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UNITEDSTATES ENVIRONMENTALPROTECTION AGENCY REGION5 77 WEST JACKSONBOULEVARD b CHICAGO,IL60604-3590 2011JAN—6P113:20

REPLYTO THEAUENTION OF: Via UPS Overnight Delivery C-14J

January 6,2011

Honorable Barbara A. Gunning Office of Administrative Law Judges U.S. Environmental Protection Agency Mail Code 1900L 1099 l4tl Street, NW, Suite 350 Franklin Court Washington, D.C. 20005

Re: In the Matter of Liphatech, Inc. Docket No. FIFRA-05-2010-0016

Dear Judge Gunning:

Pursuant to your Order of December 29, 2010, please find enclosed a copy of Complainant’s First Amended Complaint, which was filed on January 6, 2011, in the above referenced-matter. The enclosed Complainant’s First Amended Complaint is identical in substance to the proposed pleading attached to Complainant’s Motionfor Leave to Amend the Complaint, filed on October 1, 2010, except for the following changes: (1) the docket number for the above-referenced matter is included in the First Amended Complaint; (2) the undersigned is substituted for Ms. Cynthia King (page 99 of the First Amended Complaint); (3) Mr. Bruce F. Sypniewski is substituted for Ms. Margaret M. Guerriero (page 102 of the First Amended Complaint); and (4) the enclosed First Amended Complaint includes attachments. Sincerely, _—

Gary . teinb uer Assista gional Counsel

Enclosure cc: Mr. Michael H. Simpson (w/ enclosure) Reinhart Boerner Van Deuren s.c. 1000 North Water Street, Suite 1700 Milwaukee, WI 53202 (via UPS overnight)

RecycledlRecyclable • Printed with Vegetable Oil Based inks on 100% Recycled Paper (50% Postconsumer)

the

widespread pesticide,

of

directions

copy

registration

Milwaukee,

Division,

of

Respondent.

Milwaukee, Liphatech, ______)

In

EPA

the

uses

the

of

Federal

Matter

5.

4.

3.

2.

may

the 1.

for

when

United

for

and

which labeling

of

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Wisconsin

classify

UNITED

Wisconsin,

its

a

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Section

The

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of:

commonly applied

pesticide

use.

States

it

Respondent

Complainant

is

of

is

a

an

pesticide

registered,

3(d)(1)(C)

the

3(c)(1)(

STATES

53209,

in

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administrative

shall

accordance

pesticides,

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recognized

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a

file

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is

as

corporation

is,

ENVIRONMENTAL

or of

Liphatech,

First

“restricted

with

7

by

FIFRA,

for

U.S.C.

a

and

with

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if

business

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to

all

Act,

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Insecticide, Docket

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assess

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claims

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states a

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FIFRA-05-2010-0016

to

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or Region

State

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penalty

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West

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1361(a)

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the

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it,

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and

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and

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complete

a

14(a) for regulatory restrictions, unreasonable adverse effects on the environment, including injury to the applicator. See also 40 C.F.R. §ss152.170, 171 and 175.

6. Section 12(a)(1)(B) of FIFRA, 7 U.S.C. § 136j(a)(1)(B), states that it is unlawful for any person to distribute or sell to any person any registered pesticide if any claims made for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required with its registration under Section 3 of FIFRA, 7 U.S.C. § 136a.

7. PARAGRAPH TNTHE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

8. Section 12(a)(2)(E) of FIFRA, 7 U.S.C. § 136j(a)(2)(E), states that it is unlawful for any person who is a registrant, wholesaler, dealer, retailer, or other distributor to advertise a product registered under FIFRA for restricted use without giving the classification of the product assigned to it under Section 3 of FIFRA, 7 U.S.C. § 136a.

9. Section 13(a) of FIFRA, 7 U.S.C. § 136k(a), states whenever any pesticide is found by the Administrator in any State and there is reason to believe on the basis of inspection that such pesticide is in violation of any of the provisions of FIFRA, or that such pesticide has been or is intended to be distributed or sold in violation of any provision of FIFRA, the

Administrator may issue a written or printed “stop sale, use, or removal” order (SSURO) to any person who owns, controls, or has custody of such pesticide, and after receipt of such order no person shall sell, use, or remove the pesticide described in the order except in accordance with the provisions of the order.

10. Section 24(c) of FIFRA, 7 U.S.C. § 136v(c), states, in pertinent part, that a State may provide registration for additional uses of federally registered pesticides formulated for distribution and use within that State to meet special local needs in accord with the purposes of

2 FIFRA. Such registration shall be deemed registration under Section 3 of FIFRA, 7 U.S.C.

§ 136a, but shall authorize distribution and use only within such State. See also 40 C.F.R.

§ 162.153.

11. 40 C.F.R. § 152.168 states in pertinent part, as follows:

(a) Any product classified for restricted use shall not be advertised unless the

advertisement contains a statement of its restricted use classification.

(b) The requirement in paragraph (a) applies to all advertisements of the

product, including, but not limited, to:

(1) Brochures, pamphlets, circulars and similar material offered to

purchasers at the point of sale or by direct mail.

(2) Newspapers, magazines, newsletters and other material in

circulation or available to the public.

(3) Broadcast media such as radio and television.

(4) Telephone advertising.

(5) Billboards and posters.

(c) The requirement may be satisfied for printed material by inclusion of the

statement “Restricted Use Pesticide” or the terms of restriction,

prominently in the advertisement. The requirement may be satisfied with

respect to broadcast or telephone advertising by inclusion in the broadcast

of the spoken words “Restricted use pesticide” or a statement of the terms

of restriction.

12. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

3

preventing,

40

pertinent

aquatic

§152.5(c).

in

COMPLAINT.

for

whether

§ “means pesticide

EPA

it

FIFRA

if

136(gg),

as

pertinent

claims

C.F.R.

shipment,

part

interprets

19.

18.

pant

17.

16.

15.

14.

makes

13.

any

incorporated

part,

of

made

users

§

and

destroying,

part,

152.3,

the

individual,

or

or

“as

The

The

The

PARAGRAPH

The

it

The

animal

40

40

or

this

for

statement

receive

as unlawful

the

any

C.F.R.

C.F.R.

in

term

it

term

term

term

term

all

provision

pertinent

as

general

or

insect,

life

labels

repelling,

partnership,

part

“pesticide”

“pest” and

“labeling”

not.”

“distribute

“person”

§

§

required

for

or

152.3

168:22

of

(having

virus,

and

rodent,

public

as

any

part,

IN

its

is

extending

or

all

defined

as

THE

distribution

person

as

in

states,

is

bacteria,

as

or

mitigating is

association,

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have

other

so

defined

nematode,

connection

defined

defined

“any

sell”

ORIGINAL

received)

distribute,

to

in

in

access.

written,

to

is

substance

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pertinent

Section

or

in

advertisements

in

defined

or

at

any

other

4

Section

fungus,

Section

corporation,

sale

Section

with

deliver

printed,

for

sell,

pest.”

COMPLAINT

2(t)

micro-organism.

differ

part,

its

in

or sale”

offer

2(s)

weed,

2(p)(2)

of

Section

mixture

2(u)

registration

or

that

or

FIFRA,

substantially

any

offer

of

for

in

or

of graphic

or

FIFRA.

Section

any

pesticide

any

of

FIFRA,

sale,

2(gg)

of

to

any

FIFRA,

REMOVED

7

deliver.”

advertising

substances

organized

under

U.S.C.

other hold matter.

.

. of 7

.“

12(a)(1)(A)

7 from

U.S.C.

if

FIFRA,

See

for

U.S.C.

7

form

FIFRA

it

§

U.S.C.

is

also

distribution,

any

group

136(t),

intended

medium

unregistered,

IN

§

of

7

§

claim

40

136(s),

Section

terrestrial

AMENDED

and

U.S.C.

136(u),

§

of

C.F.R.

in

136(p)(2),

persons

(B)

to

for

made

hold

which

3.

and

of

or

or for 20. The term “registrant” is defined at Section 2(y) of FIFRA, 7 U.S.C. § 136(y), as a person who has registered any pesticide pursuant to the provisions of FIFRA.

