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



### MEMORANDUM Date: 24-SEP-2014 OFFICE OF CHEM IC AL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Bispyribac-sodium
. Res ponse to Public Comments on H uman H ealth Assessment Seeping Document in Support of Registration Review. 

### PC Code: 078906 

### DP Barcode: D422690 

### Decision No.: 494991 

### Registra tion No.: N/A 

### Petition No.: N/A 

### Regulatory Action: Regis tration Review Seeping Document 

### Risk Assessment Type: N/A 

### Case No.: 7258 

### TXR No
. : N/A 

### CAS No.: 125 401

- 92 -5 

### MRID No.: N/A 40 

### CFR: § 1 80.577 

### FROM: SarahJ. Levy, Chemist

# ~.J**c£ .**  

# / Risk Assessment Branch 1 (RAB I 1 

# vI Health Effects D ivision (HED , 7509P) 

### THROUGH: Geo r ge F. Kramer, Ph.D., Senior Chemist RAB 1/HED (7509P) 

### TO: Moana R. Appleyard Pesti cide Re-Evaluation Division (PRD) (7508P) HED recently compl eted a human health assessment scoping document in support ofregistration review (Memo, K. Lowe, 

### et al., 04-JUN-2014; D417912). This document stated that "it was noted during rev i ew that additional residue chemis try data (ruminant and po ultry feeding studies) were waived based on the aquatic use label (Tradew indTM) being revised to indicate that treated water may not be used as a water source for livestock until the concentration ofbispyribacsodium in water is :Sl ppb. This restriction has not been put on the TradewindTM label and w ill need to be addressed during Registration Review
. "B ispyribac-sodium Response to Previous HED Review 0422690
The registrant, Valent U.S
.A. Corporation, responded to this assessment on August 25, 2014
. Valent stated that "the original stamped approved TradewindTM label on J anuary 19, 20 11 contained the restriction that treated water could not be used as a water source for livestock until the concentration ofbispyribac-sodium in water**is~** 1 ppb. O n April20, 2001 (s ic 2011], after Valent submitted arguments as to why this restriction should be removed, the ChemSAC [C hemistry Science Advisory Counc il ] ofEPA accepted those arguments and agreed that the restriction should be removed. On May 12, 2011 Valent submitted an amended labe l remov ing the restriction, and this label was approved by EPA on June 7, 2011
. T herefore, this matter has been addressed." HED's Conclusion: This issue was taken to the HED ChemSAC on Apr il 20, 20 1 1. ChemSAC concluded that "the restriction on treated water used as a water source for livestock can be removed since it is not like ly that quantifiable res idues of the parent compound would be found in a ruminant feeding study, even at the 1 

### OX dietary burden. In addition, there is little concern for residues in po ultry as treated water is not l ikely to be used in poultry operat ions. ChemSAC further noted tha t drinking water is a more likely source of human exposure. ln fact, the most recent dietary exposure an d risk assessment for bispyribac-sodium assumed res idues of 180 ppb in drinking water (Memo: S. L evy; July 7, 20 1 0; D363348)." The resu lts were well below HED's level of concern. HED concludes that this deficiency has been resolved.

cc: S
. Levy (RAB l/HED) RDI: G. Kramer ( 1 8-SEP-2014); RAB I Chemists (24-SEP-2014) S. Levy:Sl 0953:PY-S:(703)305-0783:7509P : RAB 1 Template Version November 2003

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