Ms. Margaret Cherny

Vice President of Regulatory, 

 Government Affairs and 

 Communications

Bayer CropScience LP

2 T.W. Alexander Drive

Research Triangle Park, NC 27709

Mr. Richard Stanton

Vice President of Technology

Valent U.S.A. Corporation

1600 Riviera Avenue, Suite 200

P.O. Box 8025

Walnut Creek, CA 94596-8025

June 12, 2012

Ms. Lois Rossi

Director, Registration Division 

Office of Pesticide Programs

U.S. Environmental Protection Agency

Ariel Rios Building

1200 Pennsylvania Avenue, NW

Washington DC 20460

Re: Preliminary Comments on March 2012 Petition Concerning Clothianidin

Dear Ms. Rossi:

Bayer CropScience LP (“Bayer”) and Valent U.S.A. Corporation (“Valent”) respectfully

submit these preliminary comments regarding the “Emergency Citizen Petition” filed with the 

U.S. Environmental Protection Agency (“EPA”) on March 20, 2012, by the Pesticide Action 

Network North America (“PANNA”), Beyond Pesticides, the Center for Food Safety, and certain 

individual commercial beekeepers (hereinafter “Petition”). The Petition asks that EPA take 

various actions relating to registrations under the Federal Insecticide, Fungicide, and Rodenticide 

Act (“FIFRA”) of pesticide products containing the active ingredient clothianidin, including 

immediate suspension of the registrations, initiation of special review and cancellation 

proceedings, and issuance of a stop sale, use, and removal order (“SSURO”). Bayer and Valent 

are registrants and data submitters for clothianidin. Valent holds the Clothianidin Technical

registration (EPA Reg. No. 59639-173) and a number of end-use product registrations. Bayer 

also holds various clothianidin end-use product registrations, including for the seed treatment 
Ms. Lois Rossi

June 12, 2012 

Page 2

uses discussed in the Petition. Bayer and Valent obtained a copy of the Petition from one of the 

Petitioners’ websites.

Given the Petitioners’ request for an EPA decision within 90 days, these preliminary

comments are limited to Petitioners’ request for immediate suspension of the registrations, based 

on allegations of “imminent hazard.” Bayer and Valent expressly reserve the right to supplement 

these preliminary comments and to present additional arguments and scientific and factual 

information regarding the Petition, including in response to any subsequent notice or public

comment period.

I. SUMMARY OF COMMENTS

The Petition provides no evidence of an imminent hazard to bees or any other species, 

and falls far short of the type of showing necessary to support the extraordinary step of 

suspending a registration or issuing a stop sale, use, and removal order under FIFRA. At most, 

the Petition alleges potential intrinsic hazards under artificial study conditions. Many of the 

Petitioners’ characterizations of the science are inaccurate, and the allegations themselves are 

facially insufficient to support the Petition, which fails to address whether the alleged harm is 

likely to occur under actual conditions of use.

As EPA has concluded as recently as February 2011, extensive scientific evidence 

establishes that the continued registration of clothianidin poses no unreasonable risk to bees. 

The Petitioners inappropriately attempt to conflate potential acute exposure incidents with 

overall colony health issues (and colony collapse disorder in particular), and rely on their own 

unsupported assertions in an attempt to associate general health issues faced by managed honey

bee colonies in the United States to the use of clothianidin and other pesticide products. The 

Petitioners’ allegations in this regard are refuted by the scientific data, including 34 clothianidin 

studies relating to pollinator safety, and 30 field and semi-field studies on neonicotinoids. The 

Petitions’ allegations of an imminent hazard to bees are also refuted by recent comprehensive 

sampling of hives across 23 states conducted in conjunction with the USDA, which detected no 

clothianidin residues in any of the hives, and by the most recent annual survey data showing a 

substantial improvement in overwintering survival for managed bee colonies in 2011-2012.

The Petitioners’ allegations surrounding the pollinator field study submitted by Bayer as 

a condition of the original 2003 registration of clothianidin are simply false, and such allegations 

provide no legal basis for suspension. In fact, both before and after reclassifying that study to 

“supplemental” in 2010, EPA issued unconditional registrations of multiple clothianidin 

products. EPA has also explicitly confirmed that no additional field pollinator data are currently 

required as a condition of registration for Clothianidin Technical and the end-use product 

Poncho 600. 
Ms. Lois Rossi

June 12, 2012 

Page 3

The Petitioners’ assertion that all clothianidin products are misbranded is similarly

baseless, and ignores that all clothianidin registrations include use restrictions protective of bees. 

Finally, the claims under the Endangered Species Act provide no legal basis for suspension or an 

SSURO, or any other relief, particularly given that EPA is already undertaking the actions 

requested in the Petition. In sum, the Petition is baseless, and the Petitioners’ requests for 

emergency relief (and the initiation of cancellation proceedings) should be denied in full.

II. COMMENTS

A. Petitioners’ Allegations of an “Imminent Hazard” Are Wholly Unsupported 

The Petitioners baldly assert that the use of clothianidin “is causing unreasonable adverse 

effects” on the environment – in the form of alleged adverse effects on bees. Petition at 35. 

Citing no authority or concrete data, the Petitioners contend that “[e]very year clothianidin 

remains in use, the viability of pollinator populations deteriorates more,” and that after six 

consecutive winters of significant managed honey bee colony losses, “their populations across 

the United States could collapse.” Id. at 36. The Petitioners allege that “[e]xperts have singled 

out the recent, widespread, major increase in the use of systemic pesticides like clothianidin, 

thiamethoxam and others as particularly responsible for mortality and poor health in bee 

populations and to bees’ increasing vulnerability to other threats.” Id. at 9-10. In other portions 

of the Petition, however, the Petitioners venture only that the use of systemic pesticides in 

general “could be” a contributing factor in honey bee losses. Id. at 3. Other passages of the 

Petition cast the blame on the neonicotinoid category of pesticides,

1 while only a few focus on 

clothianidin in particular. See, e.g., Petition at 12 (alleging “evidence that neonicotinoid 

pesticides are a contributing factor” to CCD and bee losses). The Petition only briefly addresses 

 

1 Among many other false and inflammatory assertions, the Petitioners allege that 

systemic pesticides make the whole treated plant “potentially highly toxic to bees.” Petition at 3. 

This is entirely baseless. The intent of a seed treatment application of an insecticide is to control 

insects in the soil and the early plant seedling so that the plant can develop properly. Control of 

insects in the small plant by neonicotinoids, and clothianidin in particular, is only possible 

because of the systemic activity of the pesticide. The data demonstrate that as the plants reach 

bloom stage (the point at which bees are attracted to the plant) the residue levels in bee relevant 

matrices such as pollen and nectar are below levels of concern for bees, including from seed 

treatment applications. To ensure protection of bees, label directions for foliar and soil 

applications of clothianidin-containing products are specifically limited to times that prevent bee 

exposures. The environmental hazard wording covers all crops, and additional restrictions are 

provided in crop-specific sections of the label (e.g., post-bloom use for cranberry and tree nuts). 
Ms. Lois Rossi

June 12, 2012 

Page 4

the “imminent hazard” standard, and points to no concrete information or evidence that 

continuing the registered uses of clothianidin would cause unreasonable adverse effects on bee 

populations.

