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Case3:13-cv-01266-MMC Document17 Filed05/31/13 Page1 of 52




GEORGE A. KIMBRELL (Pro Hac Vice)
PETER T. JENKINS (Pro Hac Vice)
PAIGE M. TOMASELLI (State Bar No. 237737)
SYLVIA SHIH-YAU WU (State Bar No. 273549)
Center for Food Safety
303 Sacramento Street, 2nd Floor
San Francisco, CA 94111
T: (415) 826-2770 / F: (415) 826-0507
Emails: [email protected]




Counsel for Plaintiffs


[email protected]
[email protected]
[email protected]



THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

SAN FRANCISCO DIVISION












Case No. 3:13-cv-01266-LB


FIRST AMENDED COMPLAINT FOR
DECLARATORY AND INJUNCTIVE
RELIEF

Administrative Procedure Act Case


STEVE ELLIS, TOM THEOBALD, JIM
DOAN, BILL RHODES, CENTER FOR
FOOD SAFETY, BEYOND PESTICIDES,
SIERRA CLUB, and CENTER FOR
ENVIRONMENTAL HEALTH,




Plaintiffs,

v.


STEVEN P. BRADBURY, DIRECTOR OF
OFFICE OF PESTICIDE PROGRAMS,
UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY; and BOB
PERCIASEPE, ACTING
ADMINISTRATOR AND DEPUTY
ADMINISTRATOR, UNITED STATES
ENVIRONMENTAL PROTECTION
AGENCY,


Defendants.

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FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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INTRODUCTION

1.

This is a civil action for injunctive and declaratory relief. The original Complaint

was dated Mar. 21, 2013. ECF No. 1. This First Amended Complaint is filed pursuant to a

stipulation with the Defendants and approval by the Court dated May 17, 2013. ECF No. 17.

Plaintiffs Steve Ellis, Tom Theobald, Jim Doan, Bill Rhodes, Center for Food Safety (CFS),

Beyond Pesticides, Sierra Club, and Center for Environmental Health (CEH) (collectively

Plaintiffs) challenge the actions of Defendants Steven P. Bradbury, Director of Office of

Pesticide Programs of the United States Environmental Protection Agency (EPA), and Bob

Perciasepe, Acting Administrator and Deputy Administrator of EPA (collectively EPA or

Defendants) to allow the ongoing use of pesticide products containing the active ingredients

clothianidin and thiamethoxam, in violation of the Federal Insecticide, Fungicide and

Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq.; § 7(a)(2) of the Endangered Species Act

(ESA), 16 U.S.C. § 1536(a)(2); and the Administrative Procedure Act (APA), 5 U.S.C. § 701 et

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seq.

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2.

Clothianidin and its parent compound, thiamethoxam, are two widely-used

pesticides in a class of pesticides known as neonicotinoids, which have been shown to adversely

impact the survival, growth, and health of honey bees and other pollinators vital to U.S.

agriculture, and which have harmful effects on other animals, including threatened and

endangered species. In a vast and extremely risky experiment, EPA has allowed over two

million pounds of clothianidin and thiamethoxam to be used annually on more than 100 million

acres and on dozens of different plant crops without adhering to existing procedural frameworks

and with no adequate risk assessments in place.

3.

In most instances, EPA has approved clothianidin and thiamethoxam product

registrations, new uses, and use amendments without affording notice in the Federal Register and

the opportunity for public comment, in violation of the FIFRA and the APA. Substantively, EPA

has failed to modify its regulation of these pesticides in response to the many scientifically-sound

studies and adverse effect reports illustrating the risks these neonicotinoid pesticides pose.

EPA’s regulatory approvals have been a major factor in excessive honey bee mortality and the

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decline of pollinator populations in the same time period. EPA’s regulatory actions, resulting in

the continued use of clothianidin and thiamethoxam, have also continued to place threatened and

endangered species in jeopardy.

4.

In addition to suffering chronic effects leading to excess mortality, which includes

a phenomenon called Colony Collapse Disorder, hundreds of the nation’s beekeepers and honey

producers suffer from acute effects each spring, when neonicotinoid-treated corn, in particular, is

planted in virtually every state. Tens of thousands of their bee colonies have been exposed to

lethal levels of neonicotinoid-contaminated dust during corn planting season. Plaintiff

beekeepers and honey producers have suffered, and will continue to suffer, devastating economic

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hardships unless Defendants take action, which they have refused to do despite repeated formal

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5.

