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

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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: gkimbrell@centerforfoodsafety.org
pjenkins@centerforfoodsafety.org
ptomaselli@centerforfoodsafety.org
swu@centerforfoodsafety.org
Counsel for Plaintiffs
THE UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF CALIFORNIASAN FRANCISCO DIVISION

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

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Plaintiffs,

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v.

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

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Defendants.

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

FIRST AMENDED COMPLAINT FOR
DECLARATORY AND INJUNCTIVERELIEF
Administrative Procedure Act Case

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FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

Case3:13-cv-01266-LB Document17 Filed05/31/13 Page2 of 52

INTRODUCTION

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This is a civil action for injunctive and declaratory relief. The original Complaint3

was dated Mar. 21, 2013. ECF No. 1. This First Amended Complaint is filed pursuant to a4

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

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

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

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

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

9Perciasepe, Acting Administrator and Deputy Administrator of EPA (collectively EPA or

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

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clothianidin and thiamethoxam, in violation of the Federal Insecticide, Fungicide and12

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

13(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-used16

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

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

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agriculture, and which have harmful effects on other animals, including threatened and19

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

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

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

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and with no adequate risk assessments in place.

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3.

In most instances, EPA has approved clothianidin and thiamethoxam product24

registrations, new uses, and use amendments without affording notice in the Federal Register and25

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

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has failed to modify its regulation of these pesticides in response to the many scientifically-sound27

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

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EPA’s regulatory approvals have been a major factor in excessive honey bee mortality and the
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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decline of pollinator populations in the same time period. EPA’s regulatory actions, resulting in2

the continued use of clothianidin and thiamethoxam, have also continued to place threatened and3endangered species in jeopardy.
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In addition to suffering chronic effects leading to excess mortality, which includes

5a phenomenon called Colony Collapse Disorder, hundreds of the nation’s beekeepers and honey6

producers suffer from acute effects each spring, when neonicotinoid-treated corn, in particular, is7

planted in virtually every state. Tens of thousands of their bee colonies have been exposed to8lethal levels of neonicotinoid-contaminated dust during corn planting season. Plaintiff

9beekeepers 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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requests.

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EPA is well aware of recent studies and reports illustrating the risks to honey13

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

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

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letter requesting that EPA issue a stop sale order of clothianidin products.1 EPA denied the16request in February 2011.2 In March 2012, Plaintiffs CFS and Beyond Pesticides, along with17

numerous other environmental groups, beekeepers, and honey producers, filed a legal petition18(hereafter the Clothianidin Legal Petition or the Petition) asking EPA to initiate immediate

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

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

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Letter from Beyond Pesticides et al., to EPA (Dec. 8, 2010), available at
http://www.epa.gov/opp00001/about/intheworks/clothianidin-petition2.pdf.
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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/clothianidinresponse-letter.pdf.
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CFS et al., Clothianidin Legal Petition (Mar. 21, 2012), available at
http://www.centerforfoodsafety.org/wp-content/uploads/2012/10/CFS-Clothianidin-Petition-320-12.pdf.
4Letter 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-toclothianidin-petition-17july12.pdf.

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FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1thiamethoxam products and requesting suspension of the pesticide in October 2012.5 EPA also2

refused that suspension request.66.

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

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

5registration. There is intense public interest in EPA’s actions, due to the loss of honey bees and6other beneficial insects; the resulting economic, food supply, and ecosystem damages; and the7

unnecessary persistent toxic pollution of America’s private and public landscapes.
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In allowing this scenario to unfold over the last thirteen years, EPA has violated

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the FIFRA, the ESA, and the APA. EPA has denied Plaintiffs and the public mandatory notice10

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

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pollinators and threatened and endangered species, and caused unreasonable adverse

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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

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

16§ 702 (APA), 7 U.S.C. § 136n(a) (FIFRA), and 16 U.S.C. § 1540(e), (g) (ESA).
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Jurisdiction is in the District Court under the ESA citizen suit provision, which

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

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and provides that the “district courts shall have jurisdiction . . . to enforce any such provision or20

regulation . . . .” 16 U.S.C. § 1540(g)(1). Pursuant to the ESA, 16 U.S.C. § 1540(g)(2)(A),21

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

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

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

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

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Letter from Plaintiffs to EPA (Oct. 16, 2012) (on file with Plaintiffs).
Letter from EPA to Plaintiffs (Feb. 27, 2013) (on file with Plaintiffs).
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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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FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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Plaintiffs’ Sixty-Day Notice Letter.
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Jurisdiction also lies in this Court under the FIFRA’s judicial review provision, 7

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U.S.C. § 136n(a), which provides:

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District court review.

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Except as otherwise provided in this Act, the refusal of the Administrator tocancel or suspend a registration or to change a classification not following ahearing and other final actions of the Administrator not committed to thediscretion of the Administrator by law are judicially reviewable by the district
courts of the United States.
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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 ahearing, 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 theDistrict 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 theconditions imposed by EPA; b) changed the classifications of numerous conditional registrationsof 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 ahearing, on Plaintiffs’ Clothianidin Legal Petition in denying the request to declare an “imminenthazard” exists; d) failed to comply with the ESA, in approving all of the registered uses of thesecompounds, 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 asalleged herein that caused unreasonable adverse environmental and economic impacts that are
reviewable in the District Court.
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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

§ 2201 (declaratory judgment).
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Venue properly lies in this Court pursuant to 28 U.S.C. § 1391(e)(1)(c) because4

one or more Plaintiffs reside in this district, and pursuant to 28 U.S.C. § 1391(e)(1)(b), because a5

substantial part of the events or omissions giving rise to the claim occurred, or a substantial part6of property that is the subject of the action is situated, in this district.

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INTRADISTRICT ASSIGNMENT

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

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

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PARTIES11
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Beekeeper and Honey Producer Plaintiffs
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The interests of Plaintiffs Steve Ellis, Tom Theobald, Jim Doan, and Bill Rhodes

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

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

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

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

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Beekeeper and Honey Producer Plaintiffs are geographically and operationally representative of18

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

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and individuals.

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Plaintiff Mr. Steve Ellis owns and operates Old Mill Honey Company, a21

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

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season, and with several employees. The hives he manages for his business produce honey for23

market over the summer months in Minnesota, and paid pollination services in the winter and24

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

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officer in beekeeper organizations for many years. He is the Secretary of the National Honey26

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

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his bee colonies to forage, and often to do pollination, in the following types of crops and28

habitats: almonds, corn, soybeans, sunflowers, edible beans, ornamental trees, forest trees,
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1peaches, plums, residential and landscaped areas, golf courses, and lawns. Over the course of the2last six to seven years, he has observed a new type of bee kill caused by pesticide poisoning in3

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

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

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

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unsustainable. Mr. Ellis keeps bees in west central Minnesota where corn and soybeans are7

increasingly the dominant crops. It is not practically feasible to locate his bees away from these8

crops during the summer growing season.

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

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

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

12Theobald served two terms as Vice-President of the Colorado Beekeepers’ Association and was

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

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

15beekeeping practices over the last decade include allowing his bee colonies to forage in the16

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

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

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

19well as through his own research, that a primary cause of his recent and continuing losses is the20

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

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acres of agricultural land near his business, as well as on untold acres of nearby urban and22

suburban land in Boulder County.

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Plaintiff Mr. Jim Doan has run Doan Family Farms based in Hamlin, New York,24

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

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

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of New York’s apple crop each year. His common beekeeping practices over the last decade27

include allowing his bee colonies to forage, and often to do pollination, in the following types of28

crops and habitats: corn, soybeans, cucumbers, pumpkins, squash, melon, citrus, ornamental
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1trees, apples, other fruit trees, residential and landscaped areas, wheat, cabbage, berries, peas,

2and green beans. Since 2006, he has been unable to keep from losing more than 50% of his

3hives each year to symptoms that, based on his experience, are caused by both acute and chronic4

exposure to the new neonicotinoid pesticides. In the spring and summer of 2012, Mr. Doan5

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

6contaminated dust and other exposure routes related to the several cornfields around his bee

7colonies. He feared that if he continued to suffer such losses to his business, without monetary8

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

9dying.

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

11compelled to sell Doan Family Farms and he has had to reduce his many-decades old beekeeping

12business. While he remains a beekeeper, the financial and personal strains of repeated massive

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

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him to continue.

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

16commercial honey producer in Florida, based in Umatilla. A beekeeper for forty-one years, his

17company employs about fifteen people. His common beekeeping practices over the last decade

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

19soybeans, sunflowers, and residential areas with lawns, gardens, and other landscaping. Mr.

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

21company also ships bees to Georgia and other states. He seeks to maintain about 9,000 hives,22

but the impacts of pesticides, including thiamethoxam and clothianidin, make keeping that level23

very difficult. Mr. Rhodes started seeing symptoms of Colony Collapse Disorder around 200424

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

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

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

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and has a high level of concern that his own livelihood based on premium honey production is28

threatened.
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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121.

The use of systemic pesticides such as thiamethoxam and clothianidin is not2

posted with signs nor is any other notice provided to beekeepers about their use as a matter of3

common practice. Based on the Beekeeper and Honey Producer Plaintiffs’ years of experience4and their knowledge of the use of neonicotinoids on a broad range of U.S. crops and habitats, the5Beekeeper and Honey Producer Plaintiffs are reasonably certain that their bees were frequently

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

7well as within their own hives via dust, pollen, and other exposure routes. The Beekeeper and8

Honey Producer Plaintiffs are also concerned that in the future their bees will be exposed to, and9further weakened or killed by, thiamethoxam and clothianidin used in the crops and habitats their

10bees visit, other crops and habitats, as well as cumulative soil residues of thiamethoxam and11

clothianidin in those habitats.

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

13and inactions complained of herein. EPA’s failure to provide Beekeeper and Honey Producer

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

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

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

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convinced the agency not to issue those registrations or use amendments. For Beekeeper and18

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

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

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

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

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

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workload to address bee kills and poor bee health, and personal stress and anxiety from seeing24

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

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with government agencies about their farmer neighbors, and other damages. The relief sought in26

this case will provide redress for their ongoing harms and aid in preventing additional future27

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

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FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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Public Interest Group Plaintiffs
23.

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

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

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

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and thiamethoxam products and failure to take regulatory actions to suspend or cancel such6

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

7Group Plaintiffs’ members. EPA’s actions and inactions have, and will continue to have, an8adverse effect on Public Interest Group Plaintiffs’ missions and their members’ conservation,

9environmental, recreational, aesthetic, and economic interests.

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

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

12of herein. CFS is a Washington, D.C.-based, public interest, nonprofit membership organization

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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

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industrial farming and food production systems on human health, animal welfare, and the16environment. CFS has over 280,000 members nationwide. CFS seeks to protect human health17

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

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

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

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

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their food and food production methods.

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

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

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

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nonprofit corporation that promotes safe air, water, land, and food, and works to protect public26

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

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

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

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improving protection of public health and the environment.

