Author
|
Submitted to: Aquatic Animal Drug Approval Partnership (AADAP)
Publication Type: Other Publication Acceptance Date: 2/13/2009 Publication Date: 2/16/2009 Citation: Straus, D.L. 2009. Usda’s corner. Aquatic Animal Drug Approval Partnership (AADAP). 5(1):10-11. Interpretive Summary: Technical Abstract: ARS Corner The Stuttgart crew has been busy with ongoing research and the following is an update on happenings. Aquaculture America 2009. The Therapeutic Drug Research special session was a big hit again with 13 presentations and plenty of discussion followed by a NADRF meeting. The session is organized and moderated by Jim Bowker, Mark Gaikowski and Dave Straus and this was the 7th year we have held this session focused on research in aquaculture therapeutants. Annual Drug Approval Coordination Workshop. Plans are firming up for the meeting scheduled for June 9th through 11th at the LaQuinta Little Rock Downtown Conference Center; there will be additional meetings on June 8th and June 12th, so come enjoy a week in Arkansas! There will be the usual opening mixer at a local brew-pub, and the meeting will focus on priority therapeutants. The meeting gives us a chance to highlight regional aquaculture, industry tours to a catfish hatchery, baitfish farm, ornamental fish farm and hybrid striped bass production facility. Hope y’all can make this meeting and experience some Southern Hospitality! Copper Sulfate - Label for Ich. SNARC has partnered with Phelps Dodge (now Freeport-McMoRan) to draft a label for their product. FDA/CVM has concurred with the draft label we have prepared and the sponsor will begin the process of moving it through their channels to create a mock-label that they will formally submit to FDA/CVM. Copper Sulfate - Human Food Safety technical section for Ich. A hazard characterization was submitted for the Human Food Safety technical section for Triangle Brand® Copper Sulfate. In a letter received in December 2008, the FDA concluded that the microbial food safety risks associated with the proposed use of copper sulfate in fin fish was low. Based on this information, the Division of Human Food Safety considers the Human Food Safety technical section complete for ALL fin fish. Copper Sulfate Effectiveness – Fungus on Channel Catfish Eggs. Final Study Reports for the laboratory dose-confirmation (@ 10 mg/L Cu) and independent substantiation at a commercial hatchery are in process. Copper Sulfate Target Animal Safety – Channel Catfish Eggs. A Final Study Report for the Target Animal Safety study is in review by Quality Assurance and their comments will be addressed prior to submission to FDA/CVM. Potassium Permanganate - Effectiveness. Research is being conducted to develop a consistent method to induce columnaris first in channel catfish and then in hybrid striped bass. Pubs related to our drug approval work: Straus, D.L. 2008. Copper Sulfate Toxicity to Channel Catfish Fry: Yolk Sac versus Swim-up Fry. North American Journal of Aquaculture, 70(3):323-327. Straus, D.L. 2008. Comparison of Copper Sulfate Concentrations to Control Ichthyophthiriasis in Fingerling Channel Catfish. Journal of Applied Aquaculture, 20(4):272-284. |