1. The “Imminent Hazard” Standard Governs Suspension

To warrant suspension, the Petitioners must present evidence establishing that “the 

continued use of a pesticide during the time required for cancellation proceeding[s] would be 

likely to result in unreasonable adverse effects on the environment or will involve unreasonable 

hazard to the survival of a species declared endangered by the Secretary of the Interior...” 

FIFRA Section 2(l). In turn, “unreasonable adverse effects on the environment” is the same 

risk/benefit standard that governs the issuance of a pesticide registration under FIFRA Section 3, 

and the cancellation of an existing pesticide registration under Section 6. This standard is further 

defined as “unreasonable risk to man or the environment, taking into account the economic, 

social, and environmental costs and benefits of the use of [the] pesticide.” Id. § 136(bb). 

Accordingly, “in order to find an imminent hazard, it is necessary to find that the risks of use 

during the period likely to be required for cancellation proceedings appear to outweigh the 

benefits.” 49 Fed. Reg. 4452, 4453 (Feb. 6, 1984). 

Thus, the “imminent hazard” standard presents an even higher bar than the threshold for 

initiating cancellation proceedings. As the D.C. Circuit has observed, “[t]he statute authorizes 

the Administrator to reserve expedited procedures for cases in which the available data reliably 

demonstrates some sort of immediate threat or where the information before him suggests greater 

certainty concerning the pesticide’s danger to humans than would warrant merely initiating 

cancellation proceedings.” National Coalition Against Misuse of Pesticides v. EPA, 867 F.2d 

636, 644 (D.C. Cir. 1989).

The Petition falls far short of establishing any such immediate threat to bee populations, 

from any cause, let alone from clothianidin. Instead, the Petition primarily repeats well-known 

concerns regarding managed honey bee losses in recent years. The Petitioners provide no 

reliable evidence whatsoever that overwintering losses or any other significant impact on 

managed bee populations or health is associated with clothianidin use.2 

Even PANNA’s own State of the Science report, which provides a one-sided and 

selective review of a subset of the published scientific studies, acknowledges that multiple 

 

2

 To the contrary, however, the lack of correlation observed in Australia and other 

jurisdictions between neonicotinoid use and honey bee declines strongly suggest that clothianidin 

is not a likely factor in commercial honey bee losses experienced in the United States.
Ms. Lois Rossi

June 12, 2012 

Page 5

stressors have been identified by researchers and government agencies as potential contributors 

to colony collapse disorder (CCD) and overwintering losses. The potential factors identified by

researchers (including those cited in the State of the Science report) include disease, poor 

management practices by commercial beekeepers, poor nutrition provided to managed bee 

colonies, pathogens, and parasites. The Petition makes no attempt to distinguish the impacts of 

these other factors on bee health from any alleged effects from pesticides or clothianidin. 

Most of the selectively-cited studies listed in the report involved pesticides other than 

clothianidin, and were available at the time two of the Petitioners (PANNA and Beyond 

Pesticides) submitted a letter to EPA dated December 8, 2010, requesting an SSURO based on 

many of the same grounds alleged in the Petition. See Exhibit A hereto. EPA denied that 

request on February 18, 2011. S. Bradbury, Director OPP, to PANNA and Beyond Pesticides, 

Re Requested Stop Sale Use Or Removal Order For Clothianidin (Feb. 18, 2011) (hereinafter 

“EPA’s 2011 Decision”) (Exhibit B). The studies cited by Petitioners provide little or no new 

information on potential bee effects, and no evidence of any immediate threat to bees from 

continued clothianidin use. Indeed, the Petitioners do not even appear to assert that any of these 

studies reached a conclusion on the subject of an imminent hazard.

2. The Petition is Facially Insufficient

Many of the Petitioners’ assertions concerning the scientific data, including the two 

recent studies emphasized by the Petitioners, are incorrect. Given the limited time available due 

to Petitioners’ request for an expedited EPA ruling, it is not practical for Bayer and Valent to 

attempt to respond in these preliminary comments to each of Petitioners’ mischaracterizations of 

the data. However, EPA need not resolve each of Petitioners’ assertions to conclude that the 

Petition fails to establish an imminent hazard that could warrant the extraordinary remedy of 

suspending the registrations. Even based on Petitioners’ own characterizations of the studies, at 

most the Petition alleges intrinsic hazards of the chemicals (most or all of which have been 

previously identified and assessed by EPA, with any potential risks to bees addressed through 

protective use restrictions). As EPA has recently confirmed, such allegations of intrinsic hazards 

are insufficient to support a petition to cancel a pesticide registration, let alone the Petitioners’ 

request for immediate suspension based on alleged imminent hazard.

For example, the Petitioners contend that “[c]lothianidin has been linked to immune 

effects in lab animals.” Petition at 17.3 Similarly, the Petitioners assert various other alleged 

 

3

 In fact, immunotoxicity studies have been conducted with clothianidin and have shown 

no concerns relating to immune effects in animals. 
Ms. Lois Rossi

June 12, 2012 

Page 6

sub-lethal effects from neonicotinoid exposures (generally based on exaggerated exposure levels 

in a laboratory setting), such as: 

 “Chronic ingestion of neonicotinoids damages foraging behavior, overall mobility

and the communication that allows these social insects to coordinate their 

activities.” Petition at 33.

 “Neonicotinoid pesticides also have several other indirect effects on honey bees, 

such as premature shifts in hive roles. They can impair honey bees’ medium-term 

olfactory memory and associative learning abilities, which foraging honey bees 

rely on, inter alia, to find their way back to the hive. Impairment of these 

functions is consistent with the absence of dead bees inside the hives in reported 

CCD cases.” Petition at 33.

 “The sub-lethal, chronic effects are consistent with CCD, most particularly the 

absence of dead bees inside the hive. Neonicotinoid pesticides are known to 

interfere with honey bees’ cognition and orientation in ways that would prevent 

foraging bees from finding their way back to the hive. The injury to bees from 

sub-lethal exposures is reported to be cumulative, that is, with every exposure 

more damage occurs.” Petition at 15.

As noted above, Petitioners’ assertions are frequently unsupported by the scientific data, 

or relate to exaggerated exposure levels in a laboratory setting designed to create effects in test 

organisms, rather than actual exposure levels from the use of clothianidin in the field. In any 

case, allegations such as the Petitioners’, asserting various potential study effects from 

exposures, or potential pathways of exposure, are themselves insufficient to support a petition to 

suspend or cancel a registration. As EPA recently affirmed in denying NRDC’s petition to 

cancel the registrations of pesticide products containing the active ingredient 2,4-D:

The flaw in NRDC’s petition . . . is that it addresses only 2,4-D’s 

potential harm without addressing whether that harm is likely to 

occur or whether it would be unreasonable when weighed against 

2,4-D’s benefits.

