RULE: 2.26 - FDA PRIOR NOTICE Eff:
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A. Prior Notice and Registration Requirements: Pursuant to
regulations effective December 12, 2003 (see 21 CFR Parts 1 and
20), the FDA must be provided with notice of food that is imported
or offered for import into the United States (i.e., the continental
U.S., Alaska, Hawaii and Puerto Rico) by water at least eight (8)
hours prior to vessel arrival. The term "food" means:
(i) articles used for food or drink for man or other animals;
(ii) chewing gum; and
(iii) and articles used for components of food or chewing gum
(see 21 U.S.C. Sec. 321(f).
However, the term does not include meat products, poultry
products, and eggs products that are subject to the exclusive
jurisdiction of the U.S. Department of Agriculture. In addition
to prior notice of food shipments, the new FDA regulations
require that U.S. and foreign facilities which are engaged in
the manufacturing, processing, packing, or holding of food for
consumption in the United States ("subject facilities") register
with the FDA.
B. Responsibility for Prior Notice and Registration: It shall be the
responsibility of the shipper and/or consignee named in Carrier's
bill of lading (hereinafter collectively referred to as the "Cargo
Interests"), to ensure that prior notice of any shipment of food
(as that term is defined in Paragraph A) imported or offered for
import into the U.S. is provided to the FDA in accordance with
applicable regulations and that any subject facility (other than
a subject facility of Carrier) which has manufactured, processed,
packed or held such food shipment has registered with the FDA in
accordance with applicable regulations.
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 agencies 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 or the failure of a subject facility to
register with the FDA, it is expected that notice of refusal
will be provided to Carrier by the FDA and/or CBP. Carrier
will use best efforts to promptly transmit the notice
received from the authorities 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 provide adequate
prior notice or the failure of a subject facility (other than
a subject facility of Carrier) to register 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, and fines and penalties. 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
indemnification, Carrier shall be entitled to recover all
costs (including attorneys' fees) incurred in connection
with such legal action. For purposes of this paragraph, the
indemnification provided to Carrier shall also extend to
its agents, affiliates, contractors, employees, vessel-sharing
partners, slot charterers, vessel owners, and insurers.
