FDA Advisory Program Update by EPADocs


									 U.S. Food & Drug Administration

        Donald W. Kraemer
          Acting Director
         Office of Seafood
            Food Safety by Design
   1995 FDA Published “Seafood HACCP
   Effective 1997
   Requires processors to:
        Assess potential food safety hazards to determine
        if they are “reasonably likely to occur”
       Develop and implement a HACCP plan to control
        those hazards
           Seafood Safety Hazards
   Natural toxins
       Histamine formation in tuna, mahi mahi, and
       Paralytic shellfish poisoning (saxitoxin) and
        Amnesic shellfish poisoning (domoic acid) in
        colder temperate zone oysters, clams, and mussels
       Neurotoxic shellfish poisoning (brevetoxin) in
        warmer temperate zone and subtropical oysters,
        clams and mussels
       Ciguatera toxin in subtropical and tropical
        barracuda, grouper and snapper
           Seafood Safety Hazards
   Parasites in many species of near-shore fish
    consumed raw
   Drug residues
       Chloramphenicol in aquacultured shrimp and
       Fluoroquinolones in aquacultured basa (catfish)
       Malachite Green in salmon
   Unapproved use of food and color additives
       Unlabeled sulfites in warm water shrimp
          Seafood Safety Hazards
   Microbiological contamination
       Vibrio vulnificus and Vibrio parahaemolyticus in
        Gulf Coast oysters
       Listeria monocytogenes in smoked and pickled fish
       Norovirus, Hepatitis A virus, and Vibrio cholerae
        in oysters, clams and mussels
       Clostridium botulinum toxin in vacuum packaged
       Staphylococcus aureus toxin in stuffed seafood
       Salmonella in many seafood products
           Seafood Safety Hazards
   Allergens
       Unlabeled milk, eggs, peanuts in seafood products
   Physical hazards
       Metal fragments in breaded fish
       Glass fragments in packaged fishery products
   Environmental chemicals and pesticides
       Industrial chemicals, pesticides and toxic elements
        in near-shore fish
       Methyl mercury in shark, swordfish, king
        mackerel, tilefish, albacore tuna
          Chemical Contaminants
   Total Diet Study
       Tuna, Salmon, Pollack, Shrimp, Catfish
       Radionuclides, Pesticides, PCBs, VOCs, Toxic
        and Nutritional Elementals, Folic Acid
   Chemical Contaminants Field Assignments
       Pesticide program
       Toxic elements program
       Dioxin program
       Perchlorate Assignment
       Mercury assignments
        FY’05 Pesticide Program
   175 domestic, 300 import samples
   Pesticides and PCBs
   Domestic: locally caught, commercial, non-
    migratory, bottom feeders
   Import: salmon from Canada and Norway,
    aquacultured catfish, crayfish, tilapia, Nile
    perch, basa, shellfish and crustaceans
    FY’05 Toxic Elements Program
   10 domestic, 160 import samples
   Lead, cadmium, arsenic, mercury
   Fresh or frozen striped bass, salmon, flounder,
    herring, sardine, cod, bluefish, halibut, Alaska
    pollack, crab, oyster, squid, scallop, American
          FY’05 Dioxin Program
   520 domestic and import samples, 85 feed samples
   Dioxins and Dioxin-like PCBs
   Domestic: aquacultured catfish, striped bass, tilapia,
   Import: salmon, bluefish, flounder, halibut, sole,
    striped bass, wild salmon, scallop, shrimp, clam,
    oyster, crab, mussel, lobster, Alaska pollack, cod,
    sardines, swordfish, ocean perch, tuna, haddock ,
    crayfish, mackerel, croaker, sablefish, orange roughy,
    shark, weakfish, pogy
    FY’05 Perchlorate Assignment
   35 domestic and import samples
   Perchlorate
   Aquacultured catfish and salmon, wild-caught
    salmon and shrimp
     FY’05 Mercury Assignments
   Domestic and import
   470 samples fresh/frozen fish – 29 species
   100 fresh/frozen tuna, 50 samples canned tuna
   Total mercury
     Methyl Mercury Risk-Benefit
   Project by FDA with contribution from International
    Food Safety Consulting LLC
   Working on new approach for managing and
    communicating risks associated with methyl mercury
   May impact on risk management and communication
    for other hazards
   Risk/benefit analysis
       Risk to U.S. consumers of methyl mercury in seafood
       Nutritional benefits from consuming seafood

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