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AQUACULTURE DRUGS FDA PROSPECTIVE

AQUACULTURE DRUGS FDA PROSPECTIVE. Barbara Montwill FDA/CFSAN Office of Seafood Shrimp School 2005 University of Florida. Aquaculture. Aquaculture – the fastest growing business (10% per year) Global aquaculture production

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AQUACULTURE DRUGS FDA PROSPECTIVE

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  1. AQUACULTURE DRUGSFDA PROSPECTIVE Barbara Montwill FDA/CFSAN Office of Seafood Shrimp School 2005 University of Florida

  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)

  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

  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

  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

  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

  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

  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

  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)

  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

  11. Aquaculture Drugs Drugs are approved: • dosage • route of administration • species • limitation of use/ indication for use • frequency

  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)

  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 can’t be harmful residues

  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.

  15. Aquaculture DrugsApproved Current Drugs Approved for Aquaculture in USA (Total 6) • Chorionic gonadotropin (HCG) • Formalin • Oxytetracycline • Sulfadimethoxine-ormetoprim • Sulfamerazine • Tricaine methanesulfonate (MS-222)

  16. Aquaculture DrugsApproved 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)

  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

  18. Acetic Acid Calcium Chloride Calcium Oxide Carbon Dioxide Gas Fuller’s 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 Aquaculture DrugsLow Regulatory Priority

  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)

  20. Aquaculture Drugs • Details information on the approved products available at CVM’s Website: www.fda.gov/cvm

  21. FDA testing program

  22. FDA testing program • 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 ?

  23. FDA testing program • Shrimp • Chloramphenicol • Nitrofurans • Fluoroquinolones • Oxytetracycline • Quinolones: Qxolinic Acid and Flumequine • Catfish • Fluoroquinolones • Malachite green • Quinolones: Oxolinic Acid and Flumequine

  24. FDA testing program • Salmon • Quinolones: Flumequine • Ivermectin • Oxolinic Acid • Malachite green • Crab • Chloramphenicol

  25. FDA testing program • Seafood products tested • Domestic • Import

  26. FDA testing program Countries sampled based on where product is imported from: • Shrimp • Brazil • Ecuador • Indonesia • Thailand • Vietnam • China • India

  27. FDA testing programChloramphenicol • 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 • Oral solution withdrawn because of documented history of misuse in food animals

  28. FDA testing programNitrofurans • Nitrofurans (except topical applications) were banned for use in food animals in 1991. • Considered carcinogen • Recently have banning topical uses for food animals due to residues concerns

  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)

  30. FDA testing program • FDA determination of violation is based on drug residues findings with approved regulatory method • Determinative Method • Confirmatory Method

  31. FDA testing programAnalytical 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 CFSAN’s Website: www.cfsan.fda.gov/seafood1.html

  32. REQUIRMENTSFOR IMPORTED PRODUCTS

  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.

  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

  35. Importer Verification: Written Verification Procedures • Obtaining the processor’s HACCP plan and sanitation records for the lot being entered • Obtaining either a continuing or lot-by-lot certification of proper drug usage • Regularly inspecting the foreign processor’s facilities

  36. Importer Verification: Written Verification Procedures • Maintaining the processor’s HACCP plan and written guarantee that the product is processed in accordance with the U.S. requirements • Periodically end-product testing and written guarantee that the product is processed in accordance with the U.S. requirements

  37. Detention Procedures for Imported Products

  38. Typesof detention • DETENTION OF AN INDIVIDUAL ENTRY - Stopping a shipment of an individual entry (due to sample collection or physical examination) • DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE) - Stopping a shipment without collection of a physical examination by FDA

  39. Procedures for detention of individual entry • Appear violative after initial review of entry or exam • FDA samples and analyzes lot • Lot released if no violation found • Non-violation does not affect future shipment • Violative product not allowed entry

  40. Procedures for Detention without Physical Examination (DWPE) • Detention based on past violative history (individual processors, countries or geographical area) • Import Alerts has been issued that may cover one or more firms or country

  41. Detention requirements for individual shipments Individual shipments may be released from detention if: • The importer submit to FDA an Application for Authorization to Reconditioning • Each shipment is sampled and analyzed • Analysis performed by a competent private laboratory • Lab results reported to FDA for review • If not violative the shipment is released

  42. Detention requirements –removal from DWPE Firms, countries or products may be removed from DWPE if: • Minimum 5 consecutive non-violative shipments in a 6 month period (can be multiple ports) • FDA must be assured that firms are compliant over a reasonable period to remove from DWPE • At least one shipment audited by FDA to ensure analytical validity • Shipments are individual, routine, commercial entries and represent separate production operations

  43. Detention requirements –removal from DWPE • FDA may request additional documentation to ensure compliance with other provisions of U.S. laws and regulations • FDA may require an establishment inspection • Firms or countries must request removal in writing after 5 non-violative shipments in a 6 month period

  44. Private Laboratories • Private labs are employed for two purposes: • Testing of detained imports under FDA review • Manufacturer/processor testing for quality control, HACCP purposes • FDA ORA Laboratory Manual provides a guidance for private laboratories (section 7) • This guidance applies only to laboratories performing testing of product under DWPE

  45. Private Laboratories • FDA does not have authority to regulate a private laboratory, but has legal authority over regulated import products tested and can based its decision on analysis performed by private laboratory • Good relationship is necessary • FDA has option to audit • Laboratory must be: • Credible • Competent • Uses standards • Uniform • Recognized current methods • Practices quality assurance and quality control activities

  46. Private Laboratories Submission to FDA • Submit the private laboratory complete analytical package to the servicing Laboratory for the Compliance Branch of your local FDA office. • A complete analytical package should include: • Importer’s Certification • Notice of FDA Action Form with Commercial Invoice • Collection and Analysis Reports • Analytical Results Summary Sheet • Private Laboratory Certification • Analytical Worksheet: including method reference, validation of the method, instrumentation and operating parameters, all computer printouts, information on blank/fortification samples, certification of standard purity, quality controls applied and all other information necessary to determine the technical validity of the analysis

  47. Private laboratories • The Private Laboratory Guidance is available through the FDA website: www.fda.gov/ora/science_ref/lm/vol3/section/07.pdf NOTE:While the guidance is written in reference to private laboratory, it is really the importer that is responsible for the entry’s compliance with applicable laws and regulations.

  48. Private laboratories • FDA does not accept results of testing of product not under DWPE for the purpose of speeding entry reviews

  49. Shrimp School Raffle Time

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