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ordination among the Federal agencies and promoting the develop- 

 ment of aquaculture and the regulation of aqua culture practices. 



Mr. Coble. Thank you. I have no further questions, Mr. Chair- 

 man. 



Mr. M ANTON. The Chair will recognize the gentlewoman from 

 Washington. 



Mrs. Unsoeld. Thank you very much, Mr. Chairman. My pur- 

 pose in putting this legislation together is to protect the industry 

 by protecting the public's confidence in shellfish, and one of my 

 principal goals is to establish a level regulatory playing field that 

 is going to allow the domestic industry to compete with foreign im- 

 ports. 



Mr. Billy, do you agree that foreign products should have to 

 comply with a regulatory program that requires equivalent stand- 

 ards of compliance? 



Mr. Billy. Yes, I do. 



Mrs. Unsoeld. All right. How can foreign governments be re- 

 quired to meet those water quality monitoring and classification 

 standards, and does FDA have the statutory authority? Two years 

 ago when the issue came up you all said you didn't have the au- 

 thority, and so I would like to explore that. 



Mr. Billy. OK. Our current approach to working with importers 

 and foreign countries that ship molluscan shellfish to us is through 

 seeking voluntary cooperative agreements with the countries. We 

 have nine such agreements, six of which are active 



Mrs. Unsoeld. I am sorry, what — you have nine? 



Mr. Billy. Nine such agreements. 



Mrs. Unsoeld. Are you referring to MOUs? 



Mr. Billy. MOUs, that is right. These are voluntary. We seek 

 them with countries that ship products to us. We are not satisfied 

 with that approach, and so as we have considered the application 

 of HACCP to the seafood area. We believe that relevant to your 

 first question that the same kinds of requirements that are applied 

 to the domestic industry, including the molluscan shellfish indus- 

 try should also be applied to imported molluscan shellfish products. 



Mrs. Unsoeld. Currently those MOUs, as you indicate, are volun- 

 tary. You don't have them with all countries? 



Mr. Billy. That is correct. 



Mrs. Unsoeld. And when you do have them, the ones I have 

 seen, the one I have in front of me says that — it only requires that 

 the government with whom you have the MOU can ensure that 

 that country's program can do certain things, not that they do it, 

 so how would you contemplate through regulatory means to actual- 

 ly have enforcement with some teeth in it to protect our American 

 shellfish industry from shellfish coming in that have come from 

 bad water? 



Mr. Billy. You have to step back and look at the principles of 

 HACCP. Under a HACCP-type system a responsible business is re- 

 quired to identify all of the potential hazards and then more impor- 

 tantly identify the controls that are in place to address those haz- 

 ards. In the case of molluscan shellfish, this would apply not only 

 to what happens during the processing period but also the waters 

 from which those shellfish were harvested, so in a HACCP-type 

 system the importer, and through the importer the foreign proces- 