21. The Administrator of EPA may assess a civil penalty against any registrant, commercial applicator, wholesaler, dealer, retailer, other distributor who violates any provision of FIFRA of up to $6,500 for each offense that occurred after March 15, 2004 through January

12, 2009 and up to $7,500 for each offense that occurred after January 12, 2009, pursuant to

Section 14(a)(1) of FIFRA, 7 U.S.C. § 1361(a)(1),and 40 C.F.R. Part 19.

General Alle2ations

22. At all times relevant to the Complaint, Respondent was a “person” as defined at

Section 2(s) of FIFRA, 7 U.S.C. § 136(s).

23. At all times relevant to the Complaint, Respondent owned a place of business at

3600 West Elm Street, Milwaukee, Wisconsin, 53209.

24. At all times relevant to the Complaint, Respondent was a “registrant” as defined at Section 2(y) of FIFRA, 7 U.S.C. § 136(y).

Calendar Years 2007 and 2008

25. During calendar years 2007 and 2008, Respondent was the registrant of”Rozol

Pocket Gopher Bait II” (Alternate name: “Rozol Pocket Gopher Burrow Builder Formula”)

(hereinafter, “Rozol”), EPA Registration Number (EPA Reg. No.) 7173-244.

26. Upon registration of “Rozol,” EPA Reg. No. 7173-244, and at all times relevant to this Complaint, “Rozol,” EPA Reg. No. 7173-244, was classified as a restricted use product under Section 3(d), of FIFRA, 7 U.S.C. § 136a(d).

5 27. ‘Rozol,” EPA Reg. No. 7173-244, was classified as a restricted use product under

Section 3(d) of FIFRA, 7 U.S.C. § 136a(d), because of its potential secondary toxicity to nontarget organisms.

28. As a result of its classification as a restricted use product, “Rozol,” EPA Reg. No.

7173-244, can only be sold to and be used by Certified Applicators or persons under the direct supervision of Certified Applicators and only for users covered by the Certified Applicator’s certification.

29. During calendar years 2007 and 2008, “Rozol,” EPA Reg. No. 7173-244, was also registered under the authority of Section 24(c) of FIFRA, 7 U.S.C. § 136v(c), to control black-tailed prairie dogs under “Special Local Needs” supplemental labels for the States of

Kansas, Nebraska, Wyoming, Colorado, and .

30. The use of “Rozol,” EPA Reg. No. 7173-244, to control black-tailed prairie dogs was restricted to the following counties in Colorado: Adams, Arapahoe, Baca, Bent, Boulder,

Broomfield, Cheyenne, Crowley, Denver, Douglas, El Paso, Elbert, Huerfano, Jefferson, Kiowa,

Kit Carson, Larimer, Las Animas, Lincoln, Logan, Morgan, Otero, Phillips, Prowers, Pueblo,

Sedgewick, Washington, Weld and Yuma.

31. The use of”Rozol,” EPA Reg. No. 7173-244, to control black-tailed prairie dogs was restricted to the following counties in Texas: Baylor, Brewster, Coke, Crane, Crockett,

Fisher, Jones, Nolan, Presidio, Reagan, Schleicher, Shackelford, Sutton, Terrell, Throckmorton,

Tom Green, Upton and Wilbarger.

32. During calendar years 2007 and 2008, “Rozol,” EPA Reg. No. 7173-244, was a

“pesticide” as defined at Section 2(u) of FIFRA, 7 U.S.C. § 136(u).

6 33. In January of 2008, the Toxics and Pesticides Branch, EPA Region 7 requested

that the Chemicals Management Branch, EPA Region 5, investigate potential violations of

FIFRA regarding “Rozol,” EPA Reg. No. 7173-244, at Respondent’s establishment.

34. On June 2, 2008, an inspector employed by the State of Wisconsin, Bureau of

Agrichemical Management, Compliance Section and authorized to conduct inspections under

FIFRA, conducted an inspection at Respondent’s place of business located at 3600 West Elm

Street in Milwaukee, Wisconsin.

35. The inspector issued a Federal SSURO pursuant to Section 13(a) of FIFRA,

7 U.S.C. § 136k(a), to Respondent regarding “Rozol,” EPA Reg. No. 7173-244, during the June

2, 2008 inspection.

36. After the Federal SSURO was issued, Respondent sent out letters, entitled “EPA

Literature Compliance-Rozol® Pocket Gopher Bait — Burrow Builder Formula / Prairie Dog

Bait,” to its distribution partners requesting that they each destroy any and all literature, flyers

and advertisements entitled “Black-tailed Prairie Dog Control — Research Bulletin,” dated

October 17, 2007; “Livestock Weight Gain and Prairie Dogs: ESA Frontiers in Ecology & the

Environment,” November 2006 Reprint; and “True Cost of Black-tailed Prairie Dog Control

(Whitepaper),” dated November 5, 2007.

37. On June 19, 2008, the inspector returned to Respondent’s place of business

located at 3600 West Elm Street, Milwaukee, Wisconsin, to collect documentary information from Respondent regarding “Rozol,” EPA Reg. No. 7173-244.

38. On June 19, 2008, the inspector collected a written statement and documentary information regarding “Rozol,” EPA Reg. No. 7173-244, from Respondent.

7

2007

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transcripts

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four

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E).

occasions

versions

versions

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failed

failed

the

contracted

the

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without

regarding

radio

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purchase

to

to

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from

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information

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include

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include

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collected

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words

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broadcast “Rozol,

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station,

broadcast

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regarding of

about regarding

See

the

for

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versions

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radio

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for

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radio

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the

stations

also

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regarding

behalf

statement

2008

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advertisements

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2008

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in

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about

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regarding

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Nebraska;

terms

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March

without

on

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of

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separate

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separate

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restrictions

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restrictions

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all

contracted

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contracted

and

to

occasions

2007,

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the

in

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on

occasions

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McCook, A

occasions

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inclusion

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inclusion

or

through

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through

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KXXX-AM

KBUF

for

for

about

with

with

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from

KBUF

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Nebraska;

broadcast

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of

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of

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in

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on

on

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the

the

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regarding

broadcast

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regarding

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the

or

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spoken

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spoken

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about

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radio Radio

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Kansas

one

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Reg.

Nebraska,

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one

January

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of

words

stations,

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2007

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the

Broadcast

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on

of

to

from

four

from

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the

the

“restricted

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broadcast

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in

KICX-FM, EPA

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on

radio

four

on

Oberlin, versions

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2008

on

1,521

to

or

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versions

or

broadcast

station,

about

radio

to

about

use

use

occasions

No.

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Nebraska;

on

of

KBRL-AM,

pesticide”

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January

the

advertisements

or

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7

KBUF

October

of

7

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about

radio

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the

from

radio

in

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15,

March

or

8,

or

on

on

on

2007

a a KJCX-FM Broadcast

49. On 322 separate occasions (See Attachment G), from on or about September 26,

2007 to on or about December 31, 2007, KJCX-FM, in McCook, Nebraska, broadcast one of the four versions of the radio advertisement regarding “Rozol,” EPA Reg. No. 7173-244, on behalf of Respondent without the inclusion of the spoken words “restricted use pesticide” or a statement of the terms of restrictions for “Rozol,” EPA Reg. No. 7173-244.

KBRL-AMBroadcast

50. On 322 separate occasions (See Attachment G), from on or about September 26,

2007 to on or about December 31, 2007, KBRL-AM,in McCook, Nebraska, broadcast one of the four versions of the radio advertisement regarding “Rozol,” EPA Reg. No. 7173-244, on behalf of Respondent without the inclusion of the spoken words “restricted use pesticide” or a statement of the terms of restrictions for “Rozol,” EPA Reg. No. 7173-244.

KRKU-FM Broadcast

51. On 60 separate occasions (See Attachment G), from on or about September 26,

2007 to on or about December 31, 2007, KRKU-FM, in McCook, Nebraska, broadcast one of the four versions of the radio advertisement regarding “Rozol,” EPA Reg. No. 7173-244, on behalf of Respondent without the inclusion of the spoken words “restricted use pesticide” or a statement of the terms of restrictions for “Rozol,” EPA Reg. No. 7173-244.

KJBL-FM Broadcast

52. On 296 separate occasions (See Attachment G), from on or about September 26,

2007 to on or about December 31, 2007, KJBL-FM, in McCook, Nebraska. broadcast one of the four versions of the radio advertisement regarding “Rozol,” EPA Reg. No. 7173-244, on behalf

10

of

of 2007

four

the

Respondent to

versions

of

of

four

2007

of

of

the

Respondent

on

the

Respondent

the

Respondent

terms

versions

versions

to

or

to

terms

terms

terms

55.

