FOR IMMEDIATE RELEASE
Media Inquiries: 301-827-6242
December 3, 2003
Consumer Inquiries: 888-INFO-FDA
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FDA AND CBP BOLSTER SAFEGUARDS ON IMPORTED FOOD Unprecedented Agreement
Between the Agencies Advances FDA's Implementation of the Bioterrorism
Act.
The Food and Drug Administration (FDA) and the U.S. Customs and
Border Protection (CBP) today signed a memorandum of understanding (MOU)
that allows FDA to commission thousands of CBP officers in ports and
other locations to conduct, on FDA's behalf, investigations and
examinations of imported foods. This unprecedented FDA-CBP collaboration
significantly strengthens the implementation of the Bioterrorism Act to
assure the security of imported foods.
The MOU was signed by FDA Commissioner Mark B. McClellan, M.D.,
Ph.D., and CBP Deputy Commissioner Douglas Browning at U.S. Customs and
Border Protection headquarters in Washington, D.C.
"This MOU is an important milestone in our extensive efforts to
protect the safety and security of the national food supply," said
Commissioner McClellan. "It enables us to work more efficiently with
CBP, combining their strong resources with our own expertise in keeping
on the alert for potentially hazardous foods and responding to possible
threats. We are committed to using the Bioterrorism law to safeguard our
food supply to the fullest extent possible, without imposing any
unnecessary costs or restrictions on food imports."
"We are pleased to be an integral part of this new initiative to
safeguard the country's food products," said Deputy Commissioner
Browning. "This agreement reflects close cooperation and countless hours
of discussion not only with FDA, but with our trade partners here and
around the world. It also supports our twin goals of securing the border
from terrorists and terrorist weapons while ensuring the movement of
legitimate trade."
Building on FDA's and CBP's long history of close cooperation,
the MOU upgrades the two agencies' teamwork in training, day-to-day
operations, and information sharing. As part of the MOU, FDA can
commission all the CBP officers the two agencies consider necessary to
conduct examinations and investigations in accordance with the FDA's
recently issued interim final rule requiring prior notice of food
imported or offered for import to the United States. FDA and CBP will
provide specialized training for the commissioned CBP employees who will
carry out this work, and both agencies will expand their existing
cooperative arrangements to directly share information affecting the
safety and security of imported foods. The MOU is currently available at
the Federal Register and goes into effect immediately.
FDA is already in the seventh week of implementing another of the
four enabling regulations under the Bioterrorism Act, which requires
registration of food facilities that manufacture, process, pack or hold
food or feed for the U.S. market. To facilitate this massive
undertaking, which involves more than 400,000 domestic and foreign
firms, FDA created a new Internet system where these companies can log
onto any time of the day or night, seven days a week, and register in
just a few minutes. Both the prior notice and registration requirements
were proposed by FDA on January 29 of this year, submitted for
stakeholders' comments, and published as interim final rules on October
10. By using CBP's advanced ABI/ACS electronic communication systems and
working with other agencies, FDA was able to reduce the length of the
prior notice from at least 12 hours to 2-8 hours, depending on the mode
of transportation.
FDA and CBP have conducted extensive domestic and foreign
outreach jointly and independently, to explain the proposed rules to
consumers and the food industry. In addition to holding three large
public meetings via satellite downlink, FDA and CBP officials answered
questions about the rules by attending six public meetings from coast to
coast, delivered numerous presentations for trade groups and industry
associations, and discussed the proposals with government and industry
officials in Canada, Mexico, the European Union, and the Caribbean. By
now, close to 100,000 firms -- most of them foreign -- have registered
with FDA.
Finally, FDA announced today that it plans to finalize, by the
end of March 2004, the last two critical rules under the Bioterrorism
Act, both of which were proposed in May of this year. The proposals deal
with the stablishment and maintenance of records related to food, and
administrative detention for food shipments that could harm the health of
humans or animals. Both proposals received numerous substantive comments
from concerned stakeholders that the agency needs to finish analyzing and
consider before issuing the final regulations. While these two
regulations are being completed, FDA can use authorities granted by the
Bioterrorism Act to detain foods and obtain records in advance of issuing
final rules.
"We want all FDA bioterrorism regulations to be examples of a
government that communicates with stakeholders in order to craft clearly
understood rules that protect consumers without creating undue burden on
the industry," said Commissioner McClellan. "In the meantime, we have
taken steps to make sure that food that presents a threat will be
detained and all available records will be used to track down significant
food risks."
The rulemaking for the provision dealing with the administrative
detention of foods or animal feed that may pose a serious public health
hazard has no mandated deadline. FDA emphasizes that section 303 of the
Bioterrorism Act, which is in effect now, allows FDA to order the
administrative detention of any food or feed if there is credible
evidence or information indicating the article presents a threat of
serious adverse health consequences or death to humans or animals.
Congress has directed that the other proposed rule, which
requires domestic food firms and foreign transporters to establish and
maintain records of food shipments, should be completed by December 12.
While addressing the comments on this proposed rule, FDA underscores its
readiness to make use, if necessary, of authorities in sections 414(a)
and 704 (a) of the Food, Drug and Cosmetic Act, as amended by the
Bioterrorism Act, which are currently in effect. These provisions give
the agency access to firms' existing records that identify the immediate
previous sources and immediate subsequent recipients of food and feed, if
FDA believes the products are adulterated and present a serious or deadly
health hazard to humans or animals. ####
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