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



### MEMORANDUM Date: 

### July 11, 2013 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Fluopicolide 

### HED Response to Comments Submitted on the Human Health Assessment Scoping Document in Support of Registration Review.
PC Code: 027 4 12 (Fluopicolide) Decision No.: 479295 Petition No.: NA Risk Assessment Type: NA TXRNo.: NA MRIDNo.:NA DP Barcode: 0412203 Registration No . : NA Regulatory Action: Registration Review Case No.: 0755 CAS No.: 239110-15-7 40 CFR: 180.627 

### FROM: Danette Drew,

# Che~**~----­** Risk Assessment Branch V Health Effects Division (7509P) 

### THROUGH : Michael S. Metzger, Bran . ch Chief 1 

# J /} /) ()**·** 

# ... Risk Assessment Branch VNil

# ·~**~** }( 

# fl**~** Health Effects Division (7509P) 

### TO: Russell Wasem, Chemical Review Manager Pesticide Re-Evaluation Division (7508P) Office of Pesticide Programs This document was written in response to public comments fo r the Fluopicolide Human Health Risk Assessment Scoping Document in Support of Registration Review (D. Drew , 0405060 , 2110113) which was prepared as part ofthe fluopicolide Preliminary Work Plan (PWP) (Docket No . EPA-HQ-OPP

-2013-0037). The comments relating to the human health asses s m ent scoping document, and HED' s responses, are shown below:

Page 1 

### of3Comments from Valent USA Corporation Comments regarding HED Outstanding Data Requirements : 870.7800- Imrnunotoxicity Testing Valent: A study (MRID 48809201) was submitted on October 5, 2012 . HED: The immunotoxicity study (MRID 48809201) has been received by HED and a data evaluation rev iew is in the process of being finalized. This data gap has been fulfilled . 860.1380 Storage S tability Data ( Brassica head and stem, bul b, and root vegetable, and leafy vegetable) Valent: The following studies (referenced by MRID) were submitted on January 31, 20 13 . 4905440 1 ,49054402,49054403 , 49054404. HED: The submitted s to rage stab ili ty studies wi ll be evaluated during the registration review of fluopico li de to determine if those studies fu lfill the 860 . 13 80 data requirements. 860 . 1520 Processed Fo od and Feed (Asp irated Gr ain Fractions) Valent: Valent w ill propose a waiver request: Fluopico li de is not registered for use on cereals as primary crops. Tolerances are established for inadvertent residues resulting from uptake of res i dues in the soil by the following crop , rather than from potential surface residu es from a foliar spray. Therefore, we believe that the highest concentration that is calculated from the processed fractions is representative of residues in an aspirated grain fraction and no additiona l data i s necessary. HED: Following the submi ssion of a formal data waiver request, H ED will de termine if a waiver can be granted. 860.1900 Field Accumulation in Rotational Crops (Small grain, Soybean, Corn, R i ce, and Oilseed) Valent: Valent has previously negotiated a due date with the Agency of Apri l 25, 2014 to allow adequate time to compete the fie ld studies. HED: HED acknow ledges the intent of Valent to complete the required rotational crop studies by April25, 2014 .

Page 2 of3Editorial Comments: Valent: 

### Valent identified a typographical error at the top of page 2. Fluopicolide is incorrectly classified as an herbicide, 

### it is a fungicide. HED: 

### HED will correct the error in future registration review documents.

Page 3 of3