54.

53.

on

about

on

of

of

or

or

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of

without

restrictions

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of

of

about

of

about

December

without

restrictions On

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without

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radio

restrictions

without

restrictions

the

the

322

60

139

radio

December

radio

December

the

advertisement

separate

separate

the

separate

the

the

for

inclusion

31,

advertisement

advertisement

for

inclusion

for

inclusion

for

inclusion

“Rozol,”

2007,

“Rozol,”

occasions “Rozol,”

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31,

31,

occasions

occasions

of

2007,

2007,

KADL-FM,

regarding

of

the

of

EPA

of

KSTH-FM

KADL-FM

KFNF-FM

the

the

EPA

the

EPA

regarding EPA

spoken

regarding

KSTH-FM,

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spoken

spoken

spoken

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in

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words

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about

about

7

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broadcast

broadcast

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October

or

one

September

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on

or

a

or

or

behalf

of

statement

one

on

a

one

on

a

a

statement

the

statement

statement

15,

behalf

behalf

of

of

of

four

26,

2007

26,

the

the of KGNC-AM and KXGL-FM

56. Respondent contracted with KGNC-AMand KXGL-FMto broadcast these radio

advertisements regarding “Rozol,” EPA Reg. No. 7173-244, on the radio stations, KGNC-AM

and KXGL-FMin Amarillo, Texas, on 247 occasions from on or about November 12, 2007 to on

or about April 26, 2008 (See Attachment H).

KGNC-AMBroadcast

57. On 188 separate occasions (See Attachment H), from on or about November 12,

2007 to on or about April 26, 2008, KGNC-AM,in Amarillo, Texas, broadcast one of the four

versions of the radio advertisement regarding “Rozol,” EPA Reg. No. 7173-244, on behalf of

Respondent without the inclusion of the spoken words “restricted use pesticide” or a statement of

the terms of restrictions for “Rozol,” EPA Reg. No. 7173-244.

KXGL-FMBroadcast

58. On 59 separate occasions (See Attachment H), from on or about November 27,

2007 to on or about April 26, 2008, KXGL-FM,in Amarillo, broadcast one of the four versions

of the radio advertisement regarding “Rozol,” EPA Reg. No. 7173-244, on behalf of Respondent

without the inclusion of the spoken words “restricted use pesticide” or a statement of the terms of

restrictions for “Rozol,” EPA Reg. No. 7173-244.

Print Advertisements regarding “Rozol,“EPA Reg. No. 7173-244

59. The documentary information collected by the inspector on June 19, 2008 included invoices showing the purchase of print advertising by Respondent for the advertisement of”Rozol,” EPA Reg. No. 7173-244.

12 Cattle Guard Publication

60. Respondent contracted with Colorado Cattlemen’s Association to print an

advertisement regarding “Rozol,” EPA Reg. No. 7173-244, in its publication of Cattle Guard in

October 2007.

61. The October 2007 issue of Cattle Guard included an advertisement regarding

“Rozol,” EPA Reg. No. 7173-244.

62. The print advertisement in the October 2007 issue of Cattle Guard regarding

“Rozol,” EPA Reg. No. 7173-244, failed to include the words “restricted use pesticide.”

63. The print advertisement in the October 2007 issue of Cattle Guard regarding

“Rozol,” EPA Reg. No. 7173-244, failed to include any statements of the terms of restrictions of

“Rozol,” EPA Reg. No. 7173-244.

Kansas Stockman Publication

64. Respondent contracted with Kansas Livestock Association to print advertisements

regarding “Rozol,” EPA Reg. No. 7173-244, in its monthly publication of Kansas Stockman

from October 2007 through February 2008.

65. The October 2007 issue of Kansas Stockman included an advertisement regarding

“Rozol,” EPA Reg. No. 7173-244.

66. The print advertisement in the October 2007 issue of Kansas Stockman regarding

“Rozol,” EPA Reg. No. 7173-244, failed to include the words “restricted use pesticide.”

67. The print advertisement in the October 2007 issue of Kansas Stockman regarding

“Rozol,” EPA Reg. No. 7173-244, failed to include any statements of the terms of restrictions of

“Rozol,” EPA Reg. No. 7173-244.

13

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from

include

submitted

Claims

product

No.

Reg.

2,

commerce.

issue

No.

2005

the

the

7

identify

are

No.

173-244,

on

any

7173-244

labeling

labeling under

Program,

of

a

for

June

to

Registration

7173-244,

part

statements Wyoming

and

“Rozol,”

the

Section

19, of

that

accepted

accepted

accepted

label

the

Registration

2008

was

for

Livestock

statement

EPA

language

Division,

of

3

the

of

the

by

by

by Reg. 141. The Direct Mail Packages included cover letters, dated October 31, 2007, that were entitled “SUBJECT - ROZOL ® POCKET GOPHER BAIT-”

142. The cover letters, dated October 31, 2007, stated “Rozol,” EPA Reg. No. 7173-

244, was intended both “For Black — Tailed Prairie Dog (BTPD) Control” and “For Control of

Pocket Gophers.”

143. The Direct Mail Packages also included sales literature regarding “Rozol,” EPA

Reg. No. 7173-244, entitled “Black-tailed Prairie Dog Control - Research Bulletin.”

144. The date on the sales literature entitled “Black-tailed Prairie Dog Control -

Research Bulletin, “regarding “Rozol,” EPA Reg. No. 7173-244 was October 17, 2007.

145. Respondent sent the Direct Mail Packages to its distribution partners and/or customers to advertise “Rozol,” EPA Reg. No. 7173-244.

Claims in Cover Letters, dated October 31, 2007

146. During calendar years 2007 and 2008, the cover letters, dated October 31, 2007, made the following claim regarding “Rozol,” EPA Reg. No. 7173-244: “Provides the most control available in a single application.” (Emphasis in original.)

147. This claim is substantially different than any claim made for “Rozol,” EPA Reg.

No. 7173-244, as part of its March 2, 2005 “accepted label.”

148. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

149. During calendar years 2007 and 2008, the cover letters, dated October 31, 2007, made the following claim regarding “Rozol,” EPA Reg. No. 7173-244: “Poses low primary poisoning potential to birds and other non-targets.” (Emphasis in original.)

23 150. This claim is substantially different than any claim made for “Rozol,” EPA Reg.

No. 7173-244, as part of its March 2, 2005 “accepted label.”

151. PARAGRAPH TNTHE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

152. During calendar years 2007 and 2008, the cover letters, dated October 31, 2007,

made the following claim regarding “Rozol,” EPA Reg. No. 7173-244: “Both restricted-use and

general-use Rozol products are formulated using proven anticoagulant chiorophacinone at 50

PPM (parts per million) - unlike other half-strength, diphacinone-based baits containing as low

as 25PPM.”

153. This claim is substantially different than any claim made for “Rozol,” EPA Reg.

No. 7173-244, as part of its March 2, 2005 “accepted label.”

154. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

Claims in “Black — Tailed Prairie Dog Control — Research Bulletin”

155. During calendar years 2007 and 2008, the sales literature entitled “Black-tailed

Prairie Dog Control - Research Bulletin” made the following claim regarding “Rozol,” EPA

Reg. No. 7173-244: “Rozol consistently controlled Prairie Dog populations using a single application.”

156. This claim is substantially different than any claim made for “Rozol,” EPA Reg.

No. 7173-244, as part of its March 2, 2005 “accepted label.”

157. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

24

No.

COMPLAINT.

insignificant.”

Reg. Prairie

No.

COMPLAINT.

Reg. Prairie

No.

COMPLAINT.

Prairie

Reg.

(Emphasis

7173-244,

7

7173-244,

No.

No.

No.

173-244,

166.

165.

Dog 164.

163.

162.

Dog 161.

160.

159.

158.

Dog

7

7

7173-244:

173-244:

173-244:

in

Control

Control

Control

original.)

