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Download AQUACULTURE DRUGS FDA PROSPECTIVE Barbara Montwill FDA/CFSAN Office of Seafood Shrimp School 2005 University of Florida

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  • Slide 1
  • AQUACULTURE DRUGS FDA PROSPECTIVE Barbara Montwill FDA/CFSAN Office of Seafood Shrimp School 2005 University of Florida
  • Slide 2
  • Aquaculture Aquaculture the fastest growing business (10% per year) Global aquaculture production Estimated for 35 million metric tons (~30% of total seafood production) Estimated production of farm-raised shrimp 2 million metric tons U.S. shrimp import: ~75% of total supply 7 countries account for about 70% (Thailand, China, Ecuador, Vietnam, India, Indonesia and Brazil)
  • Slide 3
  • Aquaculture Aquaculture production more intensive larger number of animals per production unit higher farms density in an area Risk of rapid expansion poor water quality disease outbreaks environmental impact
  • Slide 4
  • Chemicals in Aquaculture Purpose and use Sediment and water management Enhancement of aquatic productivity Feed formulation Manipulation and enhancement of reproduction Growth promotion Health management Improvement of survival rates Transport of live organisms
  • Slide 5
  • Chemicals in Aquaculture Benefits (if carried out properly): control of infection disease prophylactic measure against infections growth and productivity promoters Concerns (over use or misuse): residue in edible portion developing bacterial resistance human health implications environmental implications
  • Slide 6
  • Pesticides Register and regulated by EPA Federal Insecticide, Fugicide and Rodenticide Act (FIFRA) Title 40 of the Code of Federal Regulations (CFR) Use and condition specified on label
  • Slide 7
  • Aquaculture Drugs As defined by the Federal Food, Drug And Cosmetic Act (FFDCA) a drug is: articles recognized in the official United States Pharmacopeia articles intended to use in diagnosis, cure, mitigation, treatment, or prevention of disease articles intended to affect the structure or function of the body of man or animal articles intended to be a component of above
  • Slide 8
  • Aquaculture Drugs Intended use of a compound determines if a compound is a drug. Antibiotics are drugs: they treat or mitigate disease or affect structure or function
  • Slide 9
  • Aquaculture Drugs ALL aquaculture drugs whether for direct medication or for addition to feed must be approved for use in the US As mandated by the Federal Food, Drug and Cosmetic Act, a new animal drug may not be sold in interstate commerce unless it is the subject of a New Animal Drug Application (NADA). Use of unapproved drugs or misuse is a violation, product is adulterated under 21 U.S.C. Section 342 (a)(1) and Section 342 (a)(2)(C)
  • Slide 10
  • Aquaculture Drugs New Animal Drug must be: Effective for the intended use Safe for the target animal Safe for human food (no harmful residues) determine if the drug has potential to cause adverse effects (e.g. cancer) determine a tolerance/ safety level Safe for environment Safe for users
  • Slide 11
  • Aquaculture Drugs Drugs are approved: dosage route of administration species limitation of use/ indication for use frequency
  • Slide 12
  • Aquaculture Drugs Any deviation from the label is considered : Extra-label use prohibited except under the provisions of Animal Drug Use Clarification Act (AMDUCA), Title 21 Code of Federal Regulations Part 530 (21CFR530)
  • Slide 13
  • Aquaculture Drugs Only by a licensed veterinarian or under his/her supervision The animal must be very sick or will die w/out treatment The veterinary must be familiar w/ the producers animals No new animal drug is approved for this illness For food animals there cant be harmful residues
  • Slide 14
  • Aquaculture Drugs Drugs banned for extra-label use in food animals: Chloramphenicol; Clenbuterol; Diethylstilbestrol (DES); Dimetridazole; Ipronidazole (and other nitroimidazoles); Furazolidone, Nitrofurazone (and other nitrofurans) Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine); Fluoroquinolones; Glycopeptides.
