Submitted to: Aquatic Animal Drug Approval Partnership (AADAP)
Publication Type: Other
Publication Acceptance Date: 11/13/2009
Publication Date: 11/16/2009
Citation: Straus, D.L. 2009. USDA's Corner. Aquatic Animal Drug Approval Partnership (AADAP). 5(3):12. Interpretive Summary:
Technical Abstract: SNARC has been working with the folks at AADAP on two studies: 1) a “near” GLP compliant Target Animal Safety study to evaluate the safety of Aquaflor® administered in feed to sunshine bass and 2) a GLP compliant Target Animal Safety study to evaluate the safety of 17a-methyltestosterone administered in feed to tilapia. The in-life phase of the Aquaflor® study was completed at SNARC and fish tissues were processed and evaluated histologically at AADAP. Results were excellent and the Final Study Report is being internally reviewed. The in-life phase of the methyltestosterone study will be completed at SNARC and is planned for January/February, 2010; a preliminary study is underway to establish a larval tilapia growth curve so that we may better predict feed amounts to be administered to fish each day of the study. Fish samples will be processed and evaluated histologically at AADAP. Collaborating with AADAP on these studies has been beneficial for the overall drug approval projects and has helped to speed things along. The high-density, low-flow columnaris disease method has been able to produce columnaris infections in catfish with some regularity. We have been able to demonstrate effectiveness of KMnO4 to channel catfish infected with columnaris and dosed after 20 hrs with a single 8 mg/L treatment. Further experiments are planned using repeated treatments at lower doses. The Final Study Report for the CuSO4 Target Animal Safety study on channel catfish eggs should be submitted to FDA/CVM by the end of the year; there have been several delays with other priorities to our research mission at SNARC. A Final Study Report for the effectiveness studies of CuSO4 on saprolegniasis of channel catfish eggs is being prepared. Dave Straus, Disease & Drug Approval Section, Harry K. Dupree – Stuttgart National Aquaculture Research Center, Agricultural Research Service, U.S. Dept. of Agriculture, Stuttgart, AR.