact Point (Complete items direcVy be/ow for identificatfon oftndfvidua/ to be contacted, if necessary, to orocessJhis aonlicati':>r) ,

Name Title 11 elephone No. (Inc!ude Area Code)

Kelly R. Hoskins Manager of Technical Affairs . ' 4(1;':~8J8-7079 Certification 6. Date Application

I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I Re<;eived

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

under applicable law.

2. Signature

\{osG.H I:C/tJ

3. Title

BY: ILJ!\j- 12 Manager of Technical Affairs

4. Typed Name: 5. Oate: 08/11/2010

Kellv R. Hoskins

95
481894.00

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

August 11,2010

Richard Gebken, PMI 0

Office ofPesticide Programs (7504P) (REGFEE)

U.S. Environmental Protection Agency

Document Processing Desk

Room 8-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Sergeant's Fipronil + Nylar Squeeze-On for Dogs

EPA File Symbol 25 I7-NEW

Dear Mr. Gebken:

Sergeant's Pet Care Products, Inc. (Sergeant's, 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 + Nylar Squeeze-On for Dogs [containing the EPA registered active

ingredients Fipronil (9.8%) and Pyriproxyfen (Nylar) (2.0%)]. Please find enclosed the

following documentation in support ofthis registration:

(I) Transmittal Document;

(2) Application for Registration (EPA Fonn 8570-1);

(3) Confidential Statement of Fonnula (EPA Fonn 8570-4) (Two Copies);

(4) Fonnulator's Exemption Statement (EPA Fonn 8570-27);

(5) Certification With Respect to Citation ofData (EPA Fonn 8570-34);

(6) Data Matrix (EPA Fonn 8570-35) - EPA and Public Versions;

(7) Product Label (Five Copies);

(8) Letter ofAuthorization;

(9) Child Resistant Packaging (CRP) Certification Statement;

(10) Bridging Argument to Cite CRP Data;

(II) Submission ofEPA Pesticide Registration Improvement Act Infonnation;

(12) Voluntary Small Business Certification Fonn;

(13) PRIA Fee Waiver Certification Statement;

(14) PRIA Fee Waiver Snpport Letter;

(15) Recent EPA Approval of 50% Small Business Waiver Request (D-425455);

(16) PRIA Category R310, Payment Confinnation Receipt; and

(17) Three Copies of Supporting Studies.

The registration of Sergeant's Fipronil + Nylar Squeeze-On for Dogs is a selective citation

registration for a new end-use product. Sergeant's is submitting new product chemistry studies in

support ofthis end-use product registration. Additionally, Sergeant's is citing acute toxicity

studies and companion animal safety data submitted to EPA on June 18, 2010 with the

registration application for Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs. The acute

481894..00

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

August 11,2010

Richard Gebken, PMlO

Office ofPesticide 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: Sergeant's Fipronil + Nylar Squeeze-On for Dogs

EPA File Symbol 2517-NEW

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 an EPA registration application for the new end-use

product Sergeant's Pipronil + Nylar Squeeze-On for Dogs [containing the EPA registered active

ingredients Fipronil (9.8%) and Pyriproxyfen (Nylar) (2.0%)]. Please find enclosed the

following documentation in support ofthis registration:

(1) Transmittal Document;

(2) Application for Registration (EPA Form 8570-1);

(3) Confidential Statement of Formula (EPA Form 8570-4) (Two Copies);

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

(5) Certification With Respect to Citation ofData (EPA Form 8570-34);

(6) Data Matrix (EPA Form 8570-35) - EPA and Public Versions;

(7) Product Label (Five Copies);

(8) Letter ofAuthorization;

(9) Child Resistant Packaging (CRP) Certification Statement;

(10) Bridging Argument to Cite CRP Data; .

(11) Submission ofEPA Pesticide Registration Improvement Act Information;

(12) Voluntary Small Business Certification Form;

(13) PRIA Fee Waiver Certification Statement;

(14) PRIA Fee Waiver Support Letter;

(15) Recent EPA Approval of 50% Small Business Waiver Request (0-425455);

(16) PRIA Category R31 0, Payment Confirmation Receipt; and

(17) Three Copies of Supporting Studies.

The registration of Sergeant's Fipronil + Nylar Squeeze-On for Dogs is a selective citation

registration for a new end-use product. Sergeant's is submitting new product chemistry studies in

support ofthis end-use product registration. Additionally, Sergeant's is citing acute toxicity

studies and companion animal safety data submitted to EPA on June 18,2010 with the

registration application for Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs. The acute

96
sargeant's Pet Care ProdUcts, Inc.

2625 South 1581t1 Plaza • Omaha, NE 68130·1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com

toxicity 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 aPRIA Category R310 (new end-use product) with a

PRIA review time of 6 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 + Nylar SqueezeOn for Dogs. If you have any questions or need additional infonnation regarding this registration

application, please contact me at 402-938-7079.

Sincerely,

0 ~suw Ie-A-T

Kelly R. Hoskins

Manager ofTechnical Affairs

Enclosures

sargeant's Pet Care ProdUcts, Inc.

2625 South 1581t1 Plaza • Omaha, NE 68130·1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com

toxicity 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 R310 (new end-use product) with a

PRIA review time of 6 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 + Nylar SqueezeOn for Dogs. If you have any questions or need additional information regarding this registration

application, please contact me at 402-938-7079.

Sincerely,

0 ~suw Ie-A-T

Kelly R. Hoskins

Manager ofTechnical Affairs

Enclosures

97
TRANSMITTAL DOCUMENT

NAME AND ADDRESS OF SUBMITTER:

Sergeant's Pet Care Products, Inc.

2625 South 158'" Plaza

Omaha, NE 68130-1770

CONTACT PERSON (Return to)

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South 158'" Plaza

Omaha, NE 68130-1770

REGULATORY ACTION SUPPORTED BY THIS PACKAGE:

This submission is prepared to support an EPA registration application for the new end-use

product Sergeant's Fipronil + Nylar Squeez(}-Qn for Dogs.

SUBMITTAL DATE:

August 11, 2010

Volwne Study Title MRIDNo.

1 Administrative Materials

2 Group A Product Chemistry For Sergeant's Fipronil + Nylar 48189401

Squeez(}-Qn For Dogs

3 Group B Product Chemistry For Sergeant's Fipronil +Nylar 49189402 Saueeze-On For Dogs

TRANSMITTAL DOCUMENT

NAME AND ADDRESS OF SUBMITTER:

Sergeant's Pet Care Products, Inc.

2625 South 158'" Plaza

Omaha, NE 68130-1770

CONTACT PERSON (Return to)

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South 158'" Plaza

Omaha, NE 68130-1770

REGULATORY ACTION SUPPORTED BY THIS PACKAGE:

This submission is prepared to support an EPA registration application for the new end-use

product Sergeant's Fipronil + Nylar Squeez(}-Qn for Dogs.

SUBMITTAL DATE:

August 11, 2010

Volwne Study Title MRIDNo.

1 Administrative Materials

2 Group A Product Chemistry For Sergeant's Fipronil + Nylar 48189401

Squeez(}-Qn For Dogs

3 Group B Product Chemistry For Sergeant's Fipronil +Nylar 49189402 Saueeze-On For Dogs

98
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

August 11, 20I0

Richard Gebken, PMIO

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 + Nylar §.gl1eeze-On for Dogs

EPA File Symbol 25 I7-j)IEW (<\.til.

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 + Nylar Squeeze-On for Dogs (EPA File Symbol 2517-NEW)

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158'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 Sergeant's Fipronil + Nylar Squeeze-On for Dogs (EPA File

Symbol 2517-NEW). All product labels have language specifying the use ofscissors 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.

Sincerely,

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

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

August 11,2010

Richard Gebken, PMIO

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 + Nylar §.gl1eeze-On for Dogs

EPA File Symbol 2517-pIEW V<\J.RDear 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 3771 0 (July 21, 1995):

• Sergeant's Fipronil + Nylar Squeeze-On for Dogs (EPA File Symbol 2517-NEW)

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 1581h Plaza, Omaha, NE 68130-1770,

EPA Company Number 2517) is submitting this child resistant packaging certification to support

for the new end-use product Sergeant's Fipronil + Nylar Squeeze-On for Dogs (EPA File

Symbol 25l7-NEW). All product labels have language specifying the use ofscissors 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.

Sincerely,

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

99
Form Al'I'ro,<" O,\IU No. 10711-<1060

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

III 401 M Street, S.W.

WASHINGTON, D.C. 20460

Plillernork Redlletion Act NOliee; TIle public rcporting burdcn for thi:; colleclion of ~llormalion is c:;tinwlcd 10 avcrage 0.25 homs per response lor registrali0n a~:il'i(jes anJ::J-25 :H'Urs pcr rc,pon'c l:u

reregislr;rtion and special rcview aClivilies, including timc for rcading lhe inslru~tion and completing lhe necessary forms Selld COllllllents regarding the burde:1 est:~lla:e or anrotller;lSpect oft:lis c,:llc~tion or

illfommlion, including suggestions for rcdllcing the hurdeu to Director: OI'PE lnfonnation Management Division (2137) U.S. Environmcnlal Pmtcetion Agency, 401 .'VI Slrce', ':;-W 'V1shillg·C1.;- OC :;0460. Do

nOl send lhe form 10 this address.

DATA MATRIX -av.-I'Z.

Date: Au ust II. 2010 EPA Rcg No./File S mbol 2:::~l?~NE;~(-~ Page I of 4

Applicant's/Registnlnl'S Namc & Address Product: Scrgeant's Fipronil .;: Nylar3~IJeez\:-

Sergcallt's Pet Care products, Inc. 2625 Soutll 158th Plaza, Olnaha, NE 68130-1770 On for Dogs

In rcdicnts: Fi ronil and Nylar

Guidelinc Rcfcrencc Number Guideline Stud Name MRIDNumber Submitter Status Note

830.1550, 830.1600, 830.1620, GrOllp A Product Chemistry For Sergeant's Flpronil + Nylar New submission Scrgeant's Pet Care Products, Inc. OWN

830.1650,830.1670,830.1750 Squeeze-On for Do,gs

830.1800 Enforeentent Analytical Method 48122601 Sergeant's Pet Care Products, Inc. OWN

830.6302,830.6303,830.6304, Group B Product Chcmistry For Sergeant's Fipronil + Nylar New submission Sergeant's Pct Carc Products, Inc. OWN

830.6313, 830.6314, 830.6315, Squccze-On for Dogs

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 Bc Submitted Sergeant's Pet Care Prodllcts, Inc. OWN

Unon Comnletion

870.1100 Acute Oral Toxicity Up and Down Proccdurc with Dog Products 48129603 Sergcant's Pct Care Prodllcts, Inc. OWN

870.1200 Acute Dcrmltl Toxicity (Limit Test) with Dog Products 48129604 Scrgcant's Pct Care Products, Inc. OWN

870.1300 Waivcr Requesl of Requirement for Further Tesling for Acute 48129605 Scrgeant's Pet Care Products, Inc. OWN

Inhalalion Toxicitv

870.2400 Acutc Eyc Irritation/Corrosion with Dog Prodllcts 48129606 Scrgeant's Pet Care Products, Inc. OWN

870.2500 Acutc Dermal Irritation/Corrosion with Dog Produets 48129607 Sergcant's Pet Care Products, Inc. OWN

870.2600 Tcst for Sensitization (Guinea Pig Maxilll isation Test) with Dog 48t29608 Sergeant's Pct Carc Products, Inc. OWN

Producls

870.7200 Companion Animal Safety for Scrgcant's Fipronil + Cyphenothrin 48129614 Sergeant's Pet Care Products, Inc. OWN

SQueeze-On for Dogs

870.7200 Companion Animal Safety Evaluation on Dogs of Spot-On 47849609 Scrgeant's Pet Care Products, Inc. OWN

Prodllcts Containing Multiple Toxicants and Insect Growth

Rc,gulators

870.7200 Companion Animal Safety Study ill Dogs: Cyphenothrin-IGR Spot- 46166108 Sergeant's Pct Carc Products, Inc. OWN on for Dogs

870.7200 Assessment ofTolcrance ofaO.25% RM 1601 Spray Formulation 43121110 Merial Limited OLD

in Dogs at3, 9, and 15 Inl/kg When Applicd 6timcs to the

1·laircoat at 28 Dav Intervals

Signature:

~'1- t- \:\-Dblu~ j-t;i\T Name and Title Date

Kclly R. f-Ioskills, Manager ofTedlll ical Affairs 08/11/2010

""~ .~,o, «".." fo.q .... " "~o'r """ ",n_ Vm;o",o ",,,,",',1. <,"h~:' ~"'", P.~.",_"<,~" A.,n,,·lnl.,n.' 11,. ('Onv

£- 517- KLV\,

Fo,m AI'I"O'c" O,\IU No. 10711-<1060

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

III 401 M Street, S.W.

WASHINGTON, D.C. 20460

Plillernork Redlletion Act NOliee; TIle public rcporting burdcn for thi:; colleclion of ~llormalion is c:;tinwlcd 10 avcrage 0.25 homs per response lor registrali0n a~:il'i(jes anJ::J-25 :H'Urs pcr rc,pon'c l:u

reregislr;rtion and special rcview aClivilies, including timc for rcading lhe inslru~tion and completing lhe necessary forms Selld COllllllents regarding the burde:1 est:~lla:e or anrotller;lSpect oft:lis c,:llc~tion or

illfommlion, including suggestions for rcdllcing the hurdeu to Director: OI'PE lnfonnation Management Division (2137) U.S. Environmcnlal Pmtcetion Agency, 401 .'VI Slrce', ':;-W 'V1shillg·C1.;- OC :;0460. Do

nOl send lhe form 10 this address.