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

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

6complained of herein. The Sierra Club is a national nonprofit organization of approximately

7600,000 members dedicated to exploring, enjoying, and protecting the wild places of the earth; to8practicing and promoting the responsible use of the earth’s ecosystems and resources; to9educating and enlisting humanity to protect and restore the quality of the natural and human10environment; and to using all lawful means to carry out these objectives. The Sierra Club is a11

California nonprofit corporation headquartered in San Francisco, CA.

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

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pollution, and industrial agriculture, all of which are involved in this case. The loss of bees and14

other beneficial insects, and the threats to native ecosystems and wildlife posed by neonicotinoid15

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

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30.

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

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

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

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

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

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practices that are safe for public health and the environment.

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

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

24contaminants in our food system. For example, CEH is a member of Californians for Pesticide

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

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

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pesticide policies and practices. CEH’s Research Director, Caroline Cox, serves on the28

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

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interest litigation to address the food safety concerns raised by the current regulatory framework3

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

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

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EPA’s ongoing registrations of clothianidin and thiamethoxam products.

632.

Public Interest Group Plaintiffs and their members have a vital interest in the7survival and health of honey bees and other plant pollinators to ensure a nutritious and safe food8

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

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

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

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

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impacted ESA-listed invertebrates, including, but not limited to, listed plant pollinators, as well13

as other indirectly impacted ESA-listed species, including, but not limited to, rangeland and14other birds. They enjoy utilizing these species for recreational, aesthetic, and other uses, and15

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

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provide.

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33.

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

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

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

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Interest Group Plaintiffs the ability to submit information to EPA that may have convinced the21

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

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

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adequate label warnings on these pesticides, resulting in the ongoing collapse of populations of24

honey bees and other beneficial insects and the continued harm to threatened and endangered25

species, further injure Public Interest Group Plaintiffs’ organizational interests as well as their26

members’ aesthetic, recreational, and economic interests. The relief sought in this case will27

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

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Defendants

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Defendant Steven P. Bradbury is the Director of the Office of Pesticide Programsof EPA, and is being sued in his official capacity.
35.

Defendant Bob Perciasepe is the Acting Administrator and Deputy Administratorof EPA, and is being sued in his official capacity.

6

36.

7

Defendants.

Defendants Bradbury and Perciasepe are collectively referred to as EPA or

STATUTORY BACKGROUND

8
9
10

Federal Insecticide, Fungicide, and Rodenticide Act
37.

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

11

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

12public notice and comment opportunities under 7 U.S.C. § 136a(c)(4):13

Notice of application.

14

17

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.

18

38.

15
16

EPA’s FIFRA-implementing regulations also impose several procedural

19

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

20

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

21
22
23
24
25
26
27
28

The Agency will issue in the Federal Register a notice of receipt of eachapplication for registration of a product that contains a new active ingredient orthat proposes a new use. After registration of the product, the Agency will issue inthe 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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1

intended function without unreasonable adverse effects on the environment,” and that “when2used in accordance with widespread and commonly recognized practice” the pesticide “will not3

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

4

(D).

5

40.

The FIFRA authorizes Defendants to register a pesticide product with conditions

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

7

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

8§ 136a(c)(5), provided that the registrants meet Defendants’ conditions, and conduct and supply

9

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

10

conditional registration is authorized under three circumstances: 1) EPA may conditionally11

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

12currently registered pesticide and use thereof, or differ only in ways that would not significantly

13

increase the risk of unreasonable adverse effects on the environment, and [] approving the14

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

15

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

16registration “to permit additional uses of such pesticide notwithstanding that data concerning the17

pesticide may be insufficient to support an unconditional amendment,” 7 U.S.C. § 136a(c)(7)(B);18

and 3) EPA may conditionally register a pesticide “containing an active ingredient not contained19

in any currently registered pesticide for a period reasonably sufficient for the generation and20

submission of required data” but “only if [EPA] determines that use of the pesticide during such21

period will not cause any unreasonable adverse effect on the environment, and that use of the22pesticide is in the public interest,” 7 U.S.C. § 136a(7)(C) (emphasis added).

23

41.

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

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

25

7 U.S.C. § 136a(c)(7)(C).

26
27

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

28
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1with widespread and commonly recognized practice, generally causes unreasonable adverse

2

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

343.

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

4

hazard.” 7 U.S.C. § 136d(c). The phrase “imminent hazard,” as defined in the FIFRA, means a5situation “when the continued use of a pesticide during the time required for cancellation

6

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

7

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

8

7 U.S.C. § 136(l).

944.

If a registrant has failed to fulfill any condition imposed on the registration, the10Administrator “shall” initiate cancellation proceedings. 7 U.S.C. § 136d(e)(1). While

11

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

12

immediately if an “imminent hazard” exists, that is, if “continued use of a pesticide during the13time required for cancellation proceeding would be likely to result in unreasonable adverse

14

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

15

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

16

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

17

45.

The culmination of the registration process is EPA’s approval of a label for the18

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

19

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

20

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

21

contain directions for use which . . . if complied with . . . are adequate to protect health and the22environment.” 7 U.S.C. § 136(q)(1)(F).

23

46.

The FIFRA registrations for clothianidin and thiamethoxam products amount to24

licenses that establish the terms and conditions under which the products may be lawfully sold,25

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

26

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

27

See 7 U.S.C. §§ 136d(c), 136(l).

28
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1

47.

The legal burden of showing that any pesticide and any approved uses thereof2

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

3

proponents. See 40 C.F.R. § 154.5.

4

Endangered Species Act

548.

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

6(FWS), to ensure that any action authorized by the agency is not likely to jeopardize the7continued existence of any threatened or endangered species, or result in the destruction or8

adverse modification of the critical habitat of such species. 16 U.S.C. § 1536(a)(2). For each9federal action, EPA must request information from FWS indicating whether any listed or

10

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

11

C.F.R. § 402.12. If listed or proposed species may be present, EPA must prepare a “biological12

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

13

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

14

49.

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

15

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

16

based on the direct, indirect, and cumulative effects of the action when added to the17environmental baseline and other interrelated and interdependent actions. 50 C.F.R. § 402.02.

18

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

19

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

20

retains ongoing discretionary authority to modify the terms and conditions of its approvals, the21

agency’s continuing authority over pesticide registrations constitutes ongoing agency action and22

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

23

50.

To complete formal consultation, FWS must provide EPA with a “biological24

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

25§ 1536(b). If FWS concludes the proposed action will jeopardize the continued existence of a26

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

27

16 U.S.C. § 1536(b)(3)(A). If the biological opinion concludes the action is not likely to28

jeopardize the continued existence of a listed species, and will not result in the destruction or
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1

adverse modification of critical habitat, FWS must provide an incidental “take” statement2

specifying the impact of such incidental taking on the listed species and any “reasonable and3

prudent measures” that FWS considers necessary or appropriate to minimize such impact, and4also setting forth the “terms and conditions” that must be complied with by EPA to implement

5

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

6

51.

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

7

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

8

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

9

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

10

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

11

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

12

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

13

52.

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

14

irretrievable commitment of resources with respect to the agency action which may foreclose the15formulation or implementation of any reasonable and prudent alternative measures. 16 U.S.C.

16§ 1536(d).

17

53.

Section 7 of the ESA also requires EPA, in consultation with and with the18

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

19

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

20

Administrative Procedure Act

21

54.

The APA provides for judicial review of final agency actions. “Agency action” is22defined to include “the whole or a part of an agency rule, order, license, sanction, relief, or the23

equivalent or denial thereof, or failure to act.” 5 U.S.C. § 551(13). The APA provides that “[a]24person suffering legal wrong because of agency action, or adversely affected or aggrieved by25

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

26

U.S.C. § 702.

27
28

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,
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1or otherwise not in accordance with the law” or “without observance of procedure required by

2law.” 5 U.S.C. § 706(2)(A), (D).

3
4

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

56
7Honey Bee Impact Facts
57.

Clothianidin and thiamethoxam are systemic insecticides that are formulated and8sold as a large number of branded products aimed at a variety of agricultural, landscaping, and9residential use markets. They are taken up by a plant’s vascular system as it grows and are

10

expressed through its tissues, including flowers, pollen, and nectar. They share a common mode11of action that damages the central nervous system of honey bees. When bees forage on pollen or

12nectar from treated crops and other plants, or are otherwise exposed to even extremely small

13levels of these compounds, paralysis and death can result. Over the past decade, the proliferating

14

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

15

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

16

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

17

58.

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

18

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

19

comparable applications, toxicity, and effects.

20

59.

Clothianidin and thiamethoxam affect bee behavior and cognition in ways that21

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

22

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

23

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

24

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

25

Neonicotinoid pesticides can also have several other indirect effects on honey bees, such as26

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

27

memory and associative learning abilities, which foraging honey bees rely on, inter alia, to find28

their way back to the hive.
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1

60.

Neonicotinoid pesticides such as clothianidin and thiamethoxam persist in a toxic

2

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

3

especially after repeat applications at the same location. No label warnings or use directions are4capable of mitigating these impacts and those warnings and directions that do exist are almost

5

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

6enforcement cases by EPA and its cooperating state agencies are exceedingly rare.

761.

Due to EPA’s actions and inactions alleged herein, clothianidin and8thiamethoxam are spread widely throughout hundreds of millions of acres of both agricultural

9and neighboring lands. The neighboring lands are where these toxic compounds are not intended10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

contaminated puddles in fields and adjacent surface water, guttation droplets on both treated and18

untreated but contaminated plants, and residues from foliar uses.

19

62.

EPA’s own scientists have regularly described severe impacts of these20

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

21

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

22

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

23

effects of both, leading to further colony collapse. Numerous recent peer-reviewed studies and24other evidence of both acute and sub-lethal harm to bees from a variety of exposure pathways

25

across diverse agricultural landscapes support the need to suspend the uses of clothianidin and26

thiamethoxam. EPA has failed to take this new science into account in: a) deciding whether an27“imminent hazard” exists requiring suspension of these pesticides; b) determining the adequacy

28
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1of the pesticide products’ labeling under FIFRA; and c) initiating and completing consultation

2

regarding potential impacts on federally-listed threatened and endangered species under the ESA.

363.

Other nations, including Austria, Italy, France, Germany, Slovenia, and Sweden,4

and recently the European Union as a whole, have recognized the imminent harm of seed5

treatment and other uses of clothianidin and thiamethoxam and suspended or restricted those6

uses. In past cases, these actions restricting or suspending the uses of clothianidin and7thiamethoxam have generally allowed honey bee colonies to thrive.

864.

EPA has maintained the active registrations of clothianidin and thiamethoxam

9

products despite known risks and data gaps. The European Food Safety Authority has issued

10authoritative reports that confirm that clothianidin and thiamethoxam products present acute11

risks to honey bee survival—risks that the European Food Safety Authority characterized as

12having been underestimated and inadequately researched by national pesticide regulators. A

13high acute risk to honey bees was identified from exposure via dust drift for the authorized uses

14

in cereals and cotton (thiamethoxam), corn and canola (thiamethoxam and clothianidin), cereals

15(clothianidin), and sunflowers (thiamethoxam—except for uses with the lowest application rate

16

authorised in the European Union). A high acute risk was also identified for exposure via

17

residues in nectar and/or pollen for the authorized uses in canola (clothianidin), and corn

18(thiamethoxam). Other risks and major data gaps were identified. The same risks and data gaps

19

exist in the United States.