EPA is well aware of recent studies and reports illustrating the risks to honey

bees, pollinators, and other sensitive species. In December 2010, Plaintiff Beyond Pesticides,

along with other environmental groups, beekeepers, and honey producers, submitted a formal

letter requesting that EPA issue a stop sale order of clothianidin products.1 EPA denied the

request in February 2011.2 In March 2012, Plaintiffs CFS and Beyond Pesticides, along with

numerous other environmental groups, beekeepers, and honey producers, filed a legal petition

(hereafter the Clothianidin Legal Petition or the Petition) asking EPA to initiate immediate

suspension and cancellation of clothianidin products.3 EPA denied the suspension request in

July 2012.4 Plaintiff CFS further submitted a comment letter regarding similar risks of


1 Letter from Beyond Pesticides et al., to EPA (Dec. 8, 2010), available at
http://www.epa.gov/opp00001/about/intheworks/clothianidin-petition2.pdf.
2 Letter from Steven Bradbury, Director, Office of Pesticide Programs, EPA, to Steve Ellis et al.
(Feb. 18, 2011), available at http://www.epa.gov/opp00001/about/intheworks/clothianidin-
response-letter.pdf.
3 CFS et al., Clothianidin Legal Petition (Mar. 21, 2012), available at
http://www.centerforfoodsafety.org/wp-content/uploads/2012/10/CFS-Clothianidin-Petition-3-
20-12.pdf.
4 Letter from Steven Bradbury, Director, Office of Pesticide Programs, EPA, to Peter T. Jenkins
(July 17, 2012), available at http://www.epa.gov/opp00001/about/intheworks/epa-respns-to-
clothianidin-petition-17july12.pdf.

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thiamethoxam products and requesting suspension of the pesticide in October 2012.5 EPA also

refused that suspension request.6

6.

In addition to the Plaintiffs, hundreds of thousands of Americans endorsed an

informal citizen petition between 2011 and 2012, urging Defendants to suspend clothianidin’s

registration. There is intense public interest in EPA’s actions, due to the loss of honey bees and

other beneficial insects; the resulting economic, food supply, and ecosystem damages; and the

unnecessary persistent toxic pollution of America’s private and public landscapes.

7.

In allowing this scenario to unfold over the last thirteen years, EPA has violated

the FIFRA, the ESA, and the APA. EPA has denied Plaintiffs and the public mandatory notice

and public comment opportunities, severely damaged the interests of Plaintiffs, injured vital

pollinators and threatened and endangered species, and caused unreasonable adverse

environmental and economic impacts.

JURISDICTION AND VENUE

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This Court has jurisdiction pursuant to 28 U.S.C. § 1331 (federal question), 28

U.S.C. § 1346 (United States as defendant), 28 U.S.C. §§ 2201-02 (declaratory relief), 5 U.S.C.

§ 702 (APA), 7 U.S.C. § 136n(a) (FIFRA), and 16 U.S.C. § 1540(e), (g) (ESA).

9.

Jurisdiction is in the District Court under the ESA citizen suit provision, which

allows “any person” to sue an agency “alleged to be in violation of any provision of [the ESA]”

and provides that the “district courts shall have jurisdiction . . . to enforce any such provision or

regulation . . . .” 16 U.S.C. § 1540(g)(1). Pursuant to the ESA, 16 U.S.C. § 1540(g)(2)(A),

Plaintiffs CFS, Beyond Pesticides, Sierra Club, Steve Ellis, and Tom Theobald have provided

Defendants with at least sixty days written notice of the their violations under the ESA and of

Plaintiffs’ intent to sue should Defendants fail to remedy such violations (hereafter the Sixty-Day

Notice Letter).7 To date, Defendants have not remedied any of the violations of law set forth in


5 Letter from Plaintiffs to EPA (Oct. 16, 2012) (on file with Plaintiffs).
6 Letter from EPA to Plaintiffs (Feb. 27, 2013) (on file with Plaintiffs).
7 Sixty-Day Notice Letter from Plaintiffs Center for Food Safety et al. to Defendants and Ken
Salazar, former Secretary of the Interior (Sept. 5, 2012) (on file with Plaintiffs).

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Plaintiffs’ Sixty-Day Notice Letter.

10.

Jurisdiction also lies in this Court under the FIFRA’s judicial review provision, 7

U.S.C. § 136n(a), which provides:


District court review.

Except as otherwise provided in this Act, the refusal of the Administrator to
cancel or suspend a registration or to change a classification not following a
hearing and other final actions of the Administrator not committed to the
discretion of the Administrator by law are judicially reviewable by the district
courts of the United States.

11.

