Environmental Assessment for Oxytetracycline Dihydrate Administered to Shrimp for Minor Use Minor Species

Phibro Animal Health Corporation, Teaneck NJ

Investigators

Abstract

Summary/Abstract PAHC is seeking approval from the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) of Terramycin® 200 for Fish Type A medicated article, containing the active pharmaceutical ingredient (API) oxytetracycline, for use in penaeid shrimp. The proposed indication is for the control of mortality in penaeid shrimp due to necrotizing hepatopancreatits (NHP) associated with Hepatobacter penaei. The work involved will include environmental assessment, conditions of use of the drug, exposure assessment, effects assessment, risk characterization, and conclusions.