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.

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