FDA IssuesFood

Food Facility Registration Mandatory With The U.S. FDA

posted by Customs & International Trade Law Blog September 18, 2010 0 comments

On December 12, 2003, the U.S. Food and Drug Administration (FDA) implemented the Bioterrorism Act of 2002.  That Act basically required that companies shipping food to the United States must first be registered with the FDA, and that importers of food must provide "prior notice" to the FDA of any particular shipment before it physically arrives in the United States.  Over the past 7 years, has the Bioterrorism Act lived up to its expectations to protect the American consumer from eating dangerously contaminated food?

In an article entitled "Scrap the Bioterrorism Act" published in February 2004, I criticized the Act as not going far enough because it did not require (1) FDA Inspectors to be located in foreign countries sending us food,  (2) cooperation with foreign food inspection governmental authorities, and (3) mandatory recall authority to the FDA for contaminated foods.  In a May 6, 2010 report by the U.S. Government Accountability Office (GAO) entitled "Food Safety:  FDA Could Strengthen Oversight of Imported Food," it came to exactly the same conclusions. 

As stated in the GAO report:

The FDA physically examines approximately 1 percent of imported food.

Imported fish and other seafood is of particular interest to the FDA.  Obviously, FDA Inspectors cannot physically inspect every shipment of imported seafood, but every shipment that contains FDA-regulated products that enters the United States is electronically reviewed by the FDA  to determine if the shipment should be physically examined or a sample laboratory tested.   Hence, the prior notice information enables FDA, working closely with U.S. Customs and Border Protection, to more effectively target inspections at the border to ensure the safety of imported foods before the food enters the commerce of the United States.

Registration of food facilities that manufacture, process, pack, or hold food is suppose to help provide FDA with information on the origin and distribution of food.  The objective is that the registration will aid in the detection and quick response to actual or potential threats to the U.S. food supply, usually by microbiological contamination such as listeria.

If  an importer is attempting to import food from a foreign facility which has not been registered with the FDA, the food will be held at the port of arrival until the registration violation is corrected.  Registration by the foreign food producer and shipper may be easily accomplished, in multiple languages, at www.FDA-USA.com.  

My conclusion is that the FDA is doing a much better job at protecting the international food supply chain, but it needs the U.S. Congress to now pass the Food Safety bill, pending there for over a year, to really do an effective job. Coincidentally, the Sunday New York Times front page article "Senate Bill on Food Safety is Stalled," makes the same argument.

You may also like

Leave a Comment