DATA MATRIX -av.-I'Z.

Date: Au ust II. 2010 EPA Rcg No./File S mbol 2:::~l?~NE;~(-~ Page I of 4

Applicant's/Registnlnl'S Namc & Address Product: Scrgeant's Fipronil .;: Nylar3~IJeez\:-

Sergcallt's Pet Care products, Inc. 2625 Soutll 158th Plaza, Olnaha, NE 68130-1770 On for Dogs

In rcdicnts: Fi ronil and Nylar

Guidelinc Rcfcrencc Number Guideline Stud Name MRIDNumber Submitter Status Note

830.1550, 830.1600, 830.1620, GrOllp A Product Chemistry For Sergeant's Flpronil + Nylar New submission Scrgeant's Pet Care Products, Inc. OWN

830.1650,830.1670,830.1750 Squeeze-On for Do,gs

830.1800 Enforeentent Analytical Method 48122601 Sergeant's Pet Care Products, Inc. OWN

830.6302,830.6303,830.6304, Group B Product Chcmistry For Sergeant's Fipronil + Nylar New submission Sergeant's Pct Carc Products, Inc. OWN

830.6313, 830.6314, 830.6315, Squccze-On for Dogs

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 Bc Submitted Sergeant's Pet Care Prodllcts, Inc. OWN

Unon Comnletion

870.1100 Acute Oral Toxicity Up and Down Proccdurc with Dog Products 48129603 Sergcant's Pct Care Prodllcts, Inc. OWN

870.1200 Acute Dcrmltl Toxicity (Limit Test) with Dog Products 48129604 Scrgcant's Pct Care Products, Inc. OWN

870.1300 Waivcr Requesl of Requirement for Further Tesling for Acute 48129605 Scrgeant's Pet Care Products, Inc. OWN

Inhalalion Toxicitv

870.2400 Acutc Eyc Irritation/Corrosion with Dog Prodllcts 48129606 Scrgeant's Pet Care Products, Inc. OWN

870.2500 Acutc Dermal Irritation/Corrosion with Dog Produets 48129607 Sergcant's Pet Care Products, Inc. OWN

870.2600 Tcst for Sensitization (Guinea Pig Maxilll isation Test) with Dog 48t29608 Sergeant's Pct Carc Products, Inc. OWN

Producls

870.7200 Companion Animal Safety for Scrgcant's Fipronil + Cyphenothrin 48129614 Sergeant's Pet Care Products, Inc. OWN

SQueeze-On for Dogs

870.7200 Companion Animal Safety Evaluation on Dogs of Spot-On 47849609 Scrgeant's Pet Care Products, Inc. OWN

Prodllcts Containing Multiple Toxicants and Insect Growth

Rc,gulators

870.7200 Companion Animal Safety Study ill Dogs: Cyphenothrin-IGR Spot- 46166108 Sergeant's Pct Carc Products, Inc. OWN on for Dogs

870.7200 Assessment ofTolcrance ofaO.25% RM 1601 Spray Formulation 43121110 Merial Limited OLD

in Dogs at3, 9, and 15 Inl/kg When Applicd 6timcs to the

1·laircoat at 28 Dav Intervals

Signature:

~'1- t- \:\-Dblu~ j-t;i\T Name and Title Date

Kclly R. f-Ioskills, Manager ofTedlll ical Affairs 08/11/2010

EP", Fo:m S,7(1.15 (9.91) [I[«ro":o and P'p<r V",io", """'bbl, S"bmil c"ly P.pe' "<:>:0" Agcn,]" lnlr<n.1 11" Copy

100
~<"<)' 'Pl' 11'P,J"';

rO'm "pp'ond O~lll No, 20711-0%0

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 20460

Papcnvork Rcduclinn Acl Nolicc: The public reporting bllrdCIi for lhis collcclion of ~lfQ(malion is cSlimaled 10 averagc 0,25 hours Ilcr response for rL'gislralion aclivilies aI1'1025~"I'rs per ·('~rons71or (ercgislmliOIl

and special (eview aClivilies, incklding lime for (eadillg lhe illSlruelion and complelillg lhc neccssary forms. SClid conllllClts (cga/ding lhe bmdcn cslimale 01 any olher aspeel of lhis collecrioll ofillfomlalion, inclu(ling

suggeslions for red...,;:ing thc burden 10 Oircclm: 01'1'1, Infomlalion Managcnlenl Divisil~l (2137) U.S. Ellviwnmenlal I'rolcclioo Agency, 401 M Slreel, S. W" Washinglon, DC 20460. Do nnl send Ihc fonn 10lhis

add(ess. --- DATA MATRIX

Dale: AUj!usl II. 20 I0 EPA Rcg NoJFilc Symbol 7517-NEW ~" ~Pal!.c 2 of 4

Applicanl's1Rcgislrant's Name & Addrcss Producl: Sergeant's Fipronil + Nylar Squcezc-On

Sergeant's Pel Care Products, Inc. 2625 S01llh 1581h Plaza, Omaha, NE 68130-1770 lor D02:S ?,1ti\1'" '{-2.W1t

IngredienlS: Fipronil and Nvlar

Guideline Reference Nnmber Guidclinc Siudy Namc MRID Number Snbmiltcr Status NOle

870.7200 Domeslic Animal SafclY: Assessmcnt oflhe Tolerancc ofa 0.25% RM 43121111 Medal Lilllited OLD

1601 Spray in Nursing Puppies Administcrcd Twicc al a 28 Day Interval

al a Dosc Ratc 01'6 ml/kg

870.7200 Domcslic Animal Safcly Siudy of RM 160le Topical Spray (Fronllinc 43444905 Melial Limiled OLD

Spray Trcalment) in Juvcnile Dous

870.7200 Discussion in Support of Bridging Domeslic Animal Safcly Dala on 43577711 Melial Limiled OLD

Pronl\ine Sora' Trealmcnllo Frontline Spot Trealment Dala Paekaue

870.7200 Domeslic Animal SafelY Siudy by '[opical Adminislralion 10 Dogs: 43863802 Merial Limitcd OLD

Pioronil Soot Trealmeni (RM 1601£)'

810.3300 Overview and Summary ofPipronillCyphcnolhrin Dog Efficacy for 48129609 Sergeant's Pct Carc Products, Inc. OWN

Sergeant's Fipronil + Cyphenothrin Soueeze-On for OMS

810.3300 Immediate Efficacy ofa Combined Applicalion of Pronil inc Plus 48129610 Sergeant's Pel Carc Producls, Inc. OWN

wilh Cyphenothrin as a Squeeze-on againsl Fleas (Ctenocephalides

felis) and Ticks (Rhivicevhallls sanfmineus) 011 Dogs

8\1l.3300 Immcdialc Efficacy Following Applicalion ofFronlline Plus wilh 48129611 Sergeanl's Pct Carc Producls, Inc. OWN

Cyphcnolhrin Squeczl:-on againsl Fleas (Ctenoceplwlides/efi~)and

Ticks (RhiJice ,hahlS san.c:uhle);;i on Oops

810.3300 Immediale Efficacy Following Applicalion ofFronlline wilh 48129612 Scrgcanl's Pcl Care ProduclS, Inc. OWN

Cyphenothrin Squeezc-on againsl Fleas (Ctenocephalides/elis) and

Ticks (RhinicelJlwl/(s sanPldnells! on DOl!s

810.3300 Comparalive efficacy evalualion of Sergeani's Squeeze-on and Fronlline 48129613 Scrgcanl 's Pct Carc Producls, Inc. OWN

Plus for Ihc Irealment of aduli cat flea (Ctenocephalidesfelis) and tick

(Haemaphysalis efliptica, RMpicephalus sallgJ/ineli/>' and Dermacentor

variabifis) infeslalions on dops

8)0,3300 A Dose Tilration Study 10 Determine lhe Oplimal Spray Concenlralion 43121114 Medal Limiled OLD

ofRM IUGI for Long Tcrm Conlrol oflhc Cal Fica Ctcnocephalides

felis and lhe Brown Dog Tick Rhipicephalus sanguineus in Ihe Dog

810.3300 Produci Perforlllance: A Dose Confinnalion Siudy 10 Verify Ihc 431211 15 Menal Limiled OLD

Oplimal Spray Concenlralion <If RM 1601 for Long Rcsidual Conlrol of

thc Cal Pica (Ctcnoccphalides lelis) and Ihc Brown Dog Tick

(Rhipicephalus sanguineus) in Ihc Dol"

Signalure: \LtRct '¥-- \\0 \L.-."'" l !''tAIName and Tille Dale

Kl:l1y R. Hoskins, Mamlgl:r orTt:chnical AlTairs 08/1lf2010

Fl'A 'Mm ""'-" 'O_'rJl "'''''fin;' 'TId P'n" V,,<;"", A".,OI,h" ,,,I,,,,;, ""I" P,",", v,,';~" ....<",,' In,,,,..lll.. rom'

"25 \;- K\,If;;

, ,

ro'm "I'I"ond O~lll No. 20711-0%0

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 20460

Papcnvork Rcduclinn Acl Nolicc: The public reporting bllrdCIi for lhis collcclion of ~lfQ(malion is cSlimaled 10 averagc 0,25 hours Ilcr response for rL'gislralion aclivilies aI1'1025~"I'rs per ·('~rons71or (ercgislmliOIl

and special (eview aClivilies, incklding lime for (eadillg lhe illSlruelion and complelillg lhc neccssary forms. SClid conllllClts (cga/ding lhe bmdcn cslimale 01 any olher aspeel of lhis collecrioll ofillfomlalion, inclu(ling

suggeslions for red...,;:ing!hc burden 10 Oircclm: 01'1'1, Infomlalion Managcnlenl Divisil~l (2137) U.S. Ellviwnmenlal I'rolcclioo Agency, 401 M Slreel, S. W" Washinglon, DC 20460. Do nnl send Ihc fonn 10lhis

add(ess. --- DATA MATRIX

Dale: AUj!usl II. 20 I0 EPA Rcg NoJFilc Symbol 7517-NEW ~" ~Pal!.c 2 of 4

Applicanl's1Rcgislrant's Name & Addrcss Producl: Sergeant's Fipronil + Nylar Squcezc-On

Sergeant's Pel Care Products, Inc. 2625 S01llh 1581h Plaza, Omaha, NE 68130-1770 lor D02:S ?,1ti\1'" '{-2.W1t

IngredienlS: Fipronil and Nvlar

Guideline Reference Nnmber Guidclinc Siudy Namc MRID Number Snbmiltcr Status NOle

870.7200 Domeslic Animal SafclY: Assessmcnt oflhe Tolerancc ofa 0.25% RM 43121111 Medal Lilllited OLD

1601 Spray in Nursing Puppies Administcrcd Twicc al a 28 Day Interval

al a Dosc Ratc 01'6 ml/kg

870.7200 Domcslic Animal Safcly Siudy of RM 160le Topical Spray (Fronllinc 43444905 Melial Limiled OLD

Spray Trcalment) in Juvcnile Dous

870.7200 Discussion in Support of Bridging Domeslic Animal Safcly Dala on 43577711 Melial Limiled OLD

Pronl\ine Sora' Trealmcnllo Frontline Spot Trealment Dala Paekaue

870.7200 Domeslic Animal SafelY Siudy by '[opical Adminislralion 10 Dogs: 43863802 Merial Limitcd OLD

Pioronil Soot Trealmeni (RM 1601£)'

810.3300 Overview and Summary ofPipronillCyphcnolhrin Dog Efficacy for 48129609 Sergeant's Pct Carc Products, Inc. OWN

Sergeant's Fipronil + Cyphenothrin Soueeze-On for OMS

810.3300 Immediate Efficacy ofa Combined Applicalion of Pronil inc Plus 48129610 Sergeant's Pel Carc Producls, Inc. OWN

wilh Cyphenothrin as a Squeeze-on againsl Fleas (Ctenocephalides

felis) and Ticks (Rhivicevhallls sanfmineus) 011 Dogs

8\1l.3300 Immcdialc Efficacy Following Applicalion ofFronlline Plus wilh 48129611 Sergeanl's Pct Carc Producls, Inc. OWN

Cyphcnolhrin Squeczl:-on againsl Fleas (Ctenoceplwlides/efi~)and

Ticks (RhiJice ,hahlS san.c:uhlel;;i on Oops

810.3300 Immediale Efficacy Following Applicalion ofFronlline wilh 48129612 Scrgcanl's Pcl Care ProduclS, Inc. OWN

Cyphenothrin Squeezc-on againsl Fleas (Ctenocephalides/elis) and

Ticks (RhinicelJlwl/(s sanPldnells! on DOl!s

810.3300 Comparalive efficacy evalualion of Sergeani's Squeeze-on and Fronlline 48129613 Scrgcanl 's Pct Carc Producls, Inc. OWN

Plus for Ihc Irealment of aduli cat flea (Ctenocephalidesfelis) and tick

(Haemaphysalis efliptica, RMpicephalus sallgJ/ineli/>' and Dermacentor

variabifis) infeslalions on dops

8)0,3300 A Dose Tilration Study 10 Determine lhe Oplimal Spray Concenlralion 43121114 Medal Limiled OLD

ofRM IUGI for Long Tcrm Conlrol oflhc Cal Fica Ctcnocephalides

felis and lhe Brown Dog Tick Rhipicephalus sanguineus in Ihe Dog

810.3300 Produci Perforlllance: A Dose Confinnalion Siudy 10 Verify Ihc 431211 15 Menal Limiled OLD

Oplimal Spray Concenlralion <If RM 1601 for Long Rcsidual Conlrol of

thc Cal Pica (Ctcnoccphalides lelis) and Ihc Brown Dog Tick

(Rhipicephalus sanguineus) in Ihc Dol"

Signalure: \LtR(\ '¥-- \\0 \L.-."'" l !''tAIName and Tille Dale

Kl:l1y R. Hoskins, Mamlgl:r orTt:chnical AlTairs 08/llf2010

El'A Form ~57C>-lS 9_97 EI«"oni<aod P, <I VmiOM A",lil,hl< SUO,,,;) 0,,1' p, Iv..,ioo A <"<' lnl<n..1U.. Co

101
Fo"" "1'I"Oq'<I o~lO 1'0. 2010·0060

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

WASHINGTON, D.C. 20460 !'~pen\'ork Rcduction Act Noticc: Tile public rcportillg burden for t1lis collection of iufonn~liou is eSlilll<lled 10 avcragc 0.25 hours per rcspollSC for rcgistra:k;;:acliiilies <Ind·O.25 l;Gms !-'cr r~,pon,;C7"r

rcrcgi:;lfalion and spccial review ael ivilies, including Iilllc for readillg Ille instfllction and conlplcl illg Ihc ncccssary lorlnS, Scud comments regarding Ihc burdcn esti~na~~ Dr any-Dtller :~,pcet oft::is celle;lion of

illlbrmalion, includiug sllggcslions for reducing thc burdcn 10 Dircclor: OPPE InfDrlnalion Munugcllleni Divi,ioll (2 137) U.S. Environlnenlal Prolcctioll Agcncy, 40t M Strect, $,W" Wasllingtoll, OC L0460. Do

nOI send Ihe fonn to Ihis address.

