October
27, 2003
On
Friday, October 10, 2003, the Food & Drug Administration published
new rules that require foreign and domestic food processors, manufacturers,
and packers to register with the FDA. "Part
I" is a discussion of the Food Facilities Registration
Rule.
A
second, companion regulation requires all importers of food products
to provide the FDA with advance notification prior to each importation.
[Click here for
a copy of the FDA
Prior Notice (PN) Rule.] "Part II"
is a discussion of the FDA PN Requirements.
For
imports, facility registration numbers will be required on commercial
documentation as part of the PN requirements. Affected goods
will not be admitted unless valid facility registration numbers
are provided. Food products for which a PN has been submitted
will receive a PN confirmation number. Customs entries without
the PN confirmation number will be refused admission.
Both
the registration and PN regulations go into effect on December
12, 2003. In order to comply with the registration requirements,
food facilities need to begin submitting registrations to the
FDA for approval prior to December 12, 2003, to ensure that imports
are not detained by Customs for lack of registration information.
PART
I: Food Facilities Registration Rule
I.
Background
On
May 22, 2002, Congress passed the "Public Health Security
and Bioterrorism Preparedness and Response Act of 2002,"
also known as the Bioterrorism Act (BTA). President Bush then
signed the bill into law on June 12, 2002.
Title
III of the Act is designed to protect the United States against
terrorism implemented through the food supply, so that, in the
event of an outbreak of food-borne illness, the source and cause
of the illness may be rapidly discovered.
II.
Who Must Register?
Owners,
operators and/or agents in control of foreign and domestic facilities
that manufacture, process, pack, or hold food for human
or animal consumption must register their facilities.
It
will likely fall on importers to advise their foreign manufacturers,
processors, and packers regarding these registration requirements
and to ensure that registration numbers are on invoice documents.
Importers may wish to convey to foreign facilities that beginning
on Tuesday October 28, 2003, the U.S. FDA will be holding an explanatory
satellite broadcast (with world-wide playback coverage).
The
term "food" includes: fruits, vegetables, fish, dairy
products, eggs, raw agricultural commodities for use as food or
as components of food, animal feed, pet food, feed ingredients,
food and feed additives, dietary supplements and dietary ingredients,
infant formula, beverages, live food animals, bakery goods, snack
foods, candy, and canned foods.
The
terms "manufacturing, processing, packing, packaging and
holding" are each defined in §1.227 of the interim final
regulations, as follows:
-
"Manufacturing
and processing" are essentially any operation that synthesizes,
prepares, modifies or manipulates food.
-
"Packaging" means "placing food
into a container that directly contacts the food that the consumer
receives."
-
"Packing" means "placing food into a container
other than packaging the food."
-
"Holding"
involves "storage of food," including warehousing.
Foreign
facilities that process, pack or hold food that is exported for
consumption in the U.S. are required to register unless the food
undergoes "further processing or packing" at another
foreign facility prior to export to the U.S.
III. Warehouse
Operators, Traders, Brokers and Carriers
Because
carriers, forwarders, warehouse operators and brokers are all
involved with facilitation of the delivery food, there are instances
when such members of the trade community become subject to the
registration requirements.
The
FDA states that any broker, warehouse operator, or trader who
takes possession of food will be required to register if such
person is the "owner, operator, or agent in charge of
a facility that manufactures/processes, packs or holds food
for consumption in the U.S."
VI.
Appointment Of U.S. Agents For Foreign Facilities
Foreign
food facilities are required to appoint a U.S. agent. A U.S.
agent can be an individual, corporation, partnership or association
who must (1) live or maintain a place of business in the U.S.,
and (2) be physically present in the U.S. for purposes of registration.
The
U.S. agent will generally serve as a conduit for normal and routine
communications (transmitting information clarification requests
and notices) and as a contact for emergency communications, unless
another alternative emergency contact person is indicated pursuant
to §1.233(e). For this reason, the FDA asks that contact information
be provided such that the U.S. agent is accessible 24 hours a
day, 7 days per week.
VII.
How To Register With The FDA
Registration
has opened as of October 16, 2003. Registration instructions
have been made available in three languages: English, French
and Spanish. Submissions, however, must be in English.
Each
facility must be separately registered, and information
must include the name, address and all trade names used by the
facility. For locations with several separate buildings, the
FDA recommends registration of each building unless the real estate
property-line demonstrates that the several buildings are on the
same lot and are, therefore, a single facility.
Once
registration is completed, the FDA will provide the registrant
with a receipt and assign a unique registration number to the
registered facility.
VIII. On-Line
Registration
FDA's
preferred method of registration is online.
This system provides secure (128-bit encrypted) access to allow
the facility to establish an enterprise (master) account. Multiple
sub-accounts may be created to allow multiple sub-users to input
data. Generally, the master account allows access to all information
input by the sub-accounts; however, there is an option to stipulate
that the master account is not to have access to sub-account information.
The
accounts also feature access controls consisting of (1) an account
ID, (2) a password and (3) a unique registration number for each
facility.
IX. Other
Means of Registration
While
Internet registration is preferred, facilities that do not have
access to the Internet may file via a paper form. Additionally,
firms registering many facilities may choose instead to submit
a CD-ROM with multiple forms in .pdf format. However, such filings
by mail are not recommended, because the FDA does not guarantee
timely processing times. Further, there are numerous requirements,
which, if not followed, could result in the FDA simply returning
the filing unprocessed.
