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Food and Drug Administration Response to 



Questions For The Record 



June 23. 1993 Hearing before the 



Bubcommitte on Fisheries Management 



rTimm-it- tee on Merchant Marine and Fisherie 



1. How will the anticipated European Economic Community seafood 

 standards affect the D.S. exporting seafood industry? Hill these 

 standards have any effect on the domestic seafood industry? 



European Community Council Directive 91/493 establishes 

 conditions for fish and fishery products in the EC, either from 

 domestic sources or imports. It requires that both member States 

 and countries that export to member States take measures so that 

 persons responsible for the production of fish and fishery 

 products carry out safety checks based on identifying critical 

 control points, establishing methods for monitoring these 

 critical control points, and keeping written records with a view 

 toward submitting them to a competent authority. These 

 requirements describe, in effect, the system known as Hazard 

 Analysis Critical Control Point, or "HACCF." It is reasonable to 

 expect that the effect on that segment of the U.S. industry that 

 exports to the EC will be the need to operate under a HACCP-based 

 system that is verified by a regulatory authority in the United 

 States acceptable to the EC. As FDA testified at the 

 Subcommittee's hearing, HACCP regulations are being developed by 

 FDA that will satisfy EC requirements. 



2. Do voluntary seafood safety efforts work? 



Under the Federal Food, Drug, and Cosmetic Act, it is illegal for 

 anyone to introduce unsafe food into interstate commerce. A 

 mandatory program that applies to everyone is the only realistic 

 way to enforce this statute. A voluntary system alone would not 

 work. 



As you know, in addition to the mandatory requirements of the law 

 enforced by FDA, NOAA operates a voluntary seafood inspection 

 program under a memorandum of understanding with FDA. The NOAA 

 program has traditionally focused on marketability factors, i.e., 

 quality but, as discussed below, now looks at safety issues as 

 well, and has recently switched in part to a HACCP-based approach 

 that includes critical control points for safety. The NOAA 

 program appears to work for those who volunteer to participate 

 and adhere to the requirements. 



3. Are imported seafoods adequately inspected? 



As our testimony indicates, FDA reviews all U.S. Customs entries 

 and selectively targets lots being offered for entry into the 

 U.S. for physical examination and for laboratory analysis. FDA 

 also places on automatic detention products that may be offered 



