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1.
When must Prior Notice be submitted?
Prior Notice must be received and confirmed electronically
by FDA no more than 5 days before arrival and, as
specified by the mode of transportation below, no
fewer than:
1. 2 hours before arrival by land by road
2. 4 hours before arrival by air or by land by rail
3. 8 hours before arrival by water
In addition, Prior Notice must be received and confirmed
electronically by FDA before food is mailed by international
mail. (The parcel must be accompanied by confirmation
of FDA receipt of Prior Notice.).
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2. How must the Prior Notice
be submitted?
Prior Notice must be submitted electronically. FDA
estimates more than 80 percent of Prior Notice of
imported food shipments submissions can be transmitted
through ABI/ACS. Prior Notice for international mail
food shipments, other transaction types that cannot
be made through ABI/ACS, or articles of food that
have been refused admission under section 801(m)(1)
of the Federal Food, Drug, and Cosmetic Act must be
submitted to the FDA PN System Interface (PNSI) at
http://www.access.fda.gov/. Beginning on December
12, 2003, for technical assistance in submitting Prior
Notice:
• For the United States, call 1-800-216-7331
or 301-575-0156
• From all other countries and locations, call
301-575-0156
• Send a fax to 301-210-0247
This technical assistance will be available on business
days from 7 AM until 11 PM U.S. Eastern Time. Requests
for assistance also may be emailed to furls@fda.gov.
For assistance with ABI/ACS transmission, contact
your CBP client representative. Up
3. Who must submit Prior Notice?
Any individual with knowledge of the required information
may submit the Prior Notice, including, but not limited
to, brokers, importers, and U.S. agents.
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4. What food is subject to the requirement
for submitting Prior Notice?
Prior Notice applies to food for humans and other
animals that is imported or offered for import
into the United States. For purposes of the interim
final rule, "food" is defined by reference to
section 201(f) of the Federal Food, Drug, and Cosmetic
Act. Section 201(f) defines "food" as
articles used for food or drink for man or other
animals, chewing gum, and articles used for components
of any such articles.
Examples of "food" include:
• Dietary supplements and dietary ingredients
• Infant formula
• Beverages (including alcoholic beverages and
bottled water)
• Fruits and vegetables
• Fish and seafood
• Dairy products and shell eggs
• Raw agricultural commodities for use as food
or components of food
• Canned and frozen foods
• Bakery goods, snack food, and candy (including
chewing gum)
• Live food animals
• Animal feeds and pet food
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5. What foods are excluded
from the Prior Notice requirement?
Foods that are excluded from the Prior Notice requirement
are:
(1) food carried by or otherwise accompanying an
individual arriving in the United States for that
individual's personal use (i.e., for consumption
by themselves, family, or friends, and not for sale
or other distribution);
(2) food that is exported without leaving the port
of arrival until export;
(3) meat food products, poultry products and egg
products that are subject to the exclusive jurisdiction
of the U.S. Department of Agriculture (USDA) under
the Federal Meat Inspection Act, the Poultry Products
Inspection Act, or the Egg Products Inspection Act;
and
(4) food that was made by an individual in his/her
personal residence and sent by that individual as
a personal gift (i.e., for non-business reasons)
to an individual in the United States.
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6. Will FDA provide confirmation
of receipt of Prior Notice?
Yes. FDA will issue a confirmation of Prior Notice
to the transmitter upon successful receipt of the
Prior Notice information.
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7. What information must be included
in the Prior Notice?