. . . . 

At best, NRDC is asking EPA to take a revised look at the toxicity

of 2,4-D for ecological effects and the exposure to 2,4-D for 

occupational risk. Yet, the ground for cancellation is a finding that 

risks outweigh benefits. Accordingly, NRDC’s claims that the 2,4-

D registrations should be cancelled due to 2,4-D’s ecological 
Ms. Lois Rossi

June 12, 2012 

Page 7

effects or worker risk is denied due to a failure to make a proper 

claim for cancellation by, at the very least, alleging facts that, if 

proven, would meet the statutory standard for cancellation.

S. Bradbury, Director OPP, to G. Solomon and M. Wu, NRDC, Re Denial of 2,4-D Petition 

(Apr. 7, 2012) at 4 (Exhibit C).

The current Petition is similarly flawed, as it fails to address whether the alleged potential 

harms are likely to occur based on how clothianidin is actually used. Nor do the Petitioners 

address whether any alleged harm is outweighed by the environmental and agricultural benefits 

of clothianidin. Accordingly, the Petition is insufficient on its face and is due to be denied on 

that basis.

3. The Two “New” Studies Cited in the Petition Provide No Evidence of 

Imminent Hazard

The Petitioners contend that two “critical new studies” suggest honey bee exposure 

pathways that were not previously considered. See Petition at 4, 27-30 (citing Krupke (2012)

and Tapparo (2012)). According to the Petitioners, these exposure pathways include “residues in 

pollen and nectar, dust from treated seeds and soils, planter exhaust, untreated but contaminated 

non-crop plants adjacent to treated fields, guttation droplets on both treated and untreated but 

contaminated plants and residues from foliar uses.” Petition at 4.

However, neither of these studies identified exposure levels of concern to bees or bee 

colonies from application of neonicotinoids under conditions reflective of actual use. The 

Krupke study found significant concentrations of pesticide in waste talc remaining inside seedplanting equipment after planting, but levels reported in soil, pollen and nectar (i.e., 

environmental media to which bees may be exposed) were generally consistent with previous 

research. In the field portions of the study, low exposure levels and no adverse effects were 

observed for bee colonies placed around the perimeter of a field as it was being planted with 

treated corn seeds. 

The Tapparo study found that particulate matter released by certain types of drilling 

machines during sowing of neonicotinoid-treated corn contained significant levels of insecticide. 

Sugar syrup feeders and honey bee hives were placed so that bees would fly directly through the 

air exhaust of the planter, and the study found that those individual bees efficiently intercepted

the suspended particles and were thereby exposed to an elevated dose of insecticide, higher than 

contact LD50 values. However, these experiments involved artificial conditions designed to 

ensure that bees flew directly through the exhaust, not field conditions representative of actual 

clothianidin use. The study suggests only that, if honey bees were to fly through the exhaust of 

pneumatic corn planters, those individual bees could experience an acute exposure. The research 
Ms. Lois Rossi

June 12, 2012 

Page 8

results and available records of field incidents suggest that any toxic exposure of bees to corn 

seed dust is limited in scope.4 

Clothianidin and other neonicotinoids have been used as a seed treatment on most of the 

corn planted in the United States for approximately the past six years, representing tens of 

millions of acres, with a very low number of total acute exposure incidents reported.5 The 

Petitioners seek to conflate any acute exposure incident with long-term bee colony and 

population health generally, and with CCD (a particular type of colony loss). See, e.g., Petition 

at 14. The limited number of individual instances of “bee kills,” generally associated with 

improper application methods, which resulted in acute exposures to an insecticide are unrelated 

to chronic bee colony health issues, such as those discussed in the Petition. Even if the Petitions 

had presented evidence of an acute exposure incident involving planter exhaust, such a 

phenomenon has not been scientifically linked to (and is not suspected by mainstream scientists 

to be a cause of) colony collapse disorder or widespread honey bee colony losses. 

In any case, even if Petitioners’ characterizations of the findings of these two studies 

were accurate,6they would fall far short of establishing imminent hazard to bees from 

 

4

 Seed-treatment places the neonicotinoid below the soil surface resulting in low 

potential for environmental exposure. While some acute exposure incidents have occurred in 

Europe where poorly coated seed was planted using equipment that exhausted upward, incidents 

involving substantial amounts of abraded seed dust are rare in practice. Studies have shown that 

when seeds are properly treated and coated, little neonicotinoid residue is exhausted from the 

planters. See M. Marzaro, et al., Lethal Aerial Powdering of Honey Bees With Neonicotinoids 

From Fragments of Maize Seed Coat, Bulletin of Insectology 64(1): 119-126 (2011) and 

V. Girolami, et al., Fatal Powdering of Bees in Flight with Particulates of Neonicotinoids Seed 

Coating and Humidity Implication, J. Appl. Entomol. 136:17-26 (2012) (investigating potential 

honey bee exposures from visits to flowering plants where deposition of abraded seed dust has 

occurred or by ingestion of guttation or dew droplets) (Exhibits D and E hereto).

5

 As a matter of product stewardship, the registrants and other stakeholders continue to 

work diligently to further minimize any honey bee exposure incidents, including through 

improved planting practices, better seed coatings/lubricants, and other measures. 

6

 As noted above, Bayer and Valent do not attempt in these preliminary comments to 

comprehensively address these studies or the characterizations in the Petition regarding the data, 

many of which are inaccurate. However, Bayer has previously submitted comments on the 

scientific scope and relevance of the recent Krupke and Tapparo studies, along with a few others, 

which provide additional detail. Those comments are incorporated herein by reference. See 

Continued
Ms. Lois Rossi

June 12, 2012 

Page 9

clothianidin use. Numerous field and semi-field studies have shown that pollen and nectar 

residues from neonicotinoid seed treatments are below levels of concern for honey bees and 

other bees under actual use conditions. Residues on vegetation surrounding the drilled area, and 

potential bee exposures from foraging for pollen and nectar from neighboring plants were also 

comparably low. As noted below, foliar applications of clothianidin and other neonicotinoids are 

limited, based on the labels, to times that are protective of bees. Petitioners’ assertions regarding 

exposures via guttated water of seed-treated plants are similarly misguided. Petition at 16.7 

The overwhelming weight of the scientific evidence confirms the lack of unreasonable 

adverse effects from clothianidin use. Neonicotinoid products, including clothianidin, are among 

the most intensively studied chemicals with regard to pollinator health. As EPA concluded as 

recently as February 2011, the data as a whole confirm that the registered uses of clothianidin 

cause no unreasonable adverse effect on bees. Approximately 34 studies relating to potential 

pollinator effects have been conducted on clothianidin, and over 30 pollinator field and semifield studies have been conducted on neonicotinoids in general. These studies demonstrate that 

the actual registered uses of clothianidin, including seed treatment uses, result in honey bee 

exposures below levels of concern, and do not result in unacceptable risks to bees. Such studies 

account for the variety of exposure pathways that may be relevant to actual use practices. In 

addition, long-term feeding studies with clothianidin showed no effect on bee mortality, hive 

weight gain, longevity, brood development, honey yield, and overwintering survival. Nothing in 

the Petition is sufficient to call into question EPA’s fundamental conclusions, let alone sufficient 

to demonstrate any imminent hazard to bees.8

 

Continued

MRID 48828701, C. Halder, Technical Reviews of Several Recently Published Scientific 

Articles Concerning Bee Health and the use of Neonicotinoids (submitted May 10, 2012).

