Ms. Margaret Chern y Vice President of Regulatory , Government Affairs and Communications Ba ye r CropScience LP 2 T.W. Alexander Drive Research Triangle Park, NC 27709
Mr. Richard Stanton Vice Pres ident of Technology Valent U.S.A. Corporation 1600 Riviera Avenue, Suite 200 P.O. Box 8025 Walnut Creek , CA 94596

- 8025

June 1 2 , 2012

Ms. Lo is 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 :

Ba ye r CropScience LP (“Bay er”) 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”), Be yond Pesticides , the Center for Food Safet y, 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 s pecial r eview and cancellation proceedings, and issuance of a stop sale, use, and removal order (“SSURO”). Bay er 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. Bay er also holds various clothianidin end

- use product registrations, including for the seed treatmentMs. L ois Rossi

June 12, 2012 Page 2 uses discussed in the Petition. Bay er and Valent obtained a cop y of the Petition from one of the P etitioners’ websites.
G iven the P etitioners ’ request for an EPA decision within 90 day s, these preliminary comments are limited to Petitioners ’ request for immediate suspension of the registrations , based
on allegations of “imminent hazard

. ” Ba ye r and Valent expressly reserve the right to supplement these preliminary comments and to present additional arguments and scientific and factual inform ation 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 an y other species, and falls far short of the ty pe 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. M any

of the Petition ers’ characterizations of the science are inaccurate, and the allegations themselves are faciall y insufficient to support the P etition , which fails to address whether the alleged harm is likely to occur under actual conditions of use.
As EPA has concluded as recentl y 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 colon y health issues (and colon y 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 safet y, and 30 field and semi

- field studies on neonicotinoids. The Petitions’ allegations of an i mminent hazard to bees are also refuted b y 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 subs tantial improvement in overwintering survival for managed bee colonies in 2011

- 2012

. The Petitioners ’ allegations surrounding the pollinator field study submitted by

Bay er as a condition of the original 2003 registration of clothianidin are simply false, and such allegations provide no legal basis for suspension. Infact, both before and after reclassifying that study to “supplemental” in 2010, EPA issued unconditional registrations of multiple clothianidin products . EPA has also expli citly confirmed that no additional field pollinator data are currentl y required as a condition of registration for Clothianidin Technical and the end

- use product Poncho 600.Ms. L ois Rossi

June 12, 2012 Page 3 The Petitioners’ assertion that all clothianidin products are misbranded is simi larly 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, particularl y given th at EPA is already undertaking the actions requested in the Petition. Insum, 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 Petition ers 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 n o authority

or concrete data, the Petitioners contend that “[e]very y ear clothianidin remains in use, the viability of pollinator populations deteriorates more,” and that after six consecutive winters of significant managed honey bee colon y 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 s ys temic pesticides like clothianidin, thiamethoxam and others as particularl y r esponsible for mortality and poor health in bee populations and to bees’ increasing vulnerability to other threats.” Id. at 9

- 10. Inother portions of the Petition, however, the Petitioners venture only that the use of sy stemic pesticides in general “ cou ld 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 man y other false and inflammatory assertions, the Petitioners allege that sy stemic pesticides make the whole treated plant “potentially highly toxic to bees.” Petition at 3. This is entirely

baseless. The intent of a s eed treatment application of an insecticide is to control insects in the soil and the earl y plant seedling so that the plant can develop properl y. Control of insects in the small plant by neonicotinoids, and clothianidin in particular, is only possible be cause of the s ys temic 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 conce rn for bees, including fro m 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 h azard 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. L ois Rossi

June 12, 2012 Page 4 the “imminent hazard” standard, and points to no concrete information or evidence that continuing the registered uses of clothi anidin 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 b y the Secretary of the Interior...” FIFRA Section 2( l). In tur n , “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 i s 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)

. Accordingl y, “in order to find an imminent hazard, it is nece ssary to find that the risks of use during the period likel y 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 reliabl y demonstrates some sort of immediate threat or where the information before him suggests greater certaint y concerning the pesticide’s danger to humans than would warrant merel y initiating cancellation proceedings.” National Coalition A gainst Misuse of Pesticides v. EPA , 867 F.2d 636, 644 (D.C. Cir. 198 9). The Petition falls far short of establishing an y such immediate threat to bee populations, from an y cause, let alone from clothianidin. Instead, the Petition primarily repeats well

