Page 1 of 13 Ms. Lois Rossi, Director, Regist ration Division Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency Room S4900, One Potomac Yard 2777 S. Crystal Drive Arlington, VA 22202

Subject: Spirotetramat; Re-insta tement of Registration. Response to EPA regarding th e Decision on Bee Safety Label Language (EPA Reg. No. 264-1049; EPA Reg. No. 264-1050).

Dear Ms. Rossi:

On July 13 th , 2010, Meredith Laws confirmed that two changes regarding bee safety will be required by EPA to the existing labels of spirotetramat end-use products. These are:

1. The deletion of the cucurbit vegeta bles (crop group 9) use, and;

2. The modification of the bee safety st atement for the citrus (crop group 10) use from the existing statement, viz :

Do not apply this product within 10 days prior to bloom, during bloom, or until petal fall is complete.

to:

Do not apply until after petal-fall.

Relative to the proposed modi fication of the bee safety statement for citrus, this language change raises confusion in light of the fact that EFED, in a document dated July 7 th , 2010, clearly states that the existing label language for citrus and cucurbits are sufficient to mitigate the potential hazard to bees.

We responded the afternoon of July 13 th , 2010, that these requirements are scientifically unacceptable to Bayer CropS cience given the fact that we have chronic bee field studies that show the safety of spirotetramat to bee colony health, even when applied during the bloom stage to melons [MRID# 47563303, Bayer CropScience

2 T.W. Alexander Drive

P. O. Box 12014 Research Triangle Park,

NC 27709

Tel: 919 549-2000 Date: July 20, 2010Page 2 of 13 47563302, 47563305, 47563306, 47563307, 47563308, 47563310, 47563311, and
46904462], and citrus [MRID# 47563309 and 47563304] 1 . Furthermore, the Asian Citrus Psyllid (“ACP”), a new pest (and vector of Hu anglongbing, or citrus greening) of critical importance to the citrus industry, feeds exclusively on new growth and attacks trees duri ng periods of flush, some of which occur prior to, or at, bloom time. In order to prevent ACP from transmitting the bacteria that causes citrus greening disease, it is necessary that new growth be continuously protected.

We would now like to address the revise d bee language proposed by EPA for the citrus crop group. This can be more easily expressed pictorially below:

Scenario A: Existing Citrus Trea tment Guidance relative to Bee Safety

Do not apply this product within 10 days 2 prior to bloom, during bloom, or until petal fall is complete.

1 An additional two citrus study reports will be submitted to EPA before August, 2010, one of which (the citrus study undertaken in Florida in 2009) EPA was involved in the design and for which the interim results have been made available to the EPA. A summary of the results of these

two studies can be found in Attachment 1 to this letter.

2 The setting of the language restricting applica tions to 10-days prior to blossom emergence was intentionally based on the absence of larval effects noted in the tunnel test when application was made 10 days or more prior to floweri ng in Phacelia at 150 g ai/ha (refer to Attachment 2 for a detailed summary of this test).Page 3 of 13 Scenario B: EPA Proposed Citrus Treatment Guidance relative to Bee Safety

Do not apply until after petal-fall.

Hopefully, these pictures portray the fact that citrus is not like deciduous crops, such as pome or stone fruit, tree nuts, et c. Being an evergreen crop and grown in subtropical environments, the treatment s eason has “no end”. Thus, the post-petal fall period runs full circle, from literal petal fall right up to when new blossom buds form. Bayer CropScience’s existi ng language defines a beginning and an end to the post-petal fall period that, in e ssence, defines an a pplication restricted period, unlike the language that EPA is proposing. Consequently, the language proposed by EPA is likely to create conf usion and difficulty with compliance. For instance, one could easily interpret that they would legally be able to treat the citrus crop right up until new blossom bud formation (Fig. 2) as the definition does not define a closure to the post-peta l fall period. From our viewpoint, this interpretation would satisfy the needs we see in being able to effectively treat against ACP and other key pests; however , as a responsible company, we have concerns around the confusion that will play out in the States due to fact that the language is now open to interpretation.

