9 October 2003
U.S. Issues New Rules to Protect National Food Supply
Importers face new requirements when bringing
food items into the U.S.
The Department of Health and Human Services and the Food and Drug
Administration (FDA) are announcing new rules for monitoring and
inspecting imported food in order to better protect consumers from
deliberate or accidental contamination of foods.
Unveiled at a Washington news conference October 9, the new regulations
require that importers register with the FDA to be authorized operators;
and that they inform the government in advance of every shipment
of goods that will be crossing the borders into the United States.
"We will use these regulations to work more effectively than ever
to protect America's food supply, while maintaining the regular,
free flow of commerce that is so vital to the well being of our
citizens," said FDA Commissioner Mark B. McClellan in a news release.
FDA predicts that the regulations, which take effect December
12, will result in an estimated 25,000 notifications per day that
food imports are about to come into the United States. The regulation
requiring importers to register their operations with the government
will result in a roster of some 420,000 merchants, FDA estimates.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 required FDA to develop a new regulatory regimen for
Further information about the regulations and compliance is available
The following is the text of the HHS/FDA news release:
Department of Health and Human Services
October 9, 2003
HHS ISSUES NEW RULES TO ENHANCE SECURITY OF THE U.S. FOOD SUPPLY
HHS Secretary Tommy G. Thompson today announced the issuance of
two Food and Drug Administration regulations that will bolster
the safety and security of America's food supply. The new regulations
will enable better targeted efforts to monitor and inspect imported
foods and will allow quick identification and notification of food
processors and other establishments involved in any deliberate
or accidental contamination of food.
"By requiring advance notice for imported food shipments and registering
domestic and foreign food facilities, we are providing critical
new tools for the FDA to identify potentially dangerous foods and
better keep our food supply safe and secure," Secretary Thompson
said. "These new requirements represent the latest steps in our
ongoing efforts to respond to new threats and improve the safety
of all the foods that we eat in this country."
The two new regulations will implement key provisions of the Public
Health Security and Bioterrorism Preparedness and Response Act
of 2002, which provided FDA new authority to protect the nation's
food supply against actual or threatened terrorist acts and other
"With input from the private sector, our partners in the federal
government and the governments of our trading partners, we will
use these regulations to work more effectively than ever to protect
America's food supply, while maintaining the regular, free flow
of commerce that is so vital to the well being of our citizens," said
FDA Commissioner Mark B. McClellan, M.D., Ph.D. "Coupled with other
counter-terrorism initiatives, these regulations mark a new era
of international collaboration, one that strengthens the free market
and free trade even as we face new threats to our security. We
will keep working to build on these important regulations to fulfill
our mission of helping Americans get diverse, affordable food products
that are as safe and secure as possible."
The first regulation requires food importers to provide the FDA
with advance notice of human and animal food shipments imported
or offered for import on or after Dec. 12, 2003. This will allow
FDA to know, in advance, when specific food shipments will be arriving
at U.S. ports of entry and what those shipments will contain. This
advance information will allow the FDA, working with U.S. Customs
and Border Protection (CBP), to more effectively target inspections
and ensure the safety of imported foods. The FDA expects to receive
about 25,000 notifications about incoming shipments each day.
The second regulation requires domestic and foreign food facilities
that manufacture, process, pack or hold food for human or animal
consumption in the United States to register with the agency by
Dec. 12, 2003. As a result, FDA will have for the first time a
complete roster of foreign and domestic food facilities. The requirements
will enable the FDA to quickly identify and locate affected food
processors and other establishments in the event of deliberate
or accidental contamination of food. The FDA expects about 420,000
facilities to register under this requirement.
The FDA worked closely with CBP to ensure the new regulations
promote a coordinated strategy for border protection.
"Using the electronic data required under these regulations and
a sophisticated automated targeting system, CBP and the FDA will
be working side-by-side to make joint decisions about food shipments
that could pose a potential threat to the United States," said
Commissioner Robert C. Bonner, U.S. Customs and Border Protection,
Department of Homeland Security. "This integrated risk-management
process will increase our security and facilitate the movement
of legitimate commerce -- objectives shared by both agencies. We
look forward to continuing our work with the FDA to implement the
regulations in a manner that meets these shared objectives."
The regulations reflect comments from a broad array of law enforcement,
national security, industry and other experts as the FDA worked
to effectively improve food safety and security without adding
unnecessary costs to domestic or international trade.