- known concerns regarding managed honey bee losses in recent y ears. Th e 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 strongl y suggest that clothianidin is not a likely

factor in commercial honey bee losses experienced in the United States.Ms. L ois 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) includ e disease, poor management practices by commercial beekeepers , poor nutrition provide d to managed bee colonies , pathogens, and parasites. The Petition makes no attempt to distinguish the impacts of these other factors on bee health from an y alleged effects from pesticides or clothianidin.
Most of the selectivel y - 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 , t o PANNA and Bey ond 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 an y immediate threat to bees from continued clothianidin use. Indeed, the Petitioners do not even appear to assert that an y 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 incorrec t. 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, E PA 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 bee s addressed through protective use restrictions). As EPA has recentl y confirme d, s uch 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 Infact, immunotoxicity studies have been conducted with clothianidin and have shown
no concern s relating to immune effects in animals.Ms. L ois Rossi

June 12, 2012 Page 6
sub

- lethal effects from neonicotinoid exposures (generall y based on exaggerated exposure levels in a laboratory

settin g), 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 indire ct 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 o f 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 pes ticides are known to interfere with honey

bees’ cognition and orientation in way s 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 expo sure more damage occurs.” Petition at 15

. As noted above, Petitioners’ assertions are frequently unsupported b y 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 an y case, allegations such as the Petitioners’, asserting various potential study effects from exposures, or potential pathway s of exposure, are themselves insufficient to support a pet ition to suspend or cancel a registration. As EPA recently affirmed in den yi ng 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 po tential 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 an d the exposure to 2,4

- D for occupational risk. Yet, the ground for cancellation is a finding that risks outweigh benefits. Accordingl y, NRDC’s claims that the 2,4

- D registrations should be cancelled due to 2,4

- D’s ecologicalMs. L ois Rossi

June 12, 2012 Page 7
effects or worker risk is den ied due to a failure to make a proper

claim for cancellation b y, 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 likel y to occur based on how clothianidin is actually used. Nor do the Petitioners address whether an y alleged harm is outweighed by the environmental and agricultural benefits of clothianidin. Accordingl y, 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 “ c ritical n ew s tudies” suggest honey bee exposure pathway s 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 reflecti ve of actual use. The Krupke study

found significant concentrations of pesticide in waste talc remaining inside seed

planting equipment after planting , but levels reported in soil, pollen and nectar ( i.e. , environmental media to which bees may be exposed) were generall y consistent with previous research . In the field portions of the study , l ow 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 b y certain t ypes of drilling machines during sowing of neonicotinoid

- treated corn contained significant levels of insecticide. S ugar s yrup 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 intercept ed the suspended particles and were thereb y 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 onl y that, if honey bees were to fly

through the exhaust of pneumat ic corn planters , those individual bees c ould experience an acute exposure. The researchMs. L ois Rossi

June 12, 2012 Page 8 results and available records of field incidents suggest that an y 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 Petiti oners seek to conflate an y acute exposure incident with long

- term bee colony and population health generally , and with CCD (a particular t ype of colon y 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 colon y health issues, such as those discussed in the Petition. Even if the Petitions had presented evidence of an acute exposur e incident involving planter exhaust, such a phenomenon has not been scientificall y linked to ( and is not suspected b y mainstream scientists to be a cause of

) colony collapse disorder or widespread honey bee colony

losses.
In an y case, even if Petitioner s’ characterizations of the findings of these two studies were accurate, 6 they

would fall far short of establishing imminent hazard to bees from

4 S eed

- treatment places the neonicotinoid below the soil surface resulting in low potential for environmental exposure. While some acute exposure incidents have occurred in Europe whe re poorl y coated seed was planted using equipment that exhausted upward , incidents involving substantial amounts of abraded seed dust are rare in practice. S tudies have shown that when seeds are properl y 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

I mplication, J. Appl. Entomol. 136:17

- 26 (2012) ( inves tigat ing potential honey bee exposures from visits to flowering plants where deposition of abraded seed dust has occurred or b y 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 diligentl y to further minimize any honey bee exposure incidents , including through improved planting practices, better seed coatings/lubricants, and other measures
.