The Prior Notice must be submitted electronically
and contain the following information:
• Identification of the submitter, including
name, telephone and fax numbers, email address,
and firm name and address
• Identification of the transmitter (if different
from the submitter), including name, telephone
and fax numbers, 99email address, and firm name and address
• Entry type and CBP identifier
• The identification of the article of food,
including complete FDA product code, the common
or usual name or market name, the estimated quantity described from the smallest
package size to the largest container, and the lot or code numbers or other
identifier (if applicable)
• The identification of the manufacturer
• The identification of the grower, if known
• The FDA Country of Production
• The identification of the shipper, except
for food imported by international mail
• The country from which the article of food
is shipped or, if the food is imported by international
mail, the anticipated date of mailing and country from which the food is mailed
• The anticipated arrival information (location,
date, and time) or, if the food is imported by
international mail, the U.S. recipient (name and address)
• The identification of the importer, owner,
and ultimate consignee, except for food imported
by international mail or transshipped through the United
States
• The identification of the carrier and mode
of transportation, except for food imported by
international mail
• Planned shipment information, except for food
imported by international mail
To view a sample of the Prior Notice (PN) Form, press
here.
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8. Does the carrier need the Prior
Notice confirmation upon arrival?
It is prudent to have the confirmation. For a
Prior Notice that is submitted through the ABI/ACS
interface, the Prior Notice confirmation number
together with a "PN received" message
will be made available to the filer through the
ABI/ACS interface. If Prior Notice is submitted
through the FDA PN System Interface, then the
transmitter will receive a confirmation online
as soon as the submission is confirmed. To make
it easier for the carrier or individual at the
port, the carrier should have a copy of the confirmation,
which includes a Prior Notice confirmation number
in his/her possession. For international mail
packages, the Prior Notice Confirmation Number
must accompany the package. For food carried by
or otherwise accompanying an individual arriving
in the United States, the Prior Notice Confirmation
Number must accompany the food.
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9. Can an incomplete Prior
Notice be corrected?
Yes. If the transmission fails the validation, it
will be rejected and the transmitter will have an
opportunity to make corrections.
Confirmation means the information has been received
and is facially complete. Subsequent system and manual
review by FDA staff may result in inspection of the
imported food upon arrival.
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10. What must be done if
information changes after Prior Notice confirmation
has been received?
If any of the following required information changes
after confirmation, then a new Prior Notice must be
submitted:
• Identification of the submitter, including
name, telephone and fax numbers, email address,
and firm name and address
• Identification of the transmitter (if different
from the submitter), including name, telephone
and fax numbers, email address, and firm name and address
• Entry type and CBP identifier
• The identification of the article of food,
except the estimated quantity
• The identification of the manufacturer
• The identification of the grower, if known
• The FDA Country of Production
• The identification of the shipper
• The country from which the article of food
is shipped or, for food imported by international
mail, the anticipated date of mailing
• The U.S. recipient (name and address) if the
food is imported by international mail
• The identification of the importer, owner,
and consignee
• The identification of the carrier and mode
of transportation
• Planned shipment information unless the food
will not be imported
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11. Does food that has been
refused for inadequate Prior Notice require any additional
information in Prior Notice?
Yes. The Prior Notice for food that has been refused
for inadequate Prior Notice also must include the
port of arrival, the location where the refused food
is being held, the date it arrived or will arrive
at that location, and the identification of the contact
person at that location.
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12. What are the consequences
of failing to submit adequate Prior Notice information
of an imported food shipment?
Food that is imported or offered for import with
inadequate Prior Notice is subject to refusal
and holding at the port or in secure storage.
FDA will provide its staff with enforcement guidance
containing the Agency's policies on injunctions,
prosecution, and debarment related to failure
to provide timely and accurate Prior Notice, as
well as the Agency's policies regarding refusals
under § 801(m)(1)
and holds under § 801(l). FDA intends to include
a transition period in this guidance, during which
it will emphasize education to achieve compliance.
While FDA will nonetheless be authorized to take
various types of enforcement action for violations
of the Prior Notice requirements, this planned
transition period will allow FDA to focus its resources
on the most appropriate circumstances. FDA also
intends to provide guidance to its staff on enforcing
the Prior Notice requirements after a transition
period. FDA's guidance documents will be available
to the public, and FDA will publish a notice of
availability in the Federal Register.
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13. Will additional comments
be accepted on this interim final regulation?
