UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460



### PC Code: 098301 OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION 

### DP Barcode: D413680, D413685 

### & D413688 

### Date: September4, 2013 

### MEMORANDUM SUBJECT: EFED Response to Ag Logic Chemical LLC Regardingthe Submission of Literature Data for anAcute Passerine Study and Waiver Requests for Terrestrial Plant DataRegarding the DCI for the Registration ReviewProblemFormulation for Aldicarb 

### FROM: N.E. Federoff, Wildlife Biologist Environmental Risk Branch 2 Environmental Fate and Effects Divisi n Office ofPesticide Programs (7507P) 

### THROUGH: Brian Anderson, Chief 

# - h14/.---

- ct/**~~~**1.. Environmental Risk Branch 2 

# f f./ Environmental Fate and Effects Division Office ofPesticide Programs (7507P) 

### TO: Kevin Costello, Chemical Review Manager 60 Susan Bartow, Risk Manager Reviewer Pesticide Re-evaluation Division Office ofPesticide Programs (7508P) Attached please find the Environmental Fate and Effects Division (EFED)'sresponse to a passerine literature data submissionby Ag Logic Chemical LLC, as well as waiverrequests for terrestrial plant data regarding the problem formulation DCI for Registration Review of Aldicarb. The comments are provided below, along with EFED'sresponses. ·



### MRID 49176401 & 

### 49176402 Waiver Request For Terrestrial Plant Studies AgLogic Chemical LLC feels that a tier II seedling emergence (SE) study using tomato and ryegrass is unwarranted. AgLogic Chemical LLC also feels thatthe submission ofa tier II vegetative vigor (VV) study is unwarranted. Tier 1 SE studies were submitted where the concentrationlevels were 0 (negative control) and 75 kg product/ha (10.3lbs ai/A). The most sensitive monocot species was ryegrass, with a 12 and 44% difference in shoot length and weight, respectively, comparedto the control. The most sensitive dicot species was tomato, with a 28 and 25% difference in shoot length and weight,


### 1respectively, comparedto the control. Phytotoxic effects, including stunting and necrosis, were observed inryegrass and tomatoes. Based onthe observance of>25% effects inryegrass and tomato, a tier II study withthese two species is necessary to fulfill the guideline requirement for 850.4100. The Tier I studies with ryegrass and tomato are considered supplemental. The data from the Tier I studies with com, oat, onion, cucumber, oilseed rape, soybean, sugarbeet and sunflower are all considered acceptable. Overall, this toxicity study was classified as supplemental and does not satisfy the guideline requirement for a seedling emergence toxicity studybecause >25% effects were observed in two species (i.e., ryegrass and tomato) and tier II studies have not been submitted for those species. TheSE studies used 10.3 lbs ai/A, while the currentmaximum label rate is 5 lbs ai/A. However, Kennedy (2002) did find pearl millet exposed to 15% Temik at 2.05, 3.08 and 4.1 lbs ai/A had reductions in SEat 3.08lbs ai/A (%reductionwas notreported) and 4.llbs ai/A (57% reduction in emergence). Aldicarb had inhibitory effects onpearl millet at concentrations >2.05 lbs ai/A. The biomass ofseedlingplants (shoot dry wt) that did emerge was significantlyreduced by aldicarb at applicationrates**of~4.1lbs** ai/A. As stated earlier, aldicarb is phytotoxic to someplants (phytotoxic effects, including stunting and necrosis, were observed in ryegrass and tomatoes). A waiverrequest was granted for the vegetative vigor study in 2009 (DP299878). EFED has reviewedthe requestto waive the VV study and agrees that aldicarb would not require a vegetative vigor studybecause; 1) aldicarb is not a volatile compound, and 2) there is minimal potential exposure offoliar surfaces ofnontarget plants to aldicarb as it is only applied as a granule. We recommend that the waiverbe granted for the VV studybutnot for theSE study. Even though we recommendthat the VV studybe waived atthe presenttime, itmaybe required inthe future as guidelines may change. MRID 49176403 Acute Passerine Data LD50 data for passerine species is available for thered-winged blackbird and house sparrow in the literature. EFED has reviewed the submitted references (MRID 49176403). An LD50 of 0.75 mg/kg (0.33-1.69) will be used as the endpointfor passerines and we recommend thatthe requirement for a newpasserine studybe waived. EFED has determined that these data offer enough information so as to waive the acute passerine studyrequirement (Moore etal. 2009, Balcolm et al. 1984 and Schafer and Brunton 1979). They are deemed as supplemental databecause anunknown number ofbirds andfew concentrations were used. Itis unlikely thatthe studies were conductedto current guidelines. However, it would be unlikely that an additional avian acute oral toxicity study with

# a passerine species would yield any valuable new datathat couldbeusedfor risk assessmentpurposes. Schafer and Brunton (1979) found that acute oral testing with the grackle and the house sparrow resulted inLD50 values of0.75 mg/kg (using 95% technical aldicarb) for boththese species; however, these datawere not validated. Technical aldicarb was more toxic than granular aldicarb to sparrows (0.75 mg/kg and 3.8 mg/kg, respectively). Balcomb etal. (1984) did test granular 2aldicarb 15G onthe house sparrowresulting in40% and 83% (6 birds tested) mortality from ingestion ofonly 1 granule and 40% and 80% mortality for the red wing blackbird (5 birds tested at each concentration) after ingesting 1 and 5 granules, respectively. Birds died within 15 to 18 minutes ofgranule ingestion. An acute avian toxicity test submitted to the Agency using the Mallard duckresulted in an LD50 value of 1.0 mg/kg (MRID 00107398) whichis consistant in toxicitywith other acute avian oral endpoints from the submitted literature studies. Citations Balcomb, R., R. Stevens and C. Bowen. 1984. Toxicity of 16 granular insecticides to wildcaught songbirds. Bulletin ofEnvironmental Contamination and Toxicology 33:302-307. Kennedy, C.W. 2002. Phytotoxicityinpearl millet varies among in-furrow insecticides. Crop Protection 21(9):799-802. Moore D. R. J., R. S. Teed, S. I. Rodney, R. P. Thompson and D. L. Fletcher. 2009. Refined Avian Risk Assessment for Aldicarb in the United States. Integrated Environmental Assessment Management 6 (1): 83-101. Schafer, E.W. Jr. and R.B. Brunton. 1979. Indicatorbird species for toxicity determinations. Vertebrate pestcontrol and management materials, ASTM STP 680. West Conshohocken (PA): American Society for Testing andmaterials. pp 157-168.



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