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

Summary/AbstractPAHC is seeking approval from the U.S. Food and Drug Administration (FDA) Center forVeterinary Medicine (CVM) of Terramycin 200 for Fish Type A medicated articlecontaining the active pharmaceutical ingredient (API) oxytetracycline for use in penaeidshrimp. The proposed indication is for the control of mortality in penaeid shrimp due tonecrotizing hepatopancreatits (NHP) associated with Hepatobacter penaei. The workinvolved will include environmental assessment conditions of use of the drug exposureassessment effects assessment risk characterization and conclusions.