20

65.

EPA has suggested non-mandatory best management practices (BMPs) that it

21

might promote to reduce the unreasonable adverse environmental effects of thiamethoxam and22

clothianidin. However, EPA lacks authority to mandate adherence to all of the needed

23

technological fixes and BMPs. EPA officials have publicly stated they lack comprehensive

24

enforcement power under the FIFRA to prevent farmers from killing bees and other pollinators

25

via the contaminated dust pathway associated with planting treated seeds. Even if they had such

26

authority, the time lag for the hundreds of thousands of users of clothianidin and thiamethoxam

27

products to be able to comply is such that the unreasonable adverse environmental effects would

28

continue for many years unless use of these products is suspended in the interim. EPA’s
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1suggested non-mandatory BMPs are inadequate for purpose of compliance with the FIFRA and2

the ESA.

3

66.

As a result, clothianidin- and thiamethoxam-treated seeds will continue to be4

planted across hundreds of millions of acres in 2013 and beyond. To date, EPA has provided no5

formal direction or label changes to farmers on how to minimize non-target effects, how and6

where to clean out crop planters, or what steps to take to avoid effects to nearby honey bees or7

insect-pollinated plants. Consequently, Defendants have allowed the imminent hazard to8

continue to occur, in particular as corn and other crops are planted in the spring season. Since9

the original filing of this case in March 2013, at least two of the Beekeeper and Honey Producer

10

Plaintiffs, and numerous other beekeepers across the nation, have experienced increased11mortality of their managed beehives due to this ongoing hazard, as corn and other crops are

12

planted in the months of April and May. One Beekeeper and Honey Producer Plaintiff, Jim

13

Doan, was driven out of his farm business in May 2013 because of increased mortality of his

14bees from exposure to these neonicotinoid pesticides.

15

67.

The winter of 2012-2013 was the worst year in recent years for bee mortality,

16

with official USDA estimates exceeding 30% bee loss, but with several of the Beekeeper and17

Honey Producer Plaintiffs and numerous other beekeepers across the nation experiencing much

18

worse, with 40%, 60%, and up to 100% bee losses.

19

68.

The extremely valuable and required service of almond crop pollination in

20

California, which requires millions of bee colonies, almost failed in January through March of21

2013 due to lack of viable colonies. Experts have identified systemic neonicotinoid insecticide22

use is a major contributing factor to the shortage of viable pollinators and honey bee populations,23

in combination with other factors. Experts have identified the potential for foreseeable “domino

24

effects” of cascading inadequate crop pollination due to shortages of viable pollinators. This25

could rapidly evolve into devastating, perhaps irreversible, losses to farmers, consumers, and the26

economy as a whole, since all rely on domestically-produced bee-pollinated food and fiber crops.

27

The future of commercial beekeeping is in jeopardy. Economic losses from the collapse of U.S.

28

bee colonies used in agriculture would measure in the several tens of billions of dollars. The
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1

ecological, agricultural, landscaping, and horticultural impacts of lost managed and wild2

pollinators would be devastating and perhaps irreparable.

3

69.

In recent months, EPA officials have made key public admissions at public

4

meetings, in media statements, in EPA documents, and at other venues. They have admitted that

5a) EPA’s enforcement guidance for neonicotinoid use is inadequate; b) EPA’s bee kill incident

6reporting system is inadequate; and that c) the labels on neonicotinoid products are inadequate to

7
8
9
10

mitigate adverse environmental effects, including the risk of seed dust-mediated mortality tohoney bees and other beneficial insects in or near corn fields. EPA officials have publicly
recognized the current corn planting machinery poses significant risks and needs changing, while
also recognizing that such changes will likely take many years and stating that EPA lacks
authority to mandate machinery changes. Despite these and other key admissions about the11current crisis in bee health, EPA has refused to exercise its regulatory power to address the one
12
13
14
15

factor it could address immediately—the major contribution of clothianidin and thiamethoxam tobee declines.
70.

The efficacy of clothianidin and thiamethoxam seed treatments and other uses arehighly debated. Despite claims of benefits by the registrants and in public statements by EPA

16

officials, many recent studies indicate that they provide no yield benefit in many cases and their17

prophylactic use exacts severe costs to beneficial insects, biological control agents, and18

ecosystems. I n sum, their costs to the nation as a whole exceed their benefits.

19

Non-Honey Bee Impact Facts

20

71.

Besides honey bees, there are thousands of other U.S. native bee and other insect

21

species that EPA has a duty to conserve, including, but not limited to, the rusty patched bumble

22bee, Franklin’s bumble bee, yellow-banded bumble bee, and Western bumble bee, as well as

23

non-bee insects such as butterflies, ladybugs and lacewings, dragonflies, and hoverflies. Several

24of these species are facing severe declines comparable to, or worse than, those faced by honey25

bees. Clothianidin and thiamethoxam are documented to be highly toxic to other bee species like26

the common Eastern bumble bee, alfalfa leafcutter bee, and blue orchard bee, all of which are27

valuable plant pollinators. There are numerous other beneficial insects and other invertebrates

28
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1that are severely impacted by use of clothianidin and thiamethoxam. Broad recognition exists,

2

including by EPA, that there is insufficient data to assess the impacts of clothianidin and3thiamethoxam use on the behavior, reproduction, and survival of these vital pollinators and4

insect species.

572.

EPA has never done a thorough effects analysis of the numerous thiamethoxam or6clothianidin uses it has approved for any federally-listed threatened and endangered species

7

under the ESA, and EPA similarly has failed to assess potential adverse modification of

8

designated critical habitat. It also has failed to consult with FWS as required under the ESA.

973.

More than fifteen threatened or endangered insects, including, but not limited to,10plant pollinators, ranging from beetles to butterflies to grasshoppers and other taxa, are11potentially directly affected by the use of clothianidin and thiamethoxam products. By way of

12

illustration, these species include, but are not limited to (followed by their listing dates; the vast13

majority were listed prior to the dates of EPA’s actions at issue in this First Amended

14

Complaint):

15
16
17
18
19
20
21
22
23
24
25
26
27
28

American burying beetle (Nicrophorus americanus)
Behren’s fritillary (Speyeria zerene behrensii)
Callippe silverspot (Speyeria callippe callippe)
Delhi Sands flower-loving fly (Rhaphiomidas
terminatus abdominalis)
Fender’s blue (Icaricia icarioides fenderi)Hine’s emerald dragonfly (Somatochlora hineana)
Karner blue (Plebejus melissa samuelis)
Kern primrose sphinx moth (Euproserpinus euterpe)
Lange’s metalmark (Apodemia mormo langei)
Mitchell’s satyr butterfly (Neonympha mitchellii
mitchelli)
Myrtle’s silverspot (Speyeria zerene myrtleae)
Northeastern beach tiger beetle (Cicindela
dorsalis dorsalis)
Ohlone tiger beetle (Cicindela ohlone)
Quino checkerspot butterfly (Euphydryas editha
quino)
Salt Creek tiger beetle (Cicindela nevadicalincolniana)
San Bruno elfin (Callophrys mossii bayensis)
Schaus swallowtail (Papilio aristodemus
ponceanus)

07/13/1989
12/05/1997
12/05/1997
09/23/1993
01/25/2000
01/26/1995
12/14/1992
04/08/1980
06/01/1976
05/20/1992
06/22/1992
08/07/1990
10/03/2001
01/16/1997
10/06/2005
06/01/1976
listed as threatened 4/22/1975;
as endangered 8/31/1984

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Case3:13-cv-01266-LB Document17 Filed05/31/13 Page24 of 52

Zayante band-winged grasshopper(Trimerotropis infantilis)

1

01/24/1997

2

More insect species are regularly listed and numerous “Candidate” species, including native3

bees, await further action.

474.

Harmful direct, indirect, and cumulative effects on many other non-insect

5

ESA-listed species, including, but not limited to, birds, crustaceans, mollusks, fish, mammals,

6

reptiles, and amphibians, are also foreseeable due to the known effects of clothianidin and7thiamethoxam. Listed species may be affected by direct consumption of clothianidin- and8thiamethoxam-treated seeds and plant parts, as well as by food chain and ecosystem collapses

9

associated with the vast mortality caused by these pesticides to aquatic and terrestrial

10

invertebrates. EPA has not made the required “effects” determinations or consulted with FWS

11

for any listed species or their critical habitats.

12
13

75.

compliance with the ESA is necessary:

14

Clothianidin is expected to present acute and/or chronic toxicity risk toendangered/threatened birds and mammals via possible ingestion of treated cornand canola seeds. Endangered/threatened non-target insects may be impacted via
residue laden pollen and nectar. The potential use sites cover the entire U.S.
because corn is grown in almost all U.S. states.8

15
16
17

EPA has made the same admissions in its thiamethoxam documentation.9

18
19
20
21

In its initial conditional registration of clothianidin, EPA recognized that76.

For at least one neonicotinoid insecticide, FWS scientists are on record stating“EPA is ignoring their duties with respect to consulting with FWS.” 10 This is in fact true for all
thiamethoxam and clothianidin product approvals subject to this Action. According to EPA
documents, there are hundreds of federally-listed threatened and endangered species occurrences

22
23
24
25
26
27

8

EPA, Pesticide Fact Sheet: Clothianidin, Conditional Registration 16 (May 30, 2003), available
at http://www.epa.gov/opp00001/chem_search/reg_actions/registration/fs_PC-044309_30-May03.pdf.
9See, e.g., EPA, Thiamethoxam Summary Document Registration Review: Initial Docket 5(Dec. 2011), available at http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-20110581-0002.
10E-mail from Ken Dickerson, Environmental Contaminants Biologist, FWS, to Nancy Golden,
FWS, regarding initiating informal consultation on rodenticide new uses (Jan. 3, 2012) (on filewith Plaintiffs).

28
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1

in states where clothianidin and thiamethoxam are used in which direct or indirect effects are2

foreseeable, but EPA has disregarded those effects determinations with respect to the ESA § 7

3consultation requirements.
77.

4

In March 2013, the American Bird Conservancy of Washington, D.C., released a5highly relevant scientific report, The Impact of the Nation’s Most Widely Used Insecticides on

6

Birds.11 It was researched and written by a recognized independent avian toxicologist, Pierre

7

Mineau, Ph.D. In the report, Dr. Mineau examines the key EPA risk assessment documents and8finds numerous critical errors and failures related to risks to birds in the agency’s approvals of

9clothianidin and thiamethoxam products. The report shows high direct and indirect mortality

10

risks to a broad suite of birds, as well as to aquatic invertebrates and to ecosystems generally. It

11finds that the observed acute threats to aquatic invertebrates from water contamination by EPA-

12

approved neonicotinoids “may be totally unprecedented in the history of pesticide registration.”

