. /.WORLD TRADE
ORGANIZATIONG/TBT/N/USA/32/Add.1
15 October 2003
(03-5469)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
Addendum
The following communication dated 10 October 2003 has been received from the
United States.
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Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002
The U.S. Food and Drug Administration (FDA) has issued an interim final rule, “Registration
of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act
of 2002.”  This interim final rule requires domestic and foreign facilities that manufacture/process,
pack, or hold food for human or animal consumption in the United States to register with FDA by
12 December 2003.  The interim final rule implements the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterro rism Act), which requires domestic and foreign
facilities to register with FDA by 12 December 2003, even in the absence of a final regulation.Registration is one of several tools that will enable FDA to act quickly in responding to a threatened
or actual terrorist attack on the U.S. food supply by giving FDA information about facilities that
manufacture/process, pack, or hold food for consumption in the United States.  In the event of an
outbreak of foodborne illness, such information will help FDA and other authorities determine the
source and cause of the event.  In addition, the registration information will enable FDA to notifyquickly the facilities that might be affected by th e outbreak.  FDA notified the proposed rule to the
Committee on Technical Barriers to Trade on February 5, 2003.  As stated in the notification, the
effective date of the interim final rule is December 12, 2003.
FDA is issuing this rule as an interim final rule, with an opportunity for public comment on
specific issues identified in section IX of the rule.  Submit written or electronic comments by
24 December 2003.  Submit written comments on the document to:
Dockets Management
Branch (HFA-305),
Food and Drug Administration,5630 Fishers Lane, rm.
1061, Rockville, MD 20852, U.S.A.G/TBT/N/USA/32/Add.1
Page 2
It is possible to submit electronic comments to:   http://www.fda.gov/dockets/ecomments .
Submit comments by indicating DOCKET Number 2002N-0276  and Title of document “Registration
of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act
of 2002.”
Although the agency is seeking comment on this interim final rule, it is effective
12 December 2003.  This means that the rule’s requirements will be in effect and have the force and
effect of law from that date until any subsequent modification by the issuance of a final rule.
Accordingly, as required by section 305 of the Bioterrorism Act, all covered facilities must be
registered with FDA by 12 December 2003.
Complete text of the Interim Final Rule contained in the Federal Register (FR),
68 FR 58893-58974 (available in English) can be found on the Internet at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-25849.pdf
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-25849.htm .
For further information contact:  Ms. Leslye M. Fraser, Center for Food Safety and Applied
Nutrition (HFS-4), Food and Drug Administrati on, 5100 Paint Branch Pkwy., College Park, MD
20740, Tel. 301-436-2378.
Further information can be found on the FDA web site at:http://www.fda.gov/oc/bioterrorism/bioact.html
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