103 



In its policy statement FDA called bootlegging "a practice that 

 probably leads to most shellfish illnesses." 



The second problem is that the current program is designed to protect 

 against illnesses associated with pollution from human sewage. But 

 perhaps the greatest health risks curently are from highly-toxic, 

 naturally-occurring organisms, unrelated to pollution, such as 

 Paralytic Shellfish Poisoning or PSP, Domoic Acid, and Vibrio 

 Vulnificus. 



For instance, PSP is prevalent on the West Coast during the summer 

 months. Fortunately, there are effective monitoring controls for PSP. 

 Even though many growing areas on the West Coast are shut down 

 completely during the summer, we recognize that the closures are in 

 the best interest of the industry because they insure the safety of 

 our products. 



The Gulf Coast states and FDA are faced with a similar problem in 

 Vibrio Vulnificus, a warm-water organism which can be highly toxic to 

 certain high risk individuals. The difference is that no effective 

 monitoring method or risk standard has been established for 

 Vulnificus. We are all aware of the unfortunate deaths that have been 

 associated with Vulnificus through the consumption of shellfish from 

 the Gulf of Mexico. While these fatalities have had a disastrous 

 effect on the shellfish industry in the Gulf states, the other 

 shellfish producing regions of the country have suffered as well from 

 the publicity and subsequent erosion of consumer confidence in the 

 safety of all shellfish. 