PARAGRAPH

(Emphasis

This

as

During

PARAGRAPH

This

as

During

PARAGRAPH

This

as

During

part

part

part

claim

claim

“Conclusion:

claim

“Secondary “Conclusion: - -

-

of

of

Research

calendar

of

Research

calendar

Research

calendar

its

its

its

in

is

is

is

March

March

substantially

original.) March

substantially

substantially

IN

IN

iN

years

years

years

Bulletin”

Bulletin”

Hazard

Bulletin”

THE

THE

Above-ground

THE

Rozol

2,

2,

2,

2005

2007

2005

2007

2005

2007

ORIGINAL

ORIGINAL

ORIGINAL

/

delivers

different

different

Nearly

different

made

made

made

“accepted

and

“accepted

and

“accepted

and

25

2008,

2008,

2008,

the

the

the

exposure

all

proven

than

than

than

COMPLAINT

following

COMPLAINT

following

COMPLAINT

Prairie

following

label.”

the

label.”

the

label.”

the

any

any

any

sales single

sales

sales

risk

Dogs

claim

claim

claim

claim

claim

literature

claim

literature

to

literature

application

expired

non-targets

made

made

made

REMOVED

REMOVED

REMOVED

regarding

regarding

regarding

for

for

entitled

for

entitled

entitled

underground.”

“Rozol,”

effectiveness.”

“Rozol,”

“Rozol,”

from

“Rozol,”

“Rozol,”

“Rozol,”

IN

IN

IN

“Black-tailed

“Black-tailed

“Black-tailed

AMENDED

Rozol

AMENDED

AMENDED

EPA

EPA

EPA

EPA

EPA

EPA

is

Reg.

Reg. Reg.

No.

Prairie

costly

anticoagulants

Reg.

No.

COMPLAINT.

measured Prairie

Reg.

No.

COMPLAINT.

Prairie

by

Reg.

the

7173-244,

7173-244,

7173-244,

No.

No.

No.

re-treatment.”

‘plugged

174.

173.

Dog

172.

171.

170.

Dog

169.

168.

Dog

167.

7173-244:

7173-244:

7

by

173-244:

Control

Control

Control

the

This

have

as

During

PARAGRAPH

This

as

During

PARAGRAPH

This

as

During

burrow’

‘visual

part

part

part

claim

not claim

“Traditional

claim

“Over “Over - -

-

of

of

Research

calendar

of

Research

calendar

Research

calendar

proven

count’

its

its

its census

is

is

is

all

all

March

March

substantially

March

substantially

substantially

sites,

IN

sites,

IN

to

census

years

years

years

Bulletin”

method.”

Bulletin”

Bulletin”

control

THE

effectively

THE

2,

2,

2,

94%

95%

2005

2007

2005

2007

2005

2007

method.”

ORIGINAL

ORIGINAL

products

average

different

average

different

different

made

made

made

“accepted

and

“accepted

and

“accepted

and

prevent

26

2008,

2008,

2008,

the

the

the

population

population

such

than

than

than

following

COMPLAINT

following

COMPLAINT

following

label.”

population

the

label.”

the

label.”

the

as

any

any

any

sales

sales

sales

zinc

claim

claim

claim

reduction

reduction

claim

claim

phosphide

literature

claim

literature

literature

recovery,

made

made

made

REMOVED

REMOVED

regarding

regarding

regarding

was

was

for

for

entitled

for

entitled

entitled

or

leading

“Rozol,” achieved

achieved

“Rozol,”

“Rozol,”

Diphacinone-based

“Rozol,”

“Rozol,”

“Rozol,”

IN

IN

“Black-tailed

“Black-tailed

“Black-tailed

to

AMENI)ED

AMENDED

EPA

when

the EPA

as

EPA

measured

EPA

EPA

EPA

need

Reg.

Reg.

Reg. to 175. PARAGRAPH TNTHE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

176. During calendar years 2007 and 2008, the sales literature entitled “Black-tailed

Prairie Dog Control - Research Bulletin” made the following claim regarding “Rozol,” EPA

Reg. No. 7173-244: “Kaput-D Prairie Dog Bait (25 PPM) achieved only 53% to 56% control.”

177. This claim is substantially different than any claim made for “Rozol,” EPA Reg.

No. 7173-244, as part of its March 2, 2005 “accepted label.”

178. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

179. During calendar years 2007 and 2008, the sales literature entitled “Black-tailed

Prairie Dog Control - Research Bulletin” made the following claim regarding “Rozol,” EPA

Reg. No. 7173-244: “Kaput-D Pocket Gopher Bait* (50 PPM) 2X the rate of active ingredient,

achieved oniy 56% to 57% control. *Not labeled for Black-Tailed Prairie Dog.” (Footnote found

in original text).

180. This claim is substantially different than any claim made for “Rozol,” EPA Reg.

No. 7173-244, as part of its March 2, 2005 “accepted label.”

181. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

182. During calendar years 2007 and 2008, the sales literature entitled “Black-tailed

Prairie Dog Control - Research Bulletin” made the following claim regarding “Rozol,” EPA

Reg. No. 7173-244: “Comparative Toxicity Profile Overall Risk to Birds and Mammals / Rozol is ranked over 50% lower than zinc phosphide in the EPA’s overall risk index and 1/3 lower than

Diphacinone (Kaput-D).”

27

Prairie

Reg.

No.

COMPLAINT.

Prairie

Reg.

No.

COMPLAINT.

Prairie

Reg.

dogs

No.

COMPLAINT.

7173-244,

7173-244,

7173-244,

No.

No.

No.

as

191.

Dog

190.

189.

188.

Dog

187.

186.

Dog

185.

184.

Kaput-D’ 183.

7173-244:

7

7173-244:

173-244:

Control

Control

Control

During

PARAGRAPH

This

as

During

PARAGRAPH

This

as

During

PARAGRAPH

This

as

part

s

part

part

(diphacinone).”

claim

“Conclusion:

claim

“Chlorophacinone

claim “Rozol’s - -

-

of

Research

calendar

of

Research

calendar

of

Research

calendar

its

its

its

is

is

is

March

March

substantially March

substantially

substantially

active

IN

TN

TN

years

years

years

Bulletin”

Bulletin”

Bulletin”

THE

Rozol-

THE

THE

2,

2,

2,

ingredient

2007

2005

2007

2005

2007

2005

is

ORIGINAL

ORIGINAL

ORIGINAL

the

over

different

different

made different

made

made

and

“accepted

and

“accepted

and

“accepted

lowest

100X

28

2008,

2008,

(chlorophacinone)

2008,

the

the

the

than

than

than

following

COMPLAINT

risk

following

COMPLAINT

following

COMPLAINT

more

the

label.”

the

label.”

the

label.”

any

any

any

profile

sales

sales

sales

effective

claim

claim

claim

claim

claim

literature

claim

literature

literature

among

made

made

is

made

REMOVED

REMOVED

REMOVED

on

regarding

regarding

ten

regarding

mice

Black

for

entitled

times

for

entitled

for

entitled

“Rozol,”

“Rozol,”

“Rozol,”

than

Tailed

(lOX)

“Rozol,”

“Rozol,”

“Rozol,”

IN

IN

TN

“Black-tailed

“Black-tailed

“Black-tailed

dipachinone.”

AMENDED

AMENDED

AMENDED

Prairie

less

EPA

EPA

EPA

EPA

EPA

EPA

toxic

Reg.

Reg.

Reg.

Dog to

control

“Rozol,”

that

distribution

requirements

No.

COMPLAINT.

Prairie

Reg.

differences.”

No.

COMPLAINT.

targets?”

bait

began

7

7173-244,

alternatives...

No.

173-244,

of

199.

198.

197.

196.

195.

194.

Dog

193.

192.

EPA

7173-244:

(Emphasis

black-tailed

broadcasting

or

Control

of

Reg.

Respondent’s

sale

The

The

PARAGRAPH

This

Radio

as

During

PARAGRAPH

This

as

40

part

part

of

claims

literature

C.F.R.

Why

No.

claim

claim

“Chart in

-

Advertisements

“Rozol,”

prairie

of

of

Research

calendar

original.)