Each of the fourteen claims in this Complaint involve the refusal of the

Defendants to cancel or suspend a registration or to change a classification not following a

hearing, failure to conduct required ESA analysis and consultation, and other final actions of the

Administrator not committed to his or her discretion; thus, jurisdiction lies properly in the

District Court. 7 U.S.C. § 136n(a); 16 U.S.C. § 1540(g)(1). In particular, Defendants have: a)

refused to cancel or suspend the conditionally registered uses of clothianidin and thiamethoxam

despite clear evidence that the registrants for those uses have failed to comply with the

conditions imposed by EPA; b) changed the classifications of numerous conditional registrations

of thiamethoxam and clothianidin to unconditional registrations, as well as approved

thiamethoxam and clothianidin products as unconditional registrations, despite the registrants’

failures to comply with the conditions EPA imposed on them; c) taken final action, without a

hearing, on Plaintiffs’ Clothianidin Legal Petition in denying the request to declare an “imminent

hazard” exists; d) failed to comply with the ESA, in approving all of the registered uses of these

compounds, in converting registrations to the unconditional classification and in denying an

“imminent hazard” exists; e) violated the FIFRA requirement to provide notices of clothianidin

and thiamethoxam registrations and changed use applications in the Federal Register and allow

public comment, as well as other notice requirements; f) approved inadequate labels under

FIFRA and the ESA for clothianidin and thiamethoxam products; and g) taken other actions as

alleged herein that caused unreasonable adverse environmental and economic impacts that are

reviewable in the District Court.

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12.

An actual controversy exists between the parties within the meaning of 28 U.S.C.

§ 2201 (declaratory judgment).

13.

Venue properly lies in this Court pursuant to 28 U.S.C. § 1391(e)(1)(c) because

one or more Plaintiffs reside in this district, and pursuant to 28 U.S.C. § 1391(e)(1)(b), because a

substantial part of the events or omissions giving rise to the claim occurred, or a substantial part

of property that is the subject of the action is situated, in this district.

INTRADISTRICT ASSIGNMENT

14.

Pursuant to Local Rule 3-2(c) and (d), assignment of this action is appropriate in

the San Francisco or Oakland Divisions because one or more Plaintiffs reside in San Francisco.

Beekeeper and Honey Producer Plaintiffs

PARTIES

15.

The interests of Plaintiffs Steve Ellis, Tom Theobald, Jim Doan, and Bill Rhodes

(collectively Beekeeper and Honey Producer Plaintiffs) are being, and will be, adversely affected

by EPA’s actions and inactions complained of herein. Beekeeper and Honey Producer Plaintiffs

have suffered confirmed or unconfirmed clothianidin- and thiamethoxam-related kills to their

honey bees, both acute and chronic, as well as poor colony health and failure to thrive.

Beekeeper and Honey Producer Plaintiffs are geographically and operationally representative of

this essential agricultural sector, in which there are thousands of similarly-affected businesses

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and individuals.

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16.

Plaintiff Mr. Steve Ellis owns and operates Old Mill Honey Company, a

migratory beekeeping operation with 2,300 hives of bees during the summer honey-producing

season, and with several employees. The hives he manages for his business produce honey for

market over the summer months in Minnesota, and paid pollination services in the winter and

spring in California. Mr. Ellis has over thirty-five years of experience and has served as an

officer in beekeeper organizations for many years. He is the Secretary of the National Honey

Bee Advisory Board. His common beekeeping practices over the last decade include allowing

his bee colonies to forage, and often to do pollination, in the following types of crops and

habitats: almonds, corn, soybeans, sunflowers, edible beans, ornamental trees, forest trees,

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peaches, plums, residential and landscaped areas, golf courses, and lawns. Over the course of the

last six to seven years, he has observed a new type of bee kill caused by pesticide poisoning in

the early spring, especially, but not only, at corn seeding time, and early dandelion bloom. He

has suffered major bee kills that were attributable to thiamethoxam and/or clothianidin. His fall

and winter mortality have remained between 30–60% over this period. This level of losses is

unsustainable. Mr. Ellis keeps bees in west central Minnesota where corn and soybeans are

increasingly the dominant crops. It is not practically feasible to locate his bees away from these

crops during the summer growing season.

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Plaintiff Mr. Tom Theobald is a commercial beekeeper and owner of the Niwot

Honey Farm in Niwot, Colorado. He has conducted his beekeeping business for thirty-eight

years. He was the President of the Boulder County Beekeepers Association for thirty years. Mr.

Theobald served two terms as Vice-President of the Colorado Beekeepers’ Association and was

the last County Bee Inspector in Colorado. He is losing 40–60% of his colonies each year and in

2011 and again in 2012 had his smallest honey crops in thirty-seven years. His common

beekeeping practices over the last decade include allowing his bee colonies to forage in the

following types of crops and habitats: corn, sunflowers, apples and other fruit trees, ornamental

trees, residential gardens, and various turf and/or lawn applications. He has observed, based on

his long personal and government experience with the impacts of various pesticides on bees as

well as through his own research, that a primary cause of his recent and continuing losses is the

uncontrolled use of neonicotinoid pesticides (including clothianidin and thiamethoxam) over vast

acres of agricultural land near his business, as well as on untold acres of nearby urban and

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18.

