The U.S. Food and Drug Administration has published Compliance Summary
Information re: Prior Notice of Imported Food Shipments at:
http://www.cfsan.fda.gov/~pn/pnsum.html
The Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (Bioterrorism Act), section 307, added section 801(m) to the
Federal Food, Drug, and Cosmetic Act to require that FDA receive prior
notice for food imported or offered for import into the U.S. In the
preamble to the interim final rule published October 10, 2003, FDA stated
that it would provide a transition period, during which it would emphasize
education on prior notice requirements to help industry better comply with
the regulation.
A Compliance Policy Guide was issued in December 2003 to provide guidance
on the agency's strategy for enforcing and achieving compliance with the
interim final rule. During the initial period, FDA is providing industry
and the public with summary information about the level of compliance with
the prior notice requirements, including data on the types of errors in
submitted prior notices. This information will also be analyzed to help
FDA take appropriate enforcement action when necessary.
The web site mentioned above features information on:
1. The number and types of prior notices that are being filed, and which
systems are being used to submit them, and
2. The degree of compliance with the prior notice requirements.
The information describes prior notice submissions received during the
first two months after the interim final rule became effective December
12, 2003. It summarizes the current pattern of submissions, and identifies
the biggest areas of concern. As the transition period progresses, FDA
expects to provide more detailed information specifically targeting key
areas that require attention.
# # # #
Regards,
Pamela Tom
University of California
Sea Grant Extension Program
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