2 registrants to work with the Agency to generate info rmation that will fulfill both Agency and registration needs while killing the fewest number of birds possible.”

Current policy within the Office of Pesticide Programs/Environmental Fate and Effects Division (EFED) regarding the acceptance of avian acu te effects studies conducted using the TG 223 protocol states the following:

Until the OECD TG 223 validation process is completed and the guideline has been approved by OECD, studies that utilize this guideline should not be classified; pending results of the validation, they may then be cl assified as ‘acceptable,’ assuming that they meet all other guideline requirements.

To date, the OECD has adopted the TG 223 guideline and has issued a validation report. At this time EFED is actively evaluating the results of th e OECD validation report to determine if the TG 223 effects endpoints and dose/response informa tion adequately address the purposes of the avian acute oral data requirement as desc ribed in 40 CFR Part 158. Until the Agency’s evaluation of that validation report is completed, EFED will not classify avian toxicity studies performed using the TG223 protocol and the studies cannot be used to fulfill data requirements. Therefore, we cannot say at th is time whether or not avian t oxicity studies done under TG 223 will be acceptable to meet our data requirements.

Validation work conducted on TG 223 test guideline to date has been limited to studies with the upland game birds (e.g., northern bo bwhite). Because no work has been done to date to validate this guideline for passerine species, it is doubt ful that we would accept studies done under this guideline for fulfilling requirements for passerine acute toxicity data unless additional validation work with passerines is done.

ABC Comment:

“1) ABC requests an avian oral toxici ty test using a passerine species.”

EFED concurs with this request. The Preliminary Work Plan (DP 368178) identified an avian acute oral toxicity test with a passeri ne species as a data requirement for the Registration Review of Oxamyl (PC 103801). The new Part 158 data requirements [40 CFR Part 158 (CFR 40 2007)] specify that acute avian oral toxicity data be submitted for a passerine species. A passerin e study protocol must be submitted for review by the Agency prior to initiation of this study.

ABC Comment:

“2) ABC strongly supports oxamyl to be tested under the EDSP, specifically the Tier II avian 2 generation tests. We are specifically interested in the embryo and hatchling survival data and chick health, and

sexual maturation/behavior, which is data that is not gathered from traditional reproductive studies.”3 Oxamyl is among the group of 58 pe sticide active ingredie nts issued test orde rs under Tier 1 of the EDSP between October 2009 and February 2010. This initial list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain post-applicati on agricultural scenario s, and should not be construed as a list of known or likely endocrine disruptors.

The Agency has evaluated the "Other Scientific ally Relevant Information (OSRI)" submitted in response to the Tier 1 test orders for oxamyl a nd has determined that th e Test Order Recipient needs to conduct all Tier 1 assays. Once the Agen cy has received and revi ewed all relevant data, including Tier 1 results, the Ag ency will determine which, if any, of the Tier 2 tests are necessary. Tier 2 testing is de signed to identify potentially a dverse estrogen-, androgen-, or thyroid-related (E, A, or T) endocrine effect s caused by the substance and to establish a doseresponse relationship between the do se and the E, A, or T effect(s). The weight-of-evidence analysis is conducted on a case- by-case basis by assessing all i ndividual lines of evidence and performing an integrated analysis of the data. For further information on the status of the EDSP, the policies and procedures, the te st guidelines, and th e Tier 1 screening ba ttery, please visit our

website: http://www.epa.gov/endo/

ABC Comment:

“3) ABC requests an avian reproductive and develo pmental study using a passerine species. ABC recognizes that EPA does not have an official Sta ndard Operation Procedure (SOP) to recommend to registrants for passerine reproductive studies, however, we urge EPA to look beyond the lack of SOP and investigate the potential toxicity of this compound. Passerine species are altricial birds, and hatch at a very difference developmental stage than precocial mallards and bobwhite quail. Altricial hatchlings cannot thermoregulate, walk, or see. The differen ces in embryonic development between altricial and precocial birds could potentially lead to differences in sensitively to pesticides. For this reason avian reproductive studies should be conducted in both pr ecocial and altricial avian models.”

EFED is not aware of any data to show that oxamyl is more toxic to passerine species than it is to bobwhite quail ( Colinus virginianus ) or mallard ducks ( Anas platyrhynchos ) on an acute or chronic exposure basis as it rela tes to reproductive endpoi nts. EFED is aware of incident data for passerine species associated with the use of oxamyl; however, incide nt data are typically associated with acute exposures and are not cons idered (in and of themselves) to be sufficient rationale to support chronic toxicity testing requirements. Therefor e, at this time, EFED believes that the data from the reproducti ve studies in the bobwhite quail and mallard duck studies will be adequate for assessing potential risks of oxamyl to birds from ch ronic exposure. As mentioned, EFED does not have a validated protocol for a ch ronic reproduction study in passerines. EFED is not prepared at this time to make recommenda tions regarding such a pr otocol. Any protocol developed would need to go through a process of sc ientific peer review. Therefore, EFED will not recommend requesting a chronic reproductive study using passerines for oxamyl at this time.