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Notice of FDA Bioterrorism Rule The Food and Drug
Administration (FDA) has announced two new regulations under the
Bioterrorism Act of 2002. The
first will requires importers of food, ingredients, or animal feed to
file a notice of arrival of food product before noon of the day prior to
the shipment’s scheduled arrival and no more then five days before
arrival. The second rule
requires all foreign producers, shippers, carriers, storage facilities,
and U.S. importers and distributors of foreign processed food and
ingredients to register with FDA. The
new rules are scheduled to go into effect December 12, 2003. The FDA announced
that prior notice can be submitted either through Automated Broker
Interface of the Automated Commercial System (ABI/ACS) or FDA’s Prior
Notice (PN) System Interface beginning December 12, 2003.
Registration of facilities can be done either electronically, or
by fax or mail. The most
efficient method of registration will be electronically through FDA’s
website at http://www.fda.gov/furls.
The FDA will accept fax registrations at 302-210-0247 or by
mailing form to:
U.S.
FDA (HFS-681) Failure to register
facilities or submit prior notice will be considered by FDA to be a
prohibited act whereas civil and criminal action can be taken. For technical assistance, you may call 1-800-216-7331 or
301-575-0156. |