7

 For example, Petitioners contend that “Reetz et al. found that corn seeds treated with 

clothianidin could result in toxic concentrations up to 8,000 ng/ mL in the guttated fluid; these 

concentrations, while decreasing rapidly, remained detectable over several weeks.” Id. In fact, 

while studies have shown that guttation drops may contain residues of neonicotinoids, bees do 

not generally consume guttation fluids. Even PANNA’s own State of the Science report 

concedes that “while bees readily consume guttation droplets in lab conditions, subsequent field 

studies have failed to establish that bees readily use these droplets as a water source.” PANNA, 

Pesticides and Honey Bees: State of the Science (May 2012), at 21 (Exhibit F).

8

 In its State of the Science report, PANNA asserts that studies have reported 

dramatically enhanced neonicotinoid activity when mingled with certain fungicides. See 

Continued
Ms. Lois Rossi

June 12, 2012 

Page 10

4. Recent Comprehensive Testing Detected No Clothianidin Residues in 

Sampled Honey Bee Hives

Petitioners’ suggestion that clothianidin is the cause of CCD or other imminent hazard to 

bees is also contradicted by the results of field sampling of actual hives conducted in association 

with USDA, and published in March 2010.9 A total of 887 wax, pollen, bee, and hive samples 

from 23 states and one Canadian province were tested for various pesticide residues, of which 

836 samples were tested for clothianidin residues. While 121 other pesticides and metabolites 

were detected,10 no clothianidin was detected in any of the samples. 

PANNA’s State of the Science report cites this comprehensive survey as evidence that 

other pesticides were present in hives, but fails to acknowledge that no clothianidin was detected 

in any of the samples. The Petition also fails to address this basic fact, which refutes Petitioners’ 

claims of an “imminent hazard” from clothianidin.11

5. Survey Data Show a Significant Improvement in Honey Bee 

Overwintering Survival for 2011-2012, not an Imminent Hazard

As a basis for alleging imminent hazard, the Petitioners contend that managed honey bee 

colonies have suffered overwintering losses of approximately 30% during each of the past 6 

years. Petition at 14. As discussed above, there is no basis to conclude that any portion of these 

losses is attributable to clothianidin. The Petitioners also fail to mention the fact that hives lost 

 

Continued

PANNA State of the Science at 2, 4, 11. However, such reports relate to neonicotinoids within 

the cyanoamidine class, which does not include clothianidin. No interaction at comparable 

levels has been reported for the nitroguanidine class of neonicotinoids, which includes 

clothianidin, imidacloprid, and thiamethoxam.

9 C. Mullin, et. al, High Levels of Miticides and Agrochemicals in North American 

Apiaries: Implications for Honey Bee Health, PLoS ONE 5(3) (Mar. 2010) (Exhibit G).

10

 The residues most frequently found were fluvalinate and coumaphos, miticides 

frequently applied directly to hives by commercial beekeepers to control the Varroa destructor

mite (a parasite widely considered to be a key factor in colony losses).

11

 Overall, no negative correlation has been established between pesticide residues and 

colony health (although there is at least one report of a slightly positive correlation suggesting 

that the use of miticides to control honey bee parasites resulted in healthier hives).
Ms. Lois Rossi

June 12, 2012 

Page 11

by beekeepers over the winter have generally been replaced each year. The Petition includes no 

evidence regarding bee populations in the United States over time.

12

In fact, the results from the latest annual honey bee survey conducted by the Bee 

Informed Partnership, the Apiary Inspectors of America, and USDA reportedly shows that losses 

of managed honey bee colonies over the 2011-2012 winter dropped to 21.9%, from the 

approximately 30% losses experienced in prior winters.13 This significant improvement in recent 

honey bee colony survival contradicts the Petitioners’ unsupported assertions that the status quo 

poses an “imminent hazard” to honey bee populations. 

B. Petitioners’ Allegations That a Condition of Registration Was Not Satisfied 

Provide no Legal Basis for Suspension of the Registrations, and are Meritless

Clothianidin Technical and Poncho 600 were first conditionally registered by EPA on 

May 30, 2003, under FIFRA § 3(c)(7)(C). Both of these registrations required the submission of 

additional data as a condition of registration, including submission of the pollinator field study

that is the focus of the Petition. As the Petitioners’ themselves acknowledge, Bayer completed 

that pollinator field study and submitted the results to EPA in 2006.

Nevertheless, because EPA later reclassified that study from “acceptable” to 

“supplemental” in 2010, Petitioners argue that this constitutes “an eight year period of failure by 

the registrant to comply with a critical condition [of registration] imposed specifically to assess 

the long-term threat the compound poses to honey bee survival.” Petition at 7. According to the 

Petitioners, “[c]ontinuing to allow clothianidin to be marketed, sold and used when not one study 

meets EPA’s condition for its registration is, as a matter of law, arbitrary, capricious and contrary

to the mandates of FIFRA and the APA.” Id. at 12. Petitioners request that EPA “correct its 

 

12

 Surveys of the number of managed honey-producing colonies (excluding pollinationonly colonies) reported by the USDA National Agricultural Statistical Service confirm no 

dramatic drop in overall colony numbers in the years since the introduction of neonicotinoids or 

clothianidin. While the survey is not comprehensive (for example, apiairies with five or fewer 

hives have been omitted from the survey since the mid-1980s), the data reflect steady declines in 

managed colony numbers since 1947, with average yearly declines of approximately 0.87% from 

1947 to 1981, and 1.12% from 1986 (after the introduction of Varroa) to 2010. These steady 

declines in numbers are consistent with the evolving economics of honey production and 

pollinator services in the United States since 1947.

13

 See Preliminary Results: Honey Bee Colony Losses in the U.S., Winter 2011-2012, 

available at: http://beeinformed.org/2012/05/winter2012/ (last visited June 7, 2012) (Exhibit H).
Ms. Lois Rossi

June 12, 2012 

Page 12

mistake through immediate suspension of clothianidin’s registration, pending preparation, 

publication and EPA review of the required field study . . . .” Id. at 12.

The allegations in the Petition provide no legal basis to suspend the registration of 

clothianidin products. Petitioners’ arguments are also legally and factually baseless, and reflect a 

fundamental misunderstanding of the meaning of EPA’s classification of individual studies, and 

its regulation of pesticides under FIFRA based on the entire body of scientific data.

