Issue 420, October 23, 2003
As a result of the final interim regulation (Registration of Food Facilities) published in the Federal Register relative to the Public Heath Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), all foreign and domestic facilities that manufacture/process, pack, or hold food* for human or animal consumption in the United States are required to register the Food and Drug Administration (FDA prior to December 12, 2003. In the event of a potential or actual bioterrorism incident or an outbreak of food-borne illness, this facility registration information will assist the FDA in determining the location and source of the event and permit the agency to notify quickly facilities that may be impacted.

*Examples of food include:
Dietary supplements and dietary ingredients
Infant formula
Beverages (including alcoholic beverages and bottled water
Fruit and vegetables
Fish and seafood
Dairy products and shell eggs
Raw agricultural commodities for use as food or components of food
Canned and frozen foods
Bakery goods, snack food, and candy (including chewing gum)
Live food animals
Animal feeds and pet food

It is your responsibility to ensure that your facility, and any with whom you do business, is registered prior to the effective date of December 12, 2003. Registration can be accomplished via the internet by seeking www.access.fda.gov/. If you are a foreign entity, you will be required to designate a U.S. domiciled agent (importer or broker) who has a bonafide place of business and be physically present in the U.S. This party will be the first point of communication for FDA in the event of an alert situation.

Failure to register a facility, update details or cancel a registration may result in, at minimum, delays in the clearance of goods entering the U.S. Of greater concern, however, are the potential civil and criminal actions that can be brought about by the Federal government and associated fines and penalties.

Paper submission of the Form 3537 or preparation on CD-Rom is also acceptable, however, there may be delays in processing, therefore, on-line registration is recommended. You will immediately receive a registration number from FDA that should be recorded and maintained in your compliance files.

For more explicit instructions, please review the FDA website.

Our contributing writer, Dan See, is the Technical Advisor for DHL Danzas Air & Ocean in Southfield, Michigan If you have any questions or require further information, please contact Mr. See at 248-263-8812 or daniel.see@dhl.com or 810 987-0567.

Please note that due to the complex nature of the subject matter, DHL Danzas Air & Ocean cannot be responsible for actions taken by the reader in reliance on the information contained herein without prior consultation with DHL Danzas Air & Ocean.