7

on

risk

its

its

173-244:

is

made

is

§

or

entitled

March

March

substantially

168.22.

radio

substantially

in

potential

dogs.”

about

IN

IN

EPA

the

years

in

Bulletin”

THE

THE

advertisements

“Rozol

the

2,

Direct

2,

“Compare

September

Reg.

regardin

2005

2007

2005

harm

Direct

ORIGINAL

ORIGINAL

different

No.

different

Mail made

-

“accepted

and

“accepted

proven

to

Mail

7173-244.

the

employees,

29

26,

Packages

2008,

the

“Rozol,

regarding

products

than

Packages

2007,

than

single

COMPLAINT

following

COMPLAINT

label.”

the

label.”

any

“EPA

any

made

are

sales

application

livestock,

for

claim

claim

“Rozol,”

were

advertisements,

claim

Re,.

literature

yourself-

the

made

made

made

following

REMOVED

REMOVED

No.

regarding

birds,

effectiveness

EPA

for

as

7173-244

for

entitled

there

a

pets

Reg.

“Rozol,”

“Rozol,”

part

subject

claim

“Rozol,”

are

or

IN

IN

No.

“Black-tailed

of

other

many

AMENDED

regarding

for

AMENDED

the

to

EPA

7173-244,

EPA

the

the

non-

EPA

Reg. Reg. 200. This claim is substantially different than any claim made for “Rozol,” EPA Reg.

No. 7173-244, as part of its March 2, 2005 “accepted label.”

201. PARAGRAPH TNTHE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

202. Respondent’s radio advertisements regarding “Rozol,” EPA Reg. No. 7173-244,

that began broadcasting on or about September 26, 2007, made the following claim regarding

“Rozol,” EPA Reg. No. 7173-244: “Proven in university studies on over 10,000 burrows to get

94% control with a single treatment.”

203. This claim is substantially different than any claim made for “Rozol,” EPA Reg.

No. 7173-244, as part of its March 2, 2005 “accepted label.”

204. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

205. The radio advertisements that began broadcasting on or about September 26, 2007 are advertisements, subject to the requirements of 40 C.F.R. § 168.22.

206. The claims made in the radio advertisements that began broadcasting on or about

September 26, 2007 were made as a part of the distribution or sale of “Rozol,” EPA Reg. No.

7173-244.

WebsiteAdvertisements re.garding “Rozol,“EPA Reg. No. 7173-244

207. On or about January 22, 2008, Respondent’s website at www.liphatech.com also made claims that were substantially different than claims made for “Rozol,” EPA Reg. No. 7173-

244, as part of its March 2, 2005, “accepted label.”

208. On or about January 22, 2008, Respondent’s website at www.liphatech.com also made claims that were false and misleading.

30

No.

69341. No.

No.

69341.

Dog

Ecology

Bulletin,

Prairie

literature,

entitled

pursuant

Reg.

part

requirements

7

7

7173-244,

of

Control

No.

173-244,

173-244,

215.

214.

213.

the

212.

211.

210.

Dog 209.

“EPA &

to

7173-244.

flyers

dated

distribution

the

Section

Bait,

(lVhitepaper),

of

to

On

Literature

On

to

to

On

Environment,

After

During

The

Respondent’s

and

October

40

Agriliance

Agriliance

United

“to

or

or

or

claims

C.F.R.

13(a)

advertisements

the

about

about

about

Distribution/Sale

its

the

or

June

Suppliers

distribution

17,

Compliance-Rozol®

of

sale

June

made

§

October

October

October

“dated

Service

Service

FIFRA,

“November

2007;

168.22.

website

2,

of

2,

2008,

on

“Rozol,”

2008

Inc.,

November

“Livestock

19,

8,

Respondent’s

1,

entitled

Center,

Center,

7

partners

on

2007,

2007,

Federal

U.S.C.

of

2007,

inspection,

located

January

2006

“Rozol,

EPA

located

located

Respondent

Respondent

“Black-tailed

Respondent

requesting

§

5,

Pocket

SSURO

31 Weight

Reprint;

at

Reg.

136k(a),

2007.

22,

“EPA

website

30473

the

at

at

2008

No.

Gopher

Gain

East

1250

inspector

was

and

Re.g.

that to

260 th

distributed

distributed

7

distributed

on

Prairie

is

173-244.

Respondent

Highway

issued,

and

Rundell

“True

an

they

January

No.

Bait

Street,

advertisement,

Prairie

issued

each

7173-244 Dog

Cost

Respondent

or

or

Road, Burrow

or

23

Eldora,

22,

sold

sold

destroy

Control

a

regarding

Dogs:

sold

of

and

Federal

2008,

Black-tailed

Gering,

“Rozol,”

“Rozol,”

61,

“Rozol,”

Builder

Iowa

ESA

subject any

sent

were

Grant,

SSURO,

Research

“Rozol,”

50627.

Nebraska

and

Frontiers

out

Formula

EPA

EPA

made

EPA

to

Nebraska

Prairie

all

letters,

the

Reg.

Reg.

as

EPA

Reg.

in

a /

Reg.

79044.

Reg.

Bridgeport,

“Rozol,”

Reg.

50595.

220t Reg.

220 th

Reg.

No.

Reg.

80239.

7173-244,

No.

No.

No.

No.

No.

No.

Street,

Street,

223.

222.

221.

220.

219.

218.

217.

216.

7

EPA

7173-244,

7

7

7173-244,

7

173-244,

173-244,

173-244,

173-244,

Nebraska

Webster

Webster

Reg.

On

On

On

On

On

On

On

On

to

Jim

or

or

or

or

or

or

or

or

No.

to

to

to

(Shipper’s

(Shipper’s

to

about

about

about

about

about

about

about

City,

about

City,

69336.

Knuth,

Helena

Wilbur

Van

Estes,

7173-244,

December

Iowa

December

December Iowa

December

December

Diest

December

December

October

Inc.,

located

Chemical,

Ellis,

No./Carrier’s

No./Carrier’s

50595.

50595.

Supply,

located

to

located

29,

Helena at

19,

7,

12,

6,

4,

4,

3,

104

2007,

2007,

2007,

2007,

2007,

located

2007,

2007,

located

2007,

at

at

Applewood

No.

11333

Chemical,

No.

2765

Respondent

32

Respondent

Respondent

Respondent

Respondent

Respondent

Respondent

Respondent

at

012563)

at

012559)

North

East

FM

1434

located

2397, Court, 55 th

220 th

Highway

to

to

distributed

distributed

distributed

distributed

distributed

distributed

distributed

distributed

Van

Van Avenue,

Frionia,

Street, Council

at

Diest

Diest

425

385/87,

Unit

or

Webster

Railroad

or

or

or

Texas or

or

or

Supply,

or

Supply,

Bluffs,

sold

sold

sold

sold

sold

sold

sold

sold

C,

Hartley,

79035.

“Rozol,”

Denver,

80

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

City,

Iowa

Avenue,

located

located

bags

Texas

Iowa

51503.

of

Colorado

EPA

EPA

EPA

at EPA

at

EPA

EPA

EPA

1434

1434 Reg.

68822. Reg.

Texas

Reg.

Reg.

79044. No.

No.

No.

No.

No.

Kansas

No.

7173-244,

7173-244,

7

7

No.

7

No.

7173-244,

No.

173-244,

173-244,

173-244,

79045.

232.

231.

230.

229.

228.

227.

226.

225.

224.

67846.

7173-244,

7

7173-244,

173-244,

On

On

On

to On

to On

to On

to

On

to

On

On

to

Estes,

Pro-Chem,

Estes,

Helena

Pro-Chem,

or UAP

or

or

or

or

or

or

or

or

to

to

to

about

about

about

about

about

about

about

about

about

Arrow

Wilbur-Ellis,

Helena

Distribution

located

located

Chemical,

February

February

February

February

February

January

January

January

January

located

located

Seed,

Chemical,

at

at

Highway

4302

located

25,

24,

23,

located

located North,

18,

15,

at

14,

8,

14,

5,

at

900

2008,

2008,

900

2008,

2008,

2008,

Locust

2008,

2008,

2008,

2008,

located

at

located

Ross

Ross

at

at

183,

Respondent

Respondent

Respondent

126

Respondent

Respondent

Respondent

North

Respondent

33

1

Respondent

Respondent

Street,

Mile

at

Route

Street,

Street,

North

at

North

Highway

2025

Southwest

Lubbock,

1,

Amarillo,

Amarillo,

10 th

Highway

Box

distributed

distributed

distributed

distributed

distributed

distributed

distributed

distributed

distributed

South

Street,

385/87,

431,

Texas

U.S.

Old

Texas

Texas

385/87,

Clinton,

Broken

or

or

or

or

Highway or

or

Highway

or

or

or

Hartley,

79404.

sold

sold

sold

sold

sold

sold

sold

79404.

sold

sold

79404.

