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: 027412 (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 V Nil ·~ ~ }( 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 for the Fluopicolide Human Health 

Risk Assessment Scoping Document in Support of Registration Review (D. Drew, 0405060, 

2110113) which was prepared as part of the fluopicolide Preliminary Work Plan (PWP) (Docket 

No. EPA-HQ-OPP-2013-0037). The comments relating to the human health assessment scoping 

document, and HED' s responses, are shown below: 

Page 1 of3 
Comments 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 review is in the process of being finalized. This data gap has been 

fulfilled. 

860.1380 Storage Stability Data ( Brassica head and stem, bulb, and root vegetable, and leafy 

vegetable) 

Valent: The following studies (referenced by MRID) were submitted on January 31, 

2013. 49054401,49054402,49054403, 49054404. 

HED: The submitted storage stability studies will be evaluated during the registration 

review of fluopicolide to determine if those studies fulfill the 860. 13 80 data 

requirements. 

860. 1520 Processed Food and Feed (Aspirated Grain Fractions) 

Valent: Valent will propose a waiver request: Fluopicolide is not registered for use on 

cereals as primary crops. Tolerances are established for inadvertent residues resulting 

from uptake of residues in the soil by the following crop, rather than from potential 

surface residues 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 additional data is necessary. 

HED: Following the submission of a formal data waiver request, HED will determine if 

a waiver can be granted. 

860.1900 Field Accumulation in Rotational Crops (Small grain, Soybean, Corn, Rice, and 

Oilseed) 

Valent: Valent has previously negotiated a due date with the Agency of April 25, 2014 to 

allow adequate time to compete the field studies. 

HED: HED acknowledges the intent of Valent to complete the required rotational crop 

studies by April25, 2014. 

Page 2 of3 
Editorial 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