1. Petitioners’ Allegations Provide No Basis For Suspension Under 

FIFRA

As noted above, Petitioners repeatedly assert that “immediate suspension” is warranted 

based on the allegedly unfulfilled condition of registration. However, as the statute makes clear, 

EPA is authorized to suspend an existing pesticide registration where such action is “necessary to 

prevent an imminent hazard during the time required for cancellation . . . proceedings.” 

7 U.S.C. § 136d(c)(1). The Petitioners cite no legal authority for the notion that EPA could

unilaterally suspend a registration based on an alleged failure to comply with a condition of 

registration absent an “imminent hazard” finding. 

To the contrary, the very statutory provision cited by the Petitioners makes clear that a 

failure to act to satisfy a condition of registration can result in the initiation of a formal 

cancellation process, not immediate suspension. Petition at 35. That provision states:

The Administrator shall issue a notice of intent to cancel a 

registration issued under section 136a(c)(7) of this Act [FIFRA 

Section 3(c)(7)] if ... the Administrator, at any time during the 

period provided for satisfaction of any condition imposed, 

determines that the registrant has failed to initiate and pursue 

appropriate action toward fulfilling any condition imposed. 

7 U.S.C. § 136d(e)(1). 

The Petitioners themselves emphasize that this provision imposes on EPA a duty “to 

initiate cancellation proceedings when a registrant has for example, effectively extended its 

conditional registration by delaying its own compliance with a condition.” Petition at 35 

(emphasis added). Petitioners cite nothing to support their position that an alleged failure to 

satisfy a condition of registration can provide an independent basis for immediate suspension. 

To the contrary, the statute makes clear that suspension of a registration is authorized only if 

EPA determines that action is necessary to prevent an imminent hazard during the time needed 

for cancellation proceedings. 7 U.S.C. § 136d(c)(1). 
Ms. Lois Rossi

June 12, 2012 

Page 13

Simply put, even if it were true (which it is not), the Petitioners’ allegation that a 

condition of registration was not fulfilled, which the Petitioners acknowledge “lies at the heart” 

of their Petition, provides no basis for suspension of a registration under FIFRA. Because, as 

discussed in Part A above, there is no evidence of any “imminent hazard,” there is no legal basis 

to suspend the registrations. 

2. The Condition of Registration was Satisfied, and EPA’s Subsequent 

Reclassification of a Single Study Provides no Legal Basis to Cancel or 

Suspend the Registration 

Petitioners’ allegation that the condition of registration was not fulfilled is also meritless. 

As noted above, the statute provides for cancellation proceedings where “the registrant has failed 

to initiate and pursue appropriate action toward fulfilling any condition imposed.” 7 U.S.C. § 

136d(e)(1). Although Petitioners repeatedly assert “an eight year period of failure by the 

registrant to comply with a critical condition [of registration],” the Petitioners identify no

specific action required by EPA that the registrants failed to pursue during the conditional 

registration period. Petition at 7. In fact, the record makes plain that Bayer not only acted 

diligently to initiate and pursue appropriate action toward satisfaction of the condition of 

registration, it actually completed and submitted the required pollinator field test in 2006. 

Subsequent EPA actions have made explicit that there are no additional conditions of any EPA 

clothianidin registration that require further pollinator field testing at this time.

While these preliminary comments are focused on Petitioners’ allegations of imminent 

harm and their request for immediate suspension of the registrations, a brief review of the facts 

surrounding the condition of registration emphasized by the Petitioners may be helpful to EPA’s 

review of these issues as well. The facts readily confirm that these allegations, which form the 

core of the Petition, are simply false, and provide no basis whatsoever for regulatory action 

against the existing registration of clothianidin, let alone the emergency suspension and SSURO

requested by the Petitioners. 

As directed by EPA, Bayer developed the draft study protocol for EPA review and input, 

in consultation with EPA and PMRA scientists. The protocol was submitted for EPA review in 

September 2003, just four months after the conditional registrations were issued. EPA provided 

its comments on the protocol on April 5, 2004. Bayer revised the protocol to implement EPA’s 

comments and (with the approval of EPA14), the field portion of the study was conducted during 

 

14 By the time EPA provided its comments, it was too late to conduct the study during the 

2004 growing season.
Ms. Lois Rossi

June 12, 2012 

Page 14

the 2005 growing season. In addition to the data required to be collected by EPA, the 

researchers also maintained the hives after completion of the experimental phase of the study, 

which ended in November 2005. This allowed the collection of additional data regarding 

survival of treated and untreated hives over the winter. The study report was finalized and 

submitted to EPA, along with the additional data, on August 8, 2006 (MRIDs 46907801, 

46907802).

EFED completed its review of the study, and in January 2008 provided Bayer with its 33-

page Data Evaluation Record (“DER”), which summarized the study findings and EFED’s 

conclusions. At that time, EFED classified the study as “acceptable.” A. Vaughan, EFED to K. 

Davis, RD Data Evaluation Record For MRID 46907801 (Nov. 30, 2007) (Exhibit I). EPA later

determined that all of the conditions of registration for Clothianidin Technical and Poncho 600

(which includes the seed treatment use), were satisfied. 

As part of a subsequent assessment of a proposed new use for clothianidin, EFED 

conducted a re-review of the pollinator field study. As a result, EFED initially indicated in 

November 2010 that the study would be reclassified as “invalid,” but in December 2010 issued 

its final decision that the study would be reclassified as “supplemental.” The reclassification was 

“based on an increased understanding and awareness of the potential uncertainties normally

encountered in field studies with honeybees” since the time the study was designed and 

conducted A. Pease, EFED to K. Davis and V. Eagle, RD Reclassification of MRIDs 46907801 

and 46907802 (Dec. 22, 2010) at 1 (Exhibit J). EFED’s reclassification was based on the fact, 

noted in the 2006 study report, that the presence of clothianidin residues in a limited number of 

control hives indicated that at least some worker bees from control colonies had foraged in

treated canola plots. Id. at 2; C. Scott-Dupree and C. Cutler, Memo Response to Criticism of 

Study EBTIX064 (Jan. 12, 2011) at 2 (Exhibit K). The possibility of honey bees foraging 

outside the experimental plots had been acknowledged and discussed with EPA as part of the 

design and approval of the protocol, and EPA had concurred that it was not logistically possible 

or preferable to implement the study with larger experimental plots and greater separation. Id. at 

1. The study authors, Professors Scott-Dupree and Cutler, provided EPA with a detailed 

response to EFED’s revised review of the study, outlining the steps that had been taken to 

minimize inter-plot foraging, and explaining in detail the basis for the authors’ conclusion that 

the “bees overall were highly faithful to their test plots.” Id. at 6.

