About registering producers without authorization:

The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form. By submitting this form to FDA, or by authorizing an individual to submit this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate. An individual (other than the owner, operator or agent in charge of the facility) who submits the form to the FDA also certifies that the above information submitted is true and accurate and that he/she is authorized to submit the registration on the facility's behalf. An individual authorized by the owner, operator, or agent in charge must below identify by name the individual who authorized submission of the registration. Under 18 U.S.C 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.
 
New FDA Rules Threaten America's Fine Wine Market
 
On December 12, 2003, the Food and Drug Administration imposed tough new reporting requirements on importers of foods and beverages. These new “Prior Notice” rules were in response to The Bioterrorism Act of 2002, which directed the FDA, in conjunction with U.S. Customs, to create a system for tracing contaminated food products. The system requires all importers to report shipments prior to arrival, providing detailed information on each product in the shipment, including the FDA registration number of the facility where the product was produced. As a further condition of the system, FDA cannot disclose registration numbers; they are the property of the producer and can only be given out by them.

When FDA developed these rules, it assumed that foods and beverages are ordinarily imported into the United States by a person with a direct relationship with the producer. They assumed that access to FDA registration numbers would be automatic. However, a large percentage of America’s fine wine imports are purchased on the open market—from restaurants, private collectors, auctions or merchants. For these wines, access to FDA registration numbers will be far from automatic. Not only do the purchasers (small importers and private collectors) not have direct access to producers’ registration numbers, many producers are displaying an unwillingness to give them out. In fact, there is strong evidence that a number of large American wine importers are putting pressure on the producers they represent to not give out these numbers, securing for them a monopoly in the U.S. market.

Consequences of the new laws are far-reaching and potentially devastating for consumers, producers and merchants. Each year an estimated $200,000,000 of the world’s scarcest and most sought-after wines will be denied access to the American market. Producers’ designated importers will have a virtual monopoly and a free hand to raise prices. Many of the small importers and wholesalers who breathe diversity into the American wine market could be forced to close. With them out of the way, an oligopoly of large wholesalers, who have quietly been buying up small distributors in many states, will become an even more dominant and oppressive force in the American wine market. If retailers or consumers are unhappy with their prices, or how wines are shipped and stored, there will be no alternatives.

The market for older vintages will be particularly hard hit. It will become virtually impossible for merchants, restaurants, auction houses and private collectors to obtain older wines from Europe. Even private collectors, buying wines at auction in Europe, will be unable to get their purchases home.

The implications for the world market are no less rosy. The ability of American importers to buy wine on the open market in Europe has long performed an important balancing function internationally, correcting poor producer allocations and assuring that virtually all wines eventually find a home. Without the ability of the U.S. market to pick up the slack, producers will be faced with falling prices and diminished prestige in Europe, as gluts emerge in under-performing markets. And without a market for older vintages, producers of collectible wines will sell much less wine overall.

But none of this has to be. FDA can perform its important anti-terrorism function, complying fully with its Bioterrorism Act mandate, by allowing importers to supply a complete name and address for producers in lieu of registration numbers. In the event of product contamination, the agency will be no less able to track down the source of the problem. And America’s fine wine market will be saved from sure devastation.

 
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