|Straus, David - Dave|
Submitted to: Society of Environmental Toxicology and Chemistry Abstracts
Publication Type: Abstract Only
Publication Acceptance Date: 7/15/2000
Publication Date: 11/6/2000
Citation: STRAUS, D.L., GRIFFIN, B.R. AQUACULTURE THERAPEUTICS EVALUATION AT THE HKD-SNARC. SOCIETY OF ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY ABSTRACTS. 2000. Interpretive Summary:
Technical Abstract: In the 1990/'s the United States Food and Drug Administration (FDA) - Center for Veterinary Medicine (CVM) increased it regulatory scrutiny of public and private aquaculture. TheCVM revised its procedures for issuing investigational new animal drug (INAD) drug exemptions and guidelines on therapeutic uses, questioned many previous rulings on aquaculture chemicals, and required that new data be provided to prove efficacy and to ensure their saftey 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 is safe for the animal, efficacious, and is not a threat to humans or the environment. When approved, this will be the first new aquaculture therapeutant 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.