|Straus, David - Dave|
Submitted to: US Food And Drug Administration - Public Master File - Copper Sulfate
Publication Type: Other
Publication Acceptance Date: 7/21/2000
Publication Date: 7/21/2000
Citation: GRIFFIN, B.R., STRAUS, D.L. TARGET ANIMAL SAFETY OF COPPER SULFATE AS A DISEASE THERAPEUTANT FOR CULTURED FRESHWATER FISH. US FOOD AND DRUG ADMINISTRATION-PUBLIC MASTER FILE - COPPER SULFATE. 2000. v.3. pp.274. Interpretive Summary:
Technical Abstract: The USFDA requires that chemicals used on food animals be evaluated to determine whether they cause deleterious effect to the animal's future health. Reported toxicity of copper sulfate done on different species of fish was compared to recommended doses of copper sulfate in use in fish disease control. Two numerical indices were developed; the Modified Margin of Safety (MSM) and the Expected Margin of Safety (MSE). The Modified Margin of Safety is defined as the concentration of copper sulfate that is lethal to 50% of a population exposed to the chemical for 96 hours divided by the concentration of the chemical that eliminates the disease in question in 100% of the exposed population. The Expected Margin of Safety is defined as the concentration of copper sulfate that is lethal to 50% of a population exposed to the chemical for 96 hours divided by the recommended dose based on the alkalinity of the water reported in the studies. Both indices suggest that Chinook salmon, striped bass, Coho salmon cutthroat trout and rainbow trout should not be treated with copper sulfate because of excess toxicity. Both indices indicate that fathead minnows, channel catfish, bluegill sunfish and Mossambique tilapia can be safely treated with copper sulfate.