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Due
to the events of September 11, 2001, the US Congress adopted what
is called in abbreviated terms, the “Bioterrorism Act”
2002, and ancillary regulations. They impose, inter alia, the obligation
on legal entities and individuals, domestic and foreign, that manufacture,
process, pack or hold “food” for human or animal consumption
in the USA, to register with the US Food and Drug Administration
(“FDA”), no later than December 12, 2003. A particular,
detailed form must be completed and filed for that purpose.
On that form, the manufacturer, processor, packer
or holder must designate a US agent. For various reasons a US sales
agent, distributor, dealer or customer of the manufacturer, processor,
etc. is not the appropriate party to be the designated US agent.
A more appropriate designee would be an American lawyer familiar
with entire process.
Also, the Act requires that pre-notification be given
to US Customs of each intended shipment of "food" coming
into the USA (as that term is explained herein), beginning on or
about December 12, 2003 and must, beginning very shortly before
that same date, notify the FDA in advance of each intended import
shipment. Again this must be done on a particular detailed form.
It is intended to give the FDA time to review and evaluate the data
before the food arrives and to allocate its resources as it deems
necessary to inspect particular shipments. The
purpose is to intercept contaminated or tampered food products and
thereby to help guarantee the introduction in the US market of safe
food products.
The above legal entities and individuals, domestic and foreign,
as well as transporters of “food”, are also obligated
to create and maintain detailed and comprehensive records of the
transactions and other pertinent data. Non-compliance or faulty
compliance with the above obligations is a “prohibited act”
subjecting the infringer to potentially severe possible penalties.
The U.S. Government can initiate a civil or criminal action in a
U.S. federal court to enjoin the illegal behaviour. That form may
be prepared and filed by the US importer, distributor or agent of
the "food" manufacturer, processor, packer or holder,
or the manufacturer, processor or packer itself.
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What
Food is subject to this legislation?
The
definition of “food” for purposes of the Act and
its regulations is the one contained in the U.S. Food, Drug
& Cosmetics Act. It includes food and beverages for human
and animal consumption. Food
transported in an individual’s personal luggage entering
the US and intended for personal use, meat products, poultry
and eggs that are under the exclusive control of the US
Department of Agriculture at the time of importation, are
exempted from the above obligations. All other types of “food”
are subject to this legislation and rules, whether or not intended
for final consumption in the USA.
Prior Notification Requirements On Food Shipments
As
stated, importers and purchasers of “food” that
will enter the USA are obligated to prepare and file with the
FDA a detailed, special form before any such shipment enters
the USA.
Foreign parties who are manufacturers, processors, packers,
etc. of “food” should, to protect their interests,
monitor their importers, distributors and dealers and customers
to assure, to the extent possible, their proper and timely compliance
with the Act and its regulations.
Consequences
of failure to submit or submitting a tardy or faulty Prior Notification
In addition to the
possible consequences mentioned above, food shipments concerned
can be denied entry into the USA. They may be detained at the
port of entry or sequestered in a special safe facility, with
the costs of transport and warehousing being born by the importer
or purchaser.
Food transported in an individual’s personal luggage entering
the US and intended for personal use, meat products, poultry and
eggs that are under the exclusive control of the US Department
of Agriculture at the time of importation, are exempted from the
above obligations. All other types of “food” are subject
to this legislation and rules, whether or not intended for final
consumption in the USA.
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