6 As noted above, Bay er and Valent do not attempt in these preliminary comments to comprehensivel y address these studies or the characterizations in the Petition regarding the data, many of which are inaccurate. However, Bay er has previousl y 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

ContinuedMs. L ois Rossi

June 12, 2012 Page 9
clothianidin use. Numerous field and semi

- field studies have shown that pollen and nectar residues from neonic otinoid 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 wer e also comparabl y low. As noted below, f oliar 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 similarl y misguided. Petition at 16. 7 The overwhelming weight of the scientific evidence confirms the lack of unreasonable adverse effects from clothianidin use. N eonicotinoid products , including clothianidin, are among the most intensively

stu died chemicals with regard to pollinator health. As EPA concluded as recentl y 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 potent ial pollinator effects have been conducted o n clothianidin, and over 30 pollinator field and semi

field studies have been conducted on neonicotinoids in general. These studies demonstrate that the actual registered uses of clothianidin, including seed tre atment 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 pathway s that may be relevant to actual use practices. In addition, l ong - term feeding studies with c lothianidin 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 an y imminent hazard to bees. 8

Continued MRID 48828701, C

. Halder, Technical Reviews of Several Recentl y Published Scientific Articles C oncerning 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 rapidl y, remained detectable over several weeks.” Id. In fact, while studies have shown that guttation drops may contain residues of neonicotinoids, bees do not generall y consume guttation fluids. Even P ANNA ’s own State of the Science report concedes that “while bees readil y 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

B ees: State o f the Science (May 2012) , at 21 ( Exhibit F )

.
8 Inits State of the Science report, PANNA asserts that studies have reported dramaticall y enhanced neonicotinoid activity when mingled with certain fungicides. See ContinuedMs. L ois 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 contrad icted 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 resid u es
. 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 i**  **n 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 app roximately 30% during each of the past 6 ye ars. 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 cy anoamidine class, which does not include clothianidin. No interaction at comparable levels has been reported for the nitroguanidine class of neonicotinoid s, 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 freq uently found were fluvalinate and coumaphos , miticides frequentl y applied directly to hives b y commercial beekeepers to control the Varroa destructor mite (a parasite widel y considered to be a key factor in colony losses).

11 Overall, no negative correlati on has been established between pesticide residues and colony health (although there is at least one report of a slightl y positive correlation suggesting that the use of miticides to control honey bee parasites resulted in healthier hives).Ms. L ois Rossi

June 12, 2012 Page 11 by beekeepers over the winter have generally been replaced each y ear
. 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 In formed 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 rec ent 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**  **W as Not Satisfied**  **Provide no Legal**  **Basis f or 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 c ondition of registration , including submission of the pollinator field study that is the focus of the Petition

. As the Petitioners’ themselves acknowledge, Ba ye r completed th at pollinator field study and submitted the results to EPA in 200 6

. Nevertheless, because EPA later reclassified that study from “acceptable” to “supplemental” in 2010, Petitioners argue that this constitutes “an eight year period of failure b y the registrant to compl y with a critical condition [of registration] imposed sp ecificall y 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 registrat ion 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 Survey s of the number of managed honey

- producing colonies (excluding pollination

only colonies) reported by

the USDA National Agricultural Statistical Service confirm no dramatic drop in overall colony numbers in the y ears since the introduction of neoni cotinoids 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 stead y declines in managed colon y numbers since 1947, with average y earl y declines of approximately 0.87% from 1947 to 1981, and 1.12% from 1986 (after the introduction of Varroa ) to 2010. These stead y declines in numbers are consistent with the evolving economic s of honey production and pollinator services in the United States since 1947.

13 See Preliminary

Results: Honey

Bee Colony

L osses in the U.S., Winter 2011

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

.Ms. L ois Rossi

June 12, 2012 Page 12 mistake through immediate suspension of clothianidin’s registration, pending preparation, publicati on and EPA review of the required field study

. . . . ” Id. at 12.
T he allegations in the Petition provide no legal basis to suspend the registration of clothianidin products

. Petitioners’ arguments are also legall y 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**  **Un der**  **FI FRA**  As noted above, Petitioners repeatedl y 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 compl y 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 proce ss , not immediate suspension

. Petition at 35. That provision states :

The Admi nistrator 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 an y time during the period provided for satisfaction of an y condition imposed, determines that the registrant has failed to initiate and pursue appropriate action toward fulfilling an y 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 the ir 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 s uspension 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. L ois 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, provide s 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**  **Condit ion of Registration**  **w as 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 no ted above, the statut e provides for cancellation proceedings where “ the registrant has failed to initiate and pursue appropriate action toward fulfilling an y condition imposed. ” 7 U.S.C. § 136d(e)(1). Although Petitioners repeatedl y assert “an eight ye ar 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 Bay er not only acted diligently to initiate and pursue appropriate action toward satisfaction of the condition of registration, it actuall y 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 test ing at this time

. While these preliminary

comments are focused on Petitioners’ allegations of imminent h arm 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 the se a llegations , which form the core of the Petition , are simply false, and provide no basis whatsoever for regulat ory action against the existing registration of clothianidin, let alone the emergency suspension and SSURO requested b y the Petitioners

