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for import that have a violative history or are found to be a 

 serious health hazard. This status requires the importer to 

 produce evidence that the shipment conforms to the requirements 

 of U.S. law. Moreover, most States automatically reject 

 Bolluscan shellfish imports unless they are from dealers 

 certified under the safety criteria of the National Shellfish 

 Sanitation Program, which FDA administers. These safeguards 

 notwithstanding, FDA believes that the overall system can be 

 improved through more memoranda of understanding with countries 

 that trade with the U.S. and the application of HACCP principles 

 to imports. FDA is pursuing both objectives. 



4. Should Federal seafood safety programs be consolidated into a 

 single Agency? Which Agency and why? 



The safety of seafood in interstate commerce is the sole 

 regulatory responsibility of the Food and Drug Administration. 

 Consolidation in that sense is not necessary. NOAA's voluntary 

 inspection program provides services toward the promotion of 

 sales of U.S. products for those in the industry that wish to 

 purchase NOAA's services. While it contributes to safety, it is 

 not a regulatory program. Only recently has NOAA initiated 

 adjustments to its program to directly address safety issues in 

 products. Consequently, FDA believes that it is reasonable and 

 appropriate for these two programs to be operated by different 

 agencies so long as they are linked by memoranda of understanding 

 and have good day-to-day working relationships, as is the case 

 now. Other Agencies, such as the Environmental Protection Agency 

 and the Fish and Wildlife Service, have programs that contribute 

 to seafood safety, but these programs involve environmental and 

 other issues beyond the normal scope of FDA's mission and are 

 thus appropriately located where they are. The Department of 

 Agriculture assists the expansion of the aquaculture industry 

 through its promotional efforts. 



5. Are discretionary state warnings to high-risk groups (e.g., 

 those with liver diseases, gastrointestinal disorders, and AIDS) 

 adequate to ensure safe consumption of seafood? 



This question refers to the risk of infection from Vibrio 

 bacteria in certain high-risk groups from the consumption of raw 

 or undercooked molluscan shellfish. Certain individuals who are 

 medically compromised risk serious illness and even death if they 

 consume these foods, although the likelihood that they will 

 become ill is not great. 



Vibrio vulnificus is the most virulent of the Vibrio bacteria. 

 Fatalities are primarily linked to this particular Vibrio . There 

 have been anywhere from approximately 12 to 26 cases of illness 

 from v^ vulnificus reported annually in the United States, 

 although the number appears to have gone up slightly in the past 

 year or two. At least one-third of reported illnesses have 