Plaintiff Mr. Jim Doan has run Doan Family Farms based in Hamlin, New York,

with his wife, son and several hired men. He has kept honey bees for forty-five years. In 2006

Mr. Doan ran as many as 5,300 hives in New York and Florida; his bees pollinate a vast portion

of New York’s apple crop each year. His common beekeeping practices over the last decade

include allowing his bee colonies to forage, and often to do pollination, in the following types of

crops and habitats: corn, soybeans, cucumbers, pumpkins, squash, melon, citrus, ornamental

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trees, apples, other fruit trees, residential and landscaped areas, wheat, cabbage, berries, peas,

and green beans. Since 2006, he has been unable to keep from losing more than 50% of his

hives each year to symptoms that, based on his experience, are caused by both acute and chronic

exposure to the new neonicotinoid pesticides. In the spring and summer of 2012, Mr. Doan

suffered a devastating bee kill caused by clothianidin, which very clearly came from

contaminated dust and other exposure routes related to the several cornfields around his bee

colonies. He feared that if he continued to suffer such losses to his business, without monetary

support, it would be doomed to disappear. His bees could not be replaced as fast as they were

dying.

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In late May 2013, in response to another massive bee kill, Mr. Doan was

compelled to sell Doan Family Farms and he has had to reduce his many-decades old beekeeping

business. While he remains a beekeeper, the financial and personal strains of repeated massive

neonicotinoid bee kills in addition to the other pressures of the business may be too much for

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Plaintiff Mr. Bill Rhodes owns Bill Rhodes Honey Company, the largest

commercial honey producer in Florida, based in Umatilla. A beekeeper for forty-one years, his

company employs about fifteen people. His common beekeeping practices over the last decade

include allowing his colonies to forage in the following types of crops and habitats: corn,

soybeans, sunflowers, and residential areas with lawns, gardens, and other landscaping. Mr.

Rhodes produces several premium honey varieties, both in Florida and South Dakota, and his

company also ships bees to Georgia and other states. He seeks to maintain about 9,000 hives,

but the impacts of pesticides, including thiamethoxam and clothianidin, make keeping that level

very difficult. Mr. Rhodes started seeing symptoms of Colony Collapse Disorder around 2004

and 2005, and again in 2007 and 2008. In the latter year he lost 7,200 of 9,000 hives. Major

losses have continued, far exceeding normal loss rates during the three earlier decades of his

operations. Mr. Rhodes has seen other beekeepers driven out of the business from major losses,

and has a high level of concern that his own livelihood based on premium honey production is

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threatened.



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The use of systemic pesticides such as thiamethoxam and clothianidin is not

posted with signs nor is any other notice provided to beekeepers about their use as a matter of

common practice. Based on the Beekeeper and Honey Producer Plaintiffs’ years of experience

and their knowledge of the use of neonicotinoids on a broad range of U.S. crops and habitats, the

Beekeeper and Honey Producer Plaintiffs are reasonably certain that their bees were frequently

exposed to these systemic insecticides in many of the crops and habitats their bees visited, as

well as within their own hives via dust, pollen, and other exposure routes. The Beekeeper and

Honey Producer Plaintiffs are also concerned that in the future their bees will be exposed to, and

further weakened or killed by, thiamethoxam and clothianidin used in the crops and habitats their

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bees visit, other crops and habitats, as well as cumulative soil residues of thiamethoxam and

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clothianidin in those habitats.

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Each of the Beekeeper and Honey Producer Plaintiffs is injured by EPA’s actions

and inactions complained of herein. EPA’s failure to provide Beekeeper and Honey Producer

Plaintiffs with the FIFRA-mandated notices of application for clothianidin and thiamethoxam

registration and changed uses in the Federal Register, and its failure to provide mandatory public

comment periods, denied Plaintiffs the ability to submit information to the EPA that may have

convinced the agency not to issue those registrations or use amendments. For Beekeeper and

Honey Producer Plaintiffs, the monetary damages to their businesses are significant, including

the costs of replacing killed and weakened bees; contaminated beeswax, comb, and hives;

reduced honey production and lost profits; increased labor, equipment, and supply expenditures;

and costs and lost profits from the inability to perform contracted pollination services. Their

losses are not insured or insurable. On a personal level, they have suffered from increased

workload to address bee kills and poor bee health, and personal stress and anxiety from seeing

the valuable animals in their care die, as well as being compelled to pursue enforcement actions

with government agencies about their farmer neighbors, and other damages. The relief sought in

this case will provide redress for their ongoing harms and aid in preventing additional future

damages from clothianidin and thiamethoxam, which are expected to worsen in the future absent

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change.



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Public Interest Group Plaintiffs

23.

The interests of CFS, Beyond Pesticides, Sierra Club, and CEH (collectively

Public Interest Group Plaintiffs) and their members are being, and will be, adversely affected by

EPA’s actions and inactions complained of herein. EPA’s continued registrations of clothianidin

and thiamethoxam products and failure to take regulatory actions to suspend or cancel such

product registrations harm the interests of Public Interest Group Plaintiffs and Public Interest

Group Plaintiffs’ members. EPA’s actions and inactions have, and will continue to have, an

adverse effect on Public Interest Group Plaintiffs’ missions and their members’ conservation,

environmental, recreational, aesthetic, and economic interests.

