AS PART OF THE COORDINATED EFFORT TO GENERATE DATA TO SUPPORT APPROVAL BY FDA/CVM, CORNELL UNIVERSITY RESEARCHERS WILL CONDUCT A SERIES OF STUDIES UNDER A RECENTLY SUBMITTED PROTOCOL TO FDA/CVM (AQS20E-18-SEA-TAS.2B) TO EVALUATE THE SAFETY OF AQUI-S®20E (10% EUGENOL) USED TO SEDATE MARINE FISH TO THE HANDLEABLE STAGE OF ANESTHESIA IN SALTWATER. FOR OUR PURPOSES, THE TERM "HANDLEABLE" WILL BE EQUIVALENT TO ANESTHESIA STAGES 3 - 4 AS DESCRIBED BY SUMMERFELT AND SMITH (1990) (THAT FISH BECOME HANDLEABLE WITHIN 3 MIN OR LESS AND RECOVER NORMAL SWIMMING BEHAVIOR WITHIN 5 - 10 MIN. THE OBJECTIVE OF THESE STUDIES IS TO EVALUATE THE SAFETY OF AQUI-S®20E TO SALTWATER-REARED MARINE FINFISH WHEN OVEREXPOSED TO EITHER THE HEC (1×) OR 1.5× THE HIGHEST PROPOSED EFFICACIOUS DOSE. THE RESULTS OF THESE SAFETY STUDIES WILL BE USED TO COMPLETE THE TARGET ANIMAL SAFETY (TAS) TECHNICAL SECTION DATA REQUIREMENTS FOR MARINE FINFISH AND ULTIMATELY SUPPORT A NEW ANIMAL DRUG APPLICATION TOFDA/CVM TO APPROVE THE USE OF AQUI-S®20E FOR SEDATION IN ALL FINFISH.THIS COLLABORATIVE APPROACH WILL NOT STOP AFTER THE APPROVAL OF AQUI-S®20E IS ATTAINED. PROTOCOLS FOR THE NEXT PRIORITIZED DRUG WILL BE FINALIZED AND SUBMITTED TO FDA FOR CONCURRENCE IN A COORDINATED AND TIMELY FASHION. STUDY TOPICS COULD INCLUDE EFFECTIVENESS, HUMAN FOOD SAFETY, AND/OR TARGET ANIMAL SAFETY EFFORTS, WHICHEVER TECHNICAL SECTION NEEDS RESEARCH CONDUCTED. THESE DECISIONS WILL BE MADE WITH STAKEHOLDER INPUT AS DESCRIBED BELOW. WE WILL CONTINUE TO WORK CLOSELY WITH AADAP ON MORE PROJECTS CHOSEN BY THE AQUACULTURE STAKEHOLDERS, PARTICULARLY THE DRUG APPROVAL WORKING GROUP (DAWG), TO COMPLETE AS MUCH ADDITIONAL RESEARCH AS POSSIBLE GIVEN THE TWO-YEAR FUNDING PROVIDED FOR THIS PROPOSAL.

Cornell University, Ithaca NY

Investigators