Nevertheless, six organizations, including two of the Petitioners here (PANNA and 

Beyond Pesticides), submitted a letter to EPA dated December 8, 2010, requesting that EPA 

issue a SSURO and effectively suspend the registrations of pesticide products containing 

clothianidin. Just as in the current Petition, that 2010 letter alleged that EPA’s reclassification of 

the study meant that clothianidin posed an “imminent hazard” to bees. See H. Pilatic, PANNA, 

J. Feldman, Beyond Pesticides, et. al., to L. Jackson, EPA Administrator, Requesting 
Ms. Lois Rossi

June 12, 2012 

Page 15

Clothianidin SSURO (Dec. 8, 2010) at 1 (Exhibit A). As noted above, EPA responded to that 

letter on February 18, 2011, denying the requested relief in full. See Exhibit B. The parties to 

the letter did not appeal or seek judicial review of EPA’s denial. 

In its response, EPA explained in detail why the reclassification of that individual study

does not undermine EPA’s overall determination that clothianidin use presents no unreasonable 

risk or imminent hazard to bees, as well as the role of “supplemental” data generally in 

supporting EPA regulatory decisions under FIFRA. See EPA’s 2011 Decision. The 

reclassification here was “reflective of EPA’s improved understanding of honey bee biology and 

the recognition in the scientific community of the challenges associated with field pollinator 

study designs.” Id. at 2. The fact that a study is classified as “supplemental” does not, as 

Petitioners suggest, indicate that the study was “fundamentally flawed” or insufficient to support 

an EPA risk-benefit conclusion under FIFRA. To the contrary, as EPA explained in its February

2011 response, a study classified as “supplemental” provides scientifically-sound information. 

Notwithstanding the confounding factors in field study design identified by EPA, the study

provided “useful information that has been used to better understand hive survival following 

exposure to clothianidin.” Id. at 3. 

Moreover, both before and after the 2010 reclassification of the study, EPA issued a 

number of unconditional registrations for clothianidin products under FIFRA Section 3(c)(5). 

By definition these registrations are not subject to the cancellation provision invoked by the 

Petitioners, which applies to conditional registrations issued under Section 3(c)(7). 7 U.S.C. 

§ 136d(e)(1). In fact, no clothianidin registration includes a requirement to submit additional 

pollinator field data as a current condition of registration. To the contrary, in approving a label 

amendment to Bayer’s Poncho/Votivo clothianidin end-use registration on February 24, 2011, 

EPA made explicit that there is no such condition of registration at this time: “[o]ptions are 

being evaluated [by EPA] for requesting additional data to further evaluate potential effects due 

to chronic exposure pending review of the field pollinator data that have already been submitted 

to EPA. EPA will also consider study design recommendations which may be forthcoming from 

the SETAC Pellston. Therefore this data requirement [for an additional field test for pollinators] 

is placed in reserve at this time until EPA has had an opportunity to review the available data 

and study design options.” See V. Eagle, EPA Product Manager, to R. Kneen, Bayer Regulatory

Affairs (Feb. 24, 2011) (emphasis in original) (Exhibit L).

15

 

15

 Nevertheless, Bayer and Valent are currently conducting another pollinator field study. 

While EPA has made plain that this additional study is not a current condition of registration, the 

additional data are intended to help further refine the scientific understanding of any potential 

pollinator effects. 
Ms. Lois Rossi

June 12, 2012 

Page 16

In sum, the registrants have acted diligently at all times “to initiate and pursue 

appropriate action” toward fulfilling all conditions of registration imposed by EPA. 7 U.S.C. § 

136d(e)(1). Bayer actually fulfilled the condition at issue when it completed and submitted the 

pollinator field study to EPA in 2006. While EPA later reclassified that study, EPA explicitly

has not required the submission of additional pollinator field test data as a condition of 

registration for clothianidin. Petitioners point to nothing that suggests any lack of appropriate 

action by any clothianidin registrant toward fulfilling any applicable condition of registration at 

any time.16

Petitioners also suggest that, because the pollinator field study has now been classified as 

“supplemental,” it follows that the condition of registration was never fulfilled, and that EPA

does not now have, or never had, sufficient data to support the bee-safety of clothianidin. See, 

e.g., Petition at 31 (“Well over a year has passed since EPA finally acknowledged it had 

improperly relied on the Cutler and Scott-Dupree 2007 study as satisfying the outstanding data 

requirement that the agency made a condition of clothianidin’s registration. Clothianidin thus 

exists in a regulatory limbo in which EPA continues to allow its sale and use even though Bayer 

failed to meet a crucial condition imposed back in 2003.”). 

Petitioners’ argument reflects a fundamental misunderstanding of FIFRA and how EPA 

makes regulatory determinations based on the body of scientific evidence. The mere fact that 

EPA may require additional data at one point in time to address uncertainties and refine the 

scientific understanding of particular potential risks does not suggest that the existing data are

insufficient to support registration. To the contrary, the statute explicitly authorizes EPA to grant 

conditional registrations where the existing data are sufficient to support a finding of no 

unreasonable adverse effects during the conditional registration period, while at the same time 

requiring the additional data. The two are not inconsistent, as EPA made clear in its 

February 2011 decision rejecting many of the same arguments the Petitioners present here: 

 

16 In addition, FIFRA makes clear that cancellation is authorized only where EPA 

determines that a registrant has failed to pursue appropriate action “during the period provided 

for satisfaction of any condition imposed.” 7 U.S.C. § 136d(e)(1). EPA’s reclassification of the 

study occurred in late 2010 – years after the period provided for satisfying the condition. Not 

only did Bayer fully satisfy the condition by submitting the completed study in 2006, but EPA 

concluded that all of the conditions of registration had been satisfied several months before it 

reclassified the study. As noted above, in April 2010 EPA issued an unconditional registration 

for Clothianidin Technical and Poncho 600. Petitioners’ argument that EPA must or should 

initiate cancellation proceedings against the initial 2003 conditional registrations is both moot, 

and entirely meritless under the plain language of the statute.
Ms. Lois Rossi

June 12, 2012 

Page 17

The Agency bases pesticide risk characterizations on the entire 

body of information submitted by the pesticide registrant and open 

scientific literature data. For clothianidin, the weight-of-evidence 

risk characterization [for honeybees] was based on 34 studies and 

not on the findings of a single, specific field study. Therefore, the 

reevaluation of the study in question does not change the Agency’s 

conclusion that the registered uses of clothianidin meet the FIFRA 

risk/benefit standard for registration. 

EPA’s 2011 Decision at 3.

In sum, the Petitioners inappropriately ignore EPA’s recent resolution of many of the 

same arguments repeated in the Petition, and identify no basis for EPA to reach a different 

conclusion today regarding the import of the 2010 study reclassification. 

C. Clothianidin is not “Misbranded”

In addition to seeking suspension and cancellation of clothianidin registrations directly,

the Petitioners seek the same result indirectly, contending that a “suspension and a stop sale, use,

or removal order [is] also necessary because clothianidin is misbranded.” Petition at 39. Based 

primarily on the alleged honey bee risks, discussed above, Petitioners contend that current 

clothianidin product labels “do not contain directions ‘adequate to protect health and the 

environment.’” Id. at 6. Further, the Petitioners contend that no label directions or use 

restrictions could be developed that would adequately mitigate the alleged risk, particularly for 

seed treatment uses, where Petitioners allege that “no modifications to the planting machinery

have been shown to significantly reduce” the levels of clothianidin disseminated into the 

environment. Petition at 37.