DATA MATRIX

Date: AligUSt I I, 20 I0 EPA Re No.lFile S mbol 2~17"01E',~gL\\":~. --""-__ Pa 'e 3 of 4

Appl ieant's/Registrant's Name & Address Product: Sergennt's Fiproni I ~-:Nylar ~queezc- :i

Seweant's Pet Care Products, Inc. 2625 South 158tll Plaza, Omaha, NE 68130-1770 On for Dogs ,'0

Ingrediellts: Fipronil alld Nylnr

Guidelillc Referenec Number Guidelille Studv Name MRID Number Submitter Statlls Note

810.3300 A Comparalive Evaluation ofTwo Trentment Regimes Usillg RM 43121116 Medal Limited OLD

160 I Spray for COll\rol of the Cat Flea Ctenoeephal ides felis 1lI1 the

Doe

810.3300 Laboratory E"aluation of RM 1601 Spray for Control Dermncenlor 43121117 Medal Linlited OLD

variabi lis alld RhiDeceDlmlus sanguineus 011 tile Dol!.

810.3300 An Ilivestigatioll Stlldy to Evaluate the Effect of Batllillg of 43121118 Merial Limited OLD

Laboratorv Oops on tile Effieoc 'ofRM1601 Snra

810.3300 Efficacy ofRM 160lC at 3 ml/kg and 6 ml/kg Against Ixodes 43121122 Merial Limited OLD

scapularis/dammilli Nymphs, Dermacentor variabilis N)'lllplls,

Amblyomilia ailierieanum Nymphs, Rhipicephalus sanguineus

Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair

as the Testiol!: Subslrate

810.3300 Positive Referelleed and Untreated Conlrolied, ConfirmatOIY 43577712 Medal Limited OLD

Laborntory Trial of RM 160 IE SPOT-ON Formulation Applied 10

Dogs as 3 Weigllt Class Defilled Volumes for tile Control oftile Cat

Flea Ctelloeephalides felis, the Brown Dog Tick Rllipieephalus

sanrruineus, and tile Alneriean Dol" Tick Dermacentor variabil is

810.3300 An Efficacy Study ofFrolllline Spray, Frontline Top Spot, a1td ML- 45620501 Merial Limited PAY

2,095,988 509T, for the Treatment and Control ofTricllodeetes canis

in the DOl!

810.3300 Studv Summaries: Frontline Plus For Dogs 45612701 Medal Limited PAY

810.3300 PR & 0 002410 I: Frontline Spray/Frontline Spot-OIl/ML-2, 095, 988 45620504 Merial Limited PAY

509'1'/DOl!S ISolutionIToDieal

810.3300 PR & 0 005230 I: Frolltline Spray/Frontline SpOI-01I/ML-2, 095, 988 45620505 Medal Linlited PAY

509'1'/Dogs/Solution / Tonieal

810.3300 Study to Confirm the Efficacy ofFipronil Against Lice in Dogs Ullder 45628201 Merial Limited PAY

rield Conditions

8103300 Frolltline Spray & Top Spot! Dogs/Solutioli/Topieal CI inial/Dose 45620506 Merial Limited PAY

Confirmation/ EetoDarasites, Mites, Sa.rcoples Scabiei var canis

810.3300 A Study to Evaluate the Efficacy of Frontline Plus for Control of 45866902 Medal Limited PAY

Mosquitoes, Aedes aegypti, on Dogs

810.3300 Dose Titration of a Pyriproxyfen Spot-On Formulatioll For Flea Ova 46346601 Sergeallt's Pet Care Prodllets, Ille. OWN

Sterilization.

Sigllature: \:CeLL(\- 11.-- t\osllivJ.l1 rr\-T

Name and Title Date

Kelly R. Hoskins, Manager ofTeclmieal AITairs 08/1112010

EI',' r",n, S57(1.)5 (9·'" IEI'Cl""n,< an~ 1"1'''" v",io", A"jIMI, S"om;' only Pap", """ion "~,,,«y h".rn.III«Cop.' 2 517 _ I''! 1<

,,~,,«y h<l.,n"III«Cop.'

:1 517 .1<\.IviZ

EI" 1 oro, S57(1.)5 (9 IEI'Cl""m an~ P'p,," V"'", 01 AlJI, S om only Pap", ",,,on

Fo"" "1'I"Oq'<I o~lO 1'0. 2010·0060

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

WASHINGTON, D.C. 20460 !'~pen\'ork Rcduction Act Noticc: Tile public rcportillg burden for t1lis collection of iufonn~liou is eSlilll<lled 10 avcragc 0.25 hours per rcspollSC for rcgistra:k;;:acliiilies <Ind·O.25 l;Gms !-'cr r~,pon,;C7"r

rcrcgi:;lfalion and spccial review ael ivilies, including Iilllc for readillg Ille instfllction and conlplcl illg Ihc ncccssary lorlnS, Scud comments regarding Ihc burdcn esti~na~~ Dr any-Dtller :~,pcet oft::is celle;lion of

illlbrmalion, includiug sllggcslions for reducing thc burdcn 10 Dircclor: OPPE InfDrlnalion Munugcllleni Divi,ioll (2 137) U.S. Environlnenlal Prolcctioll Agcncy, 40t M Strect, $,W" Wasllingtoll, OC L0460. Do

nOI send Ihe fonn to Ihis address.

DATA MATRIX

Date: AligUSt I I, 20 I0 EPA Re No.lFile S mbol 2~17"01E',~gL\\":~. --""-__ Pa 'e 3 of 4

Appl ieant's/Registrant's Name & Address Product: Sergennt's Fiproni I ~-:Nylar ~queezc- :i

Seweant's Pet Care Products, Inc. 2625 South 158tll Plaza, Omaha, NE 68130-1770 On for Dogs ,'0

Ingrediellts: Fipronil alld Nylnr

Guidelillc Referenec Number Guidelille Studv Name MRID Number Submitter Statlls Note

810.3300 A Comparalive Evaluation ofTwo Trentment Regimes Usillg RM 43121116 Medal Limited OLD

160 I Spray for COll\rol of the Cat Flea Ctenoeephal ides felis 1lI1 the

Doe

810.3300 Laboratory E"aluation of RM 1601 Spray for Control Dermncenlor 43121117 Medal Linlited OLD

variabi lis alld RhiDeceDlmlus sanguineus 011 tile Dol!.

810.3300 An Ilivestigatioll Stlldy to Evaluate the Effect of Batllillg of 43121118 Merial Limited OLD

Laboratorv Oops on tile Effieoc 'ofRM1601 Snra

810.3300 Efficacy ofRM 160lC at 3 ml/kg and 6 ml/kg Against Ixodes 43121122 Merial Limited OLD

scapularis/dammilli Nymphs, Dermacentor variabilis N)'lllplls,

Amblyomilia ailierieanum Nymphs, Rhipicephalus sanguineus

Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair

as the Testiol!: Subslrate

810.3300 Positive Referelleed and Untreated Conlrolied, ConfirmatOIY 43577712 Medal Limited OLD

Laborntory Trial of RM 160 IE SPOT-ON Formulation Applied 10

Dogs as 3 Weigllt Class Defilled Volumes for tile Control oftile Cat

Flea Ctelloeephalides felis, the Brown Dog Tick Rllipieephalus

sanrruineus, and tile Alneriean Dol" Tick Dermacentor variabil is

810.3300 An Efficacy Study ofFrolllline Spray, Frontline Top Spot, a1td ML- 45620501 Merial Limited PAY

2,095,988 509T, for the Treatment and Control ofTricllodeetes canis

in the DOl!

810.3300 Studv Summaries: Frontline Plus For Dogs 45612701 Medal Limited PAY

810.3300 PR & 0 002410 I: Frontline Spray/Frontline Spot-OIl/ML-2, 095, 988 45620504 Merial Limited PAY

509'1'/DOl!S ISolutionIToDieal

810.3300 PR & 0 005230 I: Frolltline Spray/Frontline SpOI-01I/ML-2, 095, 988 45620505 Medal Linlited PAY

509'1'/Dogs/Solution / Tonieal

810.3300 Study to Confirm the Efficacy ofFipronil Against Lice in Dogs Ullder 45628201 Merial Limited PAY

rield Conditions

8103300 Frolltline Spray & Top Spot! Dogs/Solutioli/Topieal CI inial/Dose 45620506 Merial Limited PAY

Confirmation/ EetoDarasites, Mites, Sa.rcoples Scabiei var canis

810.3300 A Study to Evaluate the Efficacy of Frontline Plus for Control of 45866902 Medal Limited PAY

Mosquitoes, Aedes aegypti, on Dogs

810.3300 Dose Titration of a Pyriproxyfen Spot-On Formulatioll For Flea Ova 46346601 Sergeallt's Pet Care Prodllets, Ille. OWN

Sterilization.

Sigllature: \:CeLL(\- 11.-- t\osllivJ.l1 rr\-T

Name and Title Date

Kelly R. Hoskins, Manager ofTeclmieal AITairs 08/1112010

>

." , i " A, 'I " " . 102
EPA Form 8,7<J.)5 t9·91) Elcc>roc" acd Paper Versiocs A"ilabk Submi, cnly P'per Y''''O" Ag,o,)' 10"en.1 U.. COI'Y

Form Approwd OMU No. 20JO·OO6U

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 20460

Paperwork Itednetion Act Noliee: The public rqlOl1ing burden for tllis collection ofinfom1alion is estimaled 10 average 0.25 hours per response for regislraiilln aeoivides alld li,25 hr;urs per re~pome f<lr

reregiSlrmion and special revict\' activities. including time for reading lhe instmetion and completing Ihe necessary forllls. Send eommenlS regarding tile burden eSlinDle or ar:y',:>Jle, :,sj)ect Ofli,L eoiketiull or

infonJ1alion, inehlding suggestions for reducing lhe burden 10 Director: OPPE Inlormatioll MalJa,gcmclIl Di~ision (2137) U.S. Environmental Protection Agency, 401 M Street, S.W" Washington, OC 20460. Do

nol send lhe form tu this address.

DATA MATRIX

Date: AUIJust II, 20 I0 EPA Re No./File S mbol 25i7-.N£\~~ /tR Pa e40f4

Applicanl's/Registmnt's Name & Address Product: Sergeant's Pipronil +l'-:)Idr SqueczeSergeant's Pet Care Producls, Inc, 2625 South 1581h Plaza, Omaha, NE 68130-1770 On for Dogs

In;redients: Fi':'ronil and N~;lar

Guideline Reference Number GuidelilJe Study Name MRIDNumber Sublnilter Status Note

810,3300 Analyses of ellielle)' and safety data to support label claims for 47849608 Sergeant's Pet Care Products, Inc. OWN

Sergeant"s squeeze-on for small dogs containing etofenprox lind

n\lrinroxyfen

40 CFR Part 157.32 Evalll!ltilln of the Dog Squeeze On 0.67 IJJI White Applicalnr with 48059803 Sergeant's Pet Care Products, Inc. OWN

Orange Labelilidieator (3x), scissors to open - P=I as a Poison

Prevention Paekaoe for Seraeant's Pet Care Products, Inc,

40 CPR Part 157.32 Evaillation orthe Dog Squeeze On 1,34 tnl While Applicator wilh 48059804 Sergeant's Pet Care Products, Inc. OWN

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

Prevention Packap-e for S~;Qeanl'S Pel Care Products, Inc.

40 CFR Pari 157.32 Evaluation ofthe Dog Squeeze On 2.68 ml White Applicator with 48059805 Sergeant's Pet Care Products, Inc. OWN

Red Label Indicator (3x), scissors 10 npen - P= I as a Poison

Prevention Paeka"e for SerIJeant's Pet Care Products, Inc.

40 CPR Part 157.32 Evaillation ofthe Dog Squeeze On 4.02 ml White Applicator with 48059806 Sergeltnl's Pet Care Products, Inc. OWN

Blue Label Indicator (3x), scissors to open - P= I as a Poison

Prevention Pack-a~~ for S~rp-eant's Pet Care Products, Inc.

