Important Reminder: Food companies (domestic and international) conducting
commerce in the U.S. must be registered with the U.S. Food and Drug
Administration by December 12, 2003. Furthermore, a new rule on prior
notice of shipments into the U.S. will take effect. Information on
registering and prior notice are on the FDA web site at:
http://www.cfsan.fda.gov/~dms/fsbtact.html
http://www.fda.gov/oc/bioterrorism/bioact.html
The FDA's Compliance Policy Guide pertaining to Prior Notice of Imported
Food to the U.S. is on the web at: http://www.cfsan.fda.gov/~pn/cpgpn.html
Policy and violations are covered on this site. There will be an 8-month
transitional period.
Pamela Tom, University of California, Sea Grant Extension Program
======================================================================
FDA News
FOR IMMEDIATE RELEASE
P03-103
December 11, 2003
Media Inquiries: 301-436-2335
Consumer Inquiries: 888-INFO-FDA
FDA and CBP Announce Their Transitional Compliance Policy on Food Imports
Under the Bioterrorism Act
This press release replaces an earlier version.
The United States Food and Drug Administration (FDA) and the U.S. Bureau
of Customs and Border Protection (CBP) today issued a compliance policy
guide that describes their strategy for maintaining an uninterrupted flow
of food imports while improving their safety in accordance with the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(Bioterrorism Act).
The policy guide deals with the enforcement of the Bioterrorism Act's
requirement, which becomes effective on December 12, 2003, that FDA
receive a prior notification of all human and animal food, drinks and
dietary supplements imported or offered for import to the U.S. Another
requirement of the Bioterrorism Act mandates that all facilities that
manufacture, process, pack or hold food for consumption in the U.S. be
registered with FDA. This registration requirement for foreign facilities
will be primarily enforced through the prior notice provision.
In October, FDA and CBP jointly published an interim final rule that
specified that, among other requirements, the prior notice must be
received by FDA between two and eight hours -- depending on the mode of
transportation -- before each shipment's arrival at the U.S. border. The
prior notice interim final rule also covers food packages mailed or
brought to the U.S. by individuals from abroad.
As the rule becomes effective, FDA and CBP expect a "good faith" effort at
compliance. The policy guide issued today makes clear that during the next
8 months, the two agencies will primarily rely on educating the affected
firms and individuals. During this period, the agencies will utilize
communication and education initiatives, escalating imposition of civil
monetary penalities, and ultimately refusal of shipments. This phase-in
period will end on August 12, 2004. As always, both agencies will continue
to ensure that imported products are safe for human or animal consumption.
Regarding food mailed, brought or accompanied to the U.S. by individuals
for non-personal use, FDA and CBP generally will continue their education
efforts and will not refuse its admission before August 12, 2004 because
of inadequate or lacking prior notice.
"Our intention all along has been to implement the Bioterrorism Act in a
way that would protect consumers without obstructing the food imports, on
which we depend for 20 percent of all fresh produce and up to 60 percent
of all the seafood consumed in the U.S.," said FDA Commissioner Mark B.
McClellan, M.D., Ph.D. "The goal of the transition policy is to provide
complete clarity and education about the new import requirements, and
achieve a higher level of U.S. food security without disrupting trade. I
am satisfied that this policy guide presents a realistic strategy for
facilitating the flow of this essential commerce, as well as holiday food
packages, while countering the threat of terrorism."
U.S. Customs and Border Protection Commissioner Robert C. Bonner said, "We
at the CBP for decades have worked closely with the FDA in ensuring the
safety and security of imported foods, especially perishables, that reach
our dinner tables every day. The Bioterrorism Act provides us with yet
another highly effective tool to safeguard America's food supply from the
terrorist threat."
FDA and CBP personnel have already begun an extensive campaign to educate
with written material, briefings, and seminars other government officials,
domestic and foreign food importers, brokers, transporters, and other
affected industry representatives on compliance with the Bioterrorism Act.
In addition, during the 8-month transitional period, the two agencies plan
to take the following steps:
Gather data to track compliance with the prior notice requirements and to
determine how to best use FDA's and CBP's resources to educate industry
and the public to achieve full compliance with the Bioterrorism Act.
Provide industry and the public with summary information about the level
of compliance with the prior notice rules, including data on the types of
errors in submitted prior notices.
Post the summary information on FDA's website at www.fda.gov.
Use the data and summary information to assist the industry and the public
in improving the submission of prior notice.
During the phase-in period, FDA and CBP will generally use civil monetary
penalties and refusals only in response to repetitive, flagrant and other
serious violations.
The policy guide clarifies, however, that FDA and CBP will continue their
surveillance of food imports to ensure they are safe, wholesome, and that
they comply with other U.S. requirements. The transitional policy
announced today does not affect FDA's or CBP's ability to initiate other
actions to protect U.S. consumers. If FDA decides during and after the
transition period not to refuse an imported article of food under the
provisions of the Bioterrorism Act, such decision will have no bearing on
whether the article is admissible on other grounds.
Thus, for food that is imported or offered for imports, FDA will continue
to carry out such routine food safety- and security-focused reviews,
investigations, and enforcement actions as may be necessary. From December
12, 2003 on, the enforcement of the Bioterrorism Act will be carried out,
on a round-the-clock, 7 days a week basis, by hundreds of FDA and CBP
employees.
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