OFFICE OF
CHEMICAL SAFETY AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

PC Code: 125501

DP Barcode: D 423151

October 9 , 2014

MEMORANDUM

SUBJECT: Response to Request for Waiver of Honey Bee Larval Toxicity Testing for Clofentezine

FROM: Nicholas Mastrota, Wildlife Biologist

Environmental Risk Branch 3

Environmental Fate and Effect Division Office of Pesticide Programs

THROUGH: Dana Spatz, Branch Chief

Environmental Risk Branch 3

Environmental Fate and Effects Division (7507P)

TO: Kevin Costello , Branch Chief

Wilhelmena Livingston , Chemical Review Manager Risk Management and Implementation Branch 4

Pesticide Re

- Evaluation Divi sion (750 8 P)

As part of the Clofentezine Proposed Interim Registration Review Decision (July 2014), EPA noted that the available toxicity data do not inform on the potential chronic risk to terrestrial insects, i.e. pollinators, and as such, was noted as a data gap. In response, Irvita Plant Protection has submitted a request for the Agency to waive the requirement for additional honey bee toxicity testing, including honey bee larval testing, with clofentezine (MRID 49467600)

. To support their request, t he y also

submitted the fol lowing two nonguideline studies on the toxicity of Apollo 50 SC (42% clofentezine) to

insects:

 Apollo 50 SC: Evaluation of the Effect on the Rove Beetle Aleochara bilineata in an Extended Laboratory Study. (MRID 49467601)

 Apollo 50 SC: Toxicity to the Predatory Bug Orius laevigatus Fieber (Heteroptera, Anthocoridae) Using an Extended Laboratory Test including Assessment of Effects on Sprayed Eggs (Limit Test)

. (MRID 49467602)

The EPA has conducted a cursory review of these studies. Th e studies appear to be scientifically sound

and useful to inform on the toxicity of clofentezine to predatory bugs and beetles. We agree that these

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studies show that environmental ly relevant exposure to clofentezine does not cause significant effects

on th e survival or reproduction of these two insect species. However, these studies do not provide adequate information for the EPA to assess the potential risk of bee brood effects from the use of

clofentezine. To address this uncertainty, a chronic honey bee larval toxicity test is needed to conduct a tier 1 risk assessment ( Guidance for Assessing Pesticide Risk to Bees , Environmental Fate and Effects Division, June 23, 2014).

The major shortcomings of the two submitted insect studies for addressing the uncertainty with potential effects to insect pollinators are described below :

1. One study (MRID 49467601) with a beetle (Order Coleoptera) and the other (MRID 49467602) is with a true bug (Order Heteroptera). Neither provide toxicity informat ion on Order
Hymenoptera, the order of insects which includes the vast majority of insect pollinators (bees, wasps, and ants).

2. Both studies expose the insects only one time ; however

, these studies do not inform on potential effects from chronic exposure , as would a study with repeated dosing

.

3. Neither study provide s a toxicity endpoint in terms of dose to the bee (microgram a.i./g bodyweight) and therefore cannot be used to calculate a tier

- 1 RQ for insect pollinators.

4. Both studies were conducted with an application rate of 200 g a.i./ha. This is less than the maximum registered application rate, 0.26 lb a.i./A, which is equivalent to 291 g a.i./ha.

5. One of the studies (Toxicity to the Predatory Bug, 49467602) measures only acute toxicity to

eggs a nd to juvenile insects, but rather than toxicity to all of the early life

- stages through the

emergence of adult bees , as is recommended by the EFED guidance.

Because of these shortcomings with the submitted studies , EFED recommends that the requirement of honeybee larvae toxicity testing with clofentezine not be waived at this time

.