### UNITED STATESENVIRONMENTAL PROTECTIONAGENCY WASHINGTON, D.C. 20460

OFFICE OF PREVENTION,PESTICIDESAND TOXIC SUBSTANCES
PC C de: 392201 DP Barc de: 371919 

# a DGa5Io 

### :406300 

### MEMORANDUM
SUBJECT: Spirotetrarnat (PC Code 392201):EFED Response to Cornmen s on the Notice of Receiptfor pending new uses, docket#OPP-2009-02 3. 

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TO: Rita Kumar, Risk Manager Reviewer 

### 1 John Hebert, Risk Manager,RM 07 InsecticideBranch Registration Division (7505P) 

### FROM: JosephDecant, Ecologist Environmental Risk Branch 

### V Environmental Fate and Effects Division (75071)) 

### Thru: Mah Shamim, Branch Chief Environmental Risk Branch V Environmental Fate and Effects Division (7507P)

The Environmental Fate and Effects Division (EFED) has reviewed the publid comments submitted by the Natural Resources Defense Council (NRDC) in response to the p blication of the Pesticide Product Registration Approval for spirotetramat. This document rovides the of spirotetramat. 

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EFED responses to those comments which relate to the ecological effects and enviro$mental fate 

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### Spirotetramat Notice ofReceipt for Pending New Uses: Response to Comments NRDC Comment: On October 26,2009 the U.S. Environmental ProtectionAgency (EPA) published a notice in the Federal Register requesting public comments concerningan applicationby Bayer CropScienceto register certain uses for the pesticide spirotetramat, hereinafter referred to as a Registration Application. NRDC has previously commented on the Agency's 2008 registration approvals of spirotetramat, for which EPA solicited public comments on August 6, 2009. The present comments reiterate the arguments presented to the Agency in those comments, since these are relevantto the EPA review ofthe currentRegistration Application. EPA lacks sufficient informationabout harm to bees to conductthat balancing now. Before EPA can make a valid determination that spirotetramat is safe for the environment, it must conduct a complete evaluation of the harm posed by spirotetramatto bees. This includes, at a minimum, consideration of (a) sub-lethal effects, (b) inert ingredients contained in spirotetramat formulations,and (c) the impact of spirotetramatin mixtures with otherpesticides. In relationto the risk assessment of spirotetramat,EPA must require the registrants to submit the following studies before the Agency evaluates and issues a decision on the Registration Application: A new avian reproduction study to meet Guideline 850.2300 A study of spirotetramat concentrations in nectar and pollen and how these concentrationschange overthe growing season. A new pollinatorfield studythat meets OPPTS Guideline 850.3040 

### EPA Response Data Gaps EPA acknowledges the importance of addressing any uncertainties regarding risk to birds and pollinators. EPA recently re-evaluated the required study regarding the effects of spirotetramat on avian reproduction and has required a new avian reproduction study to address deficiencies. EPA recently evaluated a number of studies that Bayer CropScience submitted in response to the conditional registration's datarequirement for a field pollinator study. These studiesincluded the assessment of spirotetramat concentrations in pollen and nectar inside the hives, concentrations in the blossoms of treated plants, and semi-field and field toxicity trials. EPA determined that the submitted studies were inadequate to address the hazard to the colony. EPA has requested that Bayer CropScience submit a new field pollinator study to satisfy the OPPTS Guideline 850.3040because based on the available data and associated uncertainty, the EFED could not refute the hypothesis that the "Exposure to adultbees to direct treatment or residues on blooming crops can leadto effectson honey bee larvae", as stated on the label. 2EPA is interested in the lethal and sub-lethal effects of spirotetramat because of the potential brood effects illustrated by previous field and semi-field trials and will work with Bayer Cropscience to design an appropriate field study to satisfy OPPTS Guideline 850.3040 and to addressuncertainties associated with the impact of spirotetramatonbee colonies. Mixtures I EPA does not routinely include, in its risk assessments, an evaluation of mixturgs of active ingredients, either those mixtures of multiple active ingredients in product formulati ns or those in the applicator's tank. In the case of the product formulationsof active ingredien s (that is, a 

# ! registered product containing more than one active ingredient), each active ingredie t is subject to an individual risk assessment for regulatory decision regarding the active ingr dient on a particular use site. If effects data are available for a formulated product containingi erts andlor more than one active ingredient, they may be used qualitativelyor quantitatively in accordance 2004;USFWSINMFSINOAA, 2004). 

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with the Agency's Overview Document and the Services' Evaluation Memorandu (USEPA, 

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Specifically, for the formulationsBY1 08830 150 OD and Movento 240 SC, acute t xicity data were available for rainbow trout (moderately toxic), midges (highly toxic for 1 0 OD and for both formulations that demonstrate they canbe classified aspractically non-toxic.

# P moderately toxic for 240 SC), and green algae. There were also acute oral toxicity ata on rats 

# d Formulated Products While data on the chronic toxicity of formulated products was lacking there were a ute toxicity data available on the formulated products BY1 08830 150 OD and Movento 240 C in some instances. Only the data available for BY1 08830 150 OD was formally revie

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ed by the

For bees, there are acute toxicity data on both of the formulations BY1 08830 Movento 240 SC that demonstrate the technical grade active ingredient and spirotetramat can both be classified aspractically non-toxic. In addition, for BY1 and Movento 240 SC, there are a number of feeding trials and field studies with a number of acute toxicity studies with other non-target terrestrial arthropods lacewings, ladybird beetles, parasitoid wasps, and predatory mites) that range inmagnitude of acute effects. Austrian Agency for Health and Food Safety (AGES) prior to the global review However, a cursory review of the data by US EPA reviewers suggest that generally assessment. the toxicity of the parent and two products for which data were available are equivalent, and concern at this time for enhanced toxicity of formulations. Therefore, the endpoints, regardless of whether for the technical grade or the formulations,were use in the global review assessment for deriving risk estimates.