13

Id. at 57. It also states: “Simply put, EPA has not been heeding the warnings of its own

14

toxicologists.” Id. at 65. In the report, Dr. Mineau examines the EPA-approved product labels

15

and finds them inadequate to address the risks to birds. The report states: “regulators are clearly16

mistaken in believing that exposure to [neonicotinoid] treated seed can be minimized by label

17

statements or adherence to good agricultural practices.” Id. at 27. The report describes EPA’s

18

analysis of avian risks as “scientifically unsound,” arbitrary, and capricious. It urges, inter alia,

19

the agency to suspend use of these products until the risks are resolved and to ban seed20

treatments altogether.

21

78.

Recently published water quality studies have indicated that neonicotinoid22

insecticide pollution occurring in surface waters has a strong negative effect on aquatic

23

invertebrate life, with potentially far-reaching consequences for the food chain and ecosystem

24
25
26
27

Dr. Pierre Mineau and Cynthia Palmer, Am. Bird Conservancy, The Impact of the Nation’s
Most Widely Used Insecticides on Birds (Mar. 2013), available at
http://www.abcbirds.org/abcprograms/policy/toxins/Neonic_FINAL.pdf.
11

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1functions. EPA’s approvals of the numerous thiamethoxam and clothianidin products failed to2consider these threats.

3

Procedural Background Facts
79.

4

Since 2000 and 2003, respectively, EPA has registered approximately more than

5

100 total thiamethoxam and clothianidin insecticide uses and products under FIFRA. See

6Appendices A and B. On information and belief, these are as indicated in Appendix A –7

Clothianidin (thirty-five products) and B – Thiamethoxam (sixty-eight products), which are

8

incorporated into this Complaint by this reference. Other registrations are believed to exist;

9

however, due to EPA’s failure to publish required notices in the Federal Register, there is a lack10of accurate and clear public records. On information and belief, for the vast majority of

11clothianidin and thiamethoxam registrations and changed use approvals, EPA did not, as required

12

under the FIFRA, 7 U.S.C. § 136a(c)(4) and 40 C.F.R. § 152.102, announce a “notice of receipt

13

of application” or a “notice of issuance” in the Federal Register or in any other public order or

14

hearing.
80.

15Additionally, on information and belief, for each of the thiamethoxam and16

clothianidin insecticide uses and products, EPA failed this requirement under the FIFRA: “within

17

30 days after the Administrator registers a pesticide under this Act the Administrator shall make18

available to the public the data called for in the registration statement.” 7 C.F.R.

19§ 136a(c)(2)(A).

20

81.

Together with a coalition of beekeepers and public interest groups, Plaintiff

21

Beyond Pesticides delivered a letter to Defendants dated December 8, 2010, requesting

22

suspension of clothianidin’s registration due to inadequate data on impacts to pollinators and23

excessive agency delay in ensuring compliance with that condition.12 By letter of February 18,

24

2011, Defendants refused that suspension request.13

25
26
27

12
13

See Letter from Beyond Pesticide et al., supra note 1.
See Letter from Steven Bradbury, supra note 2.

28
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82.

1

Plaintiffs CFS, Beyond Pesticides, Steve Ellis, and Tom Theobald, along with a2

coalition of beekeepers and honey producers, and other public interest groups, submitted the3

Clothianidin Legal Petition to EPA to suspend the registration of clothianidin on March 20, 20124

(Docket No. EPA-HQ-OPP-2012-0334), rooted in the nine-year unreasonable delay in ensuring

5

full compliance with the “conditional registration” conditions for clothianidin products.14 They

6

followed that Petition with two supplemental filings, dated May 3, 2012, and June 18, 2012,7respectively.15 These consisted of information that came to light after the Petition was filed,8

including critical new data on how certain uses of clothianidin constitute an “imminent hazard”

9

to honey bees and other beneficial insects that compelled a decision to promptly suspend

10

clothianidin’s registration.
83.

11

By letter dated July 17, 2012, Defendants denied the portion of the Petition that

12

alleged an “imminent hazard” existed.16 That letter indicated EPA did not consider the May 3,

132012 and June 18, 2012 supplemental filings in making that decision. To date, the agency has

14

yet to issue a decision based on the supplemental evidence showing imminent hazard or on any

15of the other new science and extensive mass honey bee kill data that emerged after the Petition16

was filed.

17

84.

Defendant Bradbury’s letter of July 17, 2012, stated his denial of the imminent

18

hazard claim in the Petition was EPA’s “final action pursuant to section 16 of FIFRA” with19

respect to that claim. There was no Federal Register notice, no public hearing, and no20

opportunity for notice and comment prior to this final action. The EPA has yet to resolve any of21

the remaining claims in the Petition or to reconsider its denial of an “imminent hazard” based on

22

the full administrative record before it.
85.

23
24

The evidence Plaintiffs provided in the Clothianidin Legal Petition and in their

supplemental filings described an “unreasonable adverse effect on the environment” in terms of

25
26
27

14

See Clothianidin Legal Petition, supra note 3.
On file with Plaintiff CFS; see Docket No. EPA-HQ-OPP-2012-0334, available at
http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2012-0334.
16
See Letter from Steven Bradbury, supra note 4.
15

28
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1

a vast number of bee kills impacting likely many hundreds of U.S. and Canadian colonies and2tens of millions of valuable honey bees. These acute bee kills, which were ongoing during

3

EPA’s decision-making period on the Petition, are in addition to the ongoing chronic impacts of

4clothianidin. EPA’s July 17, 2012 letter admitted the agency did not consider the ongoing bee

5kills associated with spring corn planting or any other information received after May 3, 2012,6

including the numerous clothianidin-related bee kills during the ten weeks between May 3, 20127

and July 17, 2012.

8

86.

Additionally, EPA’s response letter and related documentation showed the agency

9

did not conduct any analysis of clothianidin’s effects on endangered or threatened species and10

failed to consult with FWS regarding its final agency action denying an imminent hazard.
87.

11
12

Virtually all the information Plaintiffs have filed with respect to the various risksof clothianidin also apply to its precursor compound, the very similar insecticide thiamethoxam.
88.

13

On October 16, 2012, Plaintiffs CFS, Beyond Pesticides, and Steve Ellis delivered

14

a letter to Defendants on thiamethoxam, setting forth how that compound raises risks that are15

essentially equivalent to the risks of clothianidin and seeking a suspension of its registration as

16

well.17 That letter cited to new evidence about the dangers of thiamethoxam, including direct17

bee kills suffered by Plaintiff Steve Ellis that EPA itself attributed to thiamethoxam and/or

18

clothianidin in an official Incident Report. While EPA acknowledged receipt of the letter, by a19

response letter to CFS dated February 27, 2013, EPA has refused that suspension request also.18
89.

20

On September 6, 2012, Plaintiffs CFS, Beyond Pesticides, the Sierra Club, Steve

21

Ellis, and Tom Theobald filed a “Sixty-Day Notice of Intent to Sue Pursuant to the Endangered

22

Species Act regarding Registration and Use Approvals of Clothianidin and Thiamethoxam,

23

Neonicotinoid Insecticides,” with Defendant Perciasepe’s predecessor (Lisa Jackson) and Ken

24

Salazar, the former Secretary of the Interior, U.S. Department of the Interior.19 More than sixty

25
26
27

17

See Letter from Plaintiffs, supra note 5.
See Letter from EPA, supra note 6.
19
See Sixty-Day Notice Letter, supra note 7.
18

28
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1days have passed since the Sixty-Day Notice Letter, which sought suspension of the registrations

2

involved, and neither EPA nor the Department of the Interior has responded or resolved the3ongoing ESA violation concerns raised in the Sixty-Day Notice Letter.

4

EPA Registration Process Facts90.

5

More than ten years ago, in February 2003, EPA issued a Risk Assessment for

6clothianidin seed treatment for corn and canola.20 EPA scientists raised serious concerns about

7

the compound and called for a field test evaluating its environmental hazards prior to8

registration, specifically citing harm to pollinators:

9

The possibility of toxic exposure to nontarget pollinators through the translocationof clothianidin residues that result from seed treatment (corn and canola) has
prompted EFED [the EPA Environmental Fate and Effects Division] to require
field testing that can evaluate the possible chronic exposure to honey bee larvaeand queen. In order to fully evaluate the possibility of this toxic effect, acomplete worker bee life cycle study must be conducted, as well as an evaluationof exposure and effects to the queen.21

10
11
12
13

91.

Less than two months later, in its Addendum to the Risk Assessment in April

14
2003, EPA reversed this position, recommending conditional registration while the registrant
15
arranged for the required chronic exposure study. In contrast to its prior memorandum, EPA
16
decided it would allow the nationwide sale and use of clothianidin while the registrant arranged
17
for the study necessary to determine whether its decision would be a grave mistake. EPA
18
provided no reason for its reversal; however, the second memorandum confirmed that EPA
19
determined a study evaluating the long term toxicity to pollinators was necessary as a condition
20
for registration. To date, for clothianidin, the requirement of a complete and adequate life cycle
21
study, and evaluation of exposure and effects to the queen bee, remains unmet. This also applies
22

in the case of thiamethoxam, as EPA’s pollinator field test conditions for it incorporated and23
mirrored the conditions imposed for clothianidin.
24
25
26
27

20

Memorandum: Risk Assessment for the Seed Treatment of Clothianidin 600FS on Corn and
Canola, PC Code 044309, EPA Environmental Fate and Effects Division 2 (Feb. 20, 2003),
available at http://www.epa.gov/pesticides/chem_search/cleared_reviews/csr_PC-044309_20Feb-03_a.pdf.
21
Id. at 2.

28
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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92.

1

On June 20, 2012, without a hearing, EPA issued a conditional registration to2

Syngenta Crop Protection for CruiserMaxx Vibrance Cereals, produced from thiamethoxam.

3

The approval document states:

4

Field Test for Pollinators (test guideline 850[.]3040)[:] An acceptable study mustbe submitted or cited no later than the time this study is required to be submitted
or cited for current thiamethoxam registrations.22

5
6
7

93.

This is a vague condition in violation of the FIFRA’s conditional registration

requirements because it neither sets nor refers to any limited time period for submitting the8pollinator field test study originally required nine years prior. It refers to an alleged “time this9

study is required to be submitted or cited for current thiamethoxam registrations” when there is10

no defined period to satisfy the pollinator study condition for the other thiamethoxam

11

registrations.23 EPA’s language violates the FIFRA requirement that periods for compliance12with conditions must be “limited” and is vague, unenforceable, and arbitrary and capricious. On

13
14

information and belief, numerous other thiamethoxam and clothianidin use approvals have thesame defects.

15
16
17
18
19
20
21
22
23
24

94.

In the case of clothianidin’s approval for use on corn and canola, since 2003, atleast the following additional conditions based on data gaps, beyond the field test for pollinators,
have remained unsatisfied, according to the most recent EPA records available to Plaintiffs: a)
Whole Sediment Acute Toxicity Invertebrates, Freshwater; b) Whole Sediment Acute Toxicity
Invertebrates, Estuarine and Marine; c) Aerobic Aquatic Metabolism; d) Seed Leaching Study;
and e) Small-Scale Prospective Groundwater Monitoring Study. Numerous other conditions anddata gaps also remain unsatisfied. The available records are less clear for thiamethoxam, but thesame defects appear to exist as for clothianidin. Some of these conditions were to have been met
within three years after being first imposed in 2003 for clothianidin, and two years after being
first imposed in 2000 for thiamethoxam. Those clothianidin conditions thus are still not met—up

25
26
27

22

EPA, Notice of Pesticide Registration, June 20, 2012, available at
http://www.epa.gov/pesticides/chem_search/ppls/000100-01383-20120620.pdf.
23
Id.