24.

Plaintiff CFS brings this action on behalf of itself and its members. CFS and its

members are being, and will be, adversely affected by EPA’s actions and inactions complained

of herein. CFS is a Washington, D.C.-based, public interest, nonprofit membership organization

that has offices in San Francisco, CA; Portland, OR; and Washington, D.C.

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Since CFS’s founding in 1997, it has sought to ameliorate the adverse impacts of

industrial farming and food production systems on human health, animal welfare, and the

environment. CFS has over 280,000 members nationwide. CFS seeks to protect human health

and the environment by advocating for thorough, science-based safety testing of new agricultural

products prior to any marketing and cultivation of crops in a manner that minimizes negative

impacts such as increased use of pesticides and evolution of resistant pests and weeds. A

foundational part of CFS’s mission is to further the public’s fundamental right to know what is in

their food and food production methods.

26.

Plaintiff Beyond Pesticides brings this action on behalf of itself and its members.

Beyond Pesticides and its members are being, and will be, adversely affected by EPA’s actions

and inactions complained of herein. Based in Washington, D.C., Beyond Pesticides is a national

nonprofit corporation that promotes safe air, water, land, and food, and works to protect public

health and the environment by encouraging a transition away from the use of toxic pesticides.

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27. With Beyond Pesticides’s resources made available to the public on a national

scale, Beyond Pesticides contributes to a significant reduction in unnecessary pesticide use, thus

improving protection of public health and the environment.

28.

Plaintiff Sierra Club brings this action on behalf of itself and its members. Sierra

Club and its members are being, and will be, adversely affected by EPA’s actions and inactions

complained of herein. The Sierra Club is a national nonprofit organization of approximately

600,000 members dedicated to exploring, enjoying, and protecting the wild places of the earth; to

practicing and promoting the responsible use of the earth’s ecosystems and resources; to

educating and enlisting humanity to protect and restore the quality of the natural and human

environment; and to using all lawful means to carry out these objectives. The Sierra Club is a

California nonprofit corporation headquartered in San Francisco, CA.

29.

The Sierra Club’s concerns encompass endangered species, habitat protection,

pollution, and industrial agriculture, all of which are involved in this case. The loss of bees and

other beneficial insects, and the threats to native ecosystems and wildlife posed by neonicotinoid

insecticides, harm the interests of the Sierra Club and its members.

30.

Plaintiff CEH is a tax-exempt, nonprofit corporation with offices in Oakland,

California; and New York, New York. Founded in 1996, CEH is a nonprofit organization

dedicated to protecting the public from environmental and public health hazards, including

harmful pesticides. CEH achieves its mission by working with communities, consumers,

workers, government, and the private sector to demand and support business and agricultural

practices that are safe for public health and the environment.

31.

As part of its mission, CEH and its staff have long been involved in efforts to

combat the negative human health and environmental effects of pesticides and other harmful

contaminants in our food system. For example, CEH is a member of Californians for Pesticide

Reform, an organization whose mission is to protect public health, improve environmental

quality, and expand a sustainable and just agriculture system by seeking to change state and local

pesticide policies and practices. CEH’s Research Director, Caroline Cox, serves on the

California Department of Pesticide Regulation’s Pest Management Advisory Committee and is a

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member of the Board of Beyond Pesticides. When necessary, CEH also engages in public

interest litigation to address the food safety concerns raised by the current regulatory framework

and the negative impacts of unsafe products. The interests of CEH and its members in reducing

the harmful impacts stemming from pesticide use are being, and will be, adversely affected by

EPA’s ongoing registrations of clothianidin and thiamethoxam products.

32.

Public Interest Group Plaintiffs and their members have a vital interest in the

survival and health of honey bees and other plant pollinators to ensure a nutritious and safe food

supply and healthy natural ecosystems and gardens. Each of the Public Interest Group Plaintiffs

has a strong interest in the conservation of the vast numbers of native ESA-listed species that are

potentially impacted, directly and indirectly, by clothianidin and thiamethoxam. Several of the

Public Interest Group Plaintiffs and their members have personally visited the ranges of directly

impacted ESA-listed invertebrates, including, but not limited to, listed plant pollinators, as well

as other indirectly impacted ESA-listed species, including, but not limited to, rangeland and

other birds. They enjoy utilizing these species for recreational, aesthetic, and other uses, and

intend to continue to visit those habitats and enjoy those species and the ecosystem services they

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33.

