UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 24-SEP-2014 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Bispyribac-sodium. Response to Public Comments on Human Health 

Assessment Seeping Document in Support of Registration Review. 

PC Code: 078906 DP Barcode: D422690 

Decision No.: 494991 Registration No.: N/A 

Petition No.: N/A Regulatory Action: Registration Review Seeping Document 

Risk Assessment Type: N/A Case No.: 7258 

TXR No.: N/A CAS No.: 125401-92-5 

MRID No.: N/A 40 CFR: §180.577 

FROM: SarahJ. Levy, Chemist ~.J c£. / 

Risk Assessment Branch 1 (RAB I 

1 vI 

Health Effects Division (HED, 7509P) 

THROUGH: George F. Kramer, Ph.D., Senior Chemist 

RAB 1/HED (7509P) 

TO: Moana R. Appleyard 

Pesticide Re-Evaluation Division (PRD) (7508P) 

HED recently completed a human health assessment scoping document in support of registration 

review (Memo, K. Lowe, et al., 04-JUN-2014; D417912). This document stated that "it was 

noted during review that additional residue chemistry data (ruminant and poultry feeding studies) 

were waived based on the aquatic use label (TradewindTM) 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 will 

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 January 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. On April20, 2001 (sic 2011], after 

Valent submitted arguments as to why this restriction should be removed, the ChemSAC 

[Chemistry Science Advisory Council] ofEPA accepted those arguments and agreed that the 

restriction should be removed. On May 12, 2011 Valent submitted an amended label removing 

the restriction, and this label was approved by EPA on June 7, 2011 . Therefore, this matter has 

been addressed." 

HED's Conclusion: This issue was taken to the HED ChemSAC on April 20, 2011. ChemSAC 

concluded that "the restriction on treated water used as a water source for livestock can be 

removed since it is not likely that quantifiable residues 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 poultry as treated water is not likely to be used in poultry operations. ChemSAC 

further noted that drinking water is a more likely source of human exposure. ln fact, the most 

recent dietary exposure and risk assessment for bispyribac-sodium assumed residues of 180 ppb 

in drinking water (Memo: S. Levy; July 7, 2010; D363348)." The results 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 (18-SEP-2014); RAB I Chemists (24-SEP-2014) 

S. Levy:Sl 0953:PY -S:(703)305-0783:7509P:RAB 1 

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