The Petitioners’ invitation that EPA use its misbranding authority to effectively cancel 

the existing registrations of clothianidin, and thereby circumvent the detailed cancellation 

procedures of FIFRA Section 6, should be rejected as contrary to the statute. As the United 

States District Court for the District of Columbia recently held, “FIFRA does not give EPA the 

authority to pursue a misbranding enforcement action in lieu of a cancellation proceeding.” 

Reckitt Benckiser, Inc. v. Jackson, 762 F. Supp. 2d 34, 42 (D.D.C. 2011). Petitioners’ allegations 

that clothianidin causes unreasonable adverse effects on honey bees and other species are 

properly addressed (if at all) under the carefully crafted procedures of Section 6. 

Moreover, the Petitioners’ allegations that the current label directions are substantively

insufficient are meritless. All clothianidin product labels include statements designed to protect 

honey bees and other non-target organisms, and if any additional use instructions are warranted 

based on EPA’s current registration review process (including its updated pollinator risk 

assessment) EPA may impose refined label statements as part of that ongoing review. 
Ms. Lois Rossi

June 12, 2012 

Page 18

The Petitioners take out of context specific statements from prior EPA regulatory review 

documents, including an internal 2009 memorandum by Allen Vaughan, an EPA entomologist,17

and inappropriately seek to extrapolate those statements to all clothianidin uses. According to 

the Petitioners:

EPA should determine that no label warning or directions could 

provide adequate protection based on the available evidence. 

Indeed, the agency’s regulatory documents [e.g., the Vaughan 

memo] contain several assertions by EPA scientists to this effect. 

... It would be specious to suggest that the inability of 

precautionary labeling language to mitigate the environmental 

hazards of clothianidin is limited to a “special case” of cucurbits 

and fruiting vegetables. The degree of hazard is many orders of 

magnitude greater for corn seed treatment, such as Poncho 600, 

planted now across tens of millions of acres, than for the relatively

minor acreage of cucurbits and fruiting vegetables, and just as 

incapable of mitigation by label warnings or use directions. 

Petition at 37.

The EPA statements referenced by the Petitioners merely acknowledge that cucurbits and 

fruiting vegetables bloom and produce fruit throughout much of the growing season. Therefore, 

there may be little time when blooms, which attract bees, are not present. Contrary to 

Petitioners’ assertions, such statements by EPA do not apply more generally to other crops. In 

addition, as reflected by accepted risk assessment principles, an intrinsic hazard of a chemical 

does not necessarily increase as a function of crop acreage, and there are many examples of 

pesticides being used safely on high acreage crops. More generally, Petitioners’ attempt to take 

out-of-context particular statements by individual scientists within EPA (who are tasked with 

highlighting uncertainties and potential risks, so that they can be properly addressed), provides 

no basis to challenge EPA’s final overall risk/benefit determination, which is based on the 

Agency’s assessment of all of the data, including internal EPA reviews.

Petitioners contend that foliar applications in particular are misbranded, including retail 

products used in non-agricultural applications:

Foliar applications of the products also are misbranded .... This 

defect also applies to clothianidin-based products sold to 

landscapers and homeowners in retail stores across the nation. 

 

17

 See A. Vaughan, EFED to K. Davis, V. Eagle, and M. Laws, RD, Re Clothianidin 

Registration (Oct. 21, 2009). See Exhibit M.
Ms. Lois Rossi

June 12, 2012 

Page 19

Huge volumes of these products reportedly are sold and the rates 

recommended on the container labels can be as high as 40 times 

the rate allowed for agricultural applications, resulting in lethal 

doses. Yet, these products can be sold without any bee hazard 

statement. Compared to crop uses, this entire use area is “flying 

under the radar” of EPA control. These facts, in view of the 

Vaughan admission, show the labels on clothianidin products 

violate FIFRA.

Petition at 37-38.

Contrary to Petitioners’ assertion, homeowner and professional landscape product labels 

do include environmental hazard statements, just as agricultural products do. In the case of foliar 

sprays for home landscape use and granular products for lawn use the label reads as follows: 

“This product is toxic to bees exposed to direct treatment or residues on blooming crops. Do not 

apply during bloom or when bees are present.” See, e.g., Approved Product Label for Arena® 

50 WDG Insecticide at 3 (accepted with comments, Nov. 30, 2004) (Exhibit N); see also EPA’s 

2011 Decision at 3 (“current labels for clothianidin products used as foliar treatments include bee 

hazard statements that prohibit applications when plants are flowering and bees are in the area”). 

These residential clothianidin uses are important, as there are many invasive and damaging pest 

species in ornamental and landscape plants, and invasive beetle species are among the top risk 

factors resulting from climate change due to their negative impact on trees. With homeowner 

use products, extensive research conducted on labeling, including focus groups with EPA staff 

observers working on the consumer labeling initiative, demonstrated that short, clear label 

language is best for consumer understanding. The product label statements for these important 

registered uses of clothianidin help prevent bee exposures, and thereby help protect bees from 

any potential risks.

Petitioners’ assertion regarding use rates is inaccurate and misleading. While the use rate 

allowable for a single application of a homeowner product to a given tree may be significantly 

higher than a comparable agricultural use rate, homeowner products are subject to an overall 

maximum usage rate of 0.4 lbs of active ingredient per acre, only somewhat greater than the 

overall maximum agricultural rate of 0.2 lbs per acre, not “40 times” the agricultural rate as the 

Petitioners suggest. In addition, there are important differences between these uses that explain 

the need for a higher homeowner use rate, and confirm why actual total residential use levels 

may nonetheless be expected to be relatively small. These include:

 Agricultural rates of soil applications of clothianidin will only control certain very

sensitive pests. Those rates will not control many other pests that are common 

problems in trees growing in residential landscapes (e.g. wood boring beetles). 
Ms. Lois Rossi

June 12, 2012 

Page 20

The higher rates for use on ornamental plants are needed to control these other 

tree pests.

 Trees in residential landscapes are often much larger than the average 

commercially grown tree, and tree biomass / unit area increases exponentially

with increasing trunk diameter. Because residential trees have a greater biomass, 

a higher application rate is required to provide effective treatment of these larger 

trees.

 In a commercial agriculture setting all the trees are uniformly treated over a large 

area, densely populated with the treated trees. In a residential landscape setting, 

most trees would NOT be treated. Over a large area there are fewer trees in a 

residential landscape compared to a crop field, and far fewer treated trees.

The Petition also fails to acknowledge that the use rate is only one factor relevant to 

ensuring pollinator safety. Plant attractiveness to bees and the timing of application are also key

factors that must be considered. As discussed above, the label instructions include application 

restrictions that are sufficient to ensure safe and effective use, including pollinator protection, 

taking all of the relevant factors into account – not just use rates. 