EPA’s failure to provide Public Interest Group Plaintiffs with the FIFRA-

mandated notices of applications for the clothianidin and thiamethoxam registration and changed

uses in the Federal Register, and its failure to provide public comment periods, denied the Public

Interest Group Plaintiffs the ability to submit information to EPA that may have convinced the

agency not to issue those registrations or change amendments. Defendants’ failure to adequately

regulate clothianidin and thiamethoxam under FIFRA and the ESA, and failure to provide

adequate label warnings on these pesticides, resulting in the ongoing collapse of populations of

honey bees and other beneficial insects and the continued harm to threatened and endangered

species, further injure Public Interest Group Plaintiffs’ organizational interests as well as their

members’ aesthetic, recreational, and economic interests. The relief sought in this case will

provide redress for the ongoing harm to Public Interest Group Plaintiffs and their members.

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Defendants

34.

Defendant Steven P. Bradbury is the Director of the Office of Pesticide Programs

of EPA, and is being sued in his official capacity.

35.

Defendant Bob Perciasepe is the Acting Administrator and Deputy Administrator

of EPA, and is being sued in his official capacity.

36.

Defendants Bradbury and Perciasepe are collectively referred to as EPA or

Defendants.

Federal Insecticide, Fungicide, and Rodenticide Act

STATUTORY BACKGROUND

37.

Under the FIFRA, EPA licenses the sale, distribution, and use of pesticides

through the process of registration. 7 U.S.C. § 136a. The Administrator is required to provide

public notice and comment opportunities under 7 U.S.C. § 136a(c)(4):

Notice of application.

The Administrator shall publish in the Federal Register, promptly after
receipt of the statement and other data required pursuant to paragraphs (1)
and (2), a notice of each application for registration of any pesticide if it
contains any new active ingredient or if it would entail a changed use
pattern. The notice shall provide for a period of 30 days in which any
Federal agency or any other interested person may comment.

38.

EPA’s FIFRA-implementing regulations also impose several procedural

requirements, including, but not limited to, requiring publication of two classes of notices in the

Federal Register. Under 40 C.F.R. § 152.102:


The Agency will issue in the Federal Register a notice of receipt of each
application for registration of a product that contains a new active ingredient or
that proposes a new use. After registration of the product, the Agency will issue in
the Federal Register a notice of issuance. The notice of issuance will describe the
new chemical or new use, summarize the Agency’s regulatory conclusions, list
missing data and the conditions for their submission, and respond to comments
received on the notice of application.


Id. (emphases added).

39.

The FIFRA authorizes Defendants to register a pesticide product without any

conditions (unconditional registration) if Defendants determine that the product “will perform its

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intended function without unreasonable adverse effects on the environment,” and that “when

used in accordance with widespread and commonly recognized practice” the pesticide “will not

generally cause unreasonable adverse effects on the environment.” 7 U.S.C. § 136a(c)(5)(C)-

(D).

40.

The FIFRA authorizes Defendants to register a pesticide product with conditions

(conditional registration) if Defendants determine that the pesticide or proposed new use is so

new that insufficient data exists to support unconditional registration under 7 U.S.C.

§ 136a(c)(5), provided that the registrants meet Defendants’ conditions, and conduct and supply

studies to fill the missing data gaps within a set timeframe. 7 U.S.C. § 136a(c)(7)(C). A

conditional registration is authorized under three circumstances: 1) EPA may conditionally

register a pesticide if “the pesticide and proposed use are identical or substantially similar to any

currently registered pesticide and use thereof, or differ only in ways that would not significantly

increase the risk of unreasonable adverse effects on the environment, and [] approving the

registration . . . would not significantly increase the risk of any unreasonable adverse effect on

the environment,” 7 U.S.C. § 136a(c)(7)(A); 2) EPA may conditionally amend a pesticide’s

registration “to permit additional uses of such pesticide notwithstanding that data concerning the

pesticide may be insufficient to support an unconditional amendment,” 7 U.S.C. § 136a(c)(7)(B);

and 3) EPA may conditionally register a pesticide “containing an active ingredient not contained

in any currently registered pesticide for a period reasonably sufficient for the generation and

submission of required data” but “only if [EPA] determines that use of the pesticide during such

period will not cause any unreasonable adverse effect on the environment, and that use of the

pesticide is in the public interest,” 7 U.S.C. § 136a(7)(C) (emphasis added).

41.

Under the FIFRA, a conditional registration may only last for a period

“reasonably sufficient” to generate the outstanding data necessary for unconditional registration.

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42.

EPA has the authority to cancel a pesticide registration whenever “a pesticide or

its labeling . . . does not comply with the provisions of [the FIFRA] or, when used in accordance

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with widespread and commonly recognized practice, generally causes unreasonable adverse

effects on the environment.” 7 U.S.C. § 136d(b).

43.

EPA may immediately suspend a pesticide registration to prevent an “imminent

hazard.” 7 U.S.C. § 136d(c). The phrase “imminent hazard,” as defined in the FIFRA, means a

situation “when the continued use of a pesticide during the time required for cancellation

proceeding would be likely to result in unreasonable adverse effects on the environment or will

involve unreasonable hazard to the survival of a species declared endangered” under the ESA.

