Worldwide Customs & Regulatory Updates


January 25, 2005



UNITED STATES: Updated 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.

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.

Phase V full enforcement of the FDA Prior Notice (PN) regulations for imported food began on November 8, 2004, as confirmed by Customs and Border Protection (CBP) operational guidelines and memo to the trade issued on November 5, 2004. Full enforcement is understood to be compliance with all provisions of the PN regulations, including timely submission of Prior Notice, i.e. not later than 4 hours prior to aircraft arrival at the first US port of arrival. Increased CBP enforcement actions to confirm PN at the first port of arrival creates the possibility that some food shipments may be delayed and even refused entry if PN is not properly submitted in accordance with the FDA regulations.


Definition of Food in the Bioterrorism 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

Affected Food Commodities

  • All food items must be non-perishable.
  • 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 - to or from a business
  • Samples to be used for quality assurance, tradeshows and testing purposes
  • Transshipments through multiple U.S. ports
  • Food imported for future export
  • Food admitted into a U.S. Foreign Trade Zone (FTZ)

Excluded Food Commodities

  • 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 made in personal residence, sent by that individual as a personal gift, for non- business reasons
  • Food contact substances (e.g. packaging material, jars, containers & pesticides) which do not qualify under FDA's definition of "food"
  • Individual to individual for non-commercial/non-business purposes

FedEx will continue to monitor the status of the new provisions and periodically update this site. We strongly encourage you to regularly visit the site to stay informed with the future updates.


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

  • 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.

Exemption
The following entities are exempted from the registration requirement:

  • Private residences of individuals
  • Non-bottled water and drinking water collection & distribution establishments
  • Transport vehicles and transport facilities 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

Registration Method

FedEx will continue to monitor the status of the new provisions and periodically update this site. We strongly encourage you to regularly visit the site to stay informed with the future updates.


Prior Notice
A set of required data elements on food imports must be filed electronically with the FDA before shipment arrival. Any individual with knowledge of the required information, including but not limited to brokers, importers and US agents, may submit prior notice. To avoid delays and penalties, you must provide the Prior Notice confirmation record and the PN confirmation number/PN envelope number when tendering food shipments to FedEx. Shippers are to submit PN directly to the FDA to minimize delays for all food shipments entering or transiting the US. We would like to inform you that FedEx can not pick up the shipments if the PN confirmation has not been obtained. You can directly visit to www.access.fda.gov in order to apply for PN Confirmation.


Required Submission Timeframe
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

Information Change after Submission
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.


Required Data Elements
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

In preparing a food related shipment to the U.S., please be advised to do the following to facilitate us in handling and processing your shipment.

  • 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.
  • Indicate the PN confirmation number or PN envelope number on the description field of the AWB. The number must be written as "PNC# ____________" or "PNE# ____________".
  • Indicate the AWB number on the PN confirmation record.
  • Attach a copy of the PN confirmation record in the shipment documentations.

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.