1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

2. Aquaculture: A Need for Import Tolerances Kim R. Young Deputy Director, Division of Compliance Center for Veterinary Medicine US Food & Drug Administration

3. Presentation Overview of global aquaculture production Countries which export aquaculture products to the United States FDA’s concern of global veterinary drugs used in aquaculture

4. Aquaculture Definition: “the farming of aquatic organisms, including fish, mollusks, crustaceans, and aquatic plants. Farming implies some form of intervention in the rearing process to enhance production, such as regular stocking, feeding, protection from predators, etc. … “

5. Global Aquaculture Production 32.9 million tonnes (1999) Increasing at 9.2% per year One in 4 finfish from aquaculture One in 3 shrimp from aquaculture Over 50% of food fish will come from aquaculture in 2007

6. World Fisheries Production* * Wild Caught excludes non-human food production (e.g., fishmeal and oil) Aquaculture excludes plant production (e.g., kelp) Source: FAO

7. Asia and Aquaculture Asia produces around 90% of global volume (mainly carps) Equivalent to around 82% of value 87.1% by developing countries 76.8% from Low-Income Food Deficit Countries with per capita income below US$ 1,465.

8. Global Aquaculture Production by Principal Producers, 1998 RankProducerProduction (millions tonnes) % of Global production 1China27.0768.7 2India2.035.1 3Japan1.293.3 4Philippines0.952.4 5Indonesia0.812.1 6South Korea0.802.0 Source: FAO

9. Global Aquaculture Production by Principal Producers, 1998 RankProducerProduction (millions tonnes) % of Global production 7Bangladesh0.581.5 8Thailand0.571.4 9Vietnam0.541.4 10North Korea0.481.2 11USA0.451.1 12Norway0.411.0 Source: FAO

10. U.S. Seafood Consumption Per capital consumption 15.6 lbs. (2000) –Approx. 5 lbs aquaculture (32 %) Approx. 3.8 lbs imported aquaculture (24 %) Source: NFI

11. U.S. Top Ten Consumption List Lbs./person 1Tuna3.60 2Shrimp3.20 3Alaska Pollock1.69 4Salmon1.60 5Catfish1.23 6Cod0.77 7Clams0.49 8Crabs0.46 9Flatfish0.43 10Scallops0.28 Source: NFI

12. Major Aquaculture Products Exported to the U.S. Salmon Shrimp Mollusks –Scallops –Mussels –Oysters –Clams Tilapia Trout Striped Bass Frogs Catfish Crayfish

13. Countries Exporting Aquaculture Food Products to the U.S. ArgentinaAustraliaAustria BangladeshBrazilBurma CanadaChileChina, P.R. Costa RicaDenmarkDominican Rep. EcuadorEl SalvadorFaroe Islands FinlandFranceGermany GreeceGuatemalaGuyana HondurasHong KongIceland IndiaIndonesiaIreland IsraelItalyJamaica JapanKorea, RepublicMalaysia

14. Countries Exporting Aquaculture Food Products to the U.S. (Continued) MexicoNetherlandsNew Zealand NicaraguaNigeriaNorway OmanPakistanPanama PeruPhilippinesPoland Saudi ArabiaSingaporeSolomon Island South AfricaSpainSri Lanka SwedenSwitzerlandTaiwan TajikistanThailandTogo Trinidad & TobagoUnited KingdomUruguay VenezuelaVietnam

15. Aquaculture Species Currently Not Exported to the U.S. Amberjack Cod Flounder Halibut Red Sea Bream Sweetfish Carp Eel Grouper Mackerel Sea Perch Yellowtail

16. Examples of Drugs in Use in Foreign Aquaculture AcriflavineChloramphenicolFlumenquine AmoxicillinColistin SulfateFosfomycin AmpicillinDoxycyclineFruluphenicol BenzocaineErythromycinFuranace BicozamycinFlorfenicolFurazolidone

17. Examples of Drugs in Use in Foreign Aquaculture (Continued) JosamycinMethylene BlueOxolinic acid KanaymcinMicroxisacinOxytetracyline KitasamycinNalidixic acidNifurstyrenate LincomycinNitrofurantoinSpiramycin Malachite GreenNovobiocinSulfonamides Methyldihydro- testosterone OleandomycinThiamphenicol

18. Drugs Approved in US Aquaculture Chorionic gonadotropin Formalin solution Tricaine methanesulfonate (MS-222) Oxytetracycline Sulfamerazine Sufadimethoxine/ormetoprim combination

19. Aquaculture Safety Seafood HACCP –List Hazards Unapproved Veterinary Drugs –List Critical Control Points –List Critical Limits –List Monitoring Procedures –List Corrective Actions –List Verification Procedures –Provide for Recordkeeping System

20. Aquaculture Safety - Enforcement - Inspections –Foreign Inspections of Processors and Producers –Review of HACCP plan at the importer –Drug testing Import Alerts –Inadequate HACCP plan/implementation –Drug residues

21. Aquaculture Safety - Enforcement - (Continued) Current drug testing –Chloramphenicol in Shrimp –Flumequine in Catfish & Shrimp –Malachite Green in Catfish –Piromidic Acid in Shrimp –Oxolinic Acid in Catfish, Salmon & Shrimp –Oxytetracycline in Shrimp

22. Database for Drugs and Chemicals used in Foreign Aquaculture Objectives: –create a database containing information on drug and chemical use in foreign aquaculture, and –perform a human food safety risk assessment for each drug and chemical listed in the database.

23. Database for Drugs and Chemicals used in Foreign Aquaculture (Continued) FDA will use the results of this project to: –prioritize the monitoring of drugs and chemicals residues in the edible tissue of imported aquaculture products, –prioritize the development of methods to be used in the monitoring program, –provide a basis for promoting discussion with foreign countries regarding the hazard concerns identified by the risk assessment.

24. How to Encourage Import Tolerance Applications? Use Risk Assessments to Develop and Implement Risk Management=Residue Monitoring Program –Develop Residue Methods for High Priority Residues –Efficiently Direct Monitoring of Imports for Residues of Concern –Put Import Alerts in Effect for Countries where Monitoring Shows Residues are Not Controlled –Publicize Monitoring Results

25. Summary FDA regulates both drugs for aquaculture & inspection for aquaculture food products HACCP on Imports and Foreign Inspection Equivalency Discussions Show Wide Disparity in Drugs Permitted to be Used Potentially hundreds of Import Tolerances are needed for aquaculture species, alone