FDA is providing a 75-day comment period on this
interim final rule. In addition, to ensure that
those commenting on this interim final rule have
had the benefit of FDA's outreach and educational
efforts and have had experience with the systems,
timeframes, and data elements of this interim final
rule, the Agency intends to reopen the comment period
in March 2004 for an additional 30 days. This date
will coincide with the issuance of the plan by FDA
and CBP relating to timeframes. Regularly updated
information on this interim final rule and how to
comment on it can be accessed electronically at http://www.fda.gov/oc/bioterrorism/bioact.html.
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14. How will FDA enforce this interim
final rule during the comment period?
FDA will actively consider the exercise of its discretion
in the enforcement of the Prior Notice interim final
rule while at the same time ensuring public health
protection, both during initial implementation of
the interim final rule and thereafter. The Prior
Notice interim final rule takes effect on December
12, 2003, and covered entities are responsible for
complying with the requirements in the interim final
rule at that time. FDA recognizes that a number
of affected parties still may need assistance understanding
the interim final rule's requirements and how to
comply even after the extensive outreach and educational
activities that FDA will be conducting before December
12th. Accordingly, for this and other reasons, FDA
intends to put into place, during the initial months
following the effective date, a policy that emphasizes
assisting covered entities in understanding the
requirements and how to comply. FDA will shortly
publish a notice of availability for a Compliance
Policy Guide that will outline how FDA generally
intends to exercise its enforcement discretion.
This guidance, however, will not affect FDA's ability
to take actions that may be necessary, including
conducting inspections for food safety and security
concerns or taking any other action under the Federal
Food, Drug, and Cosmetic Act. This policy will also
not affect the ability of the Bureau of Customs
and Border Protection to assess penalties under
19 U.S.C. 1595a(b) or to take enforcement action
under any other authority.
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15.
How will express consignment shipments be affected?
Express
consignment shipments will be impacted as follows:
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Consolidated entries of merchandise subject to the
BTA will no longer be allowed. Separate entries will
be required.
-
CBP is currently working with industry representatives
to determine how Section 321 clearances from the manifest
might be retained under the BTA. Individual manual
checks from the manifest to the Prior Notice (PN)
file in ACS will be extremely inefficient and will
threaten the completion of work during the regular
sort time periods in many ECCF/ECCH operations.
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16.
Is there a De Minimus (minimum) value for merchandise
subject to the BTA?
There
is no De Minimus value for merchandise subject
to BTA, therefore, all shipments regardless of
value, must meet the Prior Notice (PN) requirements
of the BTA. This includes samples, mail, household
goods, gifts and etc. However, there are certain
very limited exemptions for PN requirements described
in question 36 below.
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17.
Do warehouse entries require PN?
Warehouse
entries are not excluded from PN requirements. Any
merchandise for which a warehouse entry has been filed
must have PN properly filed if the merchandise is
subject to the BTA.
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18.
Do warehouse withdrawals require PN?
No
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19.
Is there an impact on in-bond movements of merchandise
subject to the BTA?
Transportation
and Exportation (T&E) and Immediate Transportation
(IT) in-bond movements of merchandise are subject
to the BTA regardless of mode. Immediate Exportation
(IE) movements are exempt from BTA requirements.
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20.
What is required for T&Es?
The
carrier must indicate that the shipment contains ”Merchandise
subject to BTA”. A party involved with the shipment
(e.g. shipper, importer, broker, etc.) must file PN
using either ABI or the FDA Prior Notice System Interface
(PNSI), before the goods arrive. For T&Es, PN
must be satisfied at the port of arrival; however,
registration information is not required.
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21.
What is required for IT in-bond movements of merchandise
subject to the BTA?
If
PN is filed and there is no FDA or CBP hold, the merchandise
will be allowed to move from the port of arrival to
the port of entry. If PN is not filed, movement to
the port of entry will not be allowed.
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22.
Is PN required for merchandise subject to the BTA
that is being admitted to a Foreign-Trade Zone (FTZ)?
Yes.
PN must be met before goods are admitted into an FTZ.
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23.
Does an individual who buys food and brings
it to his or her private residence outside the
United States and then subsequently sends it
as personal gifts to someone in the United States
need a registration number? Is PN required?
