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					Questions or Comments
    (Now or later)
      Brett Koonse

         U.S. FDA
 Center for Food Safety and
      Applied Nutrition
     College Park, MD

       301.436.1415

Brett.Koonse@fda.hhs.gov
   At SST Today: FDA’s Effort to Improve
Compliance and Controls for Scombroid Toxin
Good Aquaculture Practices
Preventative Measures Farms
      Source Control
 CDC Illness Data 1990-1995


1990-1995 CDC Scombroid cases by
           number of people affected


                                       Restaurant-368
                                       Private home-82
                                       Workplace-16
                                       other-98
     1996-2006 Numbers of
     Scombroid Illness/ FDA
70
60
50
40
30
20
10
0
     1996

            1997

                   2001

                          2002

                                 2003

                                        2004

                                               2005

                                                      2006
The REAL number of scombroid toxin illnesses
could be much Higher….maybe 10 times HIGHER
       Seafood HACCP Compliance:
   Since Seafood HACCP
     regulation, 12/97,
     FDA collecting data on
     implementation
    Early on, industry steadily
    improved.
    However, in past
    4 years, has plateaued
    Overall compliance is still very good
     SEAFOOD HACCP COMPLIANCE
AS A FACTOR OF NAI, VAI, AND OAI RATES
              2002-2005

 60

 50

 40                                  2002
                                     2003
 30
                                     2004
 20                                  2005

 10

  0
       NAI        VAI        OAI
     Seafood HACCP Compliance
 Severalproduct categories
 substantially lower compliance

 Controlof Scombrotoxin
 forming species a leading
 category.
Receiving Documents for
                                I hope the tuna
Primary Processors              was good off
                                the boat!
•Harvest Boat Questionnaire
•Crew Interview Record
•Letters of Compliance from
Fishermen
•Suppliers Guarantee for Tuna
•Harvester Records
         An Agency Goal - 2008

 HHS/FDA     - Goal
 Public health
  promotion and
  protection.
 Including food-borne
   illness and food
  safety
      We Developed Seafood HACCP
                 Goal:

 To    improve compliance with
    of scombrotoxin controls

 Through   information gathered

   Implemented in a variety of
    ways
To develop a Plan to improve compliance with
scombrotoxin controls we need Information:

Conduct interviews with fisherman and processors
about:

•What works, what doesn’t
•Suggested controls
•Help or training needs

Then, perhaps do focus groups
for more detail comments
and suggestions to improve
compliance.
   Implementation of Seafood HACCP
   Compliance/Performance Goal Plan:
Use information gained to develop a program to address
causes of non-compliance
 may include:
 Working   with others; key
 technical assistance
 training
 enforcement activities
 Likely will vary by region,
 Flexible, tailored to specific
  problem areas.
Scombroid Control Interviews; Very
Preliminary Summary
              Locations:

 Northeast U.S.
 Florida Keys
 Oregon
 Indonesia
 Hawaii ?


Thanks to Sea Grant Folks in
Oregon and FL Keys and NMFS
In the NE area!
     Scombroid Control Interviews
             Summary
            Types of Fishery

Longline, seine, rod and reel, gill net, midwater
 trawler boats (mackerel)
Oregon Tuna Fishing Boat
 Scombroid Control Interviews
         Summary
           Number of Interviews

Fisherman: 14
Processors: 8
Fisherman/Processors: 2
     Scombroid Control Interviews
             Summary
           Types of Fish

 Yellowfintuna, Yellowtail tuna,
  Albacore Tuna, Bluefin Tuna
 Spanish mackerel
 Mahi
          Scombroid Control Interviews
                  Summary
                Short Fishery Details:

   RSW, Ice, Freezer
   Day boats, 3-10 days, up to 30 days out fishing
   Indonesia uses mother boats
   Some will catch one blue fin a day, others hundreds
   Some eviscerate some don’t; some “bleed out”
   Water temp for tuna generally between 58-64 F
   Air temp wide range depending on location;
      Scombroid Control Interviews Very
           Preliminary Summary
                 General Control Comments:
   Only two fishermen said they kept records
   And then only one said took temp of fish on boat and holding
    temperatures
   Most processors say they take the information from the fishermen
    for the records
   Two processors said they require the fishermen to hand them
    records
   Rest said the fishermen would not listen to them
   Not much difference between what fishermen/processors said
    Scombroid Control Interviews Summary
                General Control Comments:

   Think fishermen should be taking care of fish not doing records
   Very common; no control over sports or recreation boats, they are
    the problem….along with the “foreign” product
   Processors know the fish, don’t need records
   Problem is at retail
   Cooling rates are not right; can’t cool down a large tuna to under
    40F in 24 hrs.
   Don’t think there are illnesses or problems
   Some fishermen did say their fish quality was reduced when they
    just didn’t bring enough ice
          Scombroid Control Interviews
                  Summary
                 General Control Comments:

   Before HACCP there was never a problem. Used to ship the fish out
    within 24 hours. Now you have to check the temp and it has to be chilled
    to 40 degrees before it can be shipped. That means that it now has got be
    held for a couple of days to chill it down.

   One processors said he and others “gundecks” it, meaning they just
    make up the records.

    Gundecking it is an old naval expression about falsifying records. The
    deck below the upper deck on British sailing ships-of-war was called the
    gundeck although it carried no guns. This false deck may have been
    constructed to deceive enemies as to the amount of armament carried,
    thus the gundeck was a falsification.
      Scombroid Control Interviews Very
           Preliminary Summary
                 General Control Comments:
   FDA More concerned about getting ya than getting safe products.
   The FDA guys are poorly trained from a pragmatic standpoint and
    are taught by the book. Not making decisions on their on during
    reasonable situations.
   No consistency in FDA inspections
   Reoccurring comment: More focus should be at the dock or boats
    not processors. I have never seen an inspector at the dock.
   A tuna processor told a story about one time he received a fish from
    LA with high temp, rejected it right away. But because it was from
    a broker, they took the fish back. His point was what happened to
    that fish and who checks that. He said they normally send it to a
    freezer company and goes somewhere else.
Yes, FDA wants to Learn from Fishermen and Processors
             Conclusion
 History of Scombroid Illness in U.S.
 History of non-compliance with vessel records and
  monitoring
 HHS/FDA Goal to improve food safety
 Included in that is decrease Scombroid Illness
  outbreaks
 Want to Learn from industry where and what we
  need to focus on
 Variety of local ways to implement change
 Collaborate on addressing the Issue!
      The End

Brett.Koonse@fda.hhs.gov

				
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