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1

to seven years after their deadline, and the thiamethoxam conditions are still not met—up to2

eleven years after their deadline.
95.

3

Ten to thirteen years exceeds the amount of time reasonably sufficient to generate4

the data needed to satisfy the conditions imposed on the variety of clothianidin and5thiamethoxam products in Appendices A and B, and for EPA to decide the registrations must be

6

suspended until the conditions are satisfied. See 7 U.S.C. § 136a(c)(7)(A). Delays of seven to7

eleven years past the original EPA-imposed deadlines are unreasonable and violate FIFRA’s

8

conditional registration requirements.
96.

9

EPA’s Registration Review process for thiamethoxam recognizes that, thirteen

10years after it first approved uses of this compound, the agency still lacks vital information about

11

its environmental effects. The EPA Registration Review “Thiamethoxam Final Work Plan”

12

admits the environmental fate database is “only partially fulfilled and several ecological effects

13

data gaps were also identified.” 24 It then lists at least twenty-five tests, studies, and other data

14

requirements that must be fulfilled, including, but not limited to, such basic information as:

15

850.2100 – Avian oral toxicity with a passerine
850.3030 – Honey bee toxicity of residues on foliage study
850.3040 – Field test for pollinators
850.1735 – Whole sediment acute toxicity invertebrates, freshwaterSpecial Study – Larval toxicity study (honey bee)Special Study – Residues, pollen and nectar
Special Study – Laboratory (chronic) pollinator feeding study (honey bee)25

16
17
18
19

97.

20

The Registration Review documents for clothianidin show substantially identical

21

information gaps. The minimum level of knowledge required under the conditional registration

22

provisions of the FIFRA to protect honey bees, other beneficial insects, and ecosystems

23

generally, from unreasonable adverse effects caused by these two insecticides, does not exist.
98.

24

EPA’s Registration Review process aims for the year 2018, per the agency’s

25
26
27

24

EPA, Thiamethoxam Final Work Plan for Registration Review, June 2012, available at
http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2011-0581-0024.
25
Id.

28
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1current schedule, before making a decision on the appropriateness of thiamethoxam’s and2clothianidin’s continuing registrations. Several Plaintiffs have formally commented on the3

dockets for these reviews, stating the schedule is unreasonably slow and inadequate in light of4

known risks, and urging EPA to commit to completing the reviews no later than the end of 2013,

5

but EPA has refused. EPA has provided no indication that it will fully decide on the pending

6

Clothianidin Legal Petition to suspend clothianidin’s registration prior to 2018.

7

99.

Instead, EPA has continued to allow the sale and use of multiple clothianidin and8thiamethoxam products even though the registrants failed to satisfy essential registration

9

conditions imposed as early as 2000 that are necessary to support the required “no unreasonable

10

adverse effects on the environment” determination. These conditions are not limited to11pollinator field tests; however, the failure to obtain an adequate field test of the impacts of

12clothianidin or thiamethoxam likely is the most serious source of EPA’s injury to the Beekeeper

13

and Honey Producer Plaintiffs.

14

100.

Available EPA records as of November 2012, indicated approximately eleven15“pending” outdoor use approvals for clothianidin and thiamethoxam. On information and belief,

16

these include the following registration numbers and names, but others may exist:

1724

Clothianidin#73049-UIE – VBC3
#73049-UOR – Clothianidin 7.5 MC#08NC01 – [unnamed]
Thiamethoxam#100-RUER – A16901B CP#100-RUEE – Mainspring Insecticide#100-RUEU – A16901B Turf
#100-RUUU – CruiserMAXX Potato Extreme#100-RULT – Avicta Complete Beans 500#100-RULI – Endigo ZCX#100-RULO – SYT0113#100-RUAN – SYT0511

25

101.

18
19
20
21
22
23

The agency is likely to approve all of these proposed future uses under its

26

conditional registration review process. 7 U.S.C. § 136a(c)(7). They present the same general27

risks to Plaintiffs and the environment and the same FIFRA and ESA violations as the already-28

approved uses.
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FIRST CLAIM

1
2
3
4
5

EPA’s Denial of Imminent Hazard from Clothianidin Products Violated the APA
102.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 101, as

though fully alleged herein.
103.

EPA’s final agency action, in denying an “imminent hazard” existed in response6

to Plaintiff s’ Clothianidin Legal Petition, failed to consider any of Plaintiffs’ supplemental

7

filings, the bee kills associated with spring corn planting, or any other information it received

8

after May 3, 2012. Ignoring this information available to the agency, including the hundreds of9ongoing clothianidin-related bee kills during the ten week period between May 3 and July 17,10

2012, when EPA issued its decision, was arbitrary and capricious. See 5 U.S.C. § 706(2).

11

104.

The agency did not fully consider the likelihood of an imminent hazard recurring

12

during the time required for a cancellation or change in classification proceeding, under 7 U.S.C.

13§ 136d(c)(1). The time for such a proceeding is likely up to two years. It was, and remains,14

foreseeable that hundreds of additional bee kills will be suffered by Plaintiffs and others in the15

now ongoing 2013 and 2014 spring planting seasons because of EPA’s failure to respond based

16

on the full 2012 spring bee kill information. EPA’s arbitrary and capricious actions violated the17

APA, and its failure to reconsider its imminent hazard determination to date, more than one year

18

after the Petition was filed, in view of the risks presented, constitutes unreasonable delay under19

the APA. See 5 U.S.C. § 706(1).

20

105.

EPA’s denial of “imminent hazard” has damaged and continues to damage

21

Plaintiffs. Plaintiff beekeepers are suffering severe ongoing economic and personal damages.

22

EPA allowed clothianidin products that are harmful to Plaintiffs to be used that EPA should have23

suspended; in particular, EPA allowed the continued use of clothianidin seed treatment products

24that foreseeably would damage the survival of the Beekeeper and Honey Producers’ bees during

25

2013 and 2014.

26
27
28
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1

SECOND CLAIM

2

EPA’s Denial of Imminent Hazard for Clothianidin Products Violated the ESA and the APA

3
4
5

106.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 105, as

though fully alleged herein.
107.

EPA’s final agency action, in denying an “imminent hazard” existed in response6

to Plaintiff s’ Clothianidin Legal Petition, was arbitrary and capricious. EPA’s determination

7

that no unreasonable hazard existed to endangered or threatened species, violated the ESA and8

the APA. The FIFRA’s definition of “imminent hazard” includes whether the pesticide9“involves unreasonable hazard to the survival of a species declared endangered or threatened by

10

the Secretary [of the Interior] pursuant to the [ESA].” 7 U.S.C. § 136(l). EPA failed to prepare11

the required effects analysis or to consult with FWS regarding impacts on endangered or

12threatened species in its final agency action denying an imminent hazard.

13

108.

In addition, EPA’s continuing authority over conditional and unconditional

14

clothianidin product registrations constitutes ongoing action, and it has violated its continuing

15

obligation to consider effects on endangered species in determining whether an imminent hazard

16

exists. New scientific information, including the supplemental bee kill data and other scientific

17

information submitted by Petitioner Plaintiffs that EPA failed to consider, shows effects of18

clothianidin on invertebrates and ecosystems and compels an ESA effects determination and19

consultation with FWS. EPA’s failure to consider effects on endangered species or consult with

20

FWS was arbitrary and capricious.

21

109.

EPA’s actions violated § 7(a) of the ESA and were arbitrary and capricious

22

actions under the APA. 5 U.S.C. § 706(2). EPA allowed clothianidin products that are harmful23

to endangered and threatened species to continue to be used, which EPA should have suspended,24

and damaged Plaintiffs’ interest in avoiding jeopardy to the survival of ESA-listed species and25

preventing adverse modification of their designated critical habitats.

26
27
28
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1

THIRD CLAIM

2

EPA’s Failure to Publish Notices of Pesticide Applications for Clothianidin Products Violated
the FIFRA and the APA

3
4
5
6
7
8
9
10
11
12
13
14

110.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 109, as

though fully alleged herein.
111.

For the vast majority of clothianidin registrations and changed use approvals,

EPA did not, as required, announce a “notice of receipt of application” or a “notice of issuance”
in the Federal Register or in any other public order or hearing.
112.

As indicated in Appendix A, on information and belief, only four clothianidin

registrations had any Federal Register notice of application and none had a notice of issuance.
On information and belief, EPA issued the following clothianidin new use registrations without
first publishing notices of application or issuance in the Federal Register, in violation of 7 U.S.C.
§ 136a(c)(4) and 40 C.F.R. § 152.102:
Clothianidin Product NameEPA Registration
NumberDate of Initial
Registration

Aloft GC SC Insecticide
Aloft LC SC Insecticide
Aloft GC G Insecticide
Aloft LC G Insecticide
Insecticide TD Concentrate
Flower, Rose, and Shrub Care II
Flower, Rose, and Shrub Care III
Insecticide TD GranulePoncho 600
AE 1283742
Titan FL
Prosper T400 Insecticide and Fungicide
Seed Treatment
Prosper T200 Insecticide and Fungicide
Seed Treatment
Poncho Beta
Three-Way VAP
Sepresto 75 WS
Proceed Plus
Poncho/Votivo
Prosper Evergol

66330-365
66330-366
66330-367
66330-368
72155-8272155-94
72155-95
72155-96
264-789264-846264-984264-1034

10/18/2007
10/18/2007
10/18/2007
10/18/2007
01/28/2008
08/24/2009
07/30/2009
12/28/2009
05/30/2003
05/30/2007
07/01/2003
11/14/2006

264-1035

12/14/2006

264-1056
264-1079
264-1081
264-1082
264-1109264-1121

03/07/2008
11/21/2008
04/28/2010
01/29/2010
03/16/2010
05/11/2012

15
16
17
18
19
20
21
22
23
24
25
26
27
28

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35

Case3:13-cv-01266-LB Document17 Filed05/31/13 Page36 of 52

7

Emesto Quantum
Poncho/GB 126
VBC3 Insecticide
Darlex InsecticideV-10170 16 WSG Insecticide
Arena 0.5G
V-10170 0.25G InsecticideV-10170 0.25G GL Insecticide
Inovate Seed Protectant
NipsIt Suite Cereals of Seed Protectant
NipsIt Suite Canola Seed Protectant
Inovate Neutral Seed Protectant

8

Thus, a number of approvals lacked the public notice and opportunity for public comment

9

required under 7 U.S.C. § 136a(c)(4) and 40 C.F.R. § 152.102. Those approvals included new

10clothianidin uses on crops and habitats where Beekeeper and Honey Producer Plaintiffs’ honey11

bees foraged and pollinated. Additionally, on information and belief, for each of the clothianidin

12

insecticide uses and products, EPA also failed to meet this requirement: “within 30 days after the13

Administrator registers a pesticide under this Act the Administrator shall make available to the14

public the data called for in the registration statement.” 7 U.S.C. § 136a(c)(2)(A).