. As directed b y EPA, Bayer developed the draft study protocol for EPA review and input , in consultation with E PA 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. Bay er revised the protocol to implement EPA’s comments and ( with the approval of EPA 14 ) , 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. L ois Rossi

June 12, 2012 Page 14 the 2005 growing season. Inaddition to the d ata 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 untreate d hives over the winter. The study report w as finalized and submitted to EPA, along with the additional data, on August 8, 2006 ( MRID s 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

- re view 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 reclassif

ied as “supplemental

. ” The reclassification was “based on an increased understanding and awareness of the potential uncertainties normally encountered in field studies with honey bees” since the time th e 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 th e 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 minimi ze inter

- plot foraging, and explaining in detail the basis for the authors’ conclusion that the “bees overall were highl y faithful to their test plots.” Id. at 6. Nevertheless, six organizations, including two of the Petitioners here (PANNA and Be yond Pes ticides), 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 rec lassification of the study meant that clothianidin posed an “imminent hazard” to bees. See H. Pilatic, PANNA , J. Feldman, Beyond Pesticides, et. al., t o L. Jackson, EPA Administrator , RequestingMs. L ois Rossi

June 12, 2012 Page 15
Clothianidin SSURO (Dec. 8, 2010) at 1 ( Exhibit A )

. As noted above, EPA responded to that letter o n 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 expla i n ed in detail wh y the r eclassification of th at 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 generall y in supporting EPA regulatory decisi ons 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

. T he 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 stud y cl assified as “supplemental” provides s cientifically

- sound information

. Notwithstanding the confounding factors in field study design identified b y EPA, the study provided “useful information that has been used to be tter understand hive survival following exposure to clothianidin.” Id. at 3. Moreover, both before and after the 2010 reclassification of the stud y, EPA issued a number of unconditional registrations for clothianidin products under FIFRA Section 3(c) (5). B y definition these registrations are not subject to the cancellation provision invoked by the Petitioners, which applies to conditional registrations issued under S ection 3 (c)(7). 7 U.S.C. § 136d(e)(1). In fact, n o clothianidin registration includ es a requirement to submit additional pollinator field data as a current condition of registration. To the contrary , in approving a label amendment to Bay er’s Poncho/Votivo clothianidin end

- use registration on February 24, 2011, EPA made explicit that the re is no such condition of registration at this time: “[o]ptions are being evaluated [b y 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 recommendat ions 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, Bay er Regulatory Affairs (Feb

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

. 15

15 Nevertheless, Bay er and Valent are currentl y conducting another pollinator field study. While EPA has made plain that this additional stu dy 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. L ois Rossi

June 12, 2012 Page 16 In sum, the registrants have acted diligentl y at all times “to initiate and pursue appropriate action” toward fulfilling all co ndition s of registration imposed by EPA. 7 U.S.C. § 136d(e)(1). Bay er actually fulfilled the condition at issue when it completed an d submitt ed the pollinator field study to EPA in 2006. While EPA later reclassified th at study , EPA explicitly has not re quired the submission of additional pollinator field test data as a condition of registration for clothianidin

. Petitioners point to nothing that suggests an y l ack of appropriate action by any clothianidin registrant toward fulfilling any applicable condi tion 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

- safet y of clothianidin. See , e.g. , Petition at 31 ( “Well over a ye ar has passed since EPA finall y 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 thu s exists in a regulatory

limbo in which EPA continues to allow its sale and use even though Bay er failed to meet a crucial condition imposed back in 2003.” ). Petitioners’ argument reflects a fundamental misunderstanding of FIFRA and how EPA makes regulat ory

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 e xisting 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 cond itional registration period, while at the same time requiring the additional data. The two are not inconsistent , a s EPA made clear in its February 2011 decision rejecting man y of the same arguments the Petitioners present here :

16 Inaddition, 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 an y condition imposed.” 7 U.S.C. § 136d(e)(1). EPA’s recla ssification of the study occurred in late 2010

– ye ars after the period provided for satisfying the condition. Not only did Bay er 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 cancellati on proceedings against the initial 2003 conditional registrations is both moot, and entirel y meritless under the plain language of the statute.Ms. L ois Rossi

June 12, 2012 Page 17

T he Agency bases pesticid e 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 honey bees] was based on 34 studies and not on the fin dings 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 inappropriatel y 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 indirectl y, contending that a “suspension and a stop sale, use , or removal order [is] also nec essary 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 envir onment.’” Id. at 6

