Submitted to: Aquatic Animal Drug Approval Partnership (AADAP)
Publication Type: Other
Publication Acceptance Date: 7/20/2010
Publication Date: 7/23/2010
Citation: Straus, D.L. 2010. USDA's Corner. Aquatic Animal Drug Approval Partnership (AADAP). 6(2):12. Interpretive Summary:
Technical Abstract: In June we completed the long-awaited, in-life phase of the GLP Target Animal Safety study to evaluate the safety of 17a-methyltestosterone administered in feed to tilapia; this is another FDA-required study that we have done in partnership with the folks at AADAP. The fish tissues have been sent to AADAP to be processed and evaluated histologically. We are presently awaiting results of a data audit by the QA people and will work with AADAP on the Final Study Report. Future collaborations with the staff at AADAP are being discussed and the benefits are obvious for the overall drug approval project. Good news! A Technical Section Complete letter was received in May for the CuSO4 Target Animal Safety study on channel catfish eggs. Also, see AADAP’s good news about Aquaflor® and sunshine bass. A Final Study Report for the effectiveness range-finding (supportive) studies of CuSO4 on saprolegniasis of channel catfish eggs was submitted by our partners at Freeport-McMoRan to FDA/CVM in June and we are anxiously awaiting the verdict. Pivotal dose-confirmation Final Study Reports of the Effectiveness Technical Section are being delayed for work on the Environmental Assessment for CuSO4 in ponds. The catfish spawning season is over. This year we continued our studies on water molds (i.e., fungus) that grow on catfish egg masses. A trial with peracetic acid was completed and low doses seem to work well. Drew compared three hydrogen peroxide treatments for effectiveness against fungi and their ability to increase egg survival. The treatments (all at 250 mg/L) were immersion, flush treatments applied once daily, twice daily and a 15 minute static treatment applied once daily; preliminary results indicate that the static treatment outperformed in terms of egg survival and fungal growth. Dave Straus, Disease & Drug Approval Section, Harry K. Dupree – Stuttgart National Aquaculture Research Center, Agricultural Research Service, U.S. Dept. of Agriculture, Stuttgart, AR.