2 to both the fate and toxicity of imidacloprid. A recent review of the current literature after the completion of the Final Work Plan provides furthe r insight into the potential for imidacloprid to concentrate in plant reproductive parts. While ope n literature data reviewed by EFED to date primarily focuses on only a few crops, they rev eal that imidacloprid w ill 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 concentr ations of imidacloprid compared to nectar). Therefore, the EFED concludes that information on imidaclopri d concentrations, in va rious plant parts for different crops is essen tial to understandi ng the potential eff ects of imidacloprid to terrestrial non-target invertebrates.

To determine the sites on which to require residu e data, the Agency considered several variables, such as the estimated usage, the application method, and if th e crop was relevant to managed pollinators (i.e., whether the crop relied on ma naged pollinators for propagation, or whether managed pollinators relied on the crop as a food s ource). Five crops were selected based on these criteria: corn, citrus, stone fruit (che rry), bushberry (blueberry), and cotton. While imidacloprid is registered on a large number of cr ops, data on all crops (or from the same crop in different regions) is not considered necessary at this time. The Agency will use the subject data on a select number of sites as surrogate inform ation for other imidacloprid use sites for which data is not being required.

EFED believes that a better understanding of the fate and expression of imid acloprid in different plant matrices on crops is necessary to support a national level assessment, which therefore establishes reason for the EFED to amend its data requirements for the imidacloprid registration review. The DCI justification is pr ovided below for the various crops.3 Guideline Number: Non-guideline Study Title: Field Residue Test of Leaves, and/or Nectar, and/or Pollen in Citrus, Bushberry (Blueberry), Cotton, Corn and Stone Fruit (Cherry) Rationale for Requiring the Data

At the present time, EPA does not have scientifically valid exposure data for imidacloprid to assess the risk of this pesticide to pollinators. Imidacloprid is a systemic pesticide that is extremely toxic to bees on

an acute basis and has also shown sublethal and chronic t oxicity. It is also persistent in soil environments and translocates from the soil to the pollen and nectar of flowering plants. While open literature data reviewed by EFED to date primarily focuses on only a few crops, they reveal that imidacloprid will move into the plant parts at different concen trations 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 imidacl oprid compared to nectar). EPA therefore needs residue data in the leaves, and/or pollen, and/or nectar of several crops in order to estimate the exposure of bees to imidacloprid. The EPA selected five crops based on certain selective criteria, which includes

several variables such as the estimat ed usage, the application method, and if the crop was relevant to managed pollinators (i.e., whether the crop relied on managed pollinators for propagation, or whether managed pollinators relied on the crop as a food source ). Sampling of citrus, blueberry, and stone fruit must include leaves, pollen and nectar; sampling of cotton must include leaves and nectar; and, sampling of corn (seed treatment) must include leaves and polle n. These studies are intended to provide information on the levels of imidacloprid that may be found in di fferent plant matrices and which may lead to exposure to insect pollinators. Without exposure data , EPA cannot assess risk to pollinators.

Practical Utility of the Data

How will the data be used? The data will be used to assess exposure and risk of imidacloprid to non-target endangered and nonendangered insect species, including pollin ators. Exposure data is an integral part of the risk equation for determining the impact of pesticides to beneficial insect communities through direct exposure from their

food sources.

How could the data impact the Agency’s future decision-making? EPA is required by section 7(a)(2) of the ESA to ensu re that any action it authorizes or takes “...is not likely to jeopardize the continued existence of any endangered or threatened species or result in the

destruction or adverse modification of critical habitat” and “to use the best scientific data available” in carrying out this obligation. The data EPA intends to call in are necessary to inform the determination required by the ESA as to whether continued registra tion of a pesticide is not likely to jeopardize the species or its critical habitat. Absent this data EPA may not be able to conclude that this pesticide will not harm endangered species and may therefore need to cons ider other limitations on the use of the pesticide in order to fulfill the Agency’s statutory obligations under the ESA. The lack of these data will limit the flexibility that the Agency and registrants have in coming into compliance with the ESA and could result in use restrictions which are unnecessarily severe. In addition, the lack of these data may result in an uncertain assumed risk and potential mitigation of imidacloprid formulations under FIFRA.