Hartley,

Bow,

Oklahoma

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

60,

Texas

83,

Nebraska

Hereford,

Garden

Texas

79044.

EPA

EPA

EPA

EPA

EPA

EPA

EPA

EPA

EPA

73601.

City,

Reg.

Reg.

Reg.

Reg.

Reg. Reg.

No.

No.

No.

69001.

No.

No.

68822. No.

69001.

No.

No.

No.

No.

7173-244,

7173-244,

7173-244,

7

7

7173-244,

7173-244,

7173-244,

7173-244,

7173-244,

173-244,

173-244,

242.

241.

240.

239.

238.

237.

236.

235.

234.

233.

On

to

On

to

On

to

to

On

On

to

On

to

to

On

On

to

to On

On

to

Farmers

Estes,

Van

Helena

Arrow

Van

Pro-Chem,

Van

Heritage

Van

or

or

or

or

or

or

or

or

or

or

about

about

about

about

about

about

about

about

about

about

Diest

Diest

Diest

Diest.

located

Seed

Chemical,

Coop

March

March

March

Seed,

March

March

March

March

March

March

March

Supply,

Supply,

Supply,

located

located

Company,

at

Grain,

located

4302

19,

18,

17,

14,

13,

13, 7,

6,

10,

6,

located

located

located

located

at

at

2008,

2008,

2008,

2008,

2008,

2008,

2008,

2008,

2008,

2008,

located

900 71703

Locust

at

located

324

Respondent

Respondent

Respondent

at

Ross

Respondent

Respondent

at

Respondent

Respondent

at

Respondent

at

Respondent

Respondent

601

US

71703

at

34

71703

Street,

1434

Main

at

102

Street,

Highway

West

126

220th

U.S.

West

U.S.

Street,

Lubbock,

North

distributed

distributed

distributed

Amarillo, distributed

1 st

distributed

distributed

distributed

distributed

distributed

distributed

Street,

Highway

Highway

Avenue,

G

83,

Crawford, Street,

10 th

McCook,

Texas

Webster

Street,

Texas

or

or

or

or

or

or

or

Hoidrege, or

83, or

or

83,

Trenton,

sold

sold

sold

sold

sold

sold

79404. sold

sold

sold

sold

Nebraska

McCook,

McCook,

79404.

Nebraska

Broken

City,

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

Nebraska

Nebraska

Iowa

Bow,

69339.

Nebraska

Nebraska

69001.

EPA

EPA

EPA

EPA

EPA

EPA

EPA

EPA

EPA

EPA

50595.

Nebraska

69044.

68949.

Reg.

Reg.

Reg.

Reg.

Reg.

Reg.

Reg.

Reg.

Reg. Reg.

No.

7173-244,

No.

69001. No.

No.

No.

68822.

7173-244,

No.

No.

68822.

7

7173-244,

7

7173-244,

7173-244,

7173-244,

7173-244,

173-244,

173-244,

251.

250.

249.

248.

247.

246.

245.

244.

243.

to

to

Estes,

Arrow

On

to

On

to

On

to On

to

On

On

to

On

On

to

to On

Mark

Van

Helena

Richard

Helena

McCoy

Arrow

or

or

or

or

or

or

or

or

or

located

Seed

about

about

about

about

about

about

about

about

about

Diest

Newman,

Seed

Chemical,

Chemical,

Farms,

Company,

Robbins,

April

April

at April

April

April

April

March

March

March

Supply,

Highway

Company,

2

18,

18,

4, located

15,

located

15,

31,

2008, 24,

24,

located

2008,

located

located

located

2008,

2008,

located

2008,

2008,

2008,

2008,

2008,

183,

Respondent

at

at

located

Respondent

Respondent

Respondent

Respondent

Respondent

at

HC

6702

at

at

at

Route

at Respondent

Respondent

Respondent

20500

North

North

71703

35

126

72

at

Silverbell

Box

1,

North

126

Highway

County

Highway

distributed U.S.

Box

distributed

distributed

distributed

distributed

distributed

1,

North

distributed

distributed

distributed Crookston,

10 th

431,

Highway

Lane,

Road

385/87,

Street,

3

Clinton,

85/87,

or

or

Amarillo,

52,

or

or

or

Street,

or

sold

83,

or

or

or

sold

Broken

sold

sold Nebraska

sold

sold

Walsh,

Hartley,

Hartley,

sold

sold

sold

McCook,

Oklahoma

“Rozol,”

“Rozol,”

Broken

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

“Rozol,”

Texas

Bow,

Colorado

Texas

Texas

69212.

EPA

Bow,

Nebraska

EPA

79124.

73601.

Nebraska

EPA

EPA

EPA

EPA

EPA

EPA

EPA

79044.

79044.

Reg.

Nebraska

81092.

Reg.

Reg.

Reg.

Reg.

Reg.

Reg.

Reg.

Reg.

No. No. 252. On or about May 1, 2008, Respondent distributed or sold “Rozol,” EPA Reg. No.

7173-244, to Bayne Seed & Supply, located at 3900 North Lamont Road, Hershey, Nebraska

69143.

253. On or about May 9, 2008, Respondent distributed or sold “Rozol,” EPA Reg. No.

7173-244, to Estes, located at 4302 Locust Street, Lubbock, Texas 79404.

254. On or about May 15, 2008, Respondent distributed or sold “Rozol,” EPA Reg.

No. 7173-244, to Helena Chemical, located at North Highway 385/87, Hartley, Texas 79044.

255. On or about May 30, 2008, Respondent distributed or sold “Rozol,” EPA Reg.

No. 7173-244, to Gross Seed, located at Highway Contract Route 66 Box 13, Johnstown,

Nebraska 69214.

256. On August 22, 2008, EPA amended the Federal SSURO, dated June 2, 2008

“Rozol,” EPA Reg. No. 7173-244.

257. The August 22, 2008, amended Federal SSURO prohibited the Respondent from

distributing any further advertisement literature “Rozol,” EPA Reg. No. 7173-244 without further approval from EPA.

Calendar Year 2009 to present

258. During calendar years 2009 and 2010, Respondent was the registrant of”Rozol,”

EPA Reg. No. 7173-244.

259. On or about May 13, 2009, Respondent registered “Rozol Prairie Dog Bait,” EPA

Reg. No. 7173-286.

260. Prior to the registration of”Rozol Prairie Dog Bait,” EPA Reg. No. 7173-286, on

May 13, 2009, Respondent had registered “Rozol,” EPA Reg. No. 7173-244, under the authority

36

7

“pesticide”

persons

Certified

Bait,” toxicity

use

7 Prairie tailed

§ No.

7

“Special

of

173-286,

173-286,

173-286,

136a(d).

Section

product

7173-286,

prairie

EPA

267.

266.

265. Dog

264.

263.

262.

261.

under

to

Applicator’s

Local

was

nontarget

was

supersedes

24(c)

as

Reg.

under

Bait,”

dogs

defined

the

During

During

a

“Rozol

During

to

classified

As

Needs”

Due

During

“pesticide”

No.

of

direct control

Section

under

a EPA

FIFRA,

result

to

organisms.

7

at

calendar

certification.

calendar

the

Prairie

173-286,

calendar

the

supplemental

calendar

Reg.

supervision

Section

“Rozol,”

as

black-tailed

Section

3(d)

of

fact

a

7

as

No.

its

restricted

Dog

U.S.C.

defined

that

years

of

years

years

can

classification

2(u)

years

7

FIFRA,

24(c)

EPA

Bait,”

173-286.

Respondent

only

of

2009

2009

§

of

labels.

2009

prairie

2009

at Certified

136v(c),

use

Reg.

“Special

FIFRA,

be

EPA

Section

7

and

and

and

product

sold U.S.C.

and

No.

dogs,

as

Reg.

37

2010,

2010,

2010,

registered

7

Applicators

to

2010,

to

a

Local

7173-244.

2(u)

U.S.C.

restricted

control

and

§

“Rozol

No.

under

“Rozol

“Rozol,”

136a(d),

Respondent

of

“Rozol

Needs”

be

7

FIFRA,

173-286,

§

Section

“Rozol

used

black

Prairie

136(u).

use

and

Prairie

because

Prairie

EPA

registrations

by product,

-

only

7

Prairie

was

3(d)

tailed

Dog

was

Certified

U.S.C.