Signature:

I?Ll~ ci?- \\o.\..~; i~:fJ-'i Name a1Jd Title Date

Kelly R. l-loskins, Manager of Technical Affairs 08/11/2010

'---,

Il-RvQ.

Form Approwd OMU No. 20JO·OO6U

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 20460

Paperwork Itednetion Act Noliee: The public rqlOl1ing burden for tllis collection ofinfom1alion is estimaled 10 average 0.25 hours per response for regislraiilln aeoivides alld li,25 hr;urs per re~pome f<lr

reregiSlrmion and special revict\' activities. including time for reading lhe instmetion and completing Ihe necessary forllls. Send eommenlS regarding tile burden eSlinDle or ar:y',:>Jle, :,sj)ect Ofli,L eoiketiull or

infonJ1alion, inehlding suggestions for reducing lhe burden 10 Director: OPPE Inlormatioll MalJa,gcmclIl Di~ision (2137) U.S. Environmental Protection Agency, 401 MStreet, S.W" Washington, OC 20460. Do

nol send lhe form tu this address.

DATA MATRIX

Date: Au ustll,2010 EPA Re No./File S mbol 25i7-.w0.~~ /tR Page 4 of 4

Applicanl's/Registmnt's Name & Address Product: Sergeant's Pipronil +l'-:)Idr SqueczeSergeant's Pet Care Producls, Inc, 2625 South 1581h Plaza, Omaha, NE 68130-1770 On for Dogs

In redients: Fi ronil and N ,Iar

Guideline Reference Number GuidelilJe Study Name MRIDNumber Sublnilter Status Note

810,3300 Analyses of ellielle)' and safety data to support label claims for 47849608 Sergeant's Pet Care Products, Inc. OWN

Sergeant"s squeeze-on for small dogs containing etofenprox lind

pvrjproxyfen

40 CFR Part 157.32 Evalll!ltilln of the Dog Squeeze On 0.67 IJJI White Applicalnr with 48059803 Sergeant's Pet Care Products, Inc. OWN

Orange Labelilidieator (3x), scissors to open - P=I as a Poison

Prevention Paeka"e for Sen'-eant's Pet Care Products, Inc,

40 CPR Part 157.32 Evaillation ofthe Dog Squeeze On 1,34 tnl While Applicator wilh 48059804 Sergeant's Pet Care Products, Inc. OWN

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

Prevention Packa 'e for Semeanl's Pel Care Products, Inc.

40 CFR Pari 157.32 Evaluation ofthe Dog Squeeze On 2.68 ml White Applicator with 48059805 Sergeant's Pet Care Products, Inc. OWN

Red Label Indicator (3x), scissors 10 npen - P= I as a Poison

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

40 CPR Part 157.32 Evaillation ofthe Dog Squeeze On 4.02 ml White Applicator with 48059806 Sergeltnl's Pet Care Products, Inc. OWN

Blue Label Indicator (3x), scissors to open - P= I as a Poison

Prevention PackaQe for Semeant's Pet Care Products, Inc.

Signature: \?Ll\\- ci?- \\o.\..~; i ~:fJ-'i

Name a1Jd Title Date

Kelly R. l-loskins, Manager of Technical Affairs 08/11/2010

EPA Form 8,7!),)5 t9·91) Elcc>ron" llIld Po rVersion, A"ilobk Submi, nnly P'per y,,,,o" Ag,o,)' 10"en.1 U.. COI'Y

103
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

August 11,2010

Rosalind Gross

c/o Richard Gebken

Registration Division

Office of Pesticide Prograrus (7504P)

U.S. Environmental Protection Agency

Document Processing Desk

Room 8-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Child Resistant Packaging Information

Ser~t's Fipronil + Nylar Squeeze-On for Dogs (EPA File Symbol: 2517-

,JlI-EW) r VAl..

Dear Ms. Gross:

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

EPA Company Number 2517) is submitting a request to rely on previously submitted Child

Resistant Packaging (CRP) studies to support this new registration. The CRP data were

submitted to EPA on April 12, 2010 in support ofthe pending registration applications under

EPA File Symbols: 2517-RGT, 2517-RGA, 251 7-RGL, and 2517-RGU (all ofwhich contain

Fipronil at 9.7-9.8%).

Sergeant's generated CRP data on a standard white applicator in sizes 0.67, 1.34,2.68, and 4.02

mL. The following is a summary table ofthe applicators that were tested and submitted to EPA

in the CRP data:

Use Applicator Base Color mu Weight (mLl Color

Dog Uo to 22 lbs White 0.67 OranQ:e

Doe 23-44 Ibs White 1.34 Green

Dog 45-881bs White 2.68 Red

Dog 89-132 Ibs White 4.02 Blue

CRP data is required for this new product because ofthe inclusion ofthe active ,ingredieIit

fipronil (9.8%) in the pet squeeze-on product. The CRP testing was conducte4 on a:standard

package size and color configuration that is identical for this product. The Serg~3.~!'s Fip;'oaU .:-

Nylar Squeeze-On for Dogs product being submitted today also contains fiproni~ at'9.8%,

Additionally, Sergeant's already has dog squeeze-on products approved by EPA ccntaining 2%

Nylar (EPA Registration Numbers 2517-127 through 2517-129) that are not s"hject to CRP. This

new product contains 2% nylar.

1

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

August 11,2010

Rosalind Gross

c/o Richard Gebken

Registration Division

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 Information

~_~~t's Fipronil + Nylar Squeeze-On for Dogs (EPA File Symbol: 2517-

~) rlJ..,(l..

Dear Ms. Gross:

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

EPA Company Number 2517) is submitting a request to rely on previously submitted Child

Resistant Packaging (CRP) studies to support this new registration. The CRP data were

submitted to EPA on April 12, 2010 in support ofthe pending registration applications under

EPA File Symbols: 25l7-RGT, 25l7-RGA, 2517-RGL, and 25l7-RGU (all ofwhich contain

Fipronil at 9.7-9.8%).

Sergeant's generated CRP data on a standard white applicator in sizes 0.67, 1.34,2.68, and 4.02

mL. The following is a summary table ofthe applicators that were tested and submitted to EPA

in the CRP data:

Use Applicator Base Color FiU Weight (roL) Color

Dog Up to 22 lbs White 0.67 Orange

Dog 23-44 lbs White 1.34 Green

Dog 45-88lbs White 2.68 Red

Dog 89-132 lbs White 4.02 Blue -

CRP data is required for this new product because ofthe inclusion ofthe active ,ingredient

fipronil (9.8%) in the pet squeeze-on product. The CRP testing was conducte4 on a:standard'

package size and color configuration that is identical for this product. The Serg~3.~!~s Fip;'oaU .:-

Nylar Squeeze-On for Dogs product being submitted today also contains fiproni~ at:9.8%,

Additionally, Sergeant's already has dog squeeze-on products approved by EPA centailing' 2%

Nylar (EPA Registration Numbers 2517-127 through 2517-129) that are not s11hject to CRP. 'This

new product contains 2% nylar.

1

104
Sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeams.com

Furthennore, Sergeant's does not anticipate any additional toxicity through the combination of

fipronil and nylar. When Sergeant's Fipronil + Nylar Squeeze-On for Dogs is marketed, it will

utilize the same applicator color (white) and fill weight colors per mL fill weight as was used in

the submitted and referenced CRP testing. Based on available infonnation, the density range of

the pending products on which the CRP data were generated is the same as the new product (1.0-

1.5 gr/cc). Therefore, Sergeant's is relying on MRlD's: 48059803, 48059804, 48059805, and

48059806 to fulfill the CRP data requirements for Sergeant's Fipronil + Nylar Squeeze-On for

Dogs.

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

Sincerely,

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

2

Sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1nO • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeams.com

Furthennore, Sergeant's does not anticipate any additional toxicity through the combination of

fipronil and nylar. When Sergeant's Fipronil + Nylar Squeeze-On for Dogs is marketed, it will

utilize the same applicator color (white) and fill weight colors per mL fill weight as was used in

the submitted and referenced CRP testing. Based on available infonnation, the density range of

the pending products on which the CRP data were generated is the same as the new product (1.0-

1.5 gr/cc). Therefore, Sergeant's is relying on MRlD's: 48059803, 48059804, 48059805, and

48059806 to fulfill the CRP data requirements for Sergeant's Fipronil + Nylar Squeeze-On for

Dogs.

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

Sincerely,

Kelly R. Hoskins

Manager ofTechnical Affairs

cc: Larry Nouvel

2

105
Sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.93&7091 • www.sergeants.com

August II, 2010

Richard Gehken, PMIO

Office of Pesticide Programs (7504P) (REGFEE)

U.S. Environmental Protection Agency

Document Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Suhject: Sergeant's Fipronil + Nylar Squeeze--On for Dogs

EPA File Symho12517-NEW

Dear Mr. Gebken:

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

EPA Company Number 2517) is submitting an EPA registration application for the new end-use

product Sergeant's Epronil + Nylar Squeeze-On for Dogs [containing the EPA registered active

ingredients Fipronil (9.8%) and Pyriproxyfen (Nylar) (2.0%)]. Please find enclosed the

following documentation in support ofthis registration:

(1) Transmittal Document;

(2) Application for Registration (EPA Form 8570-1);

(3) Confidential Statement of Formula (EPA Form 8570-4) (Two Copies);

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

(5) Certification With Respect to Citation ofData (EPA Form 8570-34);

(6) Data Matrix (EPA Form 8570-35) - EPA and Public Versions;

(7) Product Label (Five Copies);

(8) Letter ofAuthorization;

(9) Child Resistant Packaging (CRP) Certification Statement;

(10) Bridging Argument to Cite CRP Data;

(11) Submission ofEPA Pesticide Registration Improvement Act Information;

(12) Voluntary Small Business Certification Form;

(13) PRIA Fee Waiver Certification Statement;

(14) PRIA Fee Waiver Support Letter;

(15) Recent EPA Approval of 50% Small Business Waiver Request (D-425455);

(16) PRIA Category R31 0, Payment Confirmation Receipt; and

(17) Three Copies of Supporting Studies.

The registration of Sergeant's Fipronil + Nylar Squeeze-On for Dogs is a selective citation

registration for a new end-use product. Sergeant's is submitting new product chemistry studies in

support ofthis end-use product registration. Additionally, Sergeant's is citing acute toxicity

studies and companion animal safety data submitted to EPA on June 18, 2010 with the

registration application for Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs. The acute

Sergeant's Pet Care Products, Inc.

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.93&7091 • www.sergeants.com

August 11, 2010

Richard Gebken, PMI0

Office of Pesticide Programs (7504P) (REGFEE)

U.S. Environmental Protection Agency

Document Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Sergeant's Fipronil + Nylar Squeeze--On for Dogs

EPA File Symbol 2517-NEW

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 an EPA registration application for the new end-use

product Sergeant's Fipronil + Nylar Squeeze-On for Dogs [containing the EPA registered active

ingredients Fipronil (9.8%) and Pyriproxyfen (Nylar) (2.0%)]. Please find enclosed the

following documentation in support ofthis registration:

(1) Transmittal Document;

(2) Application for Registration (EPA Form 8570-1);

(3) Confidential Statement of Forrnula (EPA Form 8570A) (Two Copies);

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

(5) Certification With Respect to Citation ofData (EPA Form 8570-34);

(6) Data Matrix (EPA Form 8570-35) EPA and Public Versions;

(7) Product Label (Five Copies);

(8) Letter ofAuthorization;

(9) Child Resistant Packaging (CRP) Certification Statement;

(10) Bridging Argument to Cite CRP Data;

(11) Submission ofEPA Pesticide Registration Improvement Act Information;

(12) Voluntary Small Business Certification Form;

(13) PRIA Fee Waiver Certification Statement;

(14) PRIA Fee Waiver Support Letter;

(15) Recent EPA Approval of 50% Small Business Waiver Request (D-425455);

(16) PRIA Category R31 0, Payment Confirmation Receipt; and

(17) Three Copies of Supporting Studies.

The registration of Sergeant's Fipronil +Nylar Squeeze-On for Dogs is a selective citation

registration for a new end-use product. Sergeant's is submitting new product chemistry studies in

support ofthis end-use product registration. Additionally, Sergeant's is citing acute toxicity

studies and companion animal safety data submitted to EPA on June 18, 2010 with the

registration application for Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs. The acute

106
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

toxicity studies were conducted on a "soup" that contains multiple active ingredients that can be

bridged across multiple formulated end-use products.

This registration application is considered a PRIA Category R31 0 (new end-use product) with a

PRIA review time of 6 months. Sergeant's submitted a PRlA 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 +Nylar SqueezeOn for Dogs. If you have any questions or need additional information regarding this registration

application, please contact me at 402-938-7079.

Sincerely,

t\c Su.H I'H\,T

Kelly R. Hoskins

Manager ofTechnical Affairs

Enclosures

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

toxicity studies were conducted on a "soup" that contains multiple active ingredients that can be

bridged across multiple formulated end-use products.

This registration application is considered a PRIA Category R31 0 (new end-use product) with a

PRIA review time of 6 months. Sergeant's submitted a PRlA 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 +Nylar SqueezeOn for Dogs. If you have any questions or need additional information regarding this registration

application, please contact me at 402-938-7079.

Sincerely,

t\c Su.H I'HI,T

Kelly R. Hoskins

Manager ofTechnical Affairs

Enclosures

107
TRANSMITTAL DOCUMENT

NAME AND ADDRESS OF SUBMITTER:

Sergeant's Pet Care Products, Inc.