Last, Bayer CropScience is in the proce ss of receiving input (which has/will be forwarded to EPA as well) from citrus commodity groups and other citrus experts who identify the need for Movento ® pre-bloom in order to effectively manage ACP. You will find that these experts, both from California as well as Florida, provide opinions that are cont rary to the one you received.Page 4 of 13 Relative to the proposal by EPA to delete the existing use for the cucurbit crop group, Bayer CropScience disagrees. The existing bee safety mitigation language on the existing label is the same as that for citrus, specifically:

Do not apply this product within 10 d ays prior to bloom, during bloom, or until petal fall is complete

This language renders this use impractical due to the indeterminate nature of flowering for this crop (as well as for melons) and the need for pollinators to assure enhanced production. Accord ingly, Bayer CropScience had already removed this use from their commercial label from the initial registration approval back in 2008, and has not - and does not intend - to market this use until such time as we can prove the safety of spirotetramat to bees active during blooming. To this end, Bayer CropScien ce had undertaken additional sub-chronic and chronic bee studies on melons, or surr ogate crops, to evaluate the safety of spirotetramat to bees (and th eir colonies) at targeted labe l rates. To date, 9 studies

have been conducted and submitted to EPA 3 with the intention of establishing that the precautionary bee safety language is unnecessary.

Despite the set-back brought about by the lawsuit, it is still Ba yer CropScience’s intention to pursue the removal of bee m itigation language on cucurbits as well as citrus as it continues to be our opinion, based on the scientific data, that this compound does not harm bees even when applied during bloom at the prescribed label rates for these crops, as shown by our scientific studies.

In summary, we reiterate that the laws uit brought by NRDC and the subsequent order by the Court to vacate the registra tions of spirotetramat was based on an administrative (procedural) failure by EPA. We remind the Agency that Bayer CropScience, subsequent to the regist ration, has submitted multiple chronic bee field studies [MRID# 475633-00, with a follow-up letter, dated March 29, 2010;

refer to Attachment 3 ] that support the safety to bees under the labeled use conditions, even including during bloom. Additional studies on citrus will be submitted shortly. The concerns raised by NRDC, and others, are based on Bayer CropScience’s own tunnel tests administ ered under elevated (exaggerated) dose rates that indicated the potential for spirot etramat to adversely affect bees; this is, in fact, the purpose of the t unnel tests. If anyone has data to suggest a different

conclusion than what the extensive existi ng data set show, we’d be more than willing to review it openly. Otherwise, conjecture and opinion should remain just

that.

3 The following studies on melons were submitted to the EPA in 2008 and again in March, 2010: MRID 47563303, 47563302, 47563305, 47563306, 47563307, 47563308, 47563310, 47563311,

and 46904462.Page 5 of 13 If you have any questions, please c ontact me by phone at 919.549.2824 (or via email at: clive.halder@ bayercropscience.com ).

Yours Sincerely,

Clive A. Halder, Ph.D. Director, Registrations, Insecticides, Fungicides and Seed TreatmentsPage 6 of 13 Attachment 1

Summary of Two Additional (Uns ubmitted) Citrus Field Studies

Florida Study :

The Asian citrus psyllid (ACP), Diaphorina citri , is the single greatest insect pest to the global citrus industry. Citrus grower s have numerous options for controlling the ACP, however, most

are not bee-safe. Movento ® contains a new insecticidal active i ngredient (a.i), spirotetramat, that controls ACP, however due to un certainty about bee safety, its us e is not currently allowed just prior to or during bloom, when it is most effective for ACP control.

Bayer CropScience continues to investigate the potential effects of Movento ® on western honey bee ( Apis mellifera ) brood and whole colonies when applied to citrus during bloom. Establishing the bee safety of Movento ® during bloom will enable its use in order to control this important pest. Bayer CropScience in consultation with the National Honey Bee Advisory Board, the US Environmental Protection Agency (EPA), Florid a Department of Agriculture and Consumer Services and the US Department of Agricultur e (USDA), developed a protocol for a field study to monitor colony exposure and resulting effects from application of Movento ® during bloom in citrus. Twelve colonies were placed at the edge of each of two citrus groves at the start of bloom

in March 2009 and remove d after bloom finished; one grove received a single application of

Movento ® at full citrus label rate of 0.16 lb ai/acre (175 g ai/h a) and the other received no treatments. Colonies were assessed for streng th and health (i.e., adult and brood populations, food stores, pests, and diseases ), and brood effects. Also, pol len, nectar, honey and wax samples were collected and analyzed for presence of residue s of spirotetramat. After the conclusion of field work in Florida, the colonies were re turned to a commercial beekeeping operation and transported to northern states for use in pollinat ion of several crops where typical agricultural practices were followed with no imposed limitati ons. Follow-up assessments of the health of these colonies were performed during May in Pennsylvania after apple pollination, during June in Maine after blueberry pollination, and during October in Pennsylvania after late summer pumpkin pollination.