Reg.

Dog

Dog

for

the

of

of

classified

Bait,”

prairie

Bait,”

No.

“Rozol

Dog

its

users

FIFRA,

registrant

§

Bait,”

to

Applicators

potential

136(u).

7

EPA

Bait,”

control

173-244,

covered

EPA

dogs

Prairie

EPA

as

7

Reg.

U.S.C.

a

of”Rozol

EPA

Reg.

under

restricted

secondary

black

Reg.

by

Dog

was

No.

or

No. Reg.

the No.

- a

information).

each

- the

search

inspections

the

Bait,”

Program,

No.

approved

required

Division

submitted

Sales

public.

Office

7

manager’s

173-286.

EPA

of

Ag/Animal

274.

273.

272.

271.

270.

269.

268.

by

www.liphatech.com.

accepted

Registration

by

of

by

under

Reg.

Respondent

EPA

Pesticides

Respondent.

Respondent’s

Respondent’s

On

Any

The

The

On

corresponding

No.

Sections

for

November

Health,”

a

or

“accepted

“accepted

changes

label

7

about

“Rozol

Division

173-286,

Program,

in

regarding

8

connection

which

May

in

website

website

and

Prairie

18,

label”

label”

contact

labeling

prior

must

9

13,

2009,

Registration

included

of

“Rozol

and

and

2009,

Dog

at

at

to

be

FIFRA,

information

with

www.liphatech.com

www.liphatech.com

an

that

use

submitted

any

any

Bait,”

inspector

the

Prairie

in its

a

differs

subsequent

subsequent

list

7

commerce.

Division

Office

registration

38

U.S.C.

EPA

of

(including

to

Dog

in

sales

employed

of

and

Reg.

substance

§

on

Bait,”

Pesticides

amendments

amendments

managers

accepted

136f

No.

“Rozol

May

included

advertised

phone,

EPA

by

7173-286.

and

from

13,

EPA

Prairie

Program,

by

throughout

Reg.

2009,

136g.

mobile

a

the

identify

are

Office

link

its

and

No.

labeling

Dog

a

conducted

for

pesticide

part

authorized

entitled

and

Registration

of

7173-286,

“Rozol

the

Bait,”

the

of

Pesticides

e-mail

accepted

label

the

country

products

“Contact

an

EPA

Prairie

statement

to

language

internet

that

conduct

Reg.

with

by

Dog

was

to Us Claims in the Product Information Sheet regarding “Rozol Prairie Dog Bait, “ EPA Reg. No. 7173-286, on November 18, 2009

275. On November 18, 2009, Respondent made the following claims in the Product

Information sheet regarding “Rozol Prairie Dog Bait,” EPA Reg. No. 7173-286, on

www.liphatech.com: “Proven Single Application Effectiveness — When properly applied in all

active burrows of a colony, control typically exceeds 85%, and can be as high as 100%.”

(Emphasis in original).

276. This claim is substantially different than any claim made for “Rozol Prairie Dog

Bait,” EPA Reg. No. 7173-286, as part of its May 13, 2009 “accepted label.”

277. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED IN AMENDED

COMPLAINT.

278. On November 18, 2009, Respondent made the following claims in the Product

Information sheet regarding “Rozol Prairie Dog Bait,” EPA Reg. No. 7173-286, on

www.liphatech.com: “Low cost per acre - Savings in time, labor and fuel exceed comparative

total costs of other methods such as zinc phosphide, diphacinone, phos-toxin, and foam or

propane-based systems.” (Emphasis in original).

279. This claim is substantially different than any claim made for “Rozol Prairie Dog

Bait,” EPA Reg. No. 7173-286, as part of its May 13, 2009 “accepted label.”

280. PARAGRAPH IN THE ORIGINAL COMPLAINT REMOVED TNAMENDED

COMPLAINT.

281. On November 18, 2009, Respondent made the following claims in the Product

Information sheet regarding “Rozol Prairie Dog Bait,” EPA Reg. No. 7173-286, on

39

Bait,”

wildlife.”

Diphacinone,

EPA’s

www.liphatech.com:

Information

COMPLAINT.

Bait,”

target

altogether.”(Emphasis

www.liphatech.com:

Information

COMPLAINT.

Bait,” wet.

www.liphatech.com:

It

EPA

rodent

EPA

EPA

overall

288.

287.

286.

285.

284.

283.

282.

outlasts

(Emphasis

Reg.

Reg.

Reg.

sheet

sheet

is

And

risk

This

On PARAGRAPH

This

On

PARAGRAPH

This

not

Zinc

No.

No.

No.

regarding

November

regarding

Prairie

November

assessment,

in

claim

claim

claim

in

7173-286,

“Best

7173-286, Phosphide.”

“Provides

7173-286,

“Superior

the

in

original).

original).

burrow

is

dogs

is

is

Bait

substantially

“Rozol

substantially

“Rozol

substantially

18,

18,

IN

IN

Rozol

will

as

as

Acceptance as

control,

Weatherability

2009,

during

2009,

THE

(Emphasis

THE

part

part

part

eat

Prairie

Prairie

offers

of

it

of

ORIGINAL

Respondent

of

ORIGINAL

Respondent

application

in

different

regardless

its

different

different

its

its

Dog

Dog

the

lower

May

May

in

&

May

40

burrow,

original).

Favorable

Bait,” Bait,”

-

13,

than

13,

overall

13,

than

Rozol

than

made

COMPLAINT

made COMPLAINT -

-

2009

success

2009

2009

With

EPA

EPA

any

any

so

any

does

risk

the

the

there

“accepted

Toxicity

“accepted

claim

“accepted

Reg.

many

claim

Reg.

claim

following

is

following

than

not

reduced

is

No.

No.

made

made alternative

made

less

lose

REMOVED

Zinc

REMOVED

Profile

7

label.”

7

label.”

label.”

risk

173-286,

173-286, its

for

claims

for

claims

Phosphide

for

or

effectiveness

“Rozol to

control

“Rozol “Rozol

-

methods,

non-target

According

in

in

TN

on

IN

on

the

the

Prairie

is

AMENDED

Prairie

or

AMENDED

Prairie

Product

lost

Product

if

when

the

to

Dog

Dog

Dog the

entitled

COMPLAINT

Bait,”

original).

entitled

on

COMPLAINT.

Bait,”

original).

(times)

www.liphatech.com:

Information

COMPLAINT.

www.liphatech.com:

EPA

EPA

296.

295.

294.

293.

292.

291.

290.

less 289.

“Control

“Control

Reg.

Reg.

than

sheet

On

PARAGRAPH

This

On

PARAGRAPH

This

On

PARAGRAPH

No.

regarding

No.

for

Range

Range

November

November

regarding

November

claim

claim

ZP.

Claims

7173-286,

7173-286,

“Lower

Rodents”

“Outstanding

Rodents”

Rozol

is

is

“Rozol

substantially

substantially

in

“Rozol

18,

18,

Primary

18,

IN

IN

IN

brochure

as

less

as

2009,

2009,

THE

2009,

THE

THE

regarding

part

regarding

part

Prairie

toxic Prairie

on

of

ORIGINAL

Respondent

of

Single ORIGINAL

Respondent

ORIGINAL

Poisoning

Respondent

November

different

entitled

different

its

to

its

Dog

Dog

dogs

“Rozol

May

“Rozol

May

Application

41

Bait,”

Bait,”

than

“Control

13,

than 13,

Potential

than

18,

made

COMPLAINT

made

COMPLAINT

Prairie

made

COMPLAINT

Prairie

2009

2009

ZP

EPA

EPA

2009

any

any

the

the

or

the

Range

“accepted

Dog

Effectiveness”

“accepted

claim

Dog

claim

Reg.

Reg. Diphacinone.”

-

following

following

following

Rozol’s

Bait,”

Bait,”

No. No.

made

made

Rodents”

REMOVED

REMOVED

REMOVED

label.”

7173-286,

label.”

7173-286,

toxicity

EPA

EPA

claims

for

claims

for

claims

(Emphasis

“Rozol

“Rozol

(Emphasis

Reg.