2625 South 158"' Plaza

Omaha, NE 68130-1770

CONTACT PERSON (Return to)

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South I 58'h Plaza

Omaha, NE 68130-1770

REGULATORY ACTION SUPPORTED BY THIS PACKAGE:

This submission is prepared to support an EPA registration application for the new end-use

product Sergeant's Fipronil + Nylar Squeeze-On for Dogs.

SUBMITTAL DATE:

August 11, 2010

Volume Study Title MRIDNo.

1 Administrative Materials

2 Group A Product Chemistry For Sergeant's Fipronil + Nylar

Squeeze-On For Dogs

3 Group B Product Chemistry For Sergeant's Fipronil + Nylar

Squeeze-On For Dogs

TRANSMITTAL DOCUMENT

NAME AND ADDRESS OF SUBMITTER:

Sergeant's Pet Care Products, Inc.

2625 South 158"' Plaza

Omaha, NE 68130-1770

CONTACT PERSON (Return to)

Kelly R. Hoskins

Sergeant's Pet Care Products, Inc.

2625 South I 58'h Plaza

Omaha, NE 68130-1770

REGULATORY ACTION SUPPORTED BY THIS PACKAGE:

This submission is prepared to support an EPA registration application for the new end-use

product Sergeant's Fipronil + Nylar Squeeze-On for Dogs.

SUBMITTAL DATE:

August 11, 2010

Volume Study Title MRIDNo.

1 Administrative Materials

2 Group A Product Chemistry For Sergeant's Fipronil + Nylar

Squeeze-On For Dogs

3 Group B Product Chemistry For Sergeant's Fipronil + Nylar

Squeeze-On For Dogs

108
Form approved. OMS No. 2070-0060, 2070-0057, ~., 0-01 07, 2070·0122, 2070-0t64.

& EPA

United States

Environmental Protection Agency

Washington, OC 20460

Formulator's Exemption Statement

(40 CFR 152.85)

--

Applicant's Namealld ,ll,'1dress EPA File Symbol/Registration Number

Ser£eaJl1's Pet (.ar:: Products, Inc. 2517-NEW

26~5 5:c\.;th 15'3LIIFlaza Product Name

Omaha, NE 6813~-j770 Sergeant's FiproniJ + Nylar Squeeze-On for Dogs

Date of Confidential Statement of Formula (EPA Form 8570-4)

08/11/2010

As an authorized representative of the applicant for registration of the product identified above, I certify that:

(1) This product contains the following active ingredient(s):

Fipronil

Pyriproxyfen

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use ot that active ingredient in the manufacturing,

formulation or repackaging another product which contains that active ingredient whiCh is registered under FIFRA Section 3, is purchased by

us from another person and meets the requirements of 40 CFR section 158.50(e)(2) or (3).

(3) Indicate by checking (A) or (8) below which paragraph applies:

II (A) An accurate Confidential Statement of Formula (EPA FORM 8570·4) for the above identified product is attached to this statement.

That formula statement indicates, by company name. registration number, and product name, the source of the active ingredient(s) listed in

paragraph (1).

OR

-, (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) reterenced above and 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 qualify for the formUlator's exemption.

SourCe

Active Ingredient Product Name Registration Number

Fipronil Technical

Pyriproxyfen

Signature

\-\o~l..H /7fiT Name and Title Date

V-tLLLt- f/--- • Kelly R. Hoskins, Manager of Technical AlTai'lJ 08111/2010

EPA Form 8'fi70-27 (Rev. 06-2004) Copy 1 EPA

Copy 2 - Applicant copy

Form approved. OMS No. 2070-0060, 2070-0057, ~., 0-01 07, 2070·0122, 2070-0t64.

& EPA

United States

Environmental Protection Agency

Washington, OC 20460

Formulator's Exemption Statement

(40 CFR 152.85)

--

Applicant's Namealld ,ll,'1dress EPA File Symbol/Registration Number

Ser£eaJl1's Pet (.ar:: Products, Inc. 2517-NEW

26~5 5:c\.;th 15'3LIIFlaza Product Name

Omaha, NE 6813~-j770 Sergeant's FiproniJ + Nylar Squeeze-On for Dogs

Date of Confidential Statement of Formula (EPA Form 8570-4)

08/11/2010

As an authorized representative of the applicant for registration of the product identified above, I certify that:

(1) This product contains the following active ingredient(s):

Fipronil

Pyriproxyfen

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use ot that active ingredient in the manufacturing,

formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by

us from another person and meets the requirements of 40 CFR section 158.50(e)(2) or (3).

(3) Indicate by checking (A) or (8) below which paragraph applies:

II (A) An accurate Confidential Statement of Formula (EPA FORM 8570·4) for the above identified product is attached to this statement.

That formula statement indicates, by company name. registration number, and product name, the source of the active ingredient(s) listed in

paragraph (1).

OR

-, (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) reterenced above and 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 qualify for the formUlator's exemption.

SourCe

Active Ingredient Product Name Registration Number

Fipronil Technical

Pyriproxyfen

Signature

\-\o~l..H /7fiT Name and Title Date

V-tLLLt- f/--- • Kelly R. Hoskins, Manager of Technical AlTai'lJ 08111/2010

EPA Form 8'fi70-27 (Rev. 06-2004) Copy 1 EPA

Copy 2 - Applicant copy

109 *Product ingredient source information may be entitled to confidential treatment*
Fonn Ar roved OM3 Nos. 2070-0060; 2070-{}057; 2070-{}107; 2070-{}122; 2070-0164

.............

~~ , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

~/ 1200 Pennsylvania Avenue, N.W.

WASHINGTON, D.C. 20460

Paperwork ReductionAet Notiee: The publie reporting burden forthis eolketion of information is estimated to average 1.25 hours per response for registration

and 0.25 IIc'J"S ;n;c,ponse for reregistration and special rev;ew activities, including timeforreading the instructions and complcting thc necessary rorms Send

commcnts reil3Ttlingburden Cstj.I\~(J"i any othcr aspect ofthis collection of information, inclilding suggcstiolls for reducing thc burden to: Director, Collection

S(rntegies Divi"ion (2822n, ('.S. E1vironmenta! Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the cOlnpktcd ronn

to dlis address, -'~-''''

---" Certification with Respect to Citation ofData

Applicanfs/Rellistranfs Nan-.e, AddrvSs, and Telephone Number EPA Rellislration Number/File Symbol

Sergeant's Pei Care Produrts, Inc.,'2625 South 1581h Plaza, Omaha, NE 68130·1770 2517·NEW

----- Adive InqreJie,rtlslandlor representative lest compoundts) Date

Fipmnil and Pyripmxyfen 08ltt/20tO

General Use P(.t~m(s} (list al those claimed for this product usin!! 40 CFR Part 158} Product Name

Domestic indoor non-food Sergeant's Fipronil + Nylar Squeeze·On for Dogs

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for a~ the same uses on your label, you do not need to

subm~ this fonn. You must submit the Fonnulato(s Exelllltion Statement (EPA Fonn 8570-27).

D I am responding to a Data-GalHn Notice, and have included with this fonn a ~st of companies Sellt olfers of compensation (the Data Matrixform shoul;l

be used for this purpose).

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

D I am using the cite-all method of support, and have included with this fonn [2] I am using the selective method of support (or cile-all option

a list of companies Sellt offers of compensation (the Data Matrix form under the selective method), and have included with this fonn a

should be used for this purpose}. completed list of data requirements (the Data Mabix fonn musl be

used).

SECTION tt: GEt£RAL OFFERlO PAY

IRequired it using the c~e-all method or when using the dte-all option under the selective method 10 satisfy one or more dala requirements}

D I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.

SECTION tit: CERTIFtCATION

I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported by all data submitted or dted in the

application for registration, the fOrm for reregistration, orthe Data-Call·ln response. In addition, rf the c~e-all oplion or cite-all option under the selectrve method is

indicated in Sedion t. this application is supported by all data in the Agency's files that (1) concem the properties or effects of this product or an identical or

substantially similar product, or one or more of the ingredients. in this product; and (2) is a type of data that woul;l be required to be submitted Ulder the data

requirements in effed on the dale of approval ofthls application if the application sought the initiat registration of a product of identical or similar compos~ion and

uses

I certify that for each exclusive use study ciled n support of this registration or reregistration, that I am the originat data submiller or that I have obtained

the wrillen permission of the original data subffiitterto c~e that study,

t certify that for each study c~ed in support of this registration or reregistration that is not an eXclusive use study, e~her; (a) I am the original data

submitter; (b) I have obtained the permission of the OIiginal data subm~ter to use the study in support of this application; (c) all periods of eligibility for

compensation have expired for the study; (d) the study is in the public literature; or (e) t have notified in wr~ing the company thai submitted the study and have

offered (I) to pay compensation 10 the extent required by sedions 3(c)(1)(F} andlor 3(c)(2)(B} of FIFRA; and (Ii) to commence negotiations to determine the

amount and lerms ot compensation, rf any, to be paj:;! for the use ofthe study,

I certify that in all instances where an offer of compensation is required, copies of a~ offers to pay compensation and evidence of their detivery in

accordance with sections 3(c}(1 }(F) and/or 3(cX2}(B} of FIFRA are available and will be submitted to the A{lenc.y upon request. ShotJd I fail to produce such

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity w~h

FIFRA.

I certify that the statements t have mado on this form and all attachments to it arc true, accurae, and complete. I ackno.....edge that any

knowingty mise or mlsleadlrg statement may be puntshabte bj fine or imprisonment or both Under applicablo law.

Signature

fi<,,,Lu~ !-:prT "", Typed or Printed Name and lille 12,.. '- 08/11/2010 Kelly R. Hoskins, Manager ot Technical Affairs

EPA Fonn 8570-34 (12.2003) Electrontc and Paper versions available. Submt only Paper version.

Fonn Ar roved OM3 Nos. 2070-0060; 2070-{}057; 2070-{}107; 2070-{}122; 2070-0164

.............

~~ , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

~/ 1200 Pennsylvania Avenue, N.W.

WASHINGTON, D.C. 20460

Paperwork ReductionAet Notiee: The publie reporting burden forthis eolketion of information is estimated to average 1.25 hours per response for registration

and 0.25 IIc'J"S ;n;c,ponse for reregistration and special rev;ew activities, including timeforreading the instructions and complcting thc necessary rorms Send

commcnts reil3Ttlingburden Cstj.I\~(J"i any othcr aspect ofthis collection of information, inclilding suggcstiolls for reducing thc burden to: Director, Collection

S(rntegies Divi"ion (2822n, ('.S. E1vironmenta! Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the cOlnpktcd ronn

to dlis address, -'~-''''

---" Certification with Respect to Citation ofData

Applicanfs/Rellistranfs Nan-.e, AddrvSs, and Telephone Number EPA Rellislration Number/File Symbol

Sergeant's Pei Care Produrts, Inc.,'2625 South 1581h Plaza, Omaha, NE 68130·1770 2517·NEW

----- Adive InqreJie,rtlslandlor representative lest compoundts) Date

Fipmnil and Pyripmxyfen 08ltt/20tO

General Use P(.t~m(s} (list al those claimed for this product usin!! 40 CFR Part 158} Product Name

Domestic indoor non-food Sergeant's Fipronil + Nylar Squeeze·On for Dogs

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for a~ the same uses on your label, you do not need to

subm~ this fonn. You must submit the Fonnulato(s Exelllltion Statement (EPA Fonn 8570-27).

D I am responding to a Data-GalHn Notice, and have included with this fonn a ~st of companies Sellt olfers of compensation (the Data Matrixform shoul;l

be used for this purpose).

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

D I am using the cite-all method of support, and have included with this fonn [2] I am using the selective method of support (or cile-all option

a list of companies Sellt offers of compensation (the Data Matrix form under the selective method), and have included with this fonn a

should be used for this purpose}. completed list of data requirements (the Data Mabix fonn musl be

used).

SECTION tt: GEt£RAL OFFERlO PAY

IRequired it using the c~e-all method or when using the dte-all option under the selective method 10 satisfy one or more dala requirements}

D I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.

SECTION tit: CERTIFtCATION

I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported by all data submitted or dted in the

application for registration, the fOrm for reregistration, orthe Data-Call·ln response. In addition, rf the c~e-all oplion or cite-all option under the selectrve method is

indicated in Sedion t. this application is supported by all data in the Agency's files that (1) concem the properties or effects of this product or an identical or

substantially similar product, or one or more of the ingredients. in this product; and (2) is a type of data that woul;l be required to be submitted Ulder the data

requirements in effed on the dale of approval ofthls application if the application sought the initiat registration of a product of identical or similar compos~ion and

uses

I certify that for each exclusive use study ciled n support of this registration or reregistration, that I am the originat data submiller or that I have obtained

the wrillen permission of the original data subffiitterto c~e that study,

t certify that for each study c~ed in support of this registration or reregistration that is not an eXclusive use study, e~her; (a) I am the original data

submitter; (b) I have obtained the permission of the OIiginal data subm~ter to use the study in support of this application; (c) all periods of eligibility for

compensation have expired for the study; (d) the study is in the public literature; or (e) t have notified in wr~ing the company thai submitted the study and have

offered (I) to pay compensation 10 the extent required by sedions 3(c)(1)(F} andlor 3(c)(2)(B} of FIFRA; and (Ii) to commence negotiations to determine the

amount and lerms ot compensation, rf any, to be paj:;! for the use ofthe study,

I certify that in all instances where an offer of compensation is required, copies of a~ offers to pay compensation and evidence of their detivery in

accordance with sections 3(c}(1 }(F) and/or 3(cX2}(B} of FIFRA are available and will be submitted to the A{lenc.y upon request. ShotJd I fail to produce such

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity w~h

FIFRA.