  • Slide 15
  • Aquaculture Drugs Approved Current Drugs Approved for Aquaculture in USA (Total 6) Chorionic gonadotropin (HCG) Formalin Oxytetracycline Sulfadimethoxine-ormetoprim Sulfamerazine Tricaine methanesulfonate (MS-222)
  • Slide 16
  • Aquaculture Drugs Approved Drugs approved for use in shrimp in the U.S.: Formalin (control external protozoan parasites) Some drug use under an Investigational New Animal Drug (INAD)
  • Slide 17
  • Aquaculture Drugs FDA do not object use of drugs determined to be new animal drugs of low regulatory priority if the following conditions are met: The substances are used for prescribed indications, levels The substances used according to GMPs The substances are appropriate grade for use in food animals There is not likely to be adverse effect on the environment
  • Slide 18
  • Aquaculture Drugs Low Regulatory Priority Acetic Acid Calcium Chloride Calcium Oxide Carbon Dioxide Gas Fullers Earth Garlic (whole form) Hydrogen Peroxide Ice Magnesium Sulfate Onion (whole form) Papain Potassium Chloride Povidone Iodine Sodium Bicarbonate Sodium Chloride Sodium Sulfite Thiamine Hydrochloride Urea and Tannic Acid
  • Slide 19
  • Aquaculture Drugs Classification of these substances as new animal drugs of low regulatory priority are based on current knowledge and should not be considered as an approval nor an affirmation of their safety and effectiveness does not exempt facilities from complying with other environmental requirements (e.g. with National Discharge Elimination System requirements)
  • Slide 20
  • Aquaculture Drugs Details information on the approved products available at CVMs Website: www.fda.gov/cvm
  • Slide 21
  • FDA testing program
  • Slide 22
  • Unapproved drugs administered to aquaculture fish pose a potential human health hazard. These substances may be carcinogenic, allergenic and/or may cause antibiotic resistance in man ?
  • Slide 23
  • FDA testing program Shrimp Chloramphenicol Nitrofurans Fluoroquinolones Oxytetracycline Quinolones: Qxolinic Acid and Flumequine Catfish Fluoroquinolones Malachite green Quinolones: Oxolinic Acid and Flumequine
  • Slide 24
  • FDA testing program Salmon Quinolones: Flumequine Ivermectin Oxolinic Acid Malachite green Crab Chloramphenicol
  • Slide 25
  • FDA testing program Seafood products tested Domestic Import
  • Slide 26
  • FDA testing program Countries sampled based on where product is imported from: Shrimp Brazil Ecuador Indonesia Thailand Vietnam China India
  • Slide 27
  • FDA testing program Chloramphenicol Chloramphenicol has never been approved for use in food producing animals Chloramphenicol has never been approved for use in food producing animals Causes aplastic anemia in humans Adverse reactions not dose dependent and safe level of exposure had not been determined Adverse reactions not dose dependent and safe level of exposure had not been determined Oral solution withdrawn because of documented history of misuse in food animals Oral solution withdrawn because of documented history of misuse in food animals
  • Slide 28
  • FDA testing program Nitrofurans Nitrofurans (except topical applications) were banned for use in food animals in 1991. Nitrofurans (except topical applications) were banned for use in food animals in 1991. Considered carcinogen Considered carcinogen Recently have banning topical uses for food animals due to residues concerns Recently have banning topical uses for food animals due to residues concerns
  • Slide 29
  • FDA testing program Because tested compounds are not approved, presence of any residues is a violation Only limitation is sensitivity of the analytical method, a limit of detection (LOD)
  • Slide 30
  • FDA testing program FDA determination of violation is based on drug residues findings with approved regulatory method Determinative Method Confirmatory Method
  • Slide 31
  • FDA testing program Analytical methods Analytical methods recommended by FDA Chloramphenicol: Determiantion of Chloramphenicol Residues in Shrimp and Crab Tissues by Electrospray Triple Quadrupole LC/MS/MS LC/MS/MS Analysis of Chloramphenicol in Shrimp Nitrofurans: Determination of Nitrofurans Metabolites in Shrimp using LC/MS/MS Both methods are available at CFSANs Website: www.cfsan.fda.gov/seafood1.html
  • Slide 32
  • REQUIRMENTS FOR IMPORTED PRODUCTS
  • Slide 33
  • Imported Products (21 CFR Part 123.12) HACCP for all imported fish and fishery products Under the US FDA Seafood HACCP regulation, aquaculture processors will be expected to reject fish from producers who use drugs illegally.
  • Slide 34
  • Importer Verification: Written Verification Procedures Product specifications to ensure that the product is not injurious to health and not processed under insanitary conditions, and Affirmative steps
  • Slide 35
  • Importer Verification: Written Verification Procedures Obtaining the processors HACCP plan and sanitation records for the lot being entered Obtaining either a co

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