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Published:  23 July, 2008

By Larry Walker

The bioterrorism regulations that took effect in mid-December have left both wine (and food) shippers and importers as well as the US Food and Drug Administration (FDA) in a state of confusion. Under the regulations, all producers are required to obtain a registration number from the FDA, then supply that number to a US importer. The importer must then notify the FDA when a shipment of goods is being sent and the expected time of arrival. The intent is that the FDA should be able to trace any food or wine that terrorists may have tampered with in some way. Whether this is a reasonable idea or not is another story. In fact, the FDA has apparently been swamped with registrations - estimated by some as more than 500,000. With only 600 employees to handle the forms and make the inspection, the system quickly hit the wall. Not every shipment, of course, would be inspected, but even spot inspections would be difficult. All agree that the actual online registration was no problem. One importer said it took only about 20 minutes. But what of those producers without access to the Internet or with no knowledge of English? A serious problem for the wine trade concerns negociant houses that might ship dozens of different wines in one lot. Often the wines have changed hands several times since the producer first sold them. Does the negociant-shipper have to obtain registration numbers for each wine from the original producer? That was only one of the still-unanswered questions early in the New Year. There is also a question concerning wines sold on the grey' market. Many US importers buy wines directly from brokers in Europe, rather than the producer, and are able to sell them at a lower price than the producer's official importer. In that case, it is unlikely that the producer will supply the grey-market importer with a registration number. The FDA is apparently not enforcing the regulations at this point, although there has been no formal announcement. Importers have been told that full enforcement will not begin until June or perhaps August. Also, the final version of the regulation has not yet been released. There is hope among importers that the rules will be modified, otherwise there could be major problems for some importers.