. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/691
6 February 2003
(03-0776)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:   UNITED STATES
If applicable, name of local government involved:
2. Agency responsible:   Food and Drug Administration (FDA)
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):  Food for human and animal consumption in  the United States, except for meat,
poultry and egg products that are exclusively re gulated by the US Department of Agriculture
4. Regions or countries likely to be affected, to the extent relevant or practicable:
Trading partners who import food for consumption in the United States
5. Title, language and number of pages of the notified document:  Registration of Food
Facilities Under  the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (50 pages;  available in English)
6. Description of content:   The US Food and Drug Administration (FDA) has issued a
proposed rule that would require 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 final version of the regulation would implement section305 of the Public Health Security 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.  Registration is one of several
tools that will enable FDA to act quickly in responding to a threatened or actual terrorist
attack on the US food supply or other food-related emergency by giving FDA informationabout all facilities that manufacture, process, pack, or hold food for consumption in the
United States.  In the event of an outbreak of food-borne illness, such information will both
help FDA and other authorities determine the source and cause of the event.  In addition,
the registration information will enable FDA to notify quickly the facilities that might be
impacted by the outbreak.  Following publication of the proposed rule, FDA will providefor a 60 day comment period.  FDA will consider these comments as it develops the final
rule, which will explain the final registration requirements.  FDA plans to issue the final
rule by 12 October 2003.  FDA will provide a qualitative risk assessment when it issues the
final regulation.
7. Objective and rationale:  [  X ] food safety, [ X ] animal health, [   ] plant protection,
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other
damage from pests
Registration is one of several tools that will enable FDA to act quickly in responding to a
threatened or actual terrorist attack on the US food supply by giving FDA information
about all facilities that manufacture, process, pack, or hold food for consumption in the
United States.G/SPS/N/USA/691
Page 2
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
9. Relevant documents and language(s) in which these are available:  Notice of Proposed
Rulemaking in the Federal Register  (FR), 68 FR 5378-5428  (available in English)
10. Proposed date of adoption:  12 December 2003.
11. Proposed date of entry into force:  12 December 2003.
12. Final date for comments:  Submit written or electronic comments by 4 April 2003.
Agency or authority designated to handle comments:  Food and Drug Administration
[   ] National notification authority, [ X ] National enquiry point, or address, fax number
and E-mail address (if available) of other body:
Submit written comments on the document to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 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
No. 02N-0276 and TITLE Registration of Food Facilities Under  the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002.
13. Texts available from:  [   ] National notification authority,  [ X ]  National enquiry point,
or address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point / Notification Point
Mr. William JanisU.S. Department of Agriculture
Stop 1027
Washington, DC 20250
Tel:  (202) 720-9047
Fax:  (202) 720-0677E-mail:  fstsd@usda.gov
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