For example, Petitioners contend that registered clothianidin trunk injection uses for 

ornamental and landscaping allow such uses on “trees that are foreseeably visited by many 

species of bees and other beneficial insects.” Petition at 34. However, there are few tree species 

treated with neonicotinoid products that are of concern from the perspective of attractiveness to 

pollinators. Many of the trees treated in residential landscapes are wind-pollinated and are not 

visited, or only infrequently visited, by bees. For other species that may attract bees, such as 

maples, application takes place well after flowering has finished. 

D. Petitioners’ Endangered Species Act Claims Are Meritless and Time-Barred 

Petitioners contend that “EPA has violated Section 7(a)(2) of the Endangered Species Act 

(ESA) by failing to make required ‘effects’ determinations and failing to undergo consultation 

concerning clothianidin’s impacts on native endangered and threatened species.” Petition at 6. 

The Petitioners do not explicitly argue that this allegation warrants cancellation of the 

registrations, but instead request that EPA now “make the needed effects determinations and 

initiate and complete the required consultation process.” Petition at 39. The Petitioners do not 

appear to dispute that as part of EPA’s pending registration review of clothianidin, EPA has 

already initiated the process of collecting and assessing additional endangered species data, and 

has committed to take any appropriate action under the ESA based on that review. Nonetheless, 

the Petitioners contend that EPA “must suspend the continued use of clothianidin in the interim 

to make this ESA compliance meaningful.” Petition at 39. The Petitioners cite no legal support 

that would authorize suspending the registrations on this basis.
Ms. Lois Rossi

June 12, 2012 

Page 21

The statute makes clear that suspension is authorized on endangered species grounds only

if continued use of the pesticide during the time required for cancellation proceedings “will 

involve unreasonable hazard to the survival of a species declared endangered by the Secretary of 

the Interior...” FIFRA Section 2(l); cf. Washington Toxics Coalition v. EPA, No. 01-132, 2004 

U.S. Dist. LEXIS 29886 (W.D. Wash. Jan. 22, 2004) (implementing interim injunctive measures 

for 54 active ingredients where EPA had conceded that it failed to perform a required 

consultation, but not cancelling or suspending the registrations). The Petition does not even 

allege any such hazard to the survival of an endangered species.18 Accordingly, there is no basis 

for suspension of the registrations pending EPA’s comprehensive assessment of additional ESA 

data as part of its registration review of clothianidin, which is already underway.

Moreover, to the extent the Petitioners explicitly or implicitly seek the suspension or 

cancellation of clothianidin, or any other regulatory action with similar effect, the Petition is

effectively a belated challenge to EPA’s initial 2003 clothianidin registration process. Any such 

claim is time-barred. See, e.g., Council for Endangered Species Act Reliability (CESAR) v. 

Jackson, No. 10-8254, 2011 U.S. Dist. LEXIS 135635, at *15 (D. Ariz. Nov. 23, 2011) (appeal 

pending) (holding that plaintiffs’ claim that EPA failed to consult under the ESA was effectively 

a challenge to EPA’s re-registration decision); cf. American Bird Conservancy v. FCC, 545 F.3d 

1190, 1193 (9th Cir. 2008) (Federal Communications Commission’s registrations of seven 

communications towers were “inextricably intertwined with the FCC’s obligation to consult”

under the ESA, and thus the district court lacked jurisdiction over plaintiffs’ failure to consult 

claims).

Under FIFRA and the applicable statute of limitations, Petitioners were required to 

present any claims challenging the 2003 registration of clothianidin within (at most) six years 

from the date of EPA’s initial registration decision. See Hardin v. Jackson, 625 F.3d 739, 742 

(D.C. Cir. 2010); 28 U.S.C. § 2401(a) (“Every civil action commenced against the United States 

shall be barred unless the complaint is filed within six years after the right of action first 

accrues.”). The same six-year limitations period applies to challenges alleging failure to comply 

with Section 7(a)(2) of the ESA. See, e.g., Wind River Mining Corp. v. United States, 946 F.2d 

710, 713 (9th Cir. 1991); Sierra Club v. EPA, 162 F. Supp. 2d 406, 422 n.26 (D. Md. 2001); 

Kentucky Heartwood v. Worthington, 20 F. Supp. 2d 1076, 1093 (E.D. Ky. 1998). The 

 

18

 In connection with the general allegations in the Petition relating to potential risks to 

non-target species, it is noteworthy that EPA recently concluded that: “Incorporation of the 

treated seeds into the soil by certain methods as modeled in TREX eliminated all of the risk to 

both birds and mammals in the risk picture.” J. DeCant, EFED to K. Davis and V. Eagle, RD, 

Revised Assessment for Clothianidin Registration (Dec. 2, 2012) at 51 (Exhibit O).
Ms. Lois Rossi

June 12, 2012 

Page 22

Petitioners provide no explanation for their nine-year delay in presenting their allegations to 

EPA. The untimely nature of Petitioners’ allegations provides an alternative basis for EPA to 

deny the Petition.

Finally, as the Petitioners themselves appear to concede, EPA is already implementing 

the relief requested in the Petition, by gathering additional relevant data and evaluating any

endangered species impacts under the ESA as part of the statutory registration review process. 

EPA has accelerated the registration review schedule for clothianidin, and recently solicited 

public input. Petitioners’ demand that EPA conduct a redundant review of endangered species 

data, issue effects determinations, and engage in formal consultation with the Services, is 

misplaced. EPA is already taking those actions, and is pursuing the issues diligently within the 

existing registration review framework. The relief sought in the Petition is well underway, and 

there is no basis for Petitioners’ demand that EPA conduct its assessment under whatever 

alternative schedule or process the Petitioners may prefer.19 Cf. Beyond Pesticides v. Whitman, 

294 F.Supp.2d 1, 10 (2003) (finding no jurisdiction for court challenge of EPA’s decision to 

resolve petition to suspend/cancel in the context of ongoing reregistration process, rather than to 

“to engage in the type of review [the petitioners] prefer, at the time [the petitioners] request it”).

III. CONCLUSION

The Petition provides no evidence of any unreasonable adverse effects or imminent 

hazard to bees from the continued registration of clothianidin. There is no legal or scientific

basis for EPA to grant any of the relief requested, including suspension of the registrations or 

issuance of an SSURO. The Petition should be denied.

 

19

 In addition, PANNA and other parties have already filed a federal lawsuit challenging 

the registration of clothianidin, along with hundreds of other FIFRA registration and reregistration decisions, alleging failure to comply with the ESA. See Center for Biological 

Diversity v. EPA, No. 11-293 (N.D. Cal. filed Jan. 20, 2011). EPA has evidently been 

negotiating with the plaintiffs for months to craft an appropriate settlement. There is no basis for 

PANNA and the other Petitioners to present the same issues to EPA that PANNA and others 

have already taken to federal court, and EPA need not take further action relating to the same 

allegations pending resolution of that litigation.