various irrigation methods), basal trunk spray, and tree trunk injection. EFED has 

conducted a Section 3 New Use assessment and has determined the following.

Summary of Risk conclusions 

a. Foliar, Airblast & Broadcast spray application, soil application (i.e., soil 

media drench, chemigation), basal trunk spray application

These particular application types (ground/aerial spray, soil incorporation) and/or 

maximum application rates (0.54 lbs a.i./A) are found in the 2004 risk assessments (DP 

Barcodes: D285633, D304957) with use on ornamental plants, which are listed on the 

current label in conjunction with the proposed forestry uses. The risk conclusions 

described for the 2004 assessments apply to the proposed uses as well. 

b. Tree injection

Overall, the screening level analysis conducted for the tree injection use pattern, which 

assumes total mass of chemical applied to the terrestrial and aquatic environments as well 

as distribution of concentrations in tree trunks and leaves, suggests that translocation of

dinotefuran from the site of injection to edible portions of a tree may result in effects to 

birds, mammals, and terrestrial invertebrates. Potential risks to saltwater invertebrates 

could not be precluded given the sensitivity of the mysid shrimp to relatively low 

concentrations of dinotefuran. Additional data, including a chronic study on the saltwater 

invertebrate, magnitude of residues study in injected trees and treated plants, and an 

additional bee field study would allow for refinements of potential risks. 

Risk calculations could be refined further should a limit on use of dinotefuran for the tree 

injection use pattern be proposed, either as a limit to application rate (lbs a.i./A) or 

application target (number of trees of a given size/A). Given the high toxicity of 

dinotefuran to honeybees on an acute oral and contact basis, other terrestrial invertebrates 

on a contact basis, and the lack of information on the magnitude of residues on edible 

parts of potentially treated trees as well as toxic effects on honey bee colonies, there is 

concern about the magnitude of exposure and potential effect on honey bee colonies This 

mitigation measure would limit the use of dinotefuran on a per acre basis and thus limit 

visitation potential of the bee or other pollinator/forager species to contaminated trees 

(i.e. for any given acre it could potentially visit to retrieve pollen and/or nectar the ratio 

of contaminated to untreated trees is lower, providing the pollinator with more 

alternatives for 'safer' forage).

Label recommendations

EFED recommends the following statements and clarifications be incorporated in the 

proposed label for Dinotefuran 20%, EPA Reg No. 86203-11:
1. Include a statement clarifying application timing. For example: “for trees 

pollinated by bees or other invertebrates, make applications post-bloom.” It is 

understandable that applications post-bloom for certain application types may be 

difficult for some forestry uses as non-target organisms may be in bloom while 

target organisms have reached the post-bloom period. However, it must be clear 

from the label that application of dinotefuran to blooming, pollen-shedding or 

nectar-producing parts of plants should be avoided. Currently, application timing 

is based on pest life cycle and the hazard statement for bees does not specify 

when to apply; the current hazard statement is as follows: “The product is highly 

toxic to bees exposed to direct treatment or residues on blooming crops or weeds. 

Do not apply this product or allow it to drift to blooming crops or weeds if bees 

are visiting the treatment area.” 

2. Include a statement relating the expected duration of pest control post-injection. 

For example: “Dinotefuran 20% provides 1-2 years of residual control of given 

pest.” As the 1-2 years is only an estimate based on expected levels for 

imidacloprid (e.g., IMA-jet label, 5% a.i. Reg. No. 74578-1 by Arborjet, Inc.), the 

registrant is advised to provide the study specific for dinotefuran indicating mutiyear persistence in trees and justification for the actual timeframe expected for 

pest control duration. 

3. Clarify what the substance of formulation is: a water soluble granule (SG), an 

emulsifiable concentrate (EC), wettable powder or liquid.

4. Confirm retreatment interval for soil applications (including chemigation) is 7 

days. The retreatment intervals should be clearly stated for each use pattern.

