Revisiting the status of copper sulfate research at SNARC

Authors: Straus, David - Dave

Submitted to: Meeting Abstract
Publication Type: Abstract Only
Publication Acceptance Date: 6/5/2019
Publication Date: 7/29/2019
Citation: Straus, D.L. 2019. Revisiting the status of copper sulfate research at SNARC [abstract]. Aquaculture Drug Approval Workshop, Bozeman, MT, July 29 - August 1, 2019. 25:40.

Interpretive Summary:

Technical Abstract: Revisiting the Technical Sections completed for the New Animal Drug Application (NADA) for copper sulfate will be given and the status of sponsorship will be discussed. An initial label claim will be “For the treatment of Ichthyophthiriasis (Ichthyophthirius multifiliis) on Ictalurid catfish cultured in earthen ponds.” The Technical Sections are: 1) Human Food Safety - Complete for all fin fish, 2) Effectiveness - Complete for Ich for all fish, 3) Target Animal Safety - Complete for channel catfish, 4) Environmental Assessment - Approved by FDA/CVM (Environmental Impact for earthen ponds complete letter requested by Sponsor), 5) Chemistry, Manufacturing and Control – ???, 6) Label - Draft was concurred by FDA/CVM; sponsor will submit final label, and 7) All Other Information; to be addressed. The supplemental label claim will be “To control egg mortality associated with saprolegniasis infecting channel catfish eggs.” The Technical Sections are: 1) Human Food Safety - Complete for all fin fish, 2) Effectiveness –Complete for channel catfish eggs, 3) Target Animal Safety - Complete for channel catfish eggs, and 4) Environmental Assessment; to be addressed, 5) Chemistry, Manufacturing and Control - ???, 6) Label; to be addressed, and 7) All Other Information; to be addressed.