December
4, 2003
With the December 12, 2003, implementation of the FDA’s Registration &
Prior Notice Regulations fast approaching, we provide the following
summary of developments in the implementation of the new requirements.
Broker Contracts
Customs
Brokers who perform as U.S. Agents and/or as Registering Agents
for foreign food facilities may wish to incorporate liability
provisions into their contractual agreements to manage the private
issues of liability arising from such services. For further information
please contac George R. Tuttle, III at (415) 288-0428.
CBP’s Interim Procedures
CBP has published guidance on Interim
Procedures, which will be in effect on December 12, 2003,
relating to imported food products
subject to the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002. In the initial phase, the CBP and FDA will focus on education of the trade
community and, accordingly, will not hold merchandise for
reasons of inadequate Prior Notice (except where there exists
an identified bioterrorist threat). In a timeline still to be
developed, the CBP will later phase in partial enforcement for
egregious violations, to be followed, finally, by full enforcement
of the regulations. The CBP advises that questions concerning
the entry and release of imported food products should be addressed
to the following CBP staffers:
FDA
Food Codes Published
The
FDA has published its table of FDA
food codes corresponding to HTSUS codes. These FDA codes
apply to prior notice submitted via both the ABI system and the
FDA's Prior Notice System Interface.
FDA
Guidance Publications
The
FDA has published concise summaries of the interim final rules
on Registration
and Prior Notice.
These summaries are more detailed than the FDA’s prior fact
sheets, and are capable of being emailed or faxed to foreign food
facilities.
Additional background information, FDA Registration, and Prior Notice Regulations
can be found at our BTA Information Page.
Please contact Stephen Spraitzar at (415) 288-0427
if you have any questions regarding the FDA Bioterrorism Act or
other Customs law matters.
Stephen Spraitzar is an attorney with the Law Offices
of George R. Tuttle in San Francisco. The information in this
article is general in nature and is not intended to constitute
legal advice or to create an attorney-client relationship with
respect to any event or occurrence, and may not be considered
such.
Copyright
© 2005 by Tuttle Law Offices.
All
rights reserved. Information has been obtained from sources believed
to be reliable. However, because of the possibility of human or
mechanical error by our offices or by others, we do not guarantee
the accuracy, adequacy, or completeness of any information and are
not responsible for any errors, omissions, or for the results obtained
from the use of such information.
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