Worldwide Customs & Regulatory Updates
December 12, 2003
UNITED STATES: New U.S. Food Imports Rules
As a part of The Bioterrorism Act 2002, The U.S. Food and Drug Administration (FDA) recently announced interim final rules that require registration of domestic and foreign food facilities and prior electronic notice of food imports. The new provisions will take effect December 12, 2003. FedEx strongly encourages you to review the new rules below and take the necessary actions, as failure to comply will result in shipments being delayed or possibly refused entry into the U.S.
Definition of Food in the Boiterrorism Act of 2002
- Articles used for food or drink for consumption by humans or animals
- Chewing gum
- Articles used for components of any such article
- All food as defined by FDA, "being imported or offered for import into the United States"
- Food stored or distributed in the U.S.
- Gifts, trade, and quality assurance/control samples
- Transshipments through the U.S. to another country
- Food imported for future export
- Food admitted into a U.S. Foreign Trade Zone (FTZ)
- Personal use food accompanying a traveler
- Food immediately exported, without leaving the port of arrival
- Meat, poultry, and egg products - exclusively regulated by the U.S. Department of Agriculture
- Homemade goods sent as a gift to an individual
- Food contact substances (e.g. packaging material, jars, containers & pesticides) which do not qualify under FDA's definition of "food"
Facility Registration
U.S. Food Facilities
- Owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack or hold good for human or animal consumption in the U.S. are required to register whether or not food from the facility enters interstates commerce.
- Owners, operators, or agents in charge may choose to authorize an individual or a customs broker to register on behalf of the facility.
- The requirement applies to each covered facility, not to firms or companies as a whole, e.g. a company with 10 facilities must register each one separately.
- Registration is one time, not annual. However, changes to facility registration data must be updated with the FDA within 60 days.
- Foreign food facilities that manufacture, process, pack or hold food are required to have a U.S. agent to register with FDA. It can be any person that resides or maintains a place of business in the U.S. and is physically present in the U.S. The designated U.S. agent acts as a communications liaison between FDA and the facility for both routine and emergency communications.
- If a foreign food facility that manufactures, processes, packs or holds food sends it to another foreign food facility for further manufacturing, processing or packing before the food is exported to the U.S., only the last foreign facility is required to register, except if the subsequent facility is conducting de minimis activities such as labeling. In such cases, both facilities must register.
- FedEx's customs and trade services division in the U.S., FedEx Trade Networks, can help you with the registration for a fee. Please visit FedEx Trade Networks FDA site at fda.ftn.fedex.com or call our U.S. hotline on 1.716.879.1075 for more information on the service.
- The following entities are exempted from the registration requirement:
- Private residences of individuals
- Non-bottled water and drinking water collection & distribution establishments
- Transport vehicles that hold food only in the usual course of their business as carriers
- Farms
- Restaurants
- Retail food establishments
- Non-profit food establishments
- Fishing vessels
- Facilities regulated exclusively by USDA
- Electronic registration is encouraged and will be available worldwide, 24 hours a day, 7 days a week. To access FDA's online form click here.
- Paper registration is also accepted if Internet access is not readily available. Please note that it's a much slower process, and you need to ensure that form is complete and legible.
- FedEx's customs and trade services division in the U.S., FedEx Trade Networks, can help you register your facilities for a fee. For more information on the service, please visit FedEx Trade Networks FDA site at fda.ftn.fedex.com or call our U.S. hotline on 1.716.879.1075.
- The following instructions and forms are available for download from FDA website. The completed PDF form may be printed and mailed to the U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857, or faxed to 1.301.210.0247.
Prior Notice
- A set of required data elements on food imports must be filed electronically with the FDA before shipment arrival, using either the Automated Broker Interface or the FDA website at http://www.cfsan.fda.gov/~pn/pnoview.html.
- If you are shipping food articles to the U.S., you must provide the required Prior Notice data for each shipment. Affected food articles shipping to the U.S. without this information are subject to service delay and possible refusal by the FDA.
- The specific timeframe for Prior Notice submission is determined by mode of transportation.
- 2 hours before arrival by land by road
- 4 hours before arrival by air or by land by rail
- 8 hours before arrival by water
- A new Prior Notice must be submitted if changes are made after Prior Notice confirmation has been received. When changes are submitted, the clock for Prior Notice submission will be reset.
- The following information is required for Prior Notice:
- Submitter details (name of individual, individual's phone number, name and address of submitting firm)
- Transmitter, if different than submitter
- Entry type
- CBP entry identifier
- The identity of the article of food as follows: The complete FDA product code; common or usual name or market name; estimated quantity described from the largest container to the smallest package size; and the lot or code numbers or other identifier of the food
- Manufacturer (for food no longer in its natural state). This includes the name, address and registration number
- Grower, if known
- FDA country of production
- Shipper (including name, address and registration number)
- The country from which the article is shipped
- Anticipated arrival information (port of arrival and crossing location within that port, date and time)
- Name and address of the importer, owner, and ultimate consignee
- Mode of transportation
- Carrier's Standard Carrier Abbreviation Code (SCAC) or International Air Transport Association Code (IATA)
- Planned shipment information including the 6-digit Harmonized Tariff System (HTS) code
- Mark "FS" in the commodity description on the air waybill, commercial invoice and the package.
- Mark down the Facility Registration number and the Prior Notice confirmation number you got from FDA on the air waybill and commercial invoice.
FedEx will continue to monitor the status of the new provisions and take the necessary steps to keep you informed. We strongly encourage you to regularly visit our site or call our local FedEx Customer Service Hotline for more details of the regulations and future updates.