I certify that the statements t have mado on this form and all attachments to it arc true, accurae, and complete. I ackno.....edge that any

knowingty mise or mlsleadlrg statement may be puntshabte bj fine or imprisonment or both under applicablo law.

Signature

fi<,,,Lu~ !-:prT "'" Typed or Printed Name and lille 12,.. '- 08/11/2010 Kelly R. Hoskins, Manager ot Technical Affairs

EPA Fonn 8570-34 (12.2003) Electrontc and Paper versions available. Submt only Paper version.

110
R310

Must submit Group A and Bproduct chemistry data for each proposed product.

End Use (EP) or Manufacturing Use (MP) product or Technical Grade of the Active Ingredient (TGAI)

/

EP Data MP Data

Guideline Group A: Product Chemistry Data Submitted Submitted TGAI

No. Study Title Yes No Yes No Yes No

830.1550 Product Identitv & Composition ,/

Description of materials used to ,/ 830.1600 oroducetheoroduct

830.1650 Description of formulation process ,/

830.1670 Discussion on the formation of impurities ,/

830.1700 Preliminary analvsis ,/

830.1750 Certified limits 1158.3451 ,/

830.1800 Enforcement analvtical method (:'--j5 letT .

-:l l(,!rd') ,/

EP Data MP Data

Guideline Group B: Product Chemistry Data Study Submitted Submitted TGAI

No. Title Yes No Yes No Yes No

830.6302 Color v

830.6303 Phvsical State ,/

830.6304 Odor ./

Stability to normal and elevated

830.6313 temperatures metal and metal ions

Oxidation/Reduction ,/ 830.6314 (Chemical incomoatibilitvl

830.6315 Flammabilitv ./

830.6316 Exolodability v

830.6317 Storaae stabilitv v

830.6319 Miscibilitv v

830.6320 Corrosion Characteristics v"

830.6321 Dielectric Breakdown Volto!=w v"

830.7000 oH /

830.7050 UV/ Visible Absorotion

830.7100 Viscosity ,/

830.7200 Meltino Point

830.7220 Boilina Point

830.7300 Densitv /

830.7370 Dissociation Constant

830.7550 Partition Coefficient

830.7840 Water Solubilitv

830.7950 Vaoor Pressure

Grayed out - data not reqUired

]

R310

Must submit Group A and Bproduct chemistry data for each proposed product.

End Use (EP) or Manufacturing Use (MP) product or Technical Grade of the Active Ingredient (TGAI)

/

EP Data MP Data

Guideline Group A: Product Chemistry Data Submitted Submitted TGAI

No. Study Title Yes No Yes No Yes No

830.1550 Product Identity & Composition -/

Description of materials used to ./ 830.1600 produce the product

830.1650 Description of formulation process -/

830.1670 Discussion on the formation of impurities /

830.1700 Preliminary analysis ,/

830.1750 Certified limits (158.3451 /

830.1800 Enforcement analytical method (:'is letT ~l('(:(d) -/

U

Guideline

No.

Group B:

Title

EP Data MP Data

Product Chemistry Data Study f-S"-u....:;b:..;.m.:..:r-itt;..:::e;..:::d:......-r-S::...;u:...:;b::.:.m.:..:r-itt:....:::e:....:::d'------r-T_G_A_I-.-_---4

Yes No Yes No Yes No

830.6302 Color

Ph sical State

830.6304 Odor

830.6319 Miscibilit

830.6303

Grayed out = data not required

830.7220 Boilin Point

830.7300 Densit

830.7100 Viscosit

830.6321 Dielectric Breakdown Volta e

830.7200 Meltin Point

830.6317 Store e stabilit

830.6316 Ex lodabilit

830.6315 Flammabilit

830.7000 H

830.7050 UV/ Visible Absor tion

Oxidation/Reduction

830.6314 Chemical incom atibilit

830.6320 Corrasion Characteristics

Stability to normal and elevated

830.6313 tem eratures metal and metal ions

830.7950 Va or Pressure

830.7370 Dissociation Constant

830.7550 Partition Coefficient

830.7840 Water Solubilit

1

111
R 310

New products must either: I) suppy the product specific acute toxicITy 6 pack data (nsted below),

or 2) provide a bridging rationale document. The bridging document directs opp to use a currently

registered set of 6 acute toxicity data and label: instead of submitting product specific data.

Data

Guideline Acute toxicity (6 pack) submitted Cited

No. Study Title Yes No Yes No

870.1100 Acute Oral IL0501 ,/

870.1200 Acute Dermal IL0501 0/

870.1300 Acute Inhalation ILe50) ,/

870.2400 Acute Eve Irritation 0/

870.2500 Acute Dermal Irritation 0/

870.2600 Dermal Sensitization ,/

Efficacy - which guideline is used depends on the proposed label use

Data

Guideline submitted Cited

No. Study Title Yes No Yes No Comments

810.3100 Soil Treatments for Imoorted Fire Ants

Livestock, Poultry, Fur and Wool-Bearing

810.3200 Animal Treatments

Treatments to Contrd Pests of Humans

and ,/ 810.3300 Pets

Mosquito. Black Fly. and Biting Midge

810.3400 [Sand Ry) Treatments

810.3500 Premises Treatments

I

810.3600 structural Treatments

Methods for Efficacy Testing ofTermite

810.3800 Baits

2

R 310

New products must either: I) suppy the product specific acute toxicITy 6 pack data (nsted below),

or 2) provide a bridging rationale document. The bridging document directs opp to use a currently

registered set of 6 acute toxicity data and label: instead of submitting product specific data.

Data

Guideline Acute toxicity (6 pack) submitted Cited

No. Study Title Yes No Yes No

870.1100 Acute Oral IL0501 ,/

870.1200 Acute Dermal IL0501 0/

870.1300 Acute Inhalation ILe50) ,/

870.2400 Acute Eve Irritation 0/

870.2500 Acute Dermal Irritation 0/

870.2600 Dermal Sensitization ,/

Efficacy - which guideline is used depends on the proposed label use

Data

Guideline submitted Cited

No. Study Title Yes No Yes No Comments

810.3100 Soil Treatments for Imoorted Fire Ants

Livestock, Poultry, Fur and Wool-Bearing

810.3200 Animal Treatments

Treatments to Contrd Pests of Humans

and ,/ 810.3300 Pets

Mosquito. Black Fly. and Biting Midge

810.3400 [Sand Ry) Treatments

810.3500 Premises Treatments

I

810.3600 structural Treatments

Methods for Efficacy Testing ofTermite

810.3800 Baits

2

112
Sergeant's® Master Label g,,/l..

II August 2010 Version 10.1 EPA Reg. No. 2517-)8(

Infonnation in ( ] is optional. Page 1 of 8

[CARTON LABEL - DRAFT MASTER LABEL COPY]

Sergeant's Fipronil + Nylar Squeeze-On for Dogs

[ABNs) ® ... ~'pMrfj.J)-r(} [(Sergeant's) (Sentry) VetSpotTM (Spot On) for dogs] '-"...()UL LV

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

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

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

[Apply to puppies over 12 weeks old]

[Apply to puppies 12 weeks or older]

[. Flea & Tick Control for Dogs & Puppies 12 weeks old and older]

[-For Dogs and Puppies 12 weeks of age or older]

[·For Dogs [up to 22Ibs], [23-44Ibs], [45-88Ibs], [89-132Ibs]

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

[-Controls flea reinfestation for up to [12 weeks]]

[·Fast Acting]

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

[-Dogs can be bathed 24 hours after treatment] ",

['Waterproof]

[·Long Lasting]

[-Research demonstrates that [brand name] kills adult fleas, flea eggs, flea larvae <L'l:!

pupae for up to three months.]

[-[brand name] prevents development of all flea stages for up to three months.]

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

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

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

[-Once a month treatment recommended]

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

[-Rapidly eliminates infestations with chewing lice]

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

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

[-Kills flea eggs [larvae] [pupae] for more than [63 days] [9 weeks]]

[-Aids in Control of Sarcoptic Mange]

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

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

and flea pupae]]

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

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

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

[-With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle]

[-With Nylar® to Break Flea Life Cycle]

r---------~.. ...

Sergeant's® Master Label ~u.~ 11 August 2010 Version 10.1 EPA Reg. No. 2517-XK

Information in ( ] is optional. Page 1 of 8

[CARTON LABEL - DRAFT MASTER LABEL COPY]

Sergeant's Fipronil + Nylar Squeeze-On for Dogs

[ABNs]

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

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

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

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

<:ct t • _f)-r{J ~pMUCX.fLV

:. ,. <. ~ ~.

F

···.·.R· ..·O····.··N···T:.:·.•·p····.•·•A:· N·.·.··.······E .. ·t·············•.•·•.•·.·•••••• .•.:.:.•..•..••.•.••..•..•.••...•..•....•...•.....•.....••.....•.•.•.•..•.......•...•. -: •• ;;;............:.:·'r{:··.·.··.·.··.·... .•...•......•.•..•.••.•..•..:...••.....•.....:.•....•..:..•.•..•...•.......•....•.....•...•...•...••..•.•...•.•.•...•.....•.•.•.••......•.. :.•.... : :.:...........•.•.•.....:.:.••.•.•...•......•..•....••.....•. _:.'....•:.•....•.•...•.•....: : : :•.•.•. ······:·D·"'0"···G······:.-SiiU·E.. ·:E.. ···Z·:E··- O..······N··

.. ..<:·...... ::... ...:.::i:···... . - ... .··(: .. :;.EIeR~Ni~~N¥~~R

[Apply to puppies over 12 weeks old]

[Apply to puppies 12 weeks or older]

[- Flea & Tick Control for Dogs & Puppies 12 weeks old and older]

[-For Dogs and Puppies 12 weeks of age or older]

[-For Dogs [up to 221bs], [23-441bs], [45-88 Ibs], [89-1321bs]

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

[-Controls flea reinfestation for up to [12 weeks]]

[-Fast Acting]

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

[-Dogs can be bathed 24 hours after treatment]

[-Waterproof]

[-Long Lasting]

[-Research demonstrates that [brand name] kiUs adult fleas, flea eggs, flea larvae <L'l:!

pupae for up to three months.] . .

[-[brand name] prevents development of all flea stages for up to three months.]

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

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

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

[-Once a month treatment recommended]

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

[-Rapidly eliminates infestations with chewing lice]

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

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

[-Kills flea eggs [larvae] [pupae] for more than [63 days] [9 weeks]]

[-Aids in Control ofSarcoptic Mange]

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

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

and flea pupae]]

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

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

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

[-With Nylar® Insect Growth Regulator which Breaks the Flea Life Cycle]

[-With Nylar® to Break Flea Life Cycle]

113
Sergeant's@ Master Label

II August 2010 Version 10.1 EPA Reg. No. 2517-XX

Information in I ] is optional. Page 2 of 8

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

[·Dual Action [I]: Fipronil with Nylar® lOR Effectively Breaks the Flea Life

Cycle]

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

[·Three Applications {for cartons with 3 applicators}] and/or [3 Month Supply] or [12

Week Supply]]

[-Best ifused year round!]

[·Kills Fleas Up to [4 weeks!] [2 months] [3 months]]

['(ICON Showing 4 Week Protection)]

[.4 Week Dose!]

[,1 Month Dose!]

['Easy to Use Application]

[-Specially Formulated for Dogs and Puppies]

['[Free] Calendar Stickers Inside!]

[-[Free] Brochure Inside!]

[-[Free] Brochure and Calendar Stickers Inside]

[·Patented Technology]

[·Kills Flea Eggs & Flea Larvae for more than [63days], [9 weeks]!]

[-Prevents Flea Eggs From Developing Into Biting Adults]

[·Kills Ticks for Up to [4 weeks]!]

[-Kills [all stages of]Deer Ticks (vector of Lyme Disease) for up to weeks]

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

[·Kills [Brown], [American,] [and Lone Star ]Dog Ticks for up to 4 weeks;

[-Kills Rhipicephalus sanguineus for up to 4 weeks] " .

[-When used monthly [brand name] completely breaks the flea life cy<:,(e ~Jd controls tick

and chewing lice infestations.]

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

['Apply once every [4 weeks]!]

[-4 week Flea and Tick Treatment!]

[Once A Month Flea and Tick Treatment]

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

['Kills all stages ofthe fIea life cycle]

[-Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to 4 Weeks]

['[Kills mosquitoes]]

[-Dogs can be bathed 24 hours after squeeze~on is applied]

[-Prevents and controls reinfestations]

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

[card]]

Sergeant's® Master Label

II August 2010 Version 10.1 EPA Reg. No. 2517-XX

Information in I ] is optional. Page 2 of 8

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

[·Dual Action [I]: Fipronil with Nylar® lOR Effectively Breaks the Flea Life

Cycle]

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

[·Three Applications {for cartons with 3 applicators}] and/or [3 Month Supply] or [12

Week Supply]]

[-Best ifused year round!]

[·Kills Fleas Up to [4 weeks!] [2 months] [3 months]]

['(ICON Showing 4 Week Protection)]

[.4 Week Dose!]

[,1 Month Dose!]

['Easy to Use Application]

[-Specially Formulated for Dogs and Puppies]

['[Free] Calendar Stickers Inside!]

[-[Free] Brochure Inside!]

[-[Free] Brochure and Calendar Stickers Inside]

[·Patented Technology]

[·Kills Flea Eggs & Flea Larvae for more than [63days], [9 weeks]!]

