123 



historically been from bacterial entry into the body in wounds. 

 The fatalities reported annually have ranged from approximately 5 

 to 12; again, however, this number appears to have increased 

 somewhat recently. FDA believes that these reported numbers 

 should be doubled to compensate for underreporting. Illness from 

 \L. vulnificus is not on the list of reportable diseases in all 

 States. 



FDA has concluded that high-risk individuals should avoid 

 molluscan shellfish that are not adequately cooked. FDA has 

 engaged in an education campaign targeted toward these 

 individuals. The Agency has also provided technical assistance 

 to the Interstate Shellfish Sanitation Conference in the 

 development of a discretionary point-of-purchase information 

 message and has encouraged the use of such a message. Whether 

 this message, or any such point-of-purchase message, can affect 

 high-risk consumer behavior in a positive way is not yet known, 

 but FDA believes that it is a reasonable approach. For the past 

 few years FDA has also been considering the merits of a 

 nationally mandated point-of-purchase message and is continuing 

 to do so. 



6. As of 1991, only 1,200 processors of the 4,000 processors (or 

 l/4th) nationwide had participated in the HACCP instructional 

 workshops. How has the seafood industry responded to the 

 voluntary HACCP program? Do you anticipate greater industry 

 involvement even if the HACCP inspection plan is not mandated? 



FDA defers to NOAA on the response to this question because it 

 refers to the operation of voluntary programs only. 



7. Are there overlaps and redundancies among the various Federal 

 Agency programs dealing with seafood safety that could be 

 consolidated? 



The appropriateness of such a consolidation is not clear. As 

 stated earlier, for example, FDA's program is regulatory while 

 NOAA's program is primarily service oriented. These 

 complementary approaches both serve a useful purpose but should 

 probably be operated by separate Agencies. It is true that FDA 

 and NOAA both engage in safety-related research, but the Agencies 

 work to avoid overlap and redundancy through a mechanism 

 established by a memorandum of understanding between the 

 Agencies. 



8. When the seafood inspection rule is published, does FDA 

 foresee the need for additional legislation granting the Agency 

 greater regulatory authority; for example, the power to restrict 

 fishing in certain waters? 



The question of additional authority is, for the most part, 

 unconnected to the proposed seafood inspection rule. FDA already 