"We have listened carefully to what stakeholders said about the
proposals, in order to develop rules that are both workable and
feasible," said Dr. McClellan. "The rules we are announcing today
are intended to fulfill our goal of making the food supply safer
and more secure without hindering trade."
Under the prior notice regulation, prior notice of imported foods
must be received and confirmed electronically by FDA no more than
five days before its arrival and no fewer than:
-- two hours before arrival by land via road;
-- four hours before arrival by air or by land via rail; or
-- eight hours before arrival by water.
In addition, for international mail shipments, notifications must
be made before the shipment is mailed. Also, when an individual
carries or otherwise transports foods subject to the new requirement,
advance notice of two, four or eight hours is required -- depending
on the mode of transportation. The food must also be accompanied
by confirmation of receipt for FDA review.
The regulation's timeframes reflect the FDA's work, in collaboration
with other agencies, to reduce substantially the required time
for advance notice to minimize unnecessary costs. For example,
the proposed rule issued earlier this year would have required
that importers give notice by noon the day before the arrival of
a shipment of food into the United States for all modes of transportation,
including by land by road. The final regulation requires only two
hours notice before arrival of food by land by road and could be
reduced further in the future as part of FDA-CBP plan to coordinate
border-management activities more efficiently.
The advance notice to the FDA may be submitted electronically
in most circumstances using Customs' existing ABI/ACS system, making
it easier for importers to comply with the new law. In addition,
the FDA will operate a new Prior Notice System Interface that can
receive such notifications.
The second regulation requires the owner, operator, or agent in
charge of a domestic or foreign food facility to register with
FDA, providing information about the name and address of each facility
at which, and all trade names under which, the registrant conducts
business, and information about certain categories of food the
facility produces. For a foreign facility, the registration must
include the name of the U.S. agent for the facility.
Registration is required for domestic facilities whether or not
food from the facility enters interstate commerce. Domestic facilities
are also required to provide emergency contact information. All
changes to such information must be reported within 60 days.
Except for specific exemptions, the registration requirements
apply to all facilities that manufacture, process, pack or hold
food regulated by FDA, including animal feed, dietary supplements,
infant formula, beverages (including alcoholic beverages) and food
Registration would not be required for private residences of individuals;
certain food transport vehicles; facilities that manufacture food
contact substances and pesticides; farms; restaurants; other retail
food establishments; nonprofit food establishments in which food
is prepared for or served directly to the consumer; non-processing
fishing vessels; and facilities (such as meat and poultry slaughterhouses)
that are regulated exclusively by the U.S. Department of Agriculture.
Also exempt are foreign facilities if the food from the facility
is to undergo further processing or packaging by another facility
before it is exported to the U.S.
The registration may be submitted electronically, via the Internet,
or by paper through surface mail or by fax. Registrations may also
be submitted on CD-ROM by mail. The FDA will be able to accept
electronic registration from anywhere in the world 24 hours a day,
7 days a week, beginning Oct. 16. Filling out registration online
should take about 15 minutes if a facility has its paperwork ready.
A registering facility will receive confirmation of electronic
registration and its registration number instantaneously once all
the required fields on the registration screen are filled in. There
is no fee associated with registration.
The rules take effect Dec. 12, 2003, in accordance with the Bioterrorism
Act. To assure that the regulations can be implemented efficiently
and with minimal disruption, FDA intends to exercise broad enforcement
discretion for the prior notice rule for the first four months
after implementation. During this time, FDA and CBP will educate
importers about how they can comply with the regulations, and will
work with trade associations and foreign governments to make sure
all importers are well informed of the new requirements. Thereafter,
FDA will phase in full implementation of the prior notice requirements.
FDA has already conducted extensive domestic and international
outreach and education about the new rules. In the coming weeks,
FDA will conduct national and international meetings and other
programs to provide full information about the rules. FDA also
will hold a satellite downlink public meeting on Oct. 28 to discuss
the two regulations. Information about this meeting, including
domestic and international viewing opportunities and registration,
is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/03-24921.htm.
Both the new regulations will be published as interim final rules
in the Oct. 10 issue of the Federal Register. The FDA is requesting
further public comment on the rules. The regulations are available
Note: All HHS press releases, fact sheets and other press materials
are available at http://www.hhs.gov/news.