UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

Date: December 3, 2014 

SUBJECT: Fenoxaprop-p-ethyl: Response to Registrant Comments from Bayer Crop 

Science on the Draft Preliminary Risk Assessment and Proposed New Use on 

Grass Grown for Seed 

PC Code: 129092 

Decision No.: 494947 

Petition No.: NA 

DP Barcode: D422670 

Registration No.: NA 

Risk Assessment Type: NA 

TXRNo.: NA 

Regulatory Action: Registration Review 

Case No.: NA 

CAS No.: 71283-80-2 

MRIDNo.: NA 40CFR: NA 

FROM: 

THRU: 

TO: 

Shalu Shelat, Risk Assesso~ ~~ Christopher Schlosser, Toxicologist ~s;;li----1.2/le:/ 1 't 

Donald Wilbur, Chemist ()(A_L _... Risk Assessment Branch VI V'<Tr\./ ~ '-

Health Effects Division (7509P) 

Office of Pesticide Programs 

Donna Davis, Acting Branch Chief (__.-[ l--

Risk Assessment Branch VI 

Health Effects Division (7509P) 

Office of Pesticide Programs 

Miguel Zavala, Chemical Review Manager 

Risk Management and Implementation Branch 3 (RMffi 3) 

Pesticide Re-evaluation Division (PRD) 

Office of Pesticide Programs 

HED has received comments on the review of the preliminary risk assessment for fenoxaprop-pethyl. A summary of each comment and HED's response to each comment follows. 

Page I of 2 
Comment 1: The study referenced in the right column of Table 4.5.1 on page 21 and Table 4.5.4 

on page 23 should be the 28-day inhalation toxicity (rat), instead of 21-day. 

HED Response: The agency acknowledges the error and will revise future risk assessments to 

reflect the 28-day exposure period. However, as this error does not have a regulatory impact, a 

new risk assessment will not be issued at this time. 

Comment 2: The description in the right column of Table 4.5.1 on page 21 and Table 4.5.4 on 

page 24 should state "Liver and kidney weights and urea nitrogen " 

HED Response: The agency acknowledges the error and will revise future risk assessments to 

include kidney weights in the LOAEL statement. However, as this error does not have a 

regulatory impact, a new risk assessment will not be issued at this time. 

Comment 3: In regards to the 90-day oral toxicity study, on page 53 the Agency referenced dose 

levels of I 1.9 mg/kg from the male 90-day study, and 14 mg/kg from the male 28-day study, but the 

summary on page 61 referenced dose levels of 16.5 mg/kgfrom the 90-dayfemales, and the 14 mglkg 

from the 28-day male study, and it is therefore unclear what dose levels the Agency used when 

determining the NOAEL of 80 ppm. 

HED Response: The agency acknowledges the error and will revise future risk assessments to 

reflect a NOAEL of 14 mglkg/day for males and 16 mglkg/day for females. However, since this 

study was not used as the bases for a point of departure for risk assessment, this error does not 

have a regulatory impact, a new risk assessment will not be issued at this time. 

Comment 4: The description in the bottom row and right column of table page 54 should state 

"lipids and increased Liver and kidney weights" 

HED Response: The agency acknowledges the error and will revise future risk assessments to 

include kidney weights in the LOAEL statement. However, as this error does not have a 

regulatory impact, a new risk assessment will not be issued at this time. 

Comment 5: The description in the bottom row and right column of table page 55 should state 

"Negative up to an insoluble concentration ( 100 uglmL +I-S9)." 

HED Response: The agency acknowledges the error and will revise future risk assessments to 

reflect 100 ug/ml as the insoluble concentration. However, as this error does not have a 

regulatory impact, a new risk assessment will not be issued at this time. 

Comment 6: In section A.3.4 Inhalation Exposure (Short-, and Intermediate-Term) on page 58, 

the LOAEL should be "0.3 mg/L (M only)" 

HED Response: The agency acknowledges the error and will revise future risk assessments to 

reflect the LOAEL value of 0.3 mg/L. However, since the inhalation risk assessment used the 

correct NOAEL from the study, this error does not have a regulatory impact, a new risk 

assessment will not be issued at this time. 

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