. Further, the Petitioners contend that no label directions or use restrictions could be developed that would adequately mitigate the alleged risk, particularl y for seed treatment uses, where Petitioners allege that “no modifications to the planting machinery have been shown to significantly re duce” the levels of clothianidin disseminated into the environment. Petition at 37

. The Petitioners’ invitation that EPA use its misbranding authorit y 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 recentl y held, “ FIFRA does not give EPA the authority to pursue a misbranding enforcement action in l ieu 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 spec ies are properl y 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 label s 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. L ois 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 Vaugh an 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 fruit ing 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 inc apable of mitigation by label warnings or use directions.
Petition at 37.
T he EPA statements referenced b y the Petitioners merel y 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 b y EPA do not apply more generally

to other crops. In addition, as reflected b y accepted risk assessment principles , an i ntrinsic 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 generall y, 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 as sessment 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. L aws , RD , Re Clothianidin Registration (Oct. 21, 2009)

. S ee Exhibit M.Ms. L ois 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 ti mes 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 “fl yi ng 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, h omeowner and professional landscape product label s do include environmental hazard statements, just as agricultural products do. In the case of foliar spray s for home landscape use and granular products for lawn use the label reads as follows:

“ This product is t oxic 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 L abel for Arena® 50 W D G In secticide at 3 (accepted with comments, Nov

. 30, 2004) (Exhibit N) ; s ee al so 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 r esidential clothianidin uses are important, as there are man y 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 the se important registered uses of clothianidin help prevent bee exposures, and thereby help protect bee s 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 significantl y higher than a comparable agricultural use rate, homeowner products are subject to an overall maximum usage rate of 0.4 lb s of active ingredient per acre, onl y 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. L ois 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 landscape s are often much larger than the average commerciall y 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 , densel y populated with the treated trees

. In a residential landscape setting, most trees would NOT be treated. O ver a large area there are fewer trees in a residentia l landscape compared to a crop field , and far fewer treated trees.
T he Petition also fails to acknowledge that the use rate is only one factor relevant to ensuring pollinator safet y. 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 foreseeabl y visited by man y 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 visit ed, or only

infrequently

visited , by

bees. For other species that may attract bee s , such as
m aples , 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) b y 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 alread y initiated the process o f 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 su pport that would authorize suspending the registrations on this basis.Ms. L ois Rossi

June 12, 2012 Page 21

T he 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. L EXIS 29886 (W.D. Wash. Jan. 22, 2004) ( implementing interim injunctive measures for 54 a ctive ingredients where EPA had conceded that it failed to perform a required consult ation , but not cancelling or suspending the registration s )

. The Petition does not even allege an y such hazard to the survival of an endangered species. 18 Accordingl y, 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 Pe titioners explicitly or implicitly

seek the suspension or cancellation of clothianidin, or any other regulatory

action with similar effect, the Petition is effectivel y a belated challenge to EPA’s initial 2003 clothianidin registration process. An y such
c laim is time

- barred. See, e.g. , Council for Endangered Species Act Reliability (CESAR) v. Jackson , No. 10

- 8254, 2011 U.S. Dist. L EXIS 135635, at *15 (D. Ariz . Nov. 23, 2011) (appeal pending) (holding that plaintiffs’ claim that EPA failed to consult under the ESA was effectivel y 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 to wers 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 re quired to present an y 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 ac tion commen c ed against the United States shall be barred unless the complaint is filed within six years after the right of action first accrues.”). Th e same six

- ye ar limitations period applies to challenges alleging failure to compl y 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 Inconnection with the general allegations in the Petition relating to potential risks to
non - target species, it is noteworth y that EPA recently concluded that : “Incorporation of the treated seeds into the soil by certain methods as modele d 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. L ois Rossi

June 12, 2012 Page 22
Petitio ners provide no explanation for their nine

- year delay in presenting the ir allegations to EPA. The untimely

nature of Petitioners’ allegations provide s an alternative basis for EPA to deny the Petition. Finally , as the Petitioners themselves appear to conc ede, EPA is alread y 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 recentl y 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 t yp e of review [the petitioners] prefer, at the time [the petitioners] request it”).
**III. CONCLUSION** 
The Petition provides no evidence of an y 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 Inaddition, PANNA and other parties have already filed a federal lawsuit challenging the registration of clothianidin, along with hundreds of other FI FRA registration and re

registration decisions , alleging failure to compl y with the ESA. See Center for Biological Diversity v. EPA , N o . 11

- 2 93 (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 a lready

taken to federal court, and EPA need not take further action relating to the same allegations pending resolution of that litigation.