Quantifiable residues of total Movento ® residues (spirotetramat and the metabolite, spirotetramat-enol) were detected in bee-colle cted pollen and nectar for only a few weeks postapplication to blooming citrus. Highest indivi dual detects were 3.52 ppm in whole blossoms, 0.55 ppm in bee-collected pollen and 0.04 ppm in bee-collected ne ctar. No quantifiable residues

of Movento ® were present in samples of stored polle n and honey collected from the study hives during the remainder of the study, or in the citrus blossoms of the study trees collected the following year. Based on the low le vels of residues, it appears th ere is a high degree of safety

with Movento ® use during citrus bloom. There were no significant differences between the control and treatment groups of hives for any colony strength and health measurements, and brood cohort success, during the in -citrus phase of the study. Both groups of hives started experiencing high losses of colonies between the blueberry pollination period and the fall colony

assessments. Varroa mite and Nosema counts were high in both groups of hives throughout most of the study period, and deformed-wing c ondition accounted for almost one-third of intrahive mortality before leaving ci trus. Hive monitoring and asse ssment results strongly suggestPage 7 of 13 that the primary causes of the high colony loss es by fall, in both groups of hives, were Varroa

destructor

, Nosema spp., deformed-wing virus, queen i ssues (i.e. direct losses, failed replacement, poor performance), and multiple a nd various other pathogens and factors possibly to a lesser degree.

Argentina Study

An extensive citrus field study was also performed in Argentina. The test item Spirotetramat OD 150 was applied in flowering citrus orchards of approximately 2-3 ha size. There were 2 treatment groups, each with 4 repl icates. Treatment group 1 served as untreated control. The plots of treatment group 2 received 2 applicatio ns of 96 g a.s./ha/m canopy height in a spray interval of 14 days or 16 days, resulting in 2 applications of 278.4 g a.s./ha on plot 2, 240.0 g a.s./ha on plot 3, 230.4 g a.s./ha on plot 4, and 172.8 g a.s./ha on plot 8, respectively (differences in applications were based on canopy height). All plots were in approximately 3 km distance of

each other.

Three bee hives were set up on each plot. During the assessments, the bee colonies were observed for potential treatment -related effects on brood (eggs, unsealed brood – larvae, and sealed brood - pupae), as well as hive weight, colony strength, pollen a nd nectar/honey storage. Additionally, mortality in front of each hive was assessed for up to 6 days in 24 h intervals and thereafter in 48 h intervals after the applications . Citrus blossoms were collected and analyzed for spirotetramat residues. Concurrently, the numb er of foraging bees on the citrus blossoms was

assessed.

Citrus blossom residues measur ed after the first applicatio n ranged from 1.69-6.9 ppm (1 day after application) to 0.010-0.72 ppm (15 days after application). No effects on brood development (eggs, larvae, pupae) and abundance of adult honey bees were found. Also, there were no effects on foraging activity, mortality determined in front of the hives, hive weight development or the food storage behavior.

These study reports are expected to be submitted to EPA very soon. However, summaries of the study findings from the US study have alr eady been communicated to the Agency.Page 8 of 13 Attachment 2

Rationale behind Setting the 10-Day Period Prior to Blossom Emergence

For use in citrus, the following language is recommended until EPA has an opportunity to review all available bee safety data, “Do not apply this product within 10 days prior to bloom, during bloom, or until petal fall is co mplete.” The important agronomic reasons for why a pre-bloom application is needed we re presented above. In addition, even under

the conditions where mild and transient brood effects were noted (enclosed exposures),

data submitted to EPA demonstrated that there were no effects on brood when the applications were made 10 days or more before flowering (MRID 47276901).

