FDA - Food Import Information Filing Regulations Interim Final Rule
October 31, 2003
Acronyms:
FDA = Food and Drug Administration
USDA = United States Department of Agriculture
CBP = Customs and Border Protection
ABI = Automated Broker Interface
ACS = Automated Commercial Systems
FROB = Foreign Remaining On Board (Vessel)
T & E = Transportation Entry
Link to the FDA's website regarding Import Rules and Regulations:
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ImportsExports/default.htm
There are two sets of regulations:
- The first deals with the prior notice filing of advance food shipment information.
- The second deals with the registration of food facilities with the FDA.
I) Prior Notice Filing of Imported Food
- Food Shipments Covered: The regulations' definition of "food" which is covered by these
regulations is all food and beverages for human or animal consumption,
except meat food products, poultry food products or egg
products regulated exclusively by the USDA. Meat and poultry products regulated
by USDA include all raw beef, pork, lamb, chicken and turkey, as well as processed meat
and poultry products, including hams, sausage, soups, stews, pizza and frozen dinners.
Egg products regulated by USDA include dried, frozen or liquid eggs
with or without added ingredients.
All food products not otherwise exempted, which are imported into the U.S., are covered by the
regulations.
All such products moving in transit through the U.S. for Canadian, Mexican or other foreign
destination also are covered by the Rule. (T&E bonds will cover those.)
Food shipments exempt from Rule:
- FROB cargo and relay
cargo moving on an IE bond are not covered as they are not
considered "imported" into the U.S. These food shipments are
off-loaded at a U.S. port and then directly re-exported from that U.S.
port of arrival without ever leaving the port.
- Food for an individual's personal use when it accompanies an individual arriving in
the United States for consumption by themselves, family and friends, not
for sale or other distribution.
- Food made by an individual in a personal residence sent by that individual as a personal
gift for non-business reasons.
- Meat, poultry or eggs
subject to exclusive jurisdiction of the U. S. Department of Agriculture
(USDA)
- Information Filing Requirements:
Who Must File Prior Notice?
The regulations do not require a specific person to file, but require that each such
shipment have a prior notice filing. FDA regulations provide that any person with knowledge
of the required information can submit the filing. Such parties would include but are not
limited to the exporter, the importer, the shipper's broker or agent.
When must the filing be made?
The time periods are specific to each mode of transportation:
- Truck- at least 2 hours before arriving at the port of arrival
- Air and Rail – at least 4 hours before arriving at the port of arrival
- Water- at least 8 hours before arriving at the port of arrival
- Mail shipments- before the articles are mailed
Where is the Information to be filed?
The information is to be filed through CBP's Automated Broker Interface of the
Automated Commercial System (ABI/ACS). Filing is to be conducted by shippers or brokers.
The alternative system for filing is the FDA PN System Interface.
Information Accuracy:
The party submitting the information is responsible for the information's
accuracy.
What Information Must Be Filed?
(All information must be in English except names and street names)
- Identification of the submitter, including name, telephone and fax numbers, email address,
and firm name and address
- Identification of the transmitter (if different from the submitter), including name,
telephone and fax numbers, email address, and firm name and address
- Entry type and CBP identifier
- The identification of the article of food, including complete FDA product code,
the common or usual name or market name, the estimated
quantity described from the smallest package size to the largest container,
and the lot or code numbers or other identifier (if applicable)
- The identification of the manufacturer
- The identification of the grower, if known
- The FDA Country of Production
- The identification of the shipper, except for food imported by international mail
- The country from which the article of food is shipped or, if the food is
imported by international mail, the anticipated date of mailing and country
from which the food is mailed
- The anticipated arrival information (location, date, and time) or, if the food
is imported by international mail, the U.S. recipient (name and address)
- The identification of the importer, owner, and ultimate consignee, except for
food imported by international mail or transshipped through the United States
- The identification of the carrier and mode of transportation, except for food
imported by international mail
- Planned shipment information, except for food imported by international mail
When Must Updates or Changes be Filed?
Amendments are no longer permitted. If required information-except quantity, anticipated
arrival information including the anticipated date of mailing, and planned shipment
information – changes after FDA has confirmed the prior notice for review, the prior
notice should be cancelled and a prior notice with the correct information must be submitted.
- Consequences for Not Filing or for Inadequate Filings
Failure to submit the required prior notice is a prohibited act subject to civil and
criminal penalties.
Food arriving at the port of arrival without adequate prior notice is subject to
refusal of admission. Refused food is considered "general order" merchandise.
Refused food must be moved under an appropriate custodial bond, and may
not be entered or delivered to any importer, owner or ultimate consignee. Prior
notice must be submitted or corrected and resubmitted to FDA and confirmed by
FDA for review.
Refused food may be exported under CBP's supervision, unless the food has been
detained or seized under other authority.
All charges resulting from refusal will be borne by the cargo owner/ representative.
IE: additional transportation costs, storage, etc.
The consequences are the same for imports from unregistered facilities where
registration is required.
II) Registration of Food Facilities (Docket No. 02N-0276)
- Facilities Requiring Registration: These regulations require a "domestic or foreign
facility … engaged in the manufacturing/processing, packing or holding of food
for consumption in the United States" to register the facility with the FDA.
Any facility that actually manufactures, processes, or packs food must register.
Also, any facility that actually holds food must register, such as a warehouse, cold storage
facility, or a grain elevator. The Supplementary Information accompanying the rule makes it clear that
this could include foreign port facilities "such as warehouses or storage and
inspection facilities belonging to private companies".
- Facility Registration Methods
FDA prefers electronic registration since it will be a quicker process.
Mailing or fax is also acceptable, however, may take longer to process.
