The US Food and Drug Administration (FDA) is due to issue its Final Rule on its Bioterrorism Act on 12th October 2003 followed by implementation on 12th December 2003. It will have a big impact on any food producer who ships to the United States.
The Act covers all food for human and animal consumption, defined by the FDA as "being imported or offered for import into the United States". The only exclusions are food taken in individual travellers' accompanied baggage for personal consumption and meat, poultry and egg products, which are regulated by the US Department of Agriculture.
UK traders will have to register their facilities with the FDA and file prior notice before any goods will be released for any onward movement from the first (air)port of entry. When you register you must name a US agent. This requirement will apply even if you do not export to the US yourself, e.g. if you sell to another UK supplier who does.
Registrations begin on 12th October 2003 and, although electronic registration will save time, paper registrations are also acceptable. Registration is free.
The penalties for failure to register include delay to the release of the goods, mandatory removal of goods to a secure facility (which must be registered with the FDA and may be off port limits but cannot be a premises owned by the importer), re-export to originating country, civil and criminal action and debarment. Any costs of removal from the (air)port, transport to the secure facility and storage therein will fall to the parties involved in the affected transactions.
Given the penalties for non-registration, if you are in doubt about whether or not to register, it is probably better to do so.
When you ship your products from December 12th you will have to file Prior Notice of each item by US product code. Product codes are quite detailed but do not correspond with HS codes. However, when completing the Prior Notice electronically the system will offer a drop down list of product codes, designed for ease of use.
Again, the penalties outlined above will apply if there is a failure to file Prior Notice on time. Prior Notice may be given up to five days before but the latest time you can file the PN is "noon of the calendar day before the day of arrival". As yet it is not clear how this rule will be affected by different time zones.
Anybody sending food (irrespective of the quantity) by post will need to file prior notice and indicate the reference number on the green customs form at the post office. Failure to do this might result in the parcel being refused entry into the USA and returned to the sender (or in some cases destroyed). Carriers such as DHL and UPS will be subject to similar procedures.
More information can be seen on
www.fda.gov (Link to an external site - Disclaimer 
)
Contact Kathleen Wright or Chris Heslop at the US Embassy on 0207 493 4599.
SITPRO Electronic News Bulletin - 25 September 2003
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