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 http://www.fda.gov/default.htm.
- 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. |
