Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -33

Accepted - Volume 2

Comment Record
Commentor Mr. JOEL FRIEDMAN Date/Time 2002-08-31 00:10:22
Organization MIKAWAYA
Category Food Industry

Comments for FDA General
1. General Comments DOCKET No. 02N-0278 The second issue I would like to comment on is the issue of non registered manufacturer's items being held at the port. My understanding of the act says that there will be a need to send a pre-arrival notification of all shipments coming to the United States. I believe that it also says there will be some type of electronic database. Based on this information, I would like to suggest that the rules be something along the lines of: 1. Prior to the shipment leaving the country of export the notice of shipment be sent to the FDA electronically (possibly on a predetermined form). That the information contained on the form, be able to be electronically bounced against the FDA database. If all the manufacturers are in the database, then electronically, the FDA database would send the shipping person a notice that it was in compliance and could proceed to ship the merchandise. Alternatively, if one or more of the manufacturers were not registered, the FDA would also send an electronic notice that those manufacturers were not registered. This would give not only the shipper but also the customer a chance to have those items excluded from the shipment so when it arrives in the United States it will not be held at the port. This would also help the FDA and the port in that it would speed up the process of getting the merchandise to the customer and out of the FDA as well as the ports hands. I have personally seen whole containers held for weeks waiting for clearance because one or two items for some reason have to be checked or tested. For small business people this can be devastating from a financial standpoint. My suggestion hopefully would eliminate one more reason to hold shipments while complying with the newly proposed regulations and the spirit of the law.

EC -33