7 U.S.C. § 136(l).

44.

If a registrant has failed to fulfill any condition imposed on the registration, the

Administrator “shall” initiate cancellation proceedings. 7 U.S.C. § 136d(e)(1). While

cancellation is pending, EPA may suspend the registration of the pesticide or new use

immediately if an “imminent hazard” exists, that is, if “continued use of a pesticide during the

time required for cancellation proceeding would be likely to result in unreasonable adverse

effects on the environment or will involve unreasonable hazard to the survival of a species

declared endangered or threatened by the Secretary [of the Interior] pursuant to the Endangered

Species Act of 1973.” 7 U.S.C. §§ 136d(c), 136(l).

45.

The culmination of the registration process is EPA’s approval of a label for the

pesticide, including use directions and appropriate warnings on safety and environmental risks.

It is a violation of the FIFRA for any person to sell or distribute a “misbranded” pesticide.

7 U.S.C. § 136j(a)(1)(E). A pesticide is misbranded if the “labeling accompanying it does not

contain directions for use which . . . if complied with . . . are adequate to protect health and the

environment.” 7 U.S.C. § 136(q)(1)(F).

46.

The FIFRA registrations for clothianidin and thiamethoxam products amount to

licenses that establish the terms and conditions under which the products may be lawfully sold,

distributed, or used. EPA retains the ongoing authority to modify the terms and conditions of

these licenses as needed; thus, each pesticide registration constitutes an ongoing agency action.

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47.

The legal burden of showing that any pesticide and any approved uses thereof

meet the FIFRA criteria to be eligible for continued registration rests with the products’

proponents. See 40 C.F.R. § 154.5.

Endangered Species Act

48.

The ESA requires EPA, in consultation with U.S. Fish and Wildlife Service

(FWS), to ensure that any action authorized by the agency is not likely to jeopardize the

continued existence of any threatened or endangered species, or result in the destruction or

adverse modification of the critical habitat of such species. 16 U.S.C. § 1536(a)(2). For each

federal action, EPA must request information from FWS indicating whether any listed or

proposed species may be present in the area of the agency action. 16 U.S.C. § 1536(c)(1); 50

C.F.R. § 402.12. If listed or proposed species may be present, EPA must prepare a “biological

assessment” to determine whether the listed species may be affected by the proposed action. 16

U.S.C. § 1536(c)(1); 50 C.F.R. § 402.12.

49.

If EPA determines that its proposed action may affect any listed species or critical

habitat, the agency must engage in formal consultation with FWS. Effects determinations are

based on the direct, indirect, and cumulative effects of the action when added to the

environmental baseline and other interrelated and interdependent actions. 50 C.F.R. § 402.02.

An agency is required to review its actions “at the earliest possible time” to determine whether

the action may affect listed species or critical habitat. 50 C.F.R. § 402.14(a). Because EPA

retains ongoing discretionary authority to modify the terms and conditions of its approvals, the

agency’s continuing authority over pesticide registrations constitutes ongoing agency action and

it has a continuing obligation to follow the requirements of the ESA.

50.

To complete formal consultation, FWS must provide EPA with a “biological

opinion” explaining how the proposed action will affect the listed species or habitat. 16 U.S.C.

§ 1536(b). If FWS concludes the proposed action will jeopardize the continued existence of a

listed species, the biological opinion must outline “reasonable and prudent alternatives.”

16 U.S.C. § 1536(b)(3)(A). If the biological opinion concludes the action is not likely to

jeopardize the continued existence of a listed species, and will not result in the destruction or

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adverse modification of critical habitat, FWS must provide an incidental “take” statement

specifying the impact of such incidental taking on the listed species and any “reasonable and

prudent measures” that FWS considers necessary or appropriate to minimize such impact, and

also setting forth the “terms and conditions” that must be complied with by EPA to implement

those measures. 16 U.S.C. § 1536(b)(4).

51.

“Take” is defined broadly to include actions that “harass, harm, pursue, hunt,

shoot, wound, [or] kill” a protected species, either through direct action or by degrading its

habitat. 16 U.S.C. § 1532(19); 50 C.F.R. § 17.3. In furtherance of Congress’s goal to conserve

species, the ESA generally prohibits the “take” of any species listed as endangered, a prohibition

FWS has extended by regulation to threatened species. 16 U.S.C. § 1538(a)(1)(B); see also 16

U.S.C. § 1533(d); 50 C.F.R. § 17.31. However, take that complies with the terms and conditions

specified in a biological opinion is not prohibited. 16 U.S.C. § 1536(o)(2).

52.

During consultation with FWS, EPA is prohibited from making any irreversible or

irretrievable commitment of resources with respect to the agency action which may foreclose the

formulation or implementation of any reasonable and prudent alternative measures. 16 U.S.C.

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53.

