Currently only one anesthetic (Finquel, also known as MS-222) is approved for use with fish, but its use is constrained by a 21-day withdrawal time (time before fish can be released in the wild or made available for human consumption). AQUI-S™ was identified as a fish anesthetic and sedative with a good probability of having a zero or short withdrawal time.

The approval of a fish anesthetic with a very short or no withdrawal time would allow hatchery personnel and fishery managers to handle fish with minimum stress during spawning, population estimates, age and growth studies, and stocking. Studies required by the Food and Drug Administration are being or were conducted to gain approval of AQUI-S™ as an anesthetic and sedative for fish cultured in public hatcheries.

STATEMENT ON ISOEUGENOL (AQUI-S™)

Isoeugenol (the active ingredient in AQUI-S™) has been under evaluation by the National Toxicology Program (NTP), an interagency program whose mission is to evaluate chemical agents for potential public health risks.  Recently, NTP was forced to delay the review of their nearly completed two-year toxicology studies on isoeugenol until February 2008 because of higher priorities.  Although the study data have not been fully analyzed, the preliminary assessments of the data do not eliminate the possibility that isoeugenol residues in treated fish could pose a human health risk.

Because we need to be absolutely certain that there are no human food safety issues that would preclude the approval of AQUI-S™, the U.S. Fish & Wildlife Service (FWS) and the U.S. Geological Survey (USGS) and other participating partner groups have agreed to institute interim measures that will be effective until the NTP meeting in February 2008.  Effective April 27, 2007, all ongoing and planned AQUI-S™ research funded under the Association of Fish and Wildlife Agencies' Multi-State Conservation Grant, and allied work supported with federal base funds of FWS and USGS will be suspended until the completion of the NTP review.  Additionally, FWS will temporarily suspend all field activities under their Investigational New Animal Drug exemption for AQUI-S™ until the NTP review is complete.

Although the decision to temporarily suspend all publicly funded AQUI-S™ research activities was not an easy decision to make, as responsible stewards of public funds it is the correct course of action.  It should be noted that significant portions of the data necessary to address many of the original AQUI-S™ goals and objectives of the Federal-State Aquaculture Drug Approval Partnership Project have already been generated.  It is also important to note that USGS is constrained from further development of residue chemistry data until a tolerance value for the residues has been established by the Center for Veterinary Medicine.  This work cannot be initiated until the results of the NTP studies are finalized.  We look forward to the opportunity of continuing our collaborative AQUI-S™ research efforts in February 2008.