For
goods purchased and sent as gifts, either the registration
number with the city and country or the full name
and address of the retailer are required for gifts
purchased commercially and sent to the United States.
PN is required in either instance.
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24. If I bake a cake in my home
(outside of the United States) and ship it as a
gift to an individual in the United States, is registration
and PN required?
No.
So long as the gift is not a commercially purchased
item, and was made in your own home, neither registration
nor PN is required. It does not matter whether
it is shipped by mail or commercially.
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25.
Are alcoholic beverages subject to the BTA?
Yes,
alcoholic beverages are subject to the BTA, and as
such, the production facility must be registered with
FDA and Prior Notification is required for all importations
of alcoholic beverages.
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26.
Is bottled water subject to the BTA?
Yes,
bottled water is subject to the BTA, and as such,
the production facility must be registered with FDA
and Prior Notification (PN) is required for all importations
of bottled water.
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27.
I import various types of canned foods. What do I
need to do to satisfy PN?
First,
each facility that you import your various products
from must be registered with the FDA. Second, each
item that you import that has a different FDA Product
Code Number and/or is from a different supplier requires
a separate PN.
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28.
What do I do with my CBP entry if I have to cancel
my PN submission?
You
must cancel your CBP entry as well.
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29.
Will CBP delete or cancel entries?
CBP
will delete entries only when appropriate. Situations
may arise when neither the FDA nor CBP will require
entry records to be maintained, such as when the covered
merchandise never arrives. CBP will utilize the entry
cancellation procedure when there are concerns with
maintaining historical records and other actions taken
by the agencies.
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30.
Are "Pen and Ink" changes allowed on entries
for BTA merchandise?
Yes,
but only for carrier and bill of lading data that
was transmitted with an entry that has not had a "hold"
placed on it because of CBP concerns over compliance
with the BTA. All other changes will require the original
entry to be cancelled and a new entry filed. This
may also require new PN information depending upon
the nature of the change being made. CBP will track
the workload generated by this requirement and re-examine
the procedure if necessary.
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31.
Are commercial samples exempt from BTA requirements?
No.
Prior Notice must be satisfied.
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32.
What if I sell my goods F.O. B., are they exempt form
PN?
No.
The manner of sale, or terms of sale, (i.e. F.O.B.,
CIF, Landed, Consignment, Duty Paid, etc.) has no
bearing on the BTA requirements.
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33.
If merchandise that is subject to the BTA is loaded
on a truck in either Canada or Mexico, and the truck
takes a ferry to the United States, which time frames
must be met? Eight (8) hours for vessel? Or two (2)
hours for truck?
The
time frames for truck (2 hours) are applicable.
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34.
Land border carriers are not necessarily bonded. Is
that an issue?
It
is only an issue if the merchandise being carried
does not meet PN requirements and the goods must be
moved to a secure facility. Only a carrier with a
Class 2 custodial bond (bonded carrier or cartman)
can move the goods to a secure facility.
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35.
Describe the entry cancellation policy for violations
of the BTA.
If
PN is not satisfied, the entry must be cancelled.
If the goods are exported, the appropriate customs
documentation must be filed. This may entail filing
an Immediate Export (IE) entry.
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36.
In as much as informal entries may not necessarily
be submitted via ABI, what information must
an importer provide with regard to these entries
to show that PN and registration requirements
have been met?
A
paper copy of the PN confirmation form from the FDA
Prior Notice System Interface (PNSI) will be required.
The FDA PNSI is an Internet portal that can be used
to file PN data directly with the FDA. It is scheduled
to be available for public use starting December 12,
2003, and will be accessible via the FDA main website.
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37.
What if the manufacturer of a BTA covered product
refuses to register with the FDA?
Goods
from that manufacturer will be refused admission.
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38.
What will happen on December 12, 2003? Will trade
come to a stand still at our borders?
No. There will be a phased in enforcement of the BTA
preceded by informed compliance.
These questions and answers were provided by the FDA
and CBP.
Register
here to Submit the Prior Notice
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