Section 7 of the ESA also requires EPA, in consultation with and with the

assistance of FWS, to utilize its authority in furtherance of the purposes of the ESA by carrying

out programs for the conservation of endangered and threatened species. 16 U.S.C. § 1536(a)(1).

Administrative Procedure Act

54.

The APA provides for judicial review of final agency actions. “Agency action” is

defined to include “the whole or a part of an agency rule, order, license, sanction, relief, or the

equivalent or denial thereof, or failure to act.” 5 U.S.C. § 551(13). The APA provides that “[a]

person suffering legal wrong because of agency action, or adversely affected or aggrieved by

agency action within the meaning of a relevant statute, is entitled to judicial review thereof.” 5

U.S.C. § 702.

55.

Under the APA, a reviewing court shall “hold unlawful and set aside agency

action, findings, and conclusions” that it finds to be “arbitrary, capricious, an abuse of discretion,

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or otherwise not in accordance with the law” or “without observance of procedure required by

law.” 5 U.S.C. § 706(2)(A), (D).

56.

Further, under the APA, a reviewing court has the authority to “compel agency

action unlawfully withheld or unreasonably delayed.” 5 U.S.C. § 706(1).

STATEMENT OF FACTS

Honey Bee Impact Facts

57.

Clothianidin and thiamethoxam are systemic insecticides that are formulated and

sold as a large number of branded products aimed at a variety of agricultural, landscaping, and

residential use markets. They are taken up by a plant’s vascular system as it grows and are

expressed through its tissues, including flowers, pollen, and nectar. They share a common mode

of action that damages the central nervous system of honey bees. When bees forage on pollen or

nectar from treated crops and other plants, or are otherwise exposed to even extremely small

levels of these compounds, paralysis and death can result. Over the past decade, the proliferating

use of the neonicotinoid class of pesticides has coincided with mass die-offs of honey bee

populations in the phenomenon known as Colony Collapse Disorder, documented as early as

2003–2004 in the United States, with the first reported case findings in 2006.

58.

Clothianidin is a transformation product of thiamethoxam. In honey bees,

thiamethoxam is metabolized into clothianidin. In short, the two are closely related with

comparable applications, toxicity, and effects.

59.

Clothianidin and thiamethoxam affect bee behavior and cognition in ways that

compromise the overall health of colonies, often causing bee colonies to collapse. Honey bees

are social insects that rely heavily on memory, cognition, and communication to coordinate

activities essential for their survival. Chronic ingestion of neonicotinoids damages foraging

behavior, overall mobility, and the communication by which they coordinate their activities.

Neonicotinoid pesticides can also have several other indirect effects on honey bees, such as

causing premature shifts in hive roles. They can impair honey bees’ medium-term olfactory

memory and associative learning abilities, which foraging honey bees rely on, inter alia, to find

their way back to the hive.

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60.

Neonicotinoid pesticides such as clothianidin and thiamethoxam persist in a toxic

state in the environment for several years, increasing the risk of cumulative toxic loading effects,

especially after repeat applications at the same location. No label warnings or use directions are

capable of mitigating these impacts and those warnings and directions that do exist are almost

never enforced. Farmers and other users are known to ignore them in many cases, yet

enforcement cases by EPA and its cooperating state agencies are exceedingly rare.

61.

Due to EPA’s actions and inactions alleged herein, clothianidin and

thiamethoxam are spread widely throughout hundreds of millions of acres of both agricultural

and neighboring lands. The neighboring lands are where these toxic compounds are not intended

to be and often are lands not owned by the farmers applying the compounds. These lands

adjacent to agricultural fields in many cases are prime remaining bee and native insect habitats.

Due to the long persistence of these compounds and the uncontrollable drifting and blowing of

contaminated dust and soil, bees and other insects are victims of multiple exposure pathways that

EPA failed to assess when the agency approved the pesticides—and still has failed to assess.

Key among these exposure pathways are residues in pollen and nectar, dust from treated seeds

and soils, planter exhaust, untreated but contaminated non-crop plants adjacent to treated fields,

contaminated puddles in fields and adjacent surface water, guttation droplets on both treated and

untreated but contaminated plants, and residues from foliar uses.

62.

EPA’s own scientists have regularly described severe impacts of these

insecticides in their internal risk assessments. Recent studies, including those by the U.S.

Department of Agriculture (USDA)’s lead bee scientists, also confirm that neonicotinoids

interact with common bee pathogens and parasites, making them more vulnerable to the deadly

effects of both, leading to further colony collapse. Numerous recent peer-reviewed studies and

other evidence of both acute and sub-lethal harm to bees from a variety of exposure pathways

across diverse agricultural landscapes support the need to suspend the uses of clothianidin and

thiamethoxam. EPA has failed to take this new science into account in: a) deciding whether an

“imminent hazard” exists requiring suspension of these pesticides; b) determining the adequacy

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