For those of you who are involved with importing into or exporting to the
U.S., I recommend that you bookmark this web addres and check it on a
regular basis: FDA Actions on New Bioterrorism Legislation
(http://www.cfsan.fda.gov/~dms/fsbtact.html)
The following items below are all accessible on the above web site.
Regards,
Pamela Tom
University of California
Sea Grant Extension Program
p.s., Thanks to Dr. Janet McDonald (FDA Public Affairs Specialist) for
briefing me on the announcements so that I could share the news with you.
===========================================================================
There was an announcement by the Joint Food and Drug Administration and
Bureau of Customs and Border Protection Plan for Increasing Integration
and Assessing the Coordination of Prior Notice Timeframes
(http://www.cfsan.fda.gov/~pn/pnplan.html)
FDA and CBP announce the following plan, which they intend to implement in
August 2004.
>From August 12, 2004, to October 12, 2004, they plan to assess existing
procedures and staffing needed to receive, review, and respond to the
prior notices submitted in accordance with the Prior Notice Interim Final
Rule (IFR) (i.e., 2 hours before arrival by land by road; 4 hours before
arrival by air or by land by rail; and 8 hours before arrival by water).
>From October 13, 2004, to November 12, 2004, they intend to identify what
changes to work practices and staffing would be necessary to determine if
FDA could continue to receive, review, and respond to all prior notice
submissions with reduced timeframes (e.g., 1 hour/30 minutes before
arrival by land by road; 2 hours before arrival by land by rail; and by
"wheels up" for flights originating in North and Central America, South
America (north of the Equator only), the Caribbean, and Bermuda; otherwise
4 hours before arrival by air).
>From November 13, 2004, to February 12, 2005, they plan to implement
necessary changes and make appropriate adjustments to ensure that they can
receive, review, and respond to all prior notice submissions with reduced
timeframes.
In March 2005, they intend to issue a prior notice final rule that
responds to the comments they received on the Prior Notice IFR, including
this plan, during the two open comment periods.
Under the statute, any timeframe must be sufficient to receive, review,
and respond to prior notice submissions, as set out in section
801(m)(2)(A) of the Federal Food, Drug, and Cosmetic Act, 21 USC
801(m)(2)(A). The agencies emphasize that the evaluation of whether to
reduce the timeframes for prior notice review will depend on the level of
compliance industry achieves during the assessment. If they are unable to
make such an assessment, their intended timeframe for issuing a prior
notice final rule may be delayed.
==========================================================================
Also, on April 14 because the Federal Register will announce the reopening
of the comment period for the Interim Final Rules on Registration and
Prior Notice. The 30-day comment period will end on May 14. See below.
ˇ Registration of Food Facilities Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002;
Reopening of Comment Period (available in PDF) April 14, 2004
http://www.cfsan.fda.gov/~acrobat/fr04414a.pdf
ˇ Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002;
Reopening of Comment Period (available in PDF) April 14, 2004
http://www.cfsan.fda.gov/~acrobat/fr04414b.pdf
===========================================================================
FDA Fact Sheets on the Interim Final Rules for Registration of Food
Facilities (http://www.cfsan.fda.gov/~dms/fsbtac12.html) and Prior Notice
of Imported Food Shipments (http://www.cfsan.fda.gov/~dms/fsbtac13.html)
are available in French, Malay, Polish, Portuguese, Spanish, Arabic,
Chinese, Hindi and Japanese.
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