Docket Management
Docket: 02D-0402 - Guidance: "Regulatory Procedures Manual, Chapter 9, Subchapter, 'Import for Export'"
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. Robert Collette Date/Time 2003-01-08 17:39:38
Organization National Fisheries Institute
Category Food Industry

Comments for FDA General
1. General Comments Dear Sir or Madam: The National Fisheries Institute (NFI) appreciates the opportunity to comment on the new Regulatory Procedures Manual, Chapter 9, Subchapter, Guidance Concerning Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned. The NFI has grave doubts concerning the legality of the draft guidance in this proposed subchapter and believes FDA should withdraw it. The National Fisheries Institute is the largest trade association for the seafood industry. Its members are involved in all aspects of the seafood industry, including the processing, distributing and importing and exporting of seafood products. NFI is also a member of the National Coalition of Food Importing Associations, which has submitted separate comments concerning this draft guidance on behalf of its member associations. NFI supports the NCFIA's comments and wishes to include them in our comments by reference. The NCFIA comments provide extensive analysis of the proposed guidance in the context of the existing statutory authorities. In addition to the serious legal questions raised, NFI is concerned that the proposed guidance would indiscriminately penalize all importers instead of targeting those who are engaged in a pattern of importing adulterated food. This is an important distinction and one that is recognized in the debarment provisions of the recently enacted Bioterrorism and Preparedness Act of 2002. The severe economic consequences associated with destruction of food, based only on the appearance of a food safety violation, have not been adequately addressed by the agency. In addition to the costs attributed to value of the destroyed goods, economic costs for importers will rise in other ways such as increased insurance premiums. Moreover, this provision could cause significant shifts in the market price and supply, if suppliers in other countries elect to avoid the U.S. market or raise prices to cover increased risks associated with product destruction. For the reasons stated in the NCFIA comment letter and those discussed above, NFI is opposed to the draft guidance and urges FDA withdraw it. Thank you for your consideration of this request. Sincerely, Robert L. Collette V.P. of Science and Technology

EC -1