Percentage of comb area covered by larval cells (at X days after beginning of exposure) Crop, Treatment and Application Rate

0 +4 +7 +15 +22 +28

Phacelia, 20 days prior to flowering spray rate: 150 g a.s./ha 10.8 15.0 10.0 5.0 19.2 23.3

Phacelia, 15 days prior to flowering, spray rate: 150 g a.s./ha 10.0 11.7 10.0 10.0 18.3 17.5

Phacelia, 10 days prior to flowering, spray rate: 150 g a.s./ha 1 16.7 14.2 7.5 8.3 15.8 19.2

Phacelia, 5 days prior to flowering, spray rate: 150 g a.s./ha 12.5 0.8 1.7 3.5 12.5 12.5

Phacelia, on flowering crop at bee flight spray rate: 150 g a.s./ha 16.7 2.5 5.0 4.2 7.5 11.7

Phacelia, on flowering crop after bee flight (21:00), spray rate: 150 g a.s./ha 11.7 7.5 3.3 5.8 16.7 12.5

Phacelia, Reference (Insegar); on flowering crop at bee flight (spray rate 150 g a.s./ha) 12.5 1.7 0.0 0.0 16.7 7.5

Phacelia, untreated

13.3 21.7 16.7 8.3 19.2 13.3

1 No effect noted when application was made 10 days or more prior to flowering in Phacelia at 150 g ai/ha.

It is also important to consider that residues measured in Phacelia are higher than those

measured in citrus even when the Phacelia rate is lower, making this a worse-case comparison for bee safety in citrus. The Phacelia residue data were submitted to the EPA (MRID 47563310) and the citrus residue da ta are included in the new report on

citrus and described above.Page 9 of 13 Measured residues

Crop and rate Pollen Nectar

Phacelia (100 g ai/ha) 2.1 - 6.1 ppm 0.20 - 0.31 ppm Citrus (175 g ai/ha) <0.01 - 0.55 ppm <0.01 - 0.04 ppmPage 10 of 13 Attachment 3

Summary of Honey Bee Studies Conducted wi th Spirotetramat versus label rate on target crop

Table 1. Honey Bee Studies - La boratory and Semi-field Tests

MRID

Number Study Title Study Description

46904461 Acute Toxicity of BYI 08330 150 OD to the Honeybee Apis mellifera L. Under Laboratory Conditions Acute contact and oral toxicity to bees for formulation in the laboratory. Purpose of study was to identify hazard.

46904449 Effects of BYI 08330 (Acute Contact and Oral) on Honey Bees ( Apis mellifera L.) in the Laboratory Acute contact and oral toxicity to bees for active ingredient in the laboratory. Purpose of study was to identify hazard.

46904469 Effects of BYI 08330 240 SC (Acute Contact and Oral) on Honey Bees ( Apis mellifera L.) in the Laboratory. Acute contact and oral toxicity to bees for formulation in the laboratory. Purpose of study was to identify hazard.

46904458 Assessment of the Side-Effects of BYI 08330 OD 100 on the Honey Bee ( Apis mellifera L.) in a Feeding Test Colony feeding test – pure sucrose solution

at a concentration of 0.0144 % a.i. fed to colony. Purpose of study was to identify

hazard.

46904470 Assessment of the Side-Effects of BYI 08330 SC 240 on the Honey Bee ( Apis mellifera L.) in a Feeding Test. Colony feeding test – pure sucrose solution

at a concentration of 0.0144 % a.i. fed to colony. Purpose of study was to identify

hazard.

46904459 Assessment of Side Effects of BYI 08330 OD 100 on the Honey Bee ( Apis mellifera L.) in the Semi-Field Tunnel test with bees

