The Aquatic Animal Drug Approval Partnership (AADAP) Program, as it functions today, actually had its genesis in the early 1990’s. In direct response to an “announcement” by the U.S. Food and Drug Administration (FDA) in 1991 that the time had finally arrived when drug and therapeutant use in aquaculture needed to be regulated, the U.S. Fish and Wildlife Service (Service), as well as many others, discontinued the use of unapproved drugs and therapeutants in fisheries programs, and engaged in the compassionate Investigational New Animal Drug (INAD) exemption process. This announcement was a “pretty hard hit” for all concerned. Prior to this development, fisheries managers’ access to needed drugs, chemicals, and therapeutants to maintain fish health and manage production programs was limited only by one’s imagination and/or access at a chemical supply company or the local Ranch N’ Home store. This situation was further exacerbated by the fact that only three therapeutants and a single anesthetic were actually approved for use in aquatic species, and use of these compounds was severely restricted by species, water temperature, and life-stage. Although compassionate INAD exemptions did allow for the continued use of certain unapproved drugs in an approved-manner (i.e., under strict FDA guidelines), fish culture had changed forever.
Recently completed field effectiveness trials
With the cooperation of partners, we were able to complete the following field effectiveness trials (final study reports will be submitted to FDA for review):
(1) Use of chloramine-T to control mortality in tiger musky caused by columnaris
(2) Use of oxytetracycline hydrochloride to control mortality in bluegill caused by columnaris
1. Pilot study - evaluate the effectiveness of 50 mg/L AQUI-S20E to lightly sedate rainbow trout for extended periods of time.
2. Pilot study - determine tissues affected by over-exposure to AQUI-S20E during light sedation for extended periods of time.
3. Submitting 5 grant applications for MUMS funding (use of Pennox343 to control mortality in cutthroat trout due to coldwater disease; use of AQUI-S20 to sedate a variety of fish to handleable in seawater.