Data gaps

Fate Studies

835.4100 Aerobic Soil Metabolism (MRID#s 45640111 and #45640112). These two 

studies were found to be supplemental. One of the studies (#45640111) was conducted as 

a preliminary study and many details of the study methods were not reported. In 

addition, the study was terminated after only 90 days. The other study (#45640112) did 

not satisfy the guideline requirement for an aerobic soil biotransformation because the 

extraction methods failed to extract a significant fraction of the identifiable 

[14C]residues, including dinotefuran, from the soil. None of these supplemental studies 

provided any data on the degradation rate of the major transformation products of 

dinotefuran. The combined studies provide sufficient data to determine the rate of 

degradation of dinotefuran, but neither study provides information about the fate of the 

major transformation products of dinotefuran. This study (MRID#45640112) can be 

upgraded if the registrant addresses the characterization of the major degradates at 

various sampling intervals. Otherwise, a new study is required to fully address the data 

requirement.
Ecotox Studies

OPPTS 850.1350 Mysid Chronic Toxicity Test

Since estuarine/marine chronic toxicity studies were not submitted for this compound 

there is an uncertainty regarding chronic risk to estuarine/marine fish and invertebrates.

However, given that dinotefuran technical is highly toxic to mysid shrimp (i.e., <1 mg 

a.i./L) on an acute basis (MRID 45639713) and the hydrolysis half-life (MRID 

45640101) of dinotefuran indicates that the parent is stable in water at pH 4-7 and is ~48 

days at pH 9, a mysid chronic toxicity study is required under 40 CFR §158.

Non-Guideline Magnitude of Residues Study: Field Residue Analysis of Edible Parts of 

Trees/Plants (Whole flowers, Leaves, Fruit, Seeds, Pollen, and Nectar [from flowers and, 

if present, extrafloral nectaries])

Submission of a magnitude of residues study that quantifies potential exposure levels 

after tree injection and other application types would be of high value to this risk 

assessment. Risks may be further quantified and refined if a magnitude of residues study 

in treated trees and plants is submitted that evaluates concentrations of dinotefuran in 

edible parts of treated trees and plants, including leaves, fruit, seeds as well as blooming, 

pollen-shedding, and nectar producing parts (i.e., flowers and, if present, extrafloral 

nectaries) of plants. The reason for asking for multiple test species and plant part residues 

stems from open literature data available for imidacloprid, another systemic 

neonicotinoid. The studies reveal that imidacloprid will move into the plant parts at 

different concentrations based on the type of plant (i.e., corn pollen will have different 

concentrations of imidacloprid compared to sunflower pollen) and the part of the plant 

(i.e., pollen will have different concentrations of imidacloprid compared to nectar). In 

addition, given that there is no information on rate of degradation of dinotefuran inside 

the plant, concentrations of degradates of dinotefuran in these plant parts would also be 

of high value to this risk assessment. Therefore, the EFED concludes that information on 

dinotefuran/degradate concentrations, in various plant parts for different crops is essential 

to understanding the potential exposure levels of dinotefuran and degradates to terrestrial 

non-target invertebrates, mammals, and birds over time. A study protocol should be 

submitted for Agency review prior to study initiation. 

OPPTS 850.3040 Field Testing for Pollinators

A new honey bee field study that provides relevant and reliable toxicity information on 

the performance of the colonies after exposure to dinotefuran is recommended. A study 

protocol should be submitted for Agency review prior to study initiation. 

Dinotefuran is highly toxic to bees on an acute oral and contact basis and when applied as 

a foliar spray at a rate of 0.13 lbs a.i./A it will remain toxic to bees on foliage for more 

than 24 hours after application (MRID 45639728). Because of this, EFED recommends 

that dinotefuran not be applied to blooming, pollen-shedding or nectar-producing parts of 

plants; but the test crop should be one on which bees will actively forage for both nectar 

and pollen (e.g., cotton, melon, alfalfa). EFED expects the study design will include 
maximum dinotefuran application rates, at minimum intervals, and maximum number of 

applications. EFED does not know how much dinotefuran can be expected to be 

translocated to the nectar and pollen when applied as a foliar, soil, or tree injection 

application to plants before nectar or pollen production. Though the currently reviewed 

field study had detected residues in pollen and nectar of flowers after foliar application, 

the study design was such that toxicity endpoints could not be reliably determined. If 

dinotefuran is being translocated to the nectar and pollen, there is uncertainty as to 

whether there is any adverse effect to foragers or to the hive over time.