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Therapeutants in Aquaculuture Agriculture vs. human use and the development of bacterial resistance Scale: Abx used 100 times more in food animals than in humans. The problem of aquaculture Aquatic "pollution" - widespread drug exposures: OTC (Ca chelation, breakdown times, water vs. sediments) Pharmaceutical companies view many aquaculture ventures as small potatoes; i.e., not worth the risk of development. BOTTOM LINE: Control versus spread of disease Currently available applications FDA-approved drugs - Approved only for specific diseases MS222 Formalin (fish, fish eggs, shrimp) Romet-30 (sulfadimethaxine, ormetoprim) (salmon, catfish) Sulfamerazine – recently removed from list Oxytetracycline (salmon, catfish, lobster) FDA-unapproved Low Regulatory Priority Treatments Primarily topical treatments for fish eggs, simple parasitic treatments 17 products ranging from acetic acid to ice to urea: Acetic acid, CaO, NaCl for protozoa, monogenes MgSO4 for monogenes Garlic, onions against crustaceans EPA-registered products Algicides – chelated copper, copper-based compounds Herbicides – shade control, organic bromides, endothall, fluidone, glyphosate, 2,4-D based compounds (large ##) Fish toxicants / piscicides – rotenone, antimycin USDA-licensed biologics Bactericins – available for Aeromonas, Yersinia, Vibrio, Edwardsiella Diagnostic kits – available for Renibacterium Feeds – unregulated? Probiotics, glycans What is the process for a new drug? Drug must be effective and safe (GRAE, GRAS) Approved new animal drug application or Have an investigational new animal drug exemption (INAD) INAD Exemptions Emergency Exemptions Extra-label use policy for veterinarians (limited basis, not for large scale, can't be mixed in feed, nor use by public, including fish pathologists specifically!) Compassionate Exemption : Allows pharm company to do research on an unapproved drug prior to approval. Must collect supporting data for NADA approval Must have framework: sponsor, monitor, investigators Sponsor, veterinarian, scientists, aquaculture facility Sponsor important to guarantee QA/QC of drug! Not all OTC are alike?! Must have safety and efficacy information (human and environmental) Can use FARAD (Food Animal Residue Avoidance Data Bank) and National Coordinator for Aquaculture NADAs. Minor Use Animal Drug Program (NRSP-7). Request a compassionate exemption from FDA Must have letter of response/approval from FDA's CVM (100 days). Annual basis only. Sponsor: aquaculture facility, association or pharmaceutical company, responsible for all communications with CVM, must develop protocols, notifys CVM of shipments. Pharm company ultimately sponsors NADA…. Monitor: veterinarian; provides QA/QC of data, does not participate in data collection, can work on behalf of sponsor. Investigators: scientists, concerned aquaculture facility; conducts trial, manages daily aspects, directs administering of drug Upon approval: Sponsor and monitor prepare clinical trials Investigators undertake trials according to protocols. Sponsors notify FDA/CVM of each drug shipment Data analysis and submission of data to FDA/CVM. Sponsor holds the INAD exemption. Issues to consider At least 2 adequate and well-controlled efficacy studies are required. Phase I: Dose-titration studies (3 doses, 1 control, 2 water temps or water quality conditions), optimal dose Phase II: Clinical field trial at 3 sites Sources, batches, lot numbers must all be recorded. Residue depletion and environmental safety data must be generated. Treatment Schedules Initial targeting - efficacy studies, control groups Types of drug studies Whole animal Cell or bacterial culture Batch vs. individual Route of administration Oral, bath, injection (im, ip, subq) Dosing interval & Duration Criteria for evaluation: morbidity, mortality, adverse reactions, etc. Tissue-residue analyses – use highest dose group Hinton-Mueller agar & Bacillus cereus HPLC Delvo-P test kit for OTC Environmental residues How much drug is left in the water or sediment How much remains in the water after filtration (if used) How much drug is excreted. Fate and effects data: Photolysis/hydrolysis Biodegradation Adsorption Sed tox Fish and invert LC50 Chronic toxicity in fish and invert NPDES permit (National Pollutant Discharge Elimination System) via EPA. Integrated Pest Management (Schisto or Onchocerca examples if time permits) Management at each level Cultural changes Breaking the life cycle