[-Prevents Flea Eggs From Developing Into Biting Adults]

[·Kills Ticks for Up to [4 weeks]!]

[-Kills [all stages of]Deer Ticks (vector of Lyme Disease) for up to weeks]

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

[·Kills [Brown], [American,] [and Lone Star ]Dog Ticks for up to 4 weeks;

[-Kills Rhipicephalus sanguineus for up to 4 weeks] " .

[-When used monthly [brand name] completely breaks the flea life cy<:,(e ~Jd controls tick

and chewing lice infestations.]

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

['Apply once every [4 weeks]!]

[-4 week Flea and Tick Treatment!]

[Once A Month Flea and Tick Treatment]

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

['Kills all stages ofthe fIea life cycle]

[-Kills Fleas, Ticks, Flea Eggs & Flea Larvae for up to 4 Weeks]

['[Kills mosquitoes]]

[-Dogs can be bathed 24 hours after squeeze~on is applied]

[-Prevents and controls reinfestations]

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

[card]]

114
11 August 2010

Information in [

Sergeant's® Master Label

Version 10.1 EPA Reg. No. 25 17-XX

l is optional. Page 3 of 8

[For Dogs & Puppies (12 weeks or older and) up to 22 lbs.)

[For Dogs 23-44lbs.[

)For Dogs 45-88 lbs.)

[For Dogs 89-132 lbs.)

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

or Side Label Panels

[Ingredient Statement may be on front or back label]

ACTIVE INGREDIENTS:

Fipronil 9.8%

Pyriproxyfen (CAS# 95737-68-1) 2.0%

OTHER INGREDIENTS: 88.2%

TOTAL: 100.0%

[Nylar® is a registered trademark ofMcLaughlin Gonnley King Company.

U.S. Patent No. 5.942.525]

KEEP OUT OF REACH OF CHILDREN

WARNING

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

NET CONTENTS:

Contains (3) [0.023 fl oz] [0.67 ml) applicators

Contains (3) [0.045 fl oz] [1.34 ml) applicators

Contains (3) [0.091 fl oz] [2.68 ml] applicators

Contains (3) [0.136 fl oz] [4.02 ml] applicators

11 August 2010

Information in [

Sergeant's@ Master Label

Version 10.1 EPA Reg. No. 25 17-XX

l is optional. Page 3 of 8

[For Dogs & Puppies (12 weeks or older and) up to 22 lbs.)

[For Dogs 23-44lbs.[

)For Dogs 45-88 lbs.)

[For Dogs 89-132 lbs.)

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

or Side Label Panels

[Ingredient Statement may be on front or back label]

ACTIVE INGREDIENTS:

Fipronil 9.8%

Pyriproxyfen (CAS# 95737-68-1) 2.0%

OTHER INGREDIENTS: 88.2%

TOTAL: 100.0%

[Nylar® is a registered trademark ofMcLaughlin Gonnley King Company.

U.S. Patent No. 5.942.525]

KEEP OUT OF REACH OF CHILDREN

WARNING

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

NET CONTENTS:

Contains (3) [0.023 fl oz] [0.67 ml) applicators

Contains (3) [0.045 fl oz] [1.34 ml) applicators

Contains (3) [0.091 fl oz] [2.68 ml] applicators

Contains (3) [0.136 fl oz] [4.02 ml] applicators

115
Version ID.l

Page 4 of8

Sergeant's® Master Label

EPA Reg. No. 2517-XX

] is optional.

1l August 2010

Information in [

[BACK/SIDE CARTON LABEL - MASTER LABEL]

[brand name} contains fipronil and the insect growth regulator (IGR) Nylar®. to effectively

kill] Fleas, Ticks [(including those that may transmit Lyme Disease)], and kills flea eggs, flea

larvae, mosquitoes and (chewing) lice. The active ingredients in [brand name] work by

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

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

[and long lasting] control of Fleas and Ticks, [and kills mosquitoes] and chewing lice [for 30

days].

[diagram with visual offipronil collecting and being released from hair follicle]

READ ENTIRE LABEL BEFORE EACH USE.

USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE.

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS. 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. Harmful ifswallowed. Harmful if absorbed through

skin. Prolonged or frequently repeated skin contact may cause allergic reactions in some

individuals.

FIRST AID

Ifln Eyes • Hold eye open and rinse slowly and gently with water for 15-20 minutes.

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

eye.

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

HOn Skin • Take off contaminated clothing.

Or Clothing • Rinse skin immediately with plenty afwater for 15-20 minutes.

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

IfSwallowed • 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.

• Do not g:ive anvthing: bv mouth to an unconscious oerson.

HOT LINE NUMBER

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

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

emergencies or pesticide incidents), y011 may call 1-800-781-4738.

NOTE TO PHYSICIAN OR VETERINARIAN

Treat patient symptomatically

II August 2010

Information in [ ] is optional.

Sergeant's® Master Label

Version ID.I EPA Reg. No. 2517-XX

Page 4 of8

F.·R..· ·.·.O.·.· .·.'.N.·.· ·..T.· ••·•·.· ·.' P.· .. ANEL. ·i·.iii.i.'.'.,··, ·.,·.i:;.i, :...•.•.••' ?? ..i...•..:.. '..'.:.·..,"·:.·.·.··,.·",,····,·,·,,· ... ,'..",..,..,·,··....;',·,,",·'············',··,',···,::··::nOGSQ1.JEEZE·'·ON ,..,...'.,,'...,.' .. ,.....'.'.',.•...,.,' ... ,.::•. ,., ... :,.•,.• ,·,·.."....',',' ..i'···:~Ip;RQ:N"jU!fij¥LAR

[BACK/SIDE CARTON LABEL - MASTER LABEL]

[brand name] contains fipronil and the insect growth regulator (IGR) Nylar®. to effectively

kill] Fleas, Ticks [(including those that may transmit Lyme Disease)], and kills flea eggs, flea

larvae, mosquitoes and (chewing) lice. The active ingredients in [brand name] work by

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

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

[and long lasting] control of Fleas and Ticks, [and kills mosquitoes] and chewing lice [for 30

days].

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

READ ENTIRE LABEL BEFORE EACH USE.

USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE.

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS. 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. Harmful ifswallowed. Harmful if absorbed through

skin. Prolonged or frequently repeated skin contact may cause allergic reactions in some

individuals.

FIRST AID

IfIn E)'es • Hold eye open and rinse slowly and gently with water for 15-20 minutes.

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

eye.

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

HOn Skin • Take off contaminated clothing.

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

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

H 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 do so by a poison control center or doctor.

• Do not give anything by mouth to an unconscious person.

HOT LINE NUMBER

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

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

emergencies or pesticide incidents), y011 may call 1-800-781-4738.

NOTE TO PHYSICIAN OR VETERINARIAN

Treat patient symptomatically

116
Version 10.1

Page 5 of8

Sergeant's® Master Label

11 August 2010 EPA Reg. No. 2517-XX

Infonnation in [ ] is optional.

DIRECTIONS FOR USE

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

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

DO NOT USE ON CATS. May be toxic and potentially fatal if applied to or ingested by cats.

FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks of age.

Weigh your dog to be sure you are applying the right dose formulated for the weight of your pet.

Do not treat your pet with more than one pesticide product at a time. Over dosing your animal

can result in serious illness and even death. Best if used year round. Certain medications can

interact with pesticides. Consult a veterinarian before using this product on debilitated, aged,

medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known

organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated

dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that

actively groom or engage in close physical contact with treated dog may be at risk ofserious

harmful effects. The most common signs ofingestion are excessive salivation and foaming at

the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your

pet for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats

exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately.

If your dog is exhibiting signs of and/or are being treated for skin dermatitis, talk to your vet

before applying any topical flea and tick control product.

Sensitivities may occur after using ANY pesticide product on pets. Ifsigns ofsensitivity

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

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

[{Outer Packaging or Insert Copy}]

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

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

the narrow end at the notches with scissors.

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

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

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

FREQUENCY OF APPLICATION

Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill

mosquitoes] [infestations]. [Studies show that] [brand name] kills fleas for up to three months.

If your pet is at high risk for flea reinfestation [, or in a highly infested environment], apply

monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills

mosquitoes within 24 hours for the first 7 days after treatment, then 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.

Version 10.1

Page 5 of8

Sergeant's® Master Label

11 August 2010 EPA Reg. No. 2517-XX

Infonnation in [ ] is optional.

DIRECTIONS FOR USE

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

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

DO NOT USE ON CATS. May be toxic and potentially fatal if applied to or ingested by cats.

FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks of age.

Weigh your dog to be sure you are applying the right dose formulated for the weight of your pet.

Do not treat your pet with more than one pesticide product at a time. Over dosing your animal

can result in serious illness and even death. Best if used year round. Certain medications can

interact with pesticides. Consult a veterinarian before using this product on debilitated, aged,

medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known

organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated

dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that

actively groom or engage in close physical contact with treated dog may be at risk ofserious

harmful effects. The most common signs ofingestion are excessive salivation and foaming at

the mouth. Ifthese symptoms occur immediately feed your dog and continue to monitor your

pet for the next 24 hours. Ifsymptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats

exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately.

If your dog is exhibiting signs of and/or are being treated for skin dermatitis, talk to your vet

before applying any topical flea and tick control product.

Sensitivities may occur after using ANY pesticide product on pets. Ifsigns ofsensitivity

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

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

[{Outer Packaging or Insert Copy}]

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

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

the narrow end at the notches with scissors.

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

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

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

FREQUENCY OF APPLICATION

Use [brand name] monthly for complete control offlea, tick [and] chewing lice [and to kill

mosquitoes] [infestations]. [Studies show that] [brand name] kills fleas for up to three months.

If your pet is at high risk for flea reinfestation [, or in a highly infested environment], apply

monthly. Apply monthly to control ticks, mosquitoes and chewing lice. [Brand name] kills

mosquitoes within 24 hours for the first 7 days after treatment, then 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.

117
Version 10.1

Page 6 of8

sergeant's® Master Label

EPA Reg. No. 25l7-XX

I is optional.

11 August 2010

Information in [

For Dogs Weighing up to 221bs.

{For cartons containing .67ml (0.023 fl. oz.) applicator tubes}

Apply one tube (.67ml)(0.023 fl. oz.) [as a spot to the dog's back between the shoulder blades]

[from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 23-44 lbs.

{For cartons containing 1.34 ml (0.045 fl. oz.) applicator tube}

[Apply two tubes (.67ml)(0.023 fl. oz.) as a spot on the dog's back between the shouider] [or]

[Apply one tube (1.34 ml)(0.045 fl. oz.) as a spot to the dog's back between the shouider blades.]

For Dogs Weighing Between 45-88Ibs.

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

Apply one tube (2.68 mi)(0.09l fl. oz.) [as a spot on the dog's back between the shoulder] [from

the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing 89-132Ihs

For cartons containing 4.02ml (0.136 fl. oz.) applicator tube}

Apply one tube (4.02 ml)(0.136 fl. oz.) [as a spot on the dog's back between the shoulder] [from

the back ofthe neck to a point midway between the neck and tail].

STORAGE AND DISPOSAL

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

7rF (2S"C)] dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight.

PESTICIDE DISPOSAL AND CONTAINER HANDLING: Non-refillable container. Do not reuse or

refill this container. Ifempty: Place in trash or 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 ofthis product are believed to adequate

and must be followed carefully. It is impossible to eliminate all risks associated with the use ofthis

product. Unintended consequences may result because of unknown factors. All such risks shall be

assumed by the user or buyer.] I 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 offitness for a particular purpose or otherwise, that extend beyond statements Oll this

label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not

be liable for indirect, special, incidental or consequential damages. To the extent consistent with

applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.]

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

P.O. Box 540399, Omaha. NE 68 i54-0399.]

In Case of Emergency, call: 1-800-781-4738 [For more information] [Visit us at:] [www.sergeants.com]

Non-Emergency callJ-800-224-PETS (7387) [Made in USA]

Version 10.1

Page 6 of8

sergeant's® Master Label

EPA Reg. No. 25l7-XX

I is optional.

11 August 2010

Information in [

For Dogs Weighing up to 221bs.

{For cartons containing .67ml (0.023 fl. oz.) applicator tubes}

Apply one tube (.67ml)(0.023 fl. oz.) [as a spot to the dog's back between the shoulder blades]

[from the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing Between 23-44 lbs.

{For cartons containing 1.34 ml (0.045 fl. oz.) applicator tube}

[Apply two tubes (.67ml)(0.023 fl. oz.) as a spot on the dog's back between the shouider] [or]

[Apply one tube (1.34 ml)(0.045 fl. oz.) as a spot to the dog's back between the shouider blades.]

For Dogs Weighing Between 45-88Ibs.

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

Apply one tube (2.68 mi)(0.09l fl. oz.) [as a spot on the dog's back between the shoulder] [from

the back ofthe neck to a point midway between the neck and tail].

For Dogs Weighing 89-132Ihs

For cartons containing 4.02ml (0.136 fl. oz.) applicator tube}

Apply one tube (4.02 ml)(0.136 fl. oz.) [as a spot on the dog's back between the shoulder] [from

the back ofthe neck to a point midway between the neck and tail].

STORAGE AND DISPOSAL

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

7rF (2S"C)] dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight.

