New FDA Food Shipping Regulations

Dear International Export Manager,

As your global transportation and related services provider, GLOBEX would like to review some important developments as mandated in the U.S. Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act or BTA) for certain food imports into the United States. We are presenting these changes which become effective December 12, 2003 for informational purposes only.

Because these developments may have an impact on shipments entering or transiting through the United States, GLOBEX strongly recommends that you review the summary information below to determine if these changes apply to your business.

New U.S. Food and Drug Administration (FDA) regulations require more information in order for certain food shipments to clear the Bureau of Customs and Border Protection (CBP) and the FDA. In order to avoid delays in shipment clearance and delivery, as well as other potential charges and/or penalties, you may be required to take important steps to comply with these new regulations.

There are two major regulations mandated under the BTA coming into force on December 12, 2003. They are:

1. Registration of Food Facilities
2. Prior Notice of Imported Food Shipments

1. Registration of Food Facilities

U.S. domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in the regulation, for human or animal consumption in the U.S. must register with the FDA by December 12, 2003.

Why Register?
Food facility registration is required to assist the FDA in determining the location and source of a potential bioterrorism incident or an outbreak of food-borne illness and enable the quick notification of facilities that may be affected.

If you are a food exporter to the United States, you will probably be required to register with the FDA, unless you qualify for an exemption from registration under the FDA regulations. Individuals or companies can complete the FDA Registration process online 24 hours a day, 7 days a week, from any location in the world by going to www.access.fda.gov. Upon completion, the FDA sends you immediate confirmation and your Registration Number. There is no cost to register your facility.

One of the requirements of the food facility registration process is for you to identify a United States agent that will act as a communications link between your foreign food facility and the FDA. By separate agreement GLOBEX may serve as your U.S. agent. If you would like further information regarding this service please contact GLOBEX

2. Prior Notice of Imported Food Shipments
As of December 12, 2003, the FDA must be electronically notified in advance of any shipments of food for human or animal consumption that are imported into, or transiting the U.S., unless the food is excluded from Prior Notice. Exclusion criteria can be found at the FDA web site www.access.fda.gov. Successful completion of the prior notification process will result in a Prior Notice confirmation number being issued by the FDA.

Prior Notice of imported food must be filed and confirmed by the FDA two to eight hours before arrival (the port where the food first arrives in the United States), depending on the mode of transport.

Why Prior Notice?
Prior Notice of imported food shipments will give the FDA time to review and evaluate information before a food product arrives in the U.S., help the FDA better deploy resources to conduct inspections and improve the process to intercept contaminated products.

Prior Notice Options

Exporter Submission
You may be able to submit Prior Notice and receive a Prior Notice confirmation number via the FDA "Prior Notice System Interface", (available on the FDA web site, www.access.fda.gov, as of December 12, 2003). In order to do so you will be required to submit a number of data elements. A listing of the required information is available on the FDA web site (referenced above) in the Prior Notice fact sheet.
If you are able to obtain and provide the Prior Notice confirmation number at the time of shipping, there will be no additional fees from GLOBEX due to these new regulations.

GLOBEX Submission

GLOBEX can submit Prior Notice to the FDA and receive the Prior Notice confirmation number on your behalf for your GLOBEX U.S. and Worldwide shipments. Prior to December 12, 2003 food shipments requiring FDA clearance were already assessed a $20 USD fee for filing. In the future, GLOBEX submission of Prior Notice for these shipments will be included in this same $20 USD fee.

The new regulations now apply to many more food shipments that did not previously require FDA filing or Prior Notice. GLOBEX can submit Prior Notice for these shipments on your behalf if none is provided. A $20 USD for this service will apply.

Shipping and Documentation Procedures
For assistance with GLOBEX shipment preparation and export documentation procedures please contact GLOBEX.

Exporter Compliance is Critical
If you are required to register with the FDA you must do so prior to shipping as of December 12, 2003.

Applicable food shipments received on or after December 12, 2003 that are not compliant with these new regulations are subject to possible delays, including return of the shipment, or delivery by CBP into general order merchandise. At the port of origin, GLOBEX may refuse incomplete documented shipments. In the United States, imported food articles from a foreign food facility may be held at the port of arrival until registration is complete. Moreover, civil or criminal sanctions may result from failure to comply with the FDA Registration and Prior Notice regulations.

This letter is for informational purposes only. It does not constitute legal advice and should not be used as such. For further information on any aspect of the new FDA regulations, including information on whether you may be exempt from the Registration requirements, you should access the FDA website at www.access.fda.gov.