Reg.

in

to

in

in

IN

IN

TN

on

its

No.

birds

its

No.

the

AMENDED

Prairie

AMENDED

Prairie

AMENDED

brochure

brochure

Product

7

7

in

in

173-286, is

173-286,

20X

Dog Dog

Bait,”

original).

wet

on

entitled

COMPLAINT.

Bait,”

preferred

in

on

entitled

COMPLAINT. Bait,”

provide

burrows

on

original).

www.liphatech.com:

www.liphatech.com: www.liphatech.com:

-

it

EPA

EPA

EPA

303.

302.

outlasts

301.

300.

299.

298.

297.

“Control

over

“Control

in

feed

Reg.

Reg. a

Reg.

colony).”

94%

This

source

On

PARAGRAPH

This

On PARAGRAPH

This

zinc

No.

No.

No.

Range

Range

November

November

control

claim

claim

phosphide

claim

7173-286,

7

7173-286,

for

173-286,

(Emphasis

“Superior

Rodents”

“Highly

Rodents”

“Proven

field

is

is

is

in

substantially

substantially

substantially

one

18,

18,

rodents

IN

IN

and

as

as

as

2009,

treatment

Palatable

2009,

THE

THE

Reliability

part

in

regarding

part

regarding

part

Weatherability

can

original).

and

of

ORIGINAL

of

be

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ORIGINAL

of

Respondent

different

its

different

different

its

its

used

provides (when

-

May

“Rozol

May

“Rozol

May Food-grade

-

42

under

In

13,

properly

than

13,

university

than

13,

than

made

COMPLAINT excellent

-

made

COMPLAINT

Prairie

Prairie

2009 Rozol

2009

diverse

2009

any

any

any

winter

the

the

“accepted

and

“accepted

claim

Dog

“accepted

claim

Dog

does

claim

trials

following

acceptance

weather

following

thoroughly

wheat

Bait,”

Bait,”

not

made

made

made

on

REMOVED

REMOVED

lose

label.”

label.”

over

label.”

conditions.”

EPA

grain

EPA

for

claims

for

claims

for

and

its

applied

“Rozol

11,400

“Rozol

“Rozol

Reg.

effectiveness

Reg.

(10%

control”

in

in

IN

IN

its

No.

its

No.

burrows

protein)

Prairie to

(Emphasis

AMENDED

Prairie

AMENDED

Prairie

brochure

brochure

all

7173-286,

(Emphasis

7

173-286,

active

Dog

when

Dog

Dog

to

is

a in

COMPLAINT.

Bait,”

(Emphasis

Livestock

on

entitled

COMPLAINT.

Bait,”

applications.”

on entitled

COMPLAINT.

www.liphatech.com:

www.liphatech.com:

EPA

EPA

310.

309.

308.

307.

306.

305.

304.

“Control “Control

-

in

Reg.

Reg.

Rozol’s

original,

PARAGRAPH

This

(Emphasis

On

PARAGRAPH

This

On

PARAGRAPH

No.

No.

Range

Range

November

November

claim

claim

primary

7

7173-286,

173-286,

footnote

‘Lower

Rodents”

“Easy-to-Use/Less

Rodents”

is

in

is

substantially

original).

substantially

toxicity

18,

IN

18,

IN

IN

deleted).

as

as

Primary

THE

2009,

2009,

THE

part

THE

regarding

part

regarding

to

of

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different

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Work

“Rozol

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is “Rozol

43

much

13,

than

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-

COMPLAINT

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made

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No

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label.”

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toxicants.”

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brochure

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7173-286,

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burrows provide

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173-244,

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entitled

44

university

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label.”

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regarding

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diverse

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need

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label.”

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made

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repeat

in

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(Emphasis

on

in

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on

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on

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its

its

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AMENDED

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brochure

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when

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in

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same

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www.liphatech.com:

7173-244,

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333.

332.

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as

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s

claim

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on

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footnote

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its

is

23,

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19,

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TN

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deleted).

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to

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birds

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inspector

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46

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readily

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constitutes

constitutes

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342.

341.

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available

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constitutes

sheet

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advertisements,

advertisements,

advertisements, and

Section part

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regarding

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information

information

information

information

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offered

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of

its

2(gg)

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IN

than

on

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on

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of

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subject

subject

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FIFRA,

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subject

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through

in

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to

to

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on

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the

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the

the

the

U.S.C. February

to

Product

47

February

requirements

requirements

requirements the

,

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website

website

website website

EPA

made

than

requirements

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§

7173-244,

7

label.”

136(gg),

173-244,

Information

23,

millo

any

Reg.

the

23,

at

at

at

at

2010

www.liphatech.com,

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www.liphatech.com,

claim

2010, following

products

of

of

of

No.

and

40

40

on

40

for

of

7173-244

made

Respondent’s

www.liphatech.com:

C.F.R.

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C.F.R.

REMOVED

40

distribution

40

Sheet

labeled

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claims

for

§

§

§

“Rozol,”

168.22. 168.22.

168.22.

§

for

in

§

or

152.3.

168.22.

TN

it

website,

on

on on

on

burrow-builder

sale

Product

AMENDED

February

February

February

November

EPA

as

“More

that

Reg.

23,

19, 10, 343. The claims made on Respondent’s website from November 18, 2009 through

February 23, 2010, were made as a part of the distribution or sale of “Rozol,” EPA Reg. No.

7173-244.

344. On November 18, 2009 through February 23, 2010, Respondent’s website, www.liphatech.com, offered “Rozol Prairie Dog Bait,” EPA Reg. No. 7173-286, for distribution or sale as that term is defined in Section 2(gg) of FIFRA, 7 U.S.C. § 136(gg), and 40 C.F.R.

§ 152.3.

345. The claims made on Respondent’s website from November 18, 2009 through

February 23, 2010, were made as apart of the distribution or sale of “Rozol Prairie Dog Bait,”

EPA Reg. No. 7173-286.

346. On March 4, 2010, due to the claims Respondent was making on its website, www.liphatech.com, from November 18, 2009 through February 23, 2010, EPA issued another

SSURO to Respondent regarding “Rozol,” EPA Reg. No. 7173-244.

347. The March 4, 2010 SSURO also addressed “Rozol Prairie Dog Bait,” EPA Reg.

No. 7173-286.’

348. Under the August 22, 2008 Amended SSURO, Respondent was prohibited from distributing marketing material or labeling regarding “Rozol,” EPA Reg. No. 7173-244, until any such material was reviewed by EPA.

349. EPA did not approve nor authorize the advertisements that were found on

Respondent’s website, www.liphatech.com, on November 18, 2009, February 10, 2010, February

19, 2010, and February 23, 2010 regarding “Rozol,” EPA Reg. No. 7173-244.

The March 4,2010 SSURO also covered a third product. “Rozol Pocket Gopher Bait,” EPA Reg. No. 7173-84.

48 350. EPA did not approve nor authorize the advertisements that were found on

Respondent’s website, www.liphatech.com, on November 18, 2009, February 10, 2010, February

19, 2010, and February 23, 2010 regarding “Rozol Prairie Dog Bait,” EPA Reg. No. 7173-286.

351. EPA did not approve the distribution of any advertisements that were found on

Respondent’s website, www.liphatech.com, on November 18, 2009, February 10, 2010, February

19, 2010 and February 23, 2010 in the form of any literature, flyers, or advertisements to

Respondent’s distributor partners for either “Rozol,” EPA Reg. No. 7173-244, nor “Rozol Prairie

Dog Bait,” EPA Reg. No. 7173-286.

352. After the March 4, 2010 Federal SSURO was issued, Respondent sent letters to

48 of its distribution partners (See Attachment I) requesting that they each destroy/disregard “any

and all literature, flyers, advertisements” regarding “Rozol,” EPA Reg. No. 7173-244, and

“Rozol Prairie Dog Bait,” EPA Reg. No. 7173-286, including brochures entitled “Control Range

Rodents, “dated September 24, 2009 or older.

353. The claims made to Respondent’s 48 distribution partners through its

advertisements, which included brochures entitled “Control Range Rodents,” dated September

24, 2009 or older, were made as a part of the distribution or sale of “Rozol,” EPA Reg. No.

7173-244.

354. The claims made to Respondent’s 48 distribution partners through its

advertisements, which included brochures entitled “Control Range Rodents, “ dated September

24, 2009 or older, were made as a part of the distribution or sale of”Rozol Prairie Dog Bait,”

EPA Reg. No. 7173-286.

49