RULE: 2.61 - FDA REGULATION OF FOOD IMPORTS Eff: 17NOV2008
| Effective | 17NOV2008 |
|---|---|
| Filed | 01NOV2007 |
| Filing Codes | IC |
Prior Notice to and Registration with the U.S. Food and
Drug Administration ("FDA")
a. Prior Notice and Registration Requirements:
Pursuant to United States regulations ("regulations")
effective December 12, 2003 (see 21 C.F.R. Part 1,
Subparts H and I), the FDA must be provided with prior
notice of the arrival of certain food (unless such food
is subject to an exception under the regulations) that
will be imported or offered for import into the United
States (i.e., the continental U.S., Alaska, Hawaii and
the Commonwealth of Puerto Rico). For certain food
shipments arriving by water (unless such food shipment
is subject to an exception under the regulations), the
prior notice of arrival must be provided to the FDA at
least eight (8) hours prior to vessel arrival in the
United States port of entry. In addition to requiring
prior notice of the arrival of certain food shipments
(unless an exception applies under the regulations), the
regulations also require that the owner, operator, or
agent-in-charge of a certain food facility in the United
States or a foreign country (unless such food facility
qualifies for an exception under the regulations), which
facility is engaged in the manufacturing/processing,
packing, or holding of food for consumption in the
United States, register such facility with the FDA
("subject food facility").
b. Responsibility for Prior Notice and Registration:
It shall not be the responsibility of the Carrier to
submit or transmit prior notice to the FDA of the
arrival of food shipments requiring such prior notice
under the regulations. Instead, it shall be the
responsibility of the party with knowledge of the
required information to be submitted or transmitted to
the FDA for such food shipments (e.g., the consignor,
shipper, consignee, or other person, including any
corporation, company or other legal entity owning or
entitled to possession of the food shipment) (hereinafter
referred collectively referred to as the "Cargo
Interests"). Furthermore, unless the Carrier is the
owner, operator, or agent-in charge of a subject food
facility required to register with the FDA under the
regulations, it shall not be the responsibility of the
Carrier to register such subject food facility. Instead,
it shall be the responsibility of the owner, operator,
or agent-in charge of the subject United States or
foreign food facility to register such facility with the
FDA.
c. Evidence of Compliance:
With respect to any food shipment for which a prior
notice confirmation number ("PN Number") is required to
be provided to the Bureau of Customs and Border
Protection ("CBP"), FDA, or any other government agency
upon arrival, it shall be the responsibility of Cargo
Interests to ensure that such PN Number has been
provided to the required agency(ies) and other persons
prior to vessel arrival. In addition, Cargo Interests
shall be required to provide Carrier with the PN Number
immediately upon written request of Carrier.
d. Failure to Comply:
1. In the event that any food shipment is delayed or
refused entry into the United States due to the failure
to provide adequate prior notice of arrival or the
failure of a subject food facility to register properly
with the FDA, it is expected that notice of refusal
will be provided to Carrier by the FDA and/or CBP.
Carrier will use commercially reasonable efforts to
promptly transmit the notice received from the FDA
and/or CBP to the Cargo Interests, who shall be
responsible for transmitting such notice to any other
persons with an interest in the cargo. Carrier shall
not be liable for any delay in the transmission of, or
failure to transmit, such notice or any consequences
thereof.
2. In the event that any food shipment is delayed or
refused entry into the United States due to the failure
to comply with the regulations (e.g., failure to provide
adequate prior notice of arrival or the failure of a
subject food facility, other than a subject food
facility of Carrier, to register properly with the FDA),
or if it is determined that cargo which should have
been refused entry has been permitted to enter the
United States, then the Cargo Interests shall be
jointly and severally liable to indemnify, hold
harmless, and reimburse Carrier (and by booking a
shipment with Carrier do thereby agree to indemnify,
hold harmless and reimburse Carrier) for any and all
costs, expenses, liabilities, damages, or losses
incurred by the Carrier as a result of such
non-compliance including, but not limited to, costs of
complying with orders and directions of FDA and/or CBP,
costs for handling and storing cargo, demurrage,
subsequent transport of the cargo by any mode of
transportation, fines, penalties and other sanctions.
Carrier shall have a lien on cargo in its possession
for amounts due hereunder and may hold cargo until such
amounts (and any other unpaid freights or charges) are
paid or sell such cargo after a reasonable period. In
the event Carrier is forced to take legal action to
collect amounts due hereunder, or to defend any action
resulting from actions or events covered by this
indemnity and hold harmless obligation, Carrier shall
be entitled to recover all costs (including attorneys'
fees) incurred in connection with such legal action.
For purposes of this paragraph, the indemnity and hold
harmless obligation provided to Carrier shall also
extend to its successors, assigns, agents, affiliates,
contractors, employees, vessel-sharing partners, slot
charterers, vessel owners, and insurers.