1
2
3
4
5
6

15

113.

264-1125264-1132
73049-482
73049-467
59639-153 / 66330-52
59639-156 / 66330-53
59639-157 / 66330-70
59639-16459639-17659639-183
59639-184
59639-187

05/11/2012
04/29/2011
09/25/2012
03/18/2010
02/23/2005
11/30/2004
10/02/2006
01/27/2009
06/21/2011
12/21/2011
01/06/2012
01/25/2012

EPA’s failure to provide Plaintiffs with the FIFRA-mandated notices of

16

application and issuance for the clothianidin registrations and changed uses in the Federal

17

Register, its denial of public comment opportunities, and its failure to make its registration data

18

available to the public within thirty days, denied Plaintiffs and the public the ability to submit

19

information to EPA that may have convinced the agency not to issue those approvals in the first20

instance, or to cancel them after they were issued, and denied Plaintiff Beekeepers knowledge

21

that would have allowed them to protect their honey bees. EPA allowed the use of products that22

cause unreasonable adverse effects and are harmful to Plaintiffs.

23

114.

EPA’s failure to publish the Federal Register notices as required under 7 U.S.C.

24§ 136a(c)(4) and 40 C.F.R. § 152.102, or to provide data required under 7 C.F.R. § 136a(2)(A),25

establishes that these clothianidin products were approved “without observance of procedure26

required by law,” in violation of the APA. 5 U.S.C. § 706(2)(D).

27
28
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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FOURTH CLAIM

1
2
3
4
5
6
7
8
9
10
11

EPA’s Failure to Publish Notices of Pesticide Applications for Thiamethoxam Products
Violated the FIFRA and the APA
115.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 114, as

though fully alleged herein.
116.

For the vast majority of thiamethoxam registrations and changed use approvals,

EPA did not, as required, announce a “notice of receipt of application” or a “notice of issuance”
in the Federal Register or in any other public order or hearing.
117.

As indicated in Appendix B, on information and belief, EPA issued the following

thiamethoxam new use registrations without first publishing notices of application or issuance in
the Federal Register, in violation of 7 U.S.C. § 136a(c)(4) and 40 C.F.R. § 152.102:

12

Thiamethoxam Product Name

13

Xamox TechnicalXamox 30L
Xamox 10TK
Xamox 100 SL
Dyna-Shield Thiamethoxam Fungicide
Agita 1GB Fly Bait
Agita 10 WG
Helix XTra Insecticide with Fungicides
Actara Insecticide
Platinum Insecticide
Cruiser Insecticide
Meridian 25WG
Flagship 25WG
Flagship 0.22G
Meridian 0.33G
Helix Insecticide with Fungicides
Platinum Ridomil Gold
Centric 40WG
Cruiser XL Insecticide and Fungicide PrePack
Cruiser Extreme
Thiamethoxam 240 SC Manufacturing Use Product
CruiserMaxx
CruiserMaxx Potato Insecticide and Fungicide
Adage - Maxim 4FS Twinpack
Actara 240 SC Insecticide
Optigard Ant Gel Bait
Thiamethoxam Ant Killer Gel

14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

EPA Registration
Number43813-29
43813-30
43813-31
43813-36
34704-939
70585-970585-10
100-935
100-938
100-939
100-941
100-943
100-955
100-960
100-961
100-973
100-974
100-1147
100-1184
100-1208
100-1246
100-1247
100-1248
100-1249
100-1250
100-1260
100-1261

FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

Date of Initial
Registration
10/21/2002
07/28/2006
05/30/2006
05/23/2006
07/10/2006
12/08/2010
12/08/2010
12/04/2000
05/17/2001
05/17/2001
12/04/2000
02/15/2007
07/30/2003
02/23/2007
02/23/2007
12/04/2000
05/17/2001
04/11/2002
02/05/2004
03/28/2005
09/6/2006
05/24/2006
05/25/2006
04/14/2006
01/18/2007
04/4/2007
04/4/200737

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1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

Endigo ZC
THX/MXM/FDL CZ
Thiamethoxam Lawn & Landscape 0.33G
Thiamethoxam Lawn & Landscape 0.22G
Platinum 75 SG Insecticide
Thiamethoxam 0.02/Lambda-Cyhalothrin
CruiserMaxx Cereals
DurivoVoliam Flexi Insecticide
Avicta Duo
Thiamethoxam 0.40/Lambda-cyhalothrin 0.16 ME
Concentrate
Thiamethoxam 0.010/Lambda-cyhalothrin 0.004
ME RTU
Meridian 0.20G
Meridian 0.14G
Agri-Flex Miticide/Insecticide
Avicta Duo 250
Cruiser PD Insecticide
Difenoconazole 0.170/Thiamethoxam
0.010/Lambda-cyhalothrin 0.004 ME RTU
Difenoconazole 0.66/Thiamethoxam 0.40/Lambdacyhalothrin 0.16 ME Concentrate
CruiserMaxx Rice
Optigard Liquid Ant Bait
Cruisermaxx Vibrance Cereals
Four-Way VAP
Avicta Complete Corn 500
Avicta Complete Corn 250
Caravan G
THX_MXM_FDL_TBZ FS
CruiserMaxx EZ
Derby
TandemCruiserMaxx Peanuts
Solvigo Miticide/Insecticide
Adage Delux
Adage Premier
Avicta complete beans
Endigo ZCXSYT0511100-1276
100-1283
100-1288
100-1289
100-1291
100-1304
100-1305
100-1318
100-1319
100-1321
100-1334

08/21/2007
09/20/2007
11/02/2007
11/02/2007
01/17/2008
04/04/2008
04/16/2008
08/26/2008
08/25/2008
10/31/2008
05/12/2009

100-1336

05/12/2009

100-1341
100-1346
100-1350
100-1353
100-1365
100-1366

06/22/2009
07/01/2009
04/06/2010
10/27/2009
08/05/2011
08/05/2011

100-1367

08/05/2011

100-1369
100-1370
100-1383
100-1384
100-1399
100-1405
100-1415
100-1426
100-1427
100-1436
100-1437
100-1438
100-1440
100-1449
100-1450
100-1457
100-1458
100-1460

07/20/2010
08/02/2010
06/20/2012
10/29/2010
06/15/2011
10/19/2011
01/11/2012
02/02/2012
02/02/2012
04/23/2012
04/23/2012
04/30/2012
06/21/2012
08/23/2012
08/23/2012
01/15/2013
01/23/2013
01/30/2013

A large number of the listed pesticides products above are not potentially covered under any
prior notice of application that was published in the Federal Register. Thus, the vast majority of
approvals lacked the public notice and opportunity for public comment required under 7 U.S.C.
§ 136a(c)(4) and 40 C.F.R. § 152.102. Those approvals included new thiamethoxam uses on
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1

crops and habitats where the Beekeeper and Honey Producer Plaintiffs’honey bees foraged and2pollinated. On information and belief, for each of the thiamethoxam insecticide uses and3

products, EPA also failed to meet this requirement: “within 30 days after the Administrator

4

registers a pesticide under this Act the Administrator shall make available to the public the data

5

called for in the registration statement.” 7 U.S.C. § 136a(c)(2)(A).

6

118.

EPA’s failure to provide Plaintiffs with the FIFRA-mandated notices of7

application and issuance for the thiamethoxam registrations and changed uses in the Federal

8

Register, its denial of public comment opportunities, and its failure to make its registration data

9

available to the public within thirty days, denied Plaintiffs and the public the ability to submit

10

information to EPA that may have convinced the agency not to issue those approvals in the first11

instance, or to cancel them after they were issued, and denied Plaintiff Beekeepers knowledge

12

that would have allowed them to protect their honey bees. EPA has allowed the uses of

13

products that cause unreasonable adverse effects and are harmful to Plaintiffs.

14

119.

EPA’s failure to publish the Federal Register notices as required under 7 U.S.C.

15§ 136a(c)(4) and 40 C.F.R. § 152.102, or to provide data required under 7 C.F.R. § 136a(2)(A),

16

establishes that these thiamethoxam products were approved “without observance of procedure17

required by law,” in violation of the APA. 5 U.S.C. § 706(2)(D).
FIFTH CLAIM

18
19
20
21
22
23
24
25
26
27
28

EPA Violated the FIFRA Conditional Registration Requirements and the APA for
Conditionally-Registered Clothianidin Products
120.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 119, as

though fully alleged herein.
121.

On information and belief, of the registered uses of clothianidin identified inAppendix A, approximately twenty-three registrations are still registered as “conditional.” A
reasonable time for the conditions on these product registrations to be met, including but notlimited to the adequate pollinator field study condition, has long passed. EPA has been arbitrary
and capricious and violated the FIFRA’s conditional registration provisions, which requirecompliance with conditions imposed within a limited, reasonable period. The FIFRA language
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1

is mandatory, providing EPA “shall issue a notice of intent to cancel a [conditional] registration

2. . . if . . . at the end of the period provided for satisfaction of any condition imposed, that3

condition has not been met.” 7 U.S.C. § 136d(e)(1) (emphasis added). EPA’s own regulations

4

are clear that the time for compliance is limited. See 40 C.F.R. § 152.114-115. On information

5and belief, the original EPA-imposed deadlines for meeting the conditions—three years in the6case of clothianidin’s initial product registration—have been violated. On information and7belief, EPA has unreasonably delayed for up to nine years in some cases and failed to issue any

8such notice for these approximately twenty-three conditional registrations.

9

122.

EPA has allowed impermissibly vague conditions for conditional registrations

10

that neither state nor refer to a limited time period for achievement. In some cases, such as the11pollinator field test study, EPA has, without a hearing, placed the conditions “in reserve,” with

12

no time period for achieving them, which violates the conditional registration requirements.

13

Despite repeated formal requests from the Plaintiffs, the Defendants’ duty to ensure compliance14with the clothianidin registration conditions has been unlawfully withheld and unreasonably

15

delayed, in violation of the FIFRA, 7 U.S.C. § 136a(c)(7), and the APA, 5 U.S.C. § 706(1).

16

123.

EPA’s actions have damaged Plaintiffs. EPA’s failure to timely ensure

17

compliance with the registration conditions it imposed has allowed clothianidin products that18

cause unreasonable adverse effects and are harmful to Plaintiffs to continue to be used, products

19that EPA should have suspended.
SIXTH CLAIM

20
21
22
23
24
25
26
27
28

EPA Violated the FIFRA Conditional Registration Requirements and the APA for
Conditionally-Registered Thiamethoxam Products
124.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 123, as

though fully alleged herein.
125.

