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



### MEMORANDUM OFFICE OF CHEMICAL SAFETY AND POLLUTIO N P REVENTION



### Date: December 3 , 20 14 SUBJECT: Fenoxaprop

- p-ethyl: Respon se to Registrant Comments from Bayer Crop Science on the Draft Preliminary Risk Assessment and Proposed New Use on Gras s Grown for Seed PC Code: 129 092 Decis i on No.: 494947 Petition No.: NA DP Barcode: D422670 Registration No.: NA Risk Assessment Type: NA TXRNo.: NA Regulatory Action: Regi s tration Review Case No.: NA CAS No.: 71283-80

- 2 40CFR: NA MRIDNo.: NA FROM:

THRU:

TO : Shalu Shelat, Ri sk

# Asse**sso~ ~~**  Christopher Schlosser , Toxicologist

### ~s;;li----1.2/le:/ 1

### 't Donald Wilbur , Chemi s t 

## ()(A_L _... Ri s k Assessment Branch 

### VI V'<Tr\./**~** '- 

### Health Effects Di visio n (7509P) Office of Pesticide Program s Donna Davis, Acting Branch C hief (__.-[ 

## l-- Ri sk Assessment Branch 

### VI Health Effects Division (7509P) Office of Pesticide Program s Migu e l Zavala , Chemical Review Manager Ri sk Management and Imp lementation Branch 3 (RMffi 3) Pe sticide Re-evaluation Divi si on (PRD) Office of Pesticide Program s HED has received comments on the review of th e preliminary risk asse ss ment for fenoxaprop

- pet

hyl. A s ummary of eac h comment and HED's re s ponse to each comment follows.

Page I o f 2Comment 1: The study referenced in the right column ofTable 4.5
. 1 on page 21 and Table 4.5.4 o n pa ge 23 should be th e 28-day inhalation toxic ity (rat), instead of 21-d ay. HED Response: The agency acknowledges the error and w ill re v i se future risk as sess ments to reflect the 28-day exposure period. However, as this error does not have a regulatory impact , a new ri s k assessment will not be i ss ued at th is time. Comment 2: Th e description in the right column ofTable 4.5.1 on page 21 and Table 4.5.4 on page 24 should state "Liver and kidney w e ights and urea nitrogen " HED Response: The agency acknowledges the error and will revi s e future ri sk assessments to includ e kidney weight s in the LOAEL statement. However , as thi s erro r does not have a regulatory impact , a new ri sk a ssess men t will not be issued at thi s time. Comment 

### 3: In r eg ard s to the 90-day oral t oxicity s tudy, on page 53 the Agen cy ref e r

e nced dose levels of I 1.9 mg/kg from the male 90-day s tud y, and 14 mg/k gfrom the male 28-da y stud y, but the summary on pa ge 61 refe r enced dose levels of16.5 mg/kgfrom the 90

-dayfemales, and the 14 mglkg from th e 28

-day male study, and it is therefo r e unclea r what dose le vels the A gen cy u sed when determining the N OAEL of 80 ppm. HED Response: The agency acknowledges the error and will revi se future risk as sess ment s to reflect a NOAEL of 14 mglkg/day for male s and 1 6 mglkg/day for female s. Howeve r , since this study was not u se d as the bases for a point of depart ure for risk as s e ss ment, this error doe s not hav e a regulatory impact , a new ri sk asse ss ment will not be iss ued at this time. Comment 4: The description in the bottom row and right c olumn of table page 54 shoul d s tate "lipids and increased Liver and kidney weights" HED Response: The agency acknowledges the error and will revi se future risk asse ss ments to includ e kidney weights in the LOAEL statement. However , as thi s error do es not ha ve a regulatory impact, a new risk a ssess ment will not be issued at this time. Comment 5: The description in the bottom row and right co lumn of table page 

### 55 s hould s tate "Negat ive up to an insoluble concentration ( 100 uglmL +I

-S9)
. " HED Response: The agency acknowledge s the error and will revi s e future ri sk assess ments to reflect 100 ug/ml as the in s oluble co ncentration. However , as thi s er ror doe s not have a regulatory impac t, a new ri sk as ses sment will not be issu ed at this time. Comment 6: In section A.3.4 Inha lation Exposure ( Short -, and I ntermediate- Term) on pa ge 58, the LOAEL should be " 0.3 mg/L (M only)" HED Response: The age ncy acknowledge s the e rror and will revi se future risk assessments to reflect the LOAEL value of 0.3 mg/L. However, s ince the inhal ation risk a ss essment used th e correct NOAEL from the study, this error does not have a regulatory impact , a new ri sk assessment will not b e i ss ued at this time. Page2of2