47276901 Summary of Orientating Research Tunnel Trials on Effects of Spirotetramat to Honey Bees According to EPPO 170: Evaluation of Brood Effect Endpoints. Summary of multiple agronomic development trials in tunnels with various crops and rates.Page 11 of 13Table 2. Spiked Pollen Feeding Studies and Residue Measurements for Risk AssessmentMRIDNumberStudy InformationStudy DescriptionComments on Rate47563305 Determination of Effects of Spirotetramat inSpiked Pollen to Honeybee Brood under SemiField Conditions (Trial 2008).Spiked pollen feeding study with the targetconcentrations of 2, 10 and 20 mg/kg pollen.Field rate not applicable but used as acomparison for the pollen and nectarresidue assessment47563306 Determination of Effects of BYI 08330 in SpikedPollen to Honeybee Brood under Semi-FieldConditions (Trial 2006).Spiked pollen feeding study with the targetconcentrations of 10, 2, 0.5, 0.2 and 0.05 mga.s./kg pollen mg/kg pollen.Field rate not applicable but used as acomparison for the pollen and nectarresidue assessment47563307 Residues of Spirotetramat and its Metabolites inBlossom Samples of Melons after SprayApplication in Spain.MelonResidue studyApplication of 72 g as/ha or 288 g as/haMelon crop used, EU field crop rateand exaggerated rate of 288 g ai/ha(seasonal max for field crops in EU)applied47563308 Residues of Spirotetramat and its Metabolites inNectar and Pollen Samples of Melons after SprayApplication (Tunnel Test) in Spain.MelonResidue studyApplication of 288 g as/ha or 96 g as/haMelon crop used, EU field crop rateapplied and exaggerated rate of 288 gai/ha (seasonal max for field crops inEU) applied47563309 Residues of Spirotetramat and its Metabolites inCitrus Blossoms after Spray Application inSpain. M/295276/01/1.CitrusResidue studyTwo applications of 112.5 g ai/ha, citrus,SpainEU citrus rate applied. Rate is lowerthan US citrus rate (2 X 176 g ai/ha)due to application based on treeheight47563310 Residues of Spirotetramat and its Metabolites inNectar and Pollen of Phacelia after SprayApplication in Germany.PhaceliaResidue studyApplication of 100 g as/ha;Phaceliaused as surrogate for fieldcrop, rate higher than single US fieldcrop rate (88 g ai/ha) applied47563311 Residues of Spirotetramat and its Metabolites inNectar and Pollen of Summer Oilseed Rape afterSpray Application in Germany.CanolaResidue studyApplication of 100 g as/haCanola crop used as surrogate forfield crop, rate higher than single USfield crop rate (88 g) appliedPage 12 of 13MRIDNumberStudy InformationStudy DescriptionComments on Rate47563312 Residues of Spirotetramat and its Metabolites inNectar and Pollen of Citrus after SprayApplication in Spain.CitrusResidue studyTwo applications of 112.5 g ai/haCitrus rate applied. Rate is lower thanUS citrus rate (2 X 176 g ai/ha) dueto application based on tree heightTable 3. Honey Bee Field StudiesMRIDNumberStudy InformationStudy DescriptionComments on Rate46904462 Assessment of Side Effects of Spirotetramat OD150 on the Honey Bee (Apis melliferaL.) in theFieldPhacelia tanacetifolia.Two treatments:4 × 72 g a.s./ha, two times before floweringand two times during flowering of the cropand foraging activity of the bees2 × 96 g a.s./ha during flowering of the cropand foraging activity of the beesPhaceliaused as surrogate for fieldcrop, EU field crop rate applied(exceeds US field crop rate of 2 X 88g ai/ha).47563302 Assessment of Effects of Spirotetramat OD 150on Honey Bee (Apis melliferaL.) Colonies undera Realistic Field Scenario in a Melon Crop in2007 (non-GLP).MelonTwo treatment groups4 applications of 72 g as/ha4 applications of 88 g as/haEU field crop rate applied (exceedsUS field crop rate of 2 X 88 g ai/ha)47563303 Assessment of Effects of Spirotetramat OD 150to Honey Bee (Apis mellifera) Colonies under aRealistic Field Scenarioin a Melon Crop-GLPTrial 2008.MelonTwo treatment groups4 applications of 75 g as/ha2 applications of 88 g as/haEU and US field crop rate (2 X 88 gai/ha) applied47563304 Assessment of Side Effects of Spirotetramat ODCitrusEU citrus rate applied (exceeds USPage 13 of 13MRIDNumberStudy InformationStudy DescriptionComments on Rate150 on the Honey Bee (Apis mellifera L.)Applied to Citrus in the Field in SpainApplication: 2 x 192 g as/hacitrus rate of 2 X 176 g ai/ha)