. /.WORLD TRADE
ORGANIZATIONG/TBT/N/USA/32
13 February 2003
(03-0933)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   UNITED STATES
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Food and Drug Administration (32)          
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Food Facilities (ICS 67)
5. Title, number of pages and language(s) of the notified document:   Registration of Food
Facilities Under the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002  (50 pages, in English)          
6. Description of content:   The Food and Drug Administ ration (FDA) is proposing a
regulation that would require domestic and foreign facilities that manufacture, process,
pack, or hold food for human or animal consumption in the Untied States to register with
DFA by 12 December 2003.  The proposed regulation would implement the Public HealthSecurity and Bioterrorism Preparedness and Response Act of 2002, which requires domestic
and foreign facilities to register with FDA by 12 December 2003, even in the absence of
final regulations.  In the event of an outbreak of food-borne illness, such information will
help FDA and other authorities determine the source and case of the event.  In addition, the
registration information will enable FDA to notify quickly the facilities that might be
impacted by the outbreak.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To 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 all facilities that manufacture, process,
pack or hold food for consumption in the United States.          
8. Relevant documents:   68 Federal Register (FR) 5378, 3 February 2003; Title 21 Code of
Federal Regulations (CFR) Part 1.  Will appear in the Federal Register when adopted.          
9. Proposed date of adoption:
Proposed date of entry into force: } 12 December 2003G/TBT/N/USA/32
Page 2
10. Final date for comments:   4 April 2003
Written comments on the document should be submitted to the Dockets Management
Branch (HFA-305), Food and Drug Admi nistration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852 U.S.A.  Electronic comments may be submitted at
http://www.fda.gov/dockets/ecomments  under DOCKET Number 02N-0276 and Title of
Document, Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 .
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
http://www.access.gpo.gov/nara/index.html
Complete text can be also be found on the Internet at:
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm looking under DOCKET NO. 
02N-0276
and at http://www.fda.gov/OHRMS/DOCKETS/98fr/03-2443.pdf