|Straus, David - Dave
Submitted to: Society of Environmental Toxicology and Chemistry (SETAC)
Publication Type: Abstract Only
Publication Acceptance Date: 8/1/1999
Publication Date: 11/12/2000
Citation: STRAUS, D.L., GRIFFIN, B.R. AQUACULTURE THERAPEUTICS EVALUATION AT THE HARRY K. DUPREE STUTTGART NATIONAL AQUACULTURE RESEARCH CENTER. SOCIETY OF ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY ABSTRACTS. 2000. p.304.
Technical Abstract: In the 1990's the United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) increased its regulatory scruitiny of public and private aquaculture. The CVM revised its procedures for issuing in- vestigational new animal drug (INAD) exemptions and guidelines on therapeu- tic uses, questioned many previous rulings on aquaculture chemicals, and required that new data be provided to prove efficacy and to ensure their safety to humans and the environment. To consider a new therapeutant for approval, the FDA requires data on efficacy, environmental risk, human food safety, product chemistry, mammalian toxicology, and target animal safety. Therapeutants being studied at the HKD - SNARC are copper sulfate, potassium permanganate and oxytetracycline. The required data have been submitted to the FDA for the use of copper sulfate to control Ichthyophthirius sp. on all fish; research has shown that this therapeutant tis safe for the animal, efficacious, and is not a threat to humans or the environment. When approved, this will be the first new aquaculture thera- peutant since formalin was approved in 1986. Current research focuses on potassium permanganate, which could be used in a situation where copper sulfate would not be suitable.