On information and belief, of the registered uses of thiamethoxam identified inAppendix B approximately fifty-four registrations are still registered as “conditional.” A
reasonable time for the conditions on these product registrations to be met, including but notlimited to the adequate pollinator field study condition, has long passed. EPA has been arbitrary
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1

and capricious and violated the FIFRA’s conditional registration provisions, which require2

compliance with conditions imposed within a limited, reasonable period. The FIFRA language

3

is mandatory, providing EPA “shall issue a notice of intent to cancel a [conditional] registration

4. . . if . . . at the end of the period provided for satisfaction of any condition imposed, that5condition has not been met.” 7 U.S.C. § 136d(e)(1) (emphasis added). EPA’s own regulations

6

are clear that the time for compliance is limited. See 40 C.F.R. § 152.114-115. On information

7

and belief, the original EPA-imposed deadlines for meeting the conditions—two years in the8case of thiamethoxam’s initial product registration—have been violated On information and9belief, EPA has unreasonably delayed for up to eleven years in some cases and failed to issue

10

any such notice for these approximately fifty-four conditional registrations.

11

126.

EPA has allowed impermissibly vague conditions for conditional registrations

12

that neither state nor refer to a limited time period for achievement. In some cases, such as the13

pollinator field test study, EPA has, without a hearing, placed the conditions “in reserve,” with

14

no time period for achieving them, which violates the conditional registration requirements.

15

Despite repeated formal requests from the Plaintiffs, the Defendants’ duty to ensure compliance16with the thiamethoxam registration conditions has been unlawfully withheld and unreasonably

17

delayed, in violation of the FIFRA, 7 U.S.C. § 136a(c)(7), and the APA, 5 U.S.C. § 706(1).

18

127.

EPA’s actions have damaged Plaintiffs. EPA’s failure to timely ensure

19

compliance with the registration conditions it imposed has allowed thiamethoxam products that20

cause unreasonable adverse effects and are harmful to Plaintiffs to continue to be used, products

21that EPA should have suspended.

22
23
24
25
26
27
28

SEVENTH CLAIM
EPA Violated the FIFRA Requirements and the APA for Unconditionally-Registered
Clothianidin Products
128.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 127, as

though fully alleged herein.
129.

EPA has unconditionally registered numerous clothianidin products for outdoor

use despite missing data on this pesticide. EPA’s classification of clothianidin products as
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1

unconditional, despite outstanding data gaps and conditions, violates the FIFRA’s provisions for2

unconditional registration. Compare 7 U.S.C. § 136a(c)(5) with 7 U.S.C. § 136a(c)(7).

3

130.

For example, on April 22, 2010, without a hearing, EPA notified Valent U.S.A.

4

Corporation that its Clothianidin Technical product, which is the foundation for clothianidin

5

formulations and was previously conditionally registered, was reclassified to unconditional. On

6

information and belief, numerous other clothianidin product uses were similarly reclassified. For

7

Clothianidin Technical and all other products whose registrations are no longer conditional, the8removal or lifting of the conditions was arbitrary and capricious and in violation of the FIFRA’s

9

conditional registration provisions because the conditions were not fully met before they were10

removed.

11

131.

On information and belief, EPA has classified fourteen clothianidin products are12

as unconditional despite the failure of the registrants to fill existing data gaps and comply with13

the past conditions, including at least the following registration numbers and names:

14
15
16
17
18
19
20
21
22
23
24

Clothianidin# 264-984 – Titan FL# 264-1121 – Prosper Evergol# 264-1125 – Emesto Quantum# 59639-153 – V-10170 16 WSG insecticide# 59639-156 – Arena 0.5 G# 59639-173 – V-10170 0.25 G insecticide# 59639-176 – Inovate seed protectant# 59639-183 – Nipsit suite cereals of seed protectant# 59639-184 – Nipsit suite canola seed protectant# 59639-187 – Inovate neutral seed protectant# 72155-96 – Insecticide TD Granule# 73049-467 – Darlex insecticide# FL 11001 – Arena 50 WDG Insecticide# ID 060015 – Poncho 600
None of these products otherwise meet the criteria for unconditional registration.
132.

EPA’s classification of these clothianidin products as unconditional registrations

25

while maintaining the conditional registrations for numerous other clothianidin products is26

inconsistent, arbitrary, capricious, and is in violation of the FIFRA’s requirements for

27

conditional registrations and the APA. EPA’s actions alleged herein contradicted the earlier

28
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1

requests by Plaintiffs that the condition classifications be maintained and that full compliance2with the pollinator field test condition, in particular, be compelled. Further, EPA’s action of

3

issuing unconditional registrations despite a preponderance of evidence that these clothianidin

4

products, when used in accordance with widespread and commonly recognized practice, cause5

unreasonable adverse effects on the environment, violated the FIFRA and the APA.

6

133.

EPA’s actions have damaged Plaintiffs. EPA’s failure to fully enforce the7conditions it imposed has allowed clothianidin products that cause unreasonable adverse effects

8

and are harmful to Plaintiffs to continue to be used, products that EPA should have suspended.

9

EIGHTH CLAIM

10
11
12
13
14

EPA Violated the FIFRA Requirements and the APA for Unconditionally-Registered
Thiamethoxam Products
134.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 133, as

though fully alleged herein.
135.

EPA has unconditionally registered numerous thiamethoxam products despite

15

missing data on this pesticide. EPA’s classification of these thiamethoxam products as

16

unconditional, despite outstanding data gaps and conditions, violates the FIFRA’s provisions for

17

unconditional registration. Compare 7 U.S.C. § 136a(c)(5) with 7 U.S.C. § 136a(c)(7).

18

136.

For all thiamethoxam products whose registrations are no longer conditional, the19removal or lifting of the conditions was arbitrary and capricious and in violation of the FIFRA’s

20

conditional registration provisions because the conditions were not fully met before they were21

removed.

22

137.

On information and belief, EPA classified seven thiamethoxam products as23

unconditional despite the failure of the registrants to fill data gaps and meet missing conditions,24

including at least the following registration numbers and names:

25
26
27
28

Thiamethoxam# 100-1184 – Cruiser XL insecticide and fungicide prepack# 100-1246 – Thiamethoxam 240 SC manufacturing product# 100-1365 – Cruiser PD insecticide# 100-1369 – Cruisermaxx rice
# 100–1405 – Avicta complete corn
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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12
3# 100-1415 – Caravan G# 34704-939 – Dyna-shield thiamethoxam fungicide
None of these products otherwise meet the criteria for unconditional registration.
138.

EPA’s classification of these products as unconditional registrations while4

maintaining the conditional registrations and outstanding data requirements on numerous other5thiamethoxam products is inconsistent, arbitrary, capricious, and is in violation of the FIFRA’s

6

requirements for conditional registrations and the APA. EPA’s actions alleged herein

7

contradicted the earlier requests by Plaintiffs that the condition classifications be maintained and8that full compliance with the pollinator field test condition, in particular, be compelled. Further,9

EPA’s actions of issuing unconditional registrations despite a preponderance of evidence that

10

these thiamethoxam products, when used in accordance with widespread and commonly

11

recognized practice, cause unreasonable adverse effects on the environment, violated the FIFRA

12

and the APA.

13

139.

EPA’s actions have damaged Plaintiffs. EPA’s failure to fully enforce the14

conditions it imposed has allowed thiamethoxam products that cause unreasonable adverse

15

effects and are harmful to Plaintiffs to continue to be used, products that EPA should have16

suspended.

17
18
19
20
21
22
23
24

NINTH CLAIM
EPA is Violating the FIFRA Suspension Requirements and the APA for Clothianidin
Products
140.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 139, as

though fully alleged herein.
141.

When used in accordance with widespread and commonly recognized practice,clothianidin currently causes unreasonable adverse effects on the environment.
142.

The legal burden of showing that any pesticide and any approved uses meet the25

FIFRA criteria to be eligible for continued registration rests with the products’ proponents. See

26

40 C.F.R. § 154.5. The proponents of clothianidin’s numerous uses have not met that burden.

27
28

143.

Plaintiffs have repeatedly formally requested EPA to suspend the registrations for

clothianidin products, listed in Appendix A, and the agency has refused. EPA’s failure to
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1

suspend the registrations of these products in view of their unreasonable adverse effects violates2

the FIFRA, 7 U.S.C. § 136d(b), and the APA, 5 U.S.C. § 706(1)-(2).

3

144.

EPA’s actions are damaging Plaintiffs as previously stated herein. EPA’s

4

ongoing failure to suspend the clothianidin registrations is allowing these products, which cause5

unreasonable adverse effects and are harmful to Plaintiffs, to continue to be used without

6

restrictions across the nation.

7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24

TENTH CLAIM
EPA is Violating the FIFRA Suspension Requirements and the APA for Thiamethoxam
Products
145.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 144, as

though fully alleged herein.
146.

When used in accordance with widespread and commonly recognized practice,thiamethoxam currently causes unreasonable adverse effects on the environment.
147.

The legal burden of showing that any pesticide and any approved uses meet the

FIFRA criteria to be eligible for continued registration rests with the products’ proponents. See
40 C.F.R. § 154.5. The proponents of thiamethoxam’s numerous uses have not met that burden.
148.

Plaintiffs have repeatedly formally requested EPA to suspend the registrations forthiamethoxam products, listed in Appendix B, and the agency has refused. EPA’s failure tosuspend the registrations of these products in view of their unreasonable adverse effects violates
the FIFRA, 7 U.S.C. § 136d(b), and the APA, 5 U.S.C. § 706(1)-(2).
149.

EPA’s actions are damaging Plaintiffs as previously stated herein. EPA’s

ongoing failure to suspend the thiamethoxam registrations is allowing these products, whichcause unreasonable adverse effects and are harmful to Plaintiffs, to continue to be used without
restrictions across the nation.
ELEVENTH CLAIM

25
26
27
28

EPA Violated the FIFRA’s Labeling Requirements for Clothianidin Products
150.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 149, as

though fully alleged herein.
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1

151.

Clothianidin product labels have warnings about bee hazards generally; however,2

they are inadequate and inconsistent across various registered products. The label warnings,

3even if followed, violate labeling requirements as they do not advise the farmer, applicator, or4other user how to avoid the harms that the labels acknowledge and are not “adequate to protect

5

health and the environment,” in violation of the FIFRA. 7 U.S.C. § 136(q)(1)(F).

6

152.

One such harm is contaminated dust from planting of treated seeds, a source of7

repeated major beekills for which EPA lacks authority to effectively enforce label warnings in

8ways that can prevent the kills from reoccurring. EPA has admitted current labeling is

9inadequate. It is arbitrary and capricious for EPA to continue to rely on inconsistent product10labels that are inadequate to fully warn of clothianidin’s environmental risks and that the agency

11lacks the ability to enforce.

12

153.

EPA’s actions have damaged Plaintiffs. EPA’s failure to comply with the

13

FIFRA’s labeling requirements has allowed uses of clothianidin products according to their

14labels in ways that that are harmful to Plaintiffs. Such harms would be avoided if the products

15

included consistent, adequate warnings and directions.

16
17
18
19
20

TWELFTH CLAIM
EPA Violated the FIFRA’s Labeling Requirements for Thiamethoxam Products
154.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 153, as

though fully alleged herein.
155.

