UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

PC C de: 392201 

DP Barc a de: 371919 

DGa5Io : 406300 

MEMORANDUM 

SUBJECT: Spirotetrarnat (PC Code 392201): EFED Response to Cornmen s on the 

Notice of Receipt for pending new uses, docket #OPP-2009-02 k 3. 

TO: Rita Kumar, Risk Manager Reviewer 1 

John Hebert, Risk Manager, RM 07 

Insecticide Branch 

Registration Division (7505P) 

FROM: Joseph Decant, 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. 

EFED responses to those comments which relate to the ecological effects and enviro$mental 4 fate 

i 

TEXT SEARCHABLE DOCUMENT - 2010
Spirotetramat Notice of Receipt for Pending New Uses: Response to 

Comments 

NRDC Comment: 

On October 26,2009 the U.S. Environmental Protection Agency (EPA) published a notice in the 

Federal Register requesting public comments concerning an application by Bayer CropScience to 

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 

relevant to the EPA review of the current Registration Application. 

EPA lacks sufficient information about harm to bees to conduct that 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 spirotetramat to bees. This includes, at a minimum, 

consideration of (a) sub-lethal effects, (b) inert ingredients contained in spirotetramat 

formulations, and (c) the impact of spirotetramat in mixtures with other pesticides. 

In relation to 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 

concentrations change over the growing season. 

A new pollinator field study that 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 data requirement for a field pollinator study. These studies included 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 

850.3040 because based on the available data and associated uncertainty, the EFED could not 

refute the hypothesis that the "Exposure to adult bees to direct treatment or residues on blooming 

crops can lead to effects on honey bee larvae", as stated on the label. 

2 
EPA 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 

address uncertainties associated with the impact of spirotetramat on bee 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 formulations of 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 containing i erts andlor 

more than one active ingredient, they may be used qualitatively or quantitatively in accordance 

2004; USFWSINMFSINOAA, 2004). 

with the Agency's Overview Document and the Services' Evaluation Memorandu 1 (USEPA, m 

Specifically, for the formulations BY1 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 can be classified as practically 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 1 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 as practically 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 in magnitude 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.