PESTICIDE DISPOSAL AND CONTAINER HANDLING: Non-refillable container. Do not reuse or

refill this container. Ifempty: Place in trash or 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 ofthis product are believed to adequate

and must be followed carefully. It is impossible to eliminate all risks associated with the use ofthis

product. Unintended consequences may result because of unknown factors. All such risks shall be

assumed by the user or buyer.] I 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 offitness for a particular purpose or otherwise, that extend beyond statements Oll this

label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not

be liable for indirect, special, incidental or consequential damages. To the extent consistent with

applicable law, the exclusive remedy ofthe user or buyer shall not exceed the purchase price paid.]

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

P.O. Box 540399, Omaha. NE 68 i54-0399.]

In Case of Emergency, call: 1-800-781-4738 [For more information] [Visit us at:] [www.sergeants.com]

Non-Emergency callJ-800-224-PETS (7387) [Made in USA]

118
Version 10.1

Page 7 of8

Sergeant's® Master Label

EPA Reg. No. 2517-XX

] is optionaL

II August 2010

Information in [

Distributed by:

Sergeant's Pet Care Products, Inc.

P.O. Box 540399

Omaha, NE 68154-0399

EPA Reg. No. 2517-XX

EPA Est. No. XXXXX-XX-XXX

[BAR CODE AREA]

IOptionallnsert or package copy]

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

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

labeling.[

[{Outer Packaging or Insert Copy}]

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:

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

2. Squeeze tube firmly to apply all ofthe solution to the dog's skin las a spot to the dog's

back between the shoulder blades.] [or] [from the back ofthe neck to a point midway

between the neck and tail.]

{Flea life cycle diagram]

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

Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

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

• Separate animals after treatment to avoid chance of ingestion

• Do NOT split tubes between pets]

[Brand Name]

[Monthly reminder card]

IApply [Brand Name] monthly for continuous protection against Fleas, Ticks, [and] chewing

lice Iand mosquitoes].]

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

[First [dose] [Treannent] (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 brand name] IPlace stickers on your calendar as a reminder to reapply

[brand name] [in 30 days.]

Version 10.1

Page 7 of8

Sergeant's® Master Label

EPA Reg. No. 2517-XX

] is optionaL

II August 2010

Information in [

Distributed by:

Sergeant's Pet Care Products, Inc.

P.O. Box 540399

Omaha, NE 68154-0399

EPA Reg. No. 2517-XX

EPA Est. No. XXXXX-XX-XXX

[BAR CODE AREA]

IOptionallnsert or package copy]

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

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

labeling.[

[{Outer Packaging or Insert Copy}]

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:

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

2. Squeeze tube firmly to apply all ofthe solution to the dog's skin las a spot to the dog's

back between the shoulder blades.] [or] [from the back ofthe neck to a point midway

between the neck and tail.]

{Flea life cycle diagram]

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

Checklist

• Read the label completely and follow directions

• Weigh your pet

• Do NOT use Dog products on Cats

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

• Separate animals after treatment to avoid chance of ingestion

• Do NOT split tubes between pets]

[Brand Name]

[Monthly reminder card]

IApply [Brand Name] monthly for continuous protection against Fleas, Ticks, [and] chewing

lice Iand mosquitoes].]

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

[First [dose] [Treannent] (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 brand name] IPlace stickers on your calendar as a reminder to reapply

[brand name] [in 30 days.]

119
II August 2010

Information in [

Sergeant's@ Master Label

Version 10.1 EPA Reg. No. 2517-XX

I is optional. Page 8 of 8

[Monthly Application Reminder Magnet (image ofreminder 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 [Brand

N arne]. 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.]

{END - OPTIONAL INSERT OR PACKAGE COPY}

TUBE I VIAL LABEL

Front Label Back Label

{Brand Name}

Fipronil 9.8%, Pyriproxyfen 2.0%

Dog 0.67 mL (or) 1.34 mL (or) 2.68 mL (or)

4.02 mL {label code}

KEEP OUT OF REACH OF CHILDREN

WARNING: Read directions and precautions

before using. Use scissors to open.

EPA REG. No. 2517-XX {label code}

[Optional: Example pictograms that mayor may not be found on the printed label]

11 August 2010

Information in [ 1is optional.

Sergeant's® Master Label

Version 10.1 EPA Reg. No. 2517-XX

Page 8 of8

[Monthly Application Reminder Magnet (image ofreminder 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 [Brand

Narne]. 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.]

{END - OPTIONAL INSERT OR PACKAGE COPY}

~g'I'Y~'PI.iAJ~gJP

Front Label Back Label

{Brand Name}

Fipronil 9.8%, Pyriproxyfen 2.0%

Dog 0.67 mL (or) 1.34 mL (or) 2.68 mL (or)

4.02 mL {label code}

KEEP OUT OF REACH OF CHILDREN

WARNING: Read directions and precautions

before using. Use scissors to open.

EPA REG. No. 2517-XX {label code}

[Optional: Example pictograrns that mayor may not be found on the printed label]

120
!5 Dccember ~009

Richard Ccbkell

Product I'vl~ll1ager 22

j)octll1lent Proeesslll~ Desk

on!:.::e n r Pesticide Progr:llns

U,S, EllVil'olllno.:ntal Pwkdillfl AgellC}'

RU(l(l1 S~49()(), (Jile P(llulll,H':: '{,elrel

2777 Snulll Crystall)ri\'c

Arlillglllll. \/A 22202-4S0 I

Dear 1vl1", Gehken:

Sergeant's Pet Care Products, Inc.

Sergeant'!; Pel Cnre Products. Inc. (Sergeant's. 2625 SoutillSgil' Plaza, Om,lIHl. Nehraska

6S 130-1770. EPA Cmnpany Number 25 J 7), aUlhnrizes Expnncm, Inc. {II 50 Connectieul

Avenue, NW, Suite 1100, Washington DC, 20(36) In n(;t nn our heh,lIL as nul'

Authorizcd Representative, f()]' £III necessary inleractions regarding all of nul' pmduct

n:gistnnion applicntions and registnninns. Plcase note lhis daes I1nl change the eurrenl

flied Allllwrized Agem 1~1r Sergeant's,

The ExpnncnL Inc. contnct is £IS t(dlows:

J<lI11CS Messin,1 and/or Rick Tills\(.'orih

Exponcnt. Inc.

I 150 Cunnecticut ;\VC" NW

Suitc II UO

\\/ashingion, DC 20036

(202) 772-4932

(202) 772-4979 fax

j mess 111 i1 ({(CX pUll eni Xo! n'rei II SW(}rt11 (O):X pOll en t. co111

!r )\1\1 hmc ,Hly <jucs,inll.s.. pieii~e conine; me ai 402--9}8-7079

/r;;~j

10-

Kelly R. Hoskins

\;bnilgcr ofTechllicill An:1irs

co.:: .!:Jmcs rVlc~sin,l

!5 Dccember ~009

Richard Ccbkell

Prod (lct I'vl ~ll1ager 22

j)octll1lent Proeesslllg Desk

on!:.::e n r Pest icide Progr:llns

U,S, EllVi l'OIIl n0.:]) ta I Prokdi lin AgellC)'

Run (l1 S~49()(), (Jile Pm Gill ,Ii':: '{,elrel

2777 Snulll Crystal I)rl\'c

Arlill£,lulL \/A 22202-450 I

Dear 1vl1", Gehken:

Sergeant's Pet Care Products, Inc.

Sergeant\; Pel Cnre Prod uds. Inc. (Sergeant's. 2625 South 15 gil' rlaza, Om,lIHl. Nehraska

6S 130-1 770, EPA Cmn pany Nlim bel' 25 J 7), aUlhnrizes Ex pnnem, Inc. ( I I50 ConnediCUI

Avenue, NW, Suite I 100, Washington DC 20(36) In n(;t nn our heh,lIL as nul'

Authorizcd Representative, f()]' £III necessary inleractions regarding all of nul' pmduct

n:gistnnion applicntions and registnninns. Plcase note lhis daes nnl change the eurrenl

fj led Allllwrized Agelll I~)r Sergeant's,

The ExpnncnL Inc. contnct is £IS t(dlows:

J<lmcs Messin,) and/or Rick Tills\(.'ori h

Exponcnt. Inc.

I 150 Cunnecticut ;\ VC" N\V

Suitc II UO

\\/ashington, DC 20036

(202) 772-4932

(202) 772-4979 fax

j meSSllli1(t(C\ pUllcni xo!I1'rtinswort1!(O).':x pOllen[.cOll1

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121
sergeant's Pet Care Products, Inc.

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

August 11, 2010

Richard Gehken, PMIO

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 ofEPA Pesticide Registration Improvement Act Information

Dear Mr. Gebken:

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

EPA Company Number 2517), is submitting Pesticide Registration Improvement Act

Information for the following new registration application:

• Sergeant's Fipronil + Nylar Squeeze~On for Dogs R310, $4,578 (50% fee waiver

82,289), Pay.gov Tracking 1D: 25101L1D, Agency Tracking 1D: 74122352206.

This registration application is for a new end-use product with supporting data and is considered

an R310, new end-use product, requires review ofdata package within RD, PRIA review time

frame 6 months, and a fee of $4,578. Sergeant1s qualifies for a PRIA fee waiver/reduction of

50% (refer to opp Decision Number D-425455).

If you have any questions or need additional information regarding this registration application,

please contact me at 402-938-7079.

Sincerely,

1l-&r ~. HoslA.N I~I

Kelly R. Hoskins

Manager ofTechnical Affairs

sergeant's Pet Care Products, Inc.

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

August 11,2010

Richard Gebken, PMI0

Office of Pesticide Programs (7504P) (REGFEE)

U.S. Environmental Protection Agency

Document Processing Desk

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Subject: Submission ofEPA Pesticide Registration Improvement Act Information

Dear Mr. Gebken:

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

EPA Company Number 2517), is submitting Pesticide Registration Improvement Act

Information for the following new registration application:

• Sergeant's Fipronil + Nylar Squeeze~On for Dogs R310, $4,578 (50% fee waiver

$2,289), Pay.gov Tracking ID: 2510ILID, Agency Tracking ill: 74122352206.

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 $4,578. Sergeant1s qualifies for a PRIA fee waiver/reduction of

50% (refer to OPP Decision Number D-425455).

If you have any questions or need additional information regarding this registration application,

please contact me at 402-938-7079.

Sincerely,

1L&r < HoslA.N !~I

Kelly R. Hoskins

Manager ofTechnical Affairs

122
Voluntary Small Business Certification Form for

Pesticide Registration Fee WaiverlReduction

Section 1: Business Identification

Company Name: Sergeant's Pet Care Products, Inc.

Address: 2625 South 158"' Plaza

Omaha, NE 68130-1770

EPA Company Number: 2517

Contact Name: Kelly R. Hoskins

Manager ofTechnical Affairs

Phone Number: 402-938-7079

Fax Number: 402-938-7091

Email: KHoskins(ii)SERGEANTS.com

Section 2: EPA Pendini! Action Identification

Product Name: Sergeant's Fipronil + Nylar Squeeze-On for

Dogs

Descrintion of Action Submitted to EPA: New end-use product with efficacy data

EPA Identification 2517-NEW

EPA Fee Category and Fee EPA PRIA fee category R31 0, 6 month

review, $4,578 (50% fee waiver $2,289)

Section 3: Small Business InformationIDocumentation

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, 2010)

revenue from pesticides for each ofthe three

most recent comnleted fiscal or tax vears.

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

emnlovees?

Documentation: include the most recent IRS 941 Refer to previously filed request ofDor W3 or other official documentation 425455 (May 4, 2010)

Voluntary Small Business Certification Form for

Pesticide Registration Fee WaiverlReduction

Section 1: Business Identification

Company Name: Sergeant's Pet Care Products, Inc.

Address: 2625 South 158"' Plaza

Omaha, NE 68130-1770

EPA Company Number: 2517

Contact Name: Kelly R. Hoskins

Manager ofTechnical Affairs

Phone Number: 402-938-7079

Fax Number: 402-938-7091

Email: KHoskins(ii)SERGEANTS.com

Section 2: EPA Pendini! Action Identification

Product Name: Sergeant's Fipronil + Nylar Squeeze-On for

Dogs

Descrintion of Action Submitted to EPA: New end-use product with efficacy data

EPA Identification 2517-NEW

EPA Fee Category and Fee EPA PRIA fee category R31 0, 6 month

review, $4,578 (50% fee waiver $2,289)

Section 3: Small Business InformationIDocumentation

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, 2010)

revenue from pesticides for each ofthe three

most recent comnleted fiscal or tax vears.

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

emnlovees?

Documentation: include the most recent IRS 941 Refer to previously filed request ofDor W3 or other official documentation 425455 (May 4, 2010)

123
Section 4: Certification Statement

I, Joe Connealy, the Vice President ofFinance (title), ofthe above-named Applicant, am

authorized and have personal knowledge sufficient to make this certification on behalf ofthis

Applicant. I hereby certify under penalty ofperjury that the information in Sections 1-3 above

and the documentation submitted and/or relied on in connection with this Applicant's Fee

WaiverlReduction request are true, complete, and correct in all material respects, and accurately

represent the current business status ofthis Applicant.

Joe Connealy

o£= -l(. 7.olo

Date

Section 4: Certification Statement

I, Joe Connealy, the Vice President ofFinance (title), ofthe above-named Applicant, am

authorized and have personal knowledge sufficient to make this certification on behalf ofthis

Applicant. I hereby certify under penalty ofperjury that the information in Sections 1-3 above

and the documentation submitted and/or relied on in connection with this Applicant's Fee

WaiverlReduction request are true, complete, and correct in all material respects, and accurately

represent the current business status ofthis Applicant.

Joe Connealy

o£= -ll. 7.olo

Date

124
Pages 125-128 - *Confidential Statement of Formula may be entitled to confidential treatment*