X.
Requirement to Update Registration Information
Registered
facilities must provide updates to the registration information
within 60 days of material changes. For example, if the ownership
of a facility changes, then the former owner must submit a cancellation
of the prior registration within 60 calendar days, and the new
owner must re-register the facility. The same requirements apply
if the facility ceases operations or no long provides food in
the United States. See §§1.234 and 1.235.
XI. Liability
The
FDA states that the failure of the owner, operator or agent in
charge of a facility to register, update, or cancel the registration
is a prohibited act under the Food, Drug & Cosmetics Act,
21 U.S.C. §331(dd), and 21 U.S.C. §§332 and 333, of the FD&C
Act, and that such violations are a basis for civil and/or criminal
actions, including agency debarment procedures.
PART
II: FDA PN Requirements
As
of December 12, 2003, the FDA will require that U.S. purchasers,
importers or their agents submit PN for the importation of food.
I. What “Foods” Are Covered By The PN Requirement?
Almost all forms of foods (including animal food products), supplements
and additives are subject to FDA’s new PN requirements.
However, not all food products are subject to the PN requirement.
The regulations at section 1.277(b) provide for limited exemptions
for certain types of food, such as:
-
Hand-carried food for personal use
-
Food
made in a home and sent from the home as a gift
-
Food imported and exported without leaving the port
-
Meat, poultry or eggs already regulated by certain USDA Inspection
Acts.
II. The Timing Requirements to Filing PN
The regulations (section 1.279) provide different filing time requirements
depending on the modality used to import the food product:
Modality |
Minimum
Notice Required |
Maximum
Notice Permissible |
Road
or Truck |
2
hours before port arrival |
Not
more than 5 days before anticipated date of port arrival |
Rail |
4
hours before port arrival |
Not
more than 5 days before anticipated date of port arrival |
Air |
4
hours before port arrival |
Not
more than 5 days before anticipated date of port arrival |
Sea |
8
hours before port arrival |
Not
more than 5 days before anticipated date of port arrival |
International
Mail |
Notice
required prior to mailing of the package |
No
limit stated |
III.
Providing PN and Entry Filing
The
FDA has created a PN System Interface to be used to provide notice
to the agency (www.access.fda.gov).
This site will be available in December 2003.
Separately,
Customs has said that it will be streamlining the PN requirements
by allowing Customs brokers to provide the required information
via the ABI/ACS systems already in place. However, if the ABI
system is not operational, the information must be submitted through
the FDA's PN system interface. If the PN system interface goes
down, the FDA will be providing fax numbers and e-mail addresses
for the trade to have on hand.
IV.
Information Required For PN
The
information (§1.281) generally required for PN is to include:
-
Name,
address and registration numbers for the persons: (1) submitting
the information, (2) transmitting the information, (3) shipper,
(4) manufacturer, (5) other originating source, (6) importer,
(7) owner, (8) ultimate consignee, and (9) U.S. recipient (as
applicable)
-
Description of the food,
common name, FDA product code, and HTS code
-
Lot
or code numbers required by regulations (low acid canned foods,
acidified foods, or infant formula)
-
Entry
type; mode of transport; SCAC or IATA code
-
FDA
Country of Production and Country of Shipment
-
Quantity (from largest container
to smallest package size)
-
Certain detailed planned
shipment information, such as the vessel name, flight or trip
number, container number, or license plate number.
-
Anticipated date, time and port of arrival (or anticipated date
of mailing)
Once the submission
of PN information has been confirmed, the FDA will issue a PN
confirmation number. The PN confirmation number must accompany
all shipments of food and should be included on the entry.
The FDA will only consider the PN requirement satisfied when the
PN confirmation number is issued.
V. Modification
of PN Information
If
submitted information is modified or changed, the FDA will require
resubmission of the data and cancellation of the previously submitted
information via the same electronic interface. Thus, if the PN
was submitted the ABI/ACS system in the first place, the broker
should cancel the PN using ACS by requesting CBP to delete the
entry. There are expected to be further changes to streamline
these methods as the electronic systems are more fully developed.
VI.
Refusal of Admission and Detention
Food
articles may be refused admission (pursuant to section 1.283(a))
and held at the port for a failure to provide PN or where inaccurate
notice is submitted. While export may be allowed for inaccurate
information, export will not allowed where no notice was submitted
at all.
Where
the PN filing has been submitted untimely, the shipment may be
released if the FDA has completed its review and advised CBP;
otherwise, the merchandise must be immediately exported with CBP
approval or detained at the port.
Detained
food may be segregated and must be moved within 24 hours (see
sections 1.283(a)(2) and (3)), under custodian bond, and the FDA
notified of its new location.
Please contact George Tuttle, III, at geo@tuttlelaw.com if you have any questions regarding FDA
Bioterrorism Regulations
or other Customs law matters.
George
R. Tuttle, III is an attorney with the Law
Offices of George R. Tuttle in San Francisco. The information
in this article is general in nature and is not intended to
constitute legal advice or to create an attorney-client relationship
with respect to any event or occurrence, and may not be considered
such.
Copyright
© 2005 by Tuttle Law Offices.
All
rights reserved. Information has been obtained from sources believed
to be reliable. However, because of the possibility of human or
mechanical error by our offices or by others, we do not guarantee
the accuracy, adequacy, or completeness of any information and are
not responsible for any errors, omissions, or for the results obtained
from the use of such information.
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