FDA on Oct. 10, 2003
issued interim final regulations implementing the section of the
Bioterrorism Act that requires importers of food for humans or
animals for consumption in the United States to notify FDA in
advance of the shipment’s arrival. The “prior-notice”
regulations took effect on Dec. 12, 2003.
The prior notice requirement applies
to importers of agricultural commodities intended for use in humans
or animals in the United States.
Among those that are exempt from
the recordkeeping requirements are:
- Agricultural commodities that
are exported without leaving the port of arrival until export.
For instance, prior notice is not required for grain imported
from Canada directly to a U.S. export facility for subsequent
export to a third-country that is not the United States.
- Meat, poultry and egg products
that are subject to exclusive regulatory jurisdiction of the
U.S. Department of Agriculture under the Federal Meat Inspection
Act, Poultry Products Inspection Act, or the Egg Products Inspection
Act.
What’s
Required
Prior Notice is to be submitted electronically,
either through the Automated Broker Interface/Automated Commercial
System (ABI/ACS) of the U.S. Department of Homeland Security’s
Customs and Border Protection (CBP), or through FDA’s Prior
Notice System Interface at http://www.accessfda.gov.
The information required is similar
to what importers previously were required to submit to CBP before
the FDA regulations were issued. Such information includes:
- identification of the person submitting
the information or the person transmitting the information;
- entry type and CBP identifier;
- identification of the type of
food and an estimate of the quantity to be imported;
- identification of the manufacturer
or, if known, grower;
- country of production;
- shipper, unless the product is
being imported by mail;
- identification of the importer,
owners and ultimate consignee (except for food being transshipped
through the United States );
- identification of the carrier;
and
- planned shipment information.
Prior notice is required to occur no more than five days before
arrival, and by no later than:
- two hours before arrival if by
land by truck;
- four hours before arrival if
by air or land by rail; and
- eight hours before arrival if
by vessel.
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