. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/690/Add.2
16 October 2003
(03-5488)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 10 October 2003 has been received from the United
States.
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Interim Final Rule; Request for Comments; Regulation Implementing Title III of the Public
Health Security and Bioter rorism Preparedness and Res ponse Act of 2002;  Section 307:
Prior Notice of Imported Food Sh ipments (Docket. No. 2002N-0278)
On 10 October 2003 the US Food and Drug Administration (FDA) published in the Federal
Register  an interim final rule implementing Section 307 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act):  Prior Notice of ImportedFood Shipments (Docket. No. 2002N-0278).  The interi m final rule requires the submission to FDA of
prior notice of food, including animal feed, that is imported or offered for import into the United
States.  The interim final rule requires that the prior notice be submitted to FDA electronically via
either the Bureau of Customs and Border Protection (CBP) Automated Broker Interface of the
Automated Commercial System or the FDA Prior Notice System Interface.  The information must besubmitted and confirmed electronically as factually complete by FDA for review no more than 5 days
and no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail),
and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival.  Food
imported or offered for import without adequate prior notice is subject to refusal and, if refused, must
be held.
Complete text of the Interim Final Rule contained in the Federal Register (FR), 68 FR 58975-
59077 (available in English) can be found on the Internet at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-25877.htm
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-25877.pdf
Further information can be found on the FDA web site at
http://www.fda.gov/oc/bioterrorism/bioact.html.   
FDA has reopened for 75 days the comment period for the interim final rule entitled "Prior
Notice of Imported Food Under the P ublic Health Security and Bioterrorism Preparedness and Response
Act of 2002".  FDA intends to reopen the comment period for an additional 30 days in March 2004 to
receive comment on the issuance of a plan by FDA and CBP relating to timeframes.
Final date for comments:  Submit written or electronic comments by 24 December 2003.G/SPS/N/USA/690/Add.2
Page 2
Submit written comments on the document to the
Dockets Management Branch (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, Room 1061,
Rockville, MD 20852, U.S.A.
It is possible to submit electronic comments to:   http://www.fda.gov/dockets/ecomments.
Submit comments by indicating DOCKET Number 2002N-0278  and Title of document "Prior Notice
of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act
of 2002".
For further information contact:  Deborah Ralston, Office of Regulatory Affairs, Office of
Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
443-6230.
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