Thiamethoxam product labels have warnings about bee hazards generally;

21

however, they are inadequate and inconsistent across various registered products. The label

22

warnings, even if followed, violate labeling requirements as they do not advise the farmer,

23

applicator, or other user how to avoid the harms that the labels acknowledge and are not24“adequate to protect health and the environment,” in violation of the FIFRA. 7 U.S.C.

25§ 136(q)(1)(F).

26

156.

One such harm is contaminated dust from planting of treated seeds, a source of27

repeated major beekills for which EPA lacks authority to effectively enforce label warnings in28

ways that can prevent the kills from reoccurring. EPA has admitted current labeling is
FIRST AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF

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1

inadequate. It is arbitrary and capricious for EPA to continue to rely on inconsistent product2labels that are inadequate to fully warn of thiamethoxam’s environmental risks and that the3agency lacks the ability to enforce.

4

157.

EPA’s actions have damaged Plaintiffs. EPA’s failure to comply with the

5

FIFRA’s labeling requirements has allowed uses of thiamethoxam products according to their

6labels in ways that that are harmful to Plaintiffs. Such harms would be avoided if the products

7

included consistent, adequate warnings and directions.
THIRTEENTH CLAIM

8
9
10
11
12

EPA’s Actions in Approving Clothianidin Products and Labels Violated the ESA
158.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 157, as

though fully alleged herein.
159.

Prior to registering the approximately thirty-five clothianidin products listed in

13

Appendix A over the last ten-year period, EPA violated Section 7 of the ESA by failing to: a)

14

ensure, in consultation with FWS, that the EPA-approved uses of clothianidin would not be

15likely to jeopardize the continued existence of any threatened or endangered species or result in16

the destruction or adverse modification of the critical habitat of such species; b) request from17

FWS information on whether any threatened or endangered species, or designated critical

18

habitat, may be present within or near the areas of the proposed uses; c) prepare, at the earliest

19

possible time, a biological assessment to determine whether any threatened and endangered20

species may be affected by the proposed uses or the agency’s changes from the conditional

21

classification for those uses; d) engage in consultation with FWS regarding the potential adverse

22

effects of clothianidin on threatened and endangered species and critical habitat; and e) ensure

23

that the agency, registrants, and users of clothianidin products would not make any irreversible

24

or irretrievable commitment of resources with respect to the sale and use of these compounds

25

prior to EPA initiating and completing consultation with FWS. EPA’s Section 7 failures26

occurred despite clear evidence in the agency’s own risk assessment documents that EPA’s

27

actions would adversely affect particular listed species and posed a risk to broad suites of listed

28
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species. These actions constitute a violation of the ESA within the meaning of 16 U.S.C.

2§ 1540(g).

3

160.

Scientific information on the impacts of clothianidin on invertebrates, birds, and4ecosystems compels ESA § 7 effects determinations and consultation with FWS. Such

5

information includes, but is by no means limited to, the March 2013 report by the American Bird

6

Conservancy, which shows high direct and indirect mortality risks to a broad suite of birds from7

clothianidin products. EPA’s continuing authority over the conditional and unconditional

8

registrations of these insecticidal products constitutes ongoing action and it has violated its

9continuing obligation to follow the requirements of the ESA.

10

161.

EPA further failed to comply with Section 7 of the ESA when it approved the11label language for the clothianidin products listed in Appendix A; the products pose adverse

12

effects to ESA-listed species because of this failure.

13

162.

EPA’s failures to comply with the ESA have allowed the clothianidin products to14

directly and indirectly harm and otherwise “take” federally-listed species, including, but not

15

limited to, plant pollinators and birds, and have also adversely impacted critical habitats,16

damaging Plaintiffs’ ability to enjoy and utilize those species and habitats and Plaintiffs’

17interests in their existence and well-being.
FOURTEENTH CLAIM

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EPA’s Actions in Approving Thiamethoxam Products and Labels Violated the ESA
163.

Plaintiffs reallege and incorporate by reference Paragraphs 1 through 162, as

though fully alleged herein.
164.

Prior to registering the approximately sixty-eight thiamethoxam products listed in

23

Appendix B over the last thirteen-year period, EPA violated Section 7 of the ESA by failing to:

24a) ensure, in consultation with FWS, that the EPA-approved uses of thiamethoxam would not be

25

likely to jeopardize the continued existence of any threatened or endangered species or result in26

the destruction or adverse modification of the critical habitat of such species; b) request from27

FWS information on whether any threatened or endangered species, or designated critical

28

habitat, may be present within or near the areas of the proposed uses; c) prepare, at the earliest
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possible time, a biological assessment to determine whether any threatened and endangered2

species may be affected by the proposed uses or the agency’s changes from the conditional

3classification for those uses; d) engage in consultation with FWS regarding the potential adverse

4

effects of thiamethoxam on threatened and endangered species and critical habitat; and e) ensure

5

that the agency, registrants, and users of thiamethoxam products would not make any irreversible

6

or irretrievable commitment of resources with respect to the sale and use of these compounds

7

prior to EPA initiating and completing consultation with FWS. EPA’s Section 7 failures8

occurred despite clear evidence in the agency’s own risk assessment documents that EPA’s

9actions would adversely affect particular listed species and posed a risk to broad suites of listed

10

species. These actions constitute a violation of the ESA within the meaning of 16 U.S.C.

11§ 1540(g).

12

165.

Scientific information on the impacts of thiamethoxam on invertebrates, birds,

13and ecosystems compels ESA § 7 effects determinations and consultation with FWS. Such

14

information includes, but is by no means limited to, the March 2013 report by the American Bird

15

Conservancy, which shows high direct and indirect mortality risks to a broad suite of birds from

16

thiamethoxam products. EPA’s continuing authority over the conditional and unconditional

17

registrations of these insecticidal products constitutes ongoing action and it has violated its

18

continuing obligation to follow the requirements of the ESA.

19

166.

EPA further failed to comply with Section 7 of the ESA when it approved the20label language for the thiamethoxam products listed in Appendix B; the products pose adverse

21

effects to ESA-listed species because of this failure.

22

167.

EPA’s failures to comply with the ESA have allowed the thiamethoxam products

23

to directly and indirectly harm and otherwise “take” federally-listed species, including, but not

24

limited to, plant pollinators and birds, and have also adversely impacted critical habitats,25

damaging Plaintiffs’ ability to enjoy and utilize those species and habitats and Plaintiffs’

26interests in their existence and well-being.

27
28
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PRAYER FOR RELIEF

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3

WHEREFORE, Plaintiffs respectfully request that this Court enter an Order:
168.

Direct EPA to fully consider the information Plaintiffs submitted and the effects

4

on ESA-listed species on the question of “imminent hazard” of clothianidin use. The Court

5

should order EPA to reconsider its final action of July 17, 2012, when Defendants denied an

6

imminent hazard pursuant to the Plaintiffs’ Petition to suspend clothianidin without considering

7

the full information filed by Plaintiffs and without consulting with FWS under the ESA on

8

whether a hazard was posed to threatened and endangered species and their critical habitats. The

9

Court should direct EPA to consider all of the information filed related to imminent hazard, to10

consult with FWS under Section 7 of the ESA, and to issue a new decision on the question of

11

imminent hazard.

12

169.

Declare that all of clothianidin’s and thiamethoxam’s registrations and changed

13

use approvals, for which a “notice of receipt of application” and/or a “notice of issuance” were14

not published in the Federal Register, are in violation of the FIFRA and its implementing

15

regulations, and vacate them. The Court should issue a declaratory judgment that those

16

approvals lacking public notices and an opportunity for public comments violated 7 U.S.C.

17§ 136a(c)(4) and 40 C.F.R. § 152.102; and that those approvals should be vacated until and18

unless EPA provides such notices and opportunity.

19

170.

Declare that clothianidin’s and thiamethoxam’s conditional and unconditional use

20

approvals violated the FIFRA and vacate them. The Court should issue a declaratory judgment

21

that compliance with the conditions EPA placed on the pesticide registrations at issue has been

22

unlawfully withheld and unreasonably delayed under the FIFRA and the APA, and should vacate

23

them. Further, the Court should issue a declaratory judgment that EPA’s removal of conditions

24

and allowance of unconditional registrations for multiple thiamethoxam and clothianidin

25

products violated the FIFRA’s conditional use provisions, was arbitrary and capricious, and26

caused unreasonable adverse effects to the environment. The Court should vacate these unlawful

27

registrations.

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171.

Order EPA to immediately suspend the registrations of clothianidin and2thiamethoxam. The Court should direct EPA to suspend all approved outdoor uses of3

clothianidin and thiamethoxam, and issue a stop sale, use or removal order for all such approved

4

outdoor products, pending compliance with the many unsatisfied conditional registration5

requirements to provide outstanding safety data including, but not limited to, the preparation,

6

publication, and agency review of a field study sufficient to support a finding that these7

compounds do not pose unreasonable adverse effects to honey bees and other insect pollinators.

8

172.

Direct EPA to cure clothianidin’s and thiamethoxam’s inadequate labels. The

9

Court should declare that clothianidin and thiamethoxam products are misbranded with labels

10

and use directions that are inadequate to prevent unreasonable adverse effects to the11environment, to beekeepers and honey producers, and to ESA-listed species. The Court should

12order EPA to develop new product labels and directions fully adequate to advise users on how to13

prevent these adverse effects.

14

173.

Direct EPA to comply with the ESA. The Court should order EPA to comply

15with the ESA by making the required “effects” determinations, and initiating and completing

16

consultation with FWS concerning clothianidin and thiamethoxam products’ impacts on native

17

endangered and threatened species and their critical habitats. The Court should order EPA to18

ensure that uses of these insecticides do not “take” threatened and endangered species or affect19

their critical habitats without appropriate mitigation and should enjoin any further use of the20

insecticides prior to completion of the ordered consultations.

21

174.

Enjoin proposed new clothianidin and thiamethoxam product uses. The Court

22

should enjoin EPA from approving any pending outdoor use approvals for clothianidin or

23

thiamethoxam, or any other future proposed outdoor uses of them, until the agency complies

24

with all of the Requests for Relief herein for the currently registered uses to avoid unreasonable

25

adverse effects to Plaintiffs and on the environment.

26
27
28

175.

Award Plaintiffs the costs of this litigation, including reasonable attorneys’ feesand expert witness fees; and176.

Grant such other relief as the Court deems just and proper.

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2

Respectfully submitted this 31st day of May, 2013.

3

10/s/ Sylvia Shih-Yau Wu
SYLVIA SHIH-YAU WU (State Bar No. 273549)
GEORGE A. KIMBRELL (Pro Hac Vice)
PETER T. JENKINS (Pro Hac Vice)
PAIGE M. TOMASELLI (State Bar No. 237737)
Center for Food Safety
303 Sacramento Street, 2nd Floor
San Francisco, CA 94111
T: (415) 826-2770 / F: (415) 826-0507
Emails: gkimbrell@centerforfoodsafety.org
pjenkins@centerforfoodsafety.org
ptomaselli@centerforfoodsafety.org
swu@centerforfoodsafety.org

11

Counsel for Plaintiffs

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