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Current
Research At The Bozeman Fish Technology Center On The Approval Of Chloramine-T
For Use In Public James Bowker, D. Carty, D.A. Erdahl, B.J. Elliott, and
A.B. Gray U.S. Fish and Wildlife Service, Bozeman Fish Technology
Center, National INAD Office, Bozeman, MT 59717 Chloramine-T is regarded as one of the most effective therapeutants used to control mortality in fish caused by bacteria associated with bacterial gill disease (BGD). However, the Food and Drug Administration (FDA) has not approved chloramine-T for use in any food animal, including fish. Therefore, before chloramine-T can be legally used in aquaculture without Investigational New Animal Drug (INAD) authorization, all technical sections necessary for approval of a New Animal Drug Application must be satisfied. Such submissions include pivotal data on efficacy, target animal safety (TAS), human food safety, and environmental fate. The USFWS Bozeman Fish Technology Center (BFTC) National INAD Office (NIO) is working cooperatively with FWS hatcheries, the USGS Upper Midwest Environmental Sciences Center, and Akzo-Nobel Chemicals, Inc. to generate the necessary data to gain FDA approval of chloramine-T for use in aquaculture. The BFTC has been responsible for conducting pivotal, near-pivotal, and ancillary chloramine-T field efficacy trials on salmonids, as well as pivotal TAS trials on various life stages of rainbow trout (Oncorhynchus mykiss). The efficacy of 12 - 20 mg/L chloramine-T has been tested on a variety of salmonids. The objective of each efficacy study has been to determine if chloramine-T treatments can control mortality in fish diagnosed with BGD. Results of efficacy studies submitted to FDA for formal review were efficacious. Results from TAS studies have also been promising. Regulated studies have been completed at two water temperatures for rainbow trout fry, fingerling and juvenile life stages. Groups of fish have been exposed to chloramine-T concentrations ranging from 0 to 100 mg/L for 3 hr in a standing bath on 3 alternate days at both 8 or 14o C. Study results have shown that there is a positive correlation between toxicity of chloramine-T and both fish size and water temperature. Additional TAS studies are planned and this work should be completed before the end of FY2000. Final approval of chloramine-T will depend on a review and approval of the complete data package by FDA (which would include submissions for human food safety and environmental fate).
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