Questions or Comments ( Now or later )

1. 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

2. At SST Today: FDA’s Effort to Improve Compliance and Controls for Scombroid Toxin

3. Good Aquaculture Practices Preventative Measures Farms Source Control

4. CDC Illness Data 1990-1995 1990-1995 CDC Scombroid cases by number of peopleaffected Restaurant-368 Private home-82 Workplace-16 other-98

5. 1996-2006 Numbers of Scombroid Illness/ FDA

6. The REAL number of scombroid toxin illnesses could be much Higher….maybe 10 times HIGHER

7. 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

8. SEAFOOD HACCP COMPLIANCE AS A FACTOR OF NAI, VAI, AND OAI RATES 2002-2005

9. Seafood HACCP Compliance • Several product categories substantially lower compliance • Control of Scombrotoxin forming species a leading category.

10. Receiving Documents for Primary Processors I hope the tuna was good off the boat! • Harvest Boat Questionnaire • Crew Interview Record • Letters of Compliance from • Fishermen • Suppliers Guarantee for Tuna • Harvester Records

11. HHS/FDA - Goal Public health promotion and protection. Including food-borne illness and food safety An Agency Goal - 2008

12. We Developed Seafood HACCP Goal: • To improve compliance with of scombrotoxin controls • Through information gathered • Implemented in a variety of ways

13. 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.

14. 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.

15. 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!

16. Scombroid Control Interviews Summary Types of Fishery Longline, seine, rod and reel, gill net, midwater trawler boats (mackerel)

17. Oregon Tuna Fishing Boat

18. Scombroid Control Interviews Summary Number of Interviews Fisherman: 14 Processors: 8 Fisherman/Processors: 2

19. Scombroid Control Interviews Summary Types of Fish • Yellowfin tuna, Yellowtail tuna, Albacore Tuna, Bluefin Tuna • Spanish mackerel • Mahi

20. 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;

21. 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

22. 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

23. 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.

24. 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.

25. Yes, FDA wants to Learn from Fishermen and Processors

